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Metoprolol Tartrate Tablet

Blood Pressure / Heart

DESCRIPTION Metoprolol tartrate USP is a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(isopropylamino)-3-[p-2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt. Its structural formula is: Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of Metoprolol tartrate USP and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (maize), sodium starch glycolate, talc and titanium dioxide. In addition, the 50 mg product contains FD&C Red No. 40 Aluminum Lake and the 100 mg product contains FD&C Blue No. 1 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake as coloring agents. FDA approved dissolution method acceptance criterion differs from the USP dissolution method acceptance criterion. Metoprolol Tartrate Tablet - Clinical Pharmacology Mechanism of Action Metoprolol Tartrate Tablets USP is a beta1-selective (cardioselective) adrenergic receptor blocker. This preferential effect is not absolute, however, and at higher plasma concentrations, Metoprolol Tartrate Tablets USP also inhibits beta2-adrenoreceptors, chiefly located in the bronchial and vascular musculature. Clinical pharmacology studies have demonstrated the beta-blocking activity of metoprolol, as shown by (1) reduction in heart rate and cardiac output at rest and upon exercise, (2) reduction of systolic blood pressure upon exercise, (3) inhibition of isoproterenol-induced tachycardia, and (4) reduction of reflex orthostatic tachycardia. Hypertension The mechanism of the antihypertensive effects of beta-blocking agents has not been fully elucidated. However, several possible mechanisms have been proposed: (1) competitive antagonism of catecholamines at peripheral (especially cardiac) adrenergic neuron sites, leading to decreased cardiac output; (2) a central effect leading to reduced sympathetic outflow to the periphery; and (3) suppression of renin activity. Angina Pectoris By blocking catecholamine-induced increases in heart rate, in velocity and extent of myocardial contraction and in blood pressure, Metoprolol Tartrate Tablets USP reduces the oxygen requirements of the heart at any given level of effort, thus making it useful in the long-term management of angina pectoris. Myocardial Infarction The precise mechanism of action of Metoprolol Tartrate Tablets USP in patients with suspected or definite myocardial infarction is not known. Pharmacodynamics Relative beta1 selectivity is demonstrated by the following: (1) In healthy subjects, Metoprolol Tartrate Tablets USP is unable to reverse the beta2-mediated vasodilating effects of epinephrine. This contrasts with the effect of nonselective (beta1 plus beta2) beta-blockers, which completely reverse the vasodilating effects of epinephrine. (2) In asthmatic patients, Metoprolol Tartrate Tablets USP reduces FEV1 and FVC significantly less than a nonselective beta-blocker, propranolol, at equivalent beta1-receptor blocking doses. Metoprolol Tartrate Tablets USP has no intrinsic sympathomimetic activity, and membrane-stabilizing activity is detectable only at doses much greater than required for beta blockade. Animal and human experiments indicate that Metoprolol Tartrate Tablets USP slows the sinus rate and decreases AV nodal conduction. Significant beta-blocking effect (as measured by reduction of exercise heart rate) occurs within one hour after oral administration, and its duration is dose-related. For example, a 50% reduction of the maximum effect after single oral doses of 20 mg, 50 mg and 100 mg occurred at 3.3 hours, 5.0 hours and 6.4 hours, respectively, in normal subjects. After repeated oral dosages of 100 mg twice daily, a significant reduction in exercise systolic blood pressure was evident at 12 hours. When the drug was infused over a 10-minute period, in normal volunteers, maximum beta blockade was achieved at approximately 20 minutes. Equivalent maximal beta-blocking effect is achieved with oral and intravenous doses in the ratio of approximately 2.5:1. There is a linear relationship between the log of plasma levels and reduction of exercise heart rate. However, antihypertensive activity does not appear to be related to plasma levels. Because of variable plasma levels attained with a given dose and lack of a consistent relationship of antihypertensive activity to dose, selection of proper dosage requires individual titration. In several studies of patients with acute myocardial infarction, intravenous followed by oral administration of Metoprolol Tartrate Tablets USP caused a reduction in heart rate, systolic blood pressure and cardiac output. Stroke volume, diastolic blood pressure and pulmonary artery end diastolic pressure remained unchanged. In patients with angina pectoris, plasma concentration measured at one hour is linearly related to the oral dose within the range of 50 mg to 400 mg. Exercise heart rate and systolic blood pressure are reduced in relation to the logarithm of the oral dose of metoprolol. The increase in exercise capacity and the reduction in left ventricular ischemia are also significantly related to the logarithm of the oral dose. Pharmacokinetics Absorption The estimated oral bioavailability of immediate-release metoprolol is about 50% be- cause of pre-systemic metabolism which is saturable leading to non-proportionate increase in the exposure with increased dose. Distribution Metoprolol is extensively distributed with a reported volume of distribution of 3.2 to 5.6 L/kg. About 10% of metoprolol in plasma is bound to serum albumin. Metoprolol is known to cross the placenta and is found in breast milk. Metoprolol is also known to cross the blood brain barrier following oral administration and CSF concentrations close to that observed in plasma have been reported. Metoprolol is not a significant P-glycoprotein substrate. Metabolism Metoprolol Tartrate Tablets USP is primarily metabolized by CYP2D6. Metoprolol is a racemic mixture of R- and S-enantiomers, and when administered orally, it exhibits stereoselective metabolism that is dependent on oxidation phenotype. CYP2D6 is absent (poor metabolizers) in about 8% of Caucasians and about 2% of most other populations. Poor CYP2D6 metabolizers exhibit several-fold higher plasma concentrations of Metoprolol Tartrate Tablets USP than extensive metabolizers with normal CYP2D6 activity thereby decreasing Metoprolol Tartrate Tablets USP’s cardioselectivity. Elimination Elimination of Metoprolol Tartrate Tablets USP is mainly by biotransformation in the liver. The mean elimination half-life of metoprolol is 3 to 4 hours; in poor CYP2D6 metabolizers the half-life may be 7 to 9 hours. Approximately 95% of the dose can be recovered in urine. In most subjects (extensive metabolizers), less than 5% of an oral dose and less than 10% of an intravenous dose are excreted as unchanged drug in the urine. In poor metabolizers, up to 30% or 40% of oral or intravenous doses, respectively, may be excreted unchanged; the rest is excreted by the kidneys as metabolites that appear to have no beta blocking activity. The renal clearance of the stereoisomers does not exhibit stereo-selectivity in renal excretion. Special Populations Geriatric Patients The geriatric population may show slightly higher plasma concentrations of metoprolol as a combined result of a decreased metabolism of the drug in elderly population and a decreased hepatic blood flow. However, this increase is not clinically significant or therapeutically relevant. Renal Impairment The systemic availability and half-life of Metoprolol Tartrate Tablets USP in patients with renal failure do not differ to a clinically significant degree from those in normal subjects. Hepatic Impairment Since the drug is primarily eliminated by hepatic metabolism, hepatic impairment may impact the pharmacokinetics of metoprolol. The elimination half-life of metoprolol is considerably prolonged, depending on severity (up to 7.2 h). Clinical Studies Hypertension In controlled clinical studies, Metoprolol Tartrate Tablets USP has been shown to be an effective antihypertensive agent when used alone or as concomitant therapy with thiazide-type diuretics, at dosages of 100 mg to 450 mg daily. In controlled, comparative, clinical studies, Metoprolol Tartrate Tablets USP has been shown to be as effective an antihypertensive agent as propranolol, methyldopa and thiazide-type diuretics, to be equally effective in supine and standing positions. Angina Pectoris In controlled clinical trials, Metoprolol Tartrate Tablets USP, administered two or four times daily, has been shown to be an effective antianginal agent, reducing the number of angina attacks and increasing exercise tolerance. The dosage used in these studies ranged from 100 mg to 400 mg daily. A controlled, comparative, clinical trial showed that Metoprolol Tartrate Tablets USP was indistinguishable from propranolol in the treatment of angina pectoris. Myocardial Infarction In a large (1,395 patients randomized), double-blind, placebo-controlled clinical study, Metoprolol Tartrate Tablets USP was shown to reduce 3-month mortality by 36% in patients with suspected or definite myocardial infarction. Patients were randomized and treated as soon as possible after their arrival in the hospital, once their clinical condition had stabilized and their hemodynamic status had been carefully evaluated. Subjects were ineligible if they had hypotension, bradycardia, peripheral signs of shock and/or more than minimal basal rales as signs of congestive heart failure. Initial treatment consisted of intravenous followed by oral administration of Metoprolol Tartrate Tablets USP or placebo, given in a coronary care or comparable unit. Oral maintenance therapy with Metoprolol Tartrate Tablets USP or placebo was then continued for 3 months. After this double-blind period, all patients were given Metoprolol Tartrate Tablets USP and followed up to one year. The median delay from the onset of symptoms to the initiation of therapy was 8 hours in both the Metoprolol Tartrate Tablets USP and placebo treatment groups. Among patients treated with Metoprolol Tartrate Tablets USP, there were comparable reductions in 3-month mortality for those treated early (no more than 8 hours) and those in whom treatment was started later. Significant reductions in the incidence of ventricular fibrillation and in chest pain following initial intravenous therapy were also observed with Metoprolol Tartrate Tablets USP and were independent of the interval between onset of symptoms and initiation of therapy. In this study, patients treated with metoprolol received the drug both very early (intra-venously) and during a subsequent 3-month period, while placebo patients received no beta-blocker treatment for this period. The study thus was able to show a benefit from the overall metoprolol regimen but cannot separate the benefit of very early intravenous treatment from the benefit of later beta-blocker therapy. Nonetheless, because the overall regimen showed a clear beneficial effect on survival without evidence of an early adverse effect on survival, one acceptable dosage regimen is the precise regimen used in the trial. Because the specific benefit of very early treatment remains to be defined, however, it is also reasonable to administer the drug orally to patients at a later time as is recommended for certain other beta-blockers. Indications and Usage for Metoprolol Tartrate Tablet Hypertension Metoprolol Tartrate Tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Metoprolol Tartrate Tablets USP are indicated in the long-term treatment of angina pectoris. Myocardial Infarction Metoprolol Tartrate Tablets USP are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous Metoprolol Tartrate Tablets USP. Oral Metoprolol Tartrate Tablets USP therapy can be initiated after intravenous Metoprolol Tartrate Tablets USP therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (seeDOSAGE AND ADMINISTRATION ,CONTRAINDICATIONS and WARNINGS). Contraindications Hypertension and Angina Metoprolol Tartrate Tablets USP are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS). Hypersensitivity to Metoprolol Tartrate Tablets USP and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross-sensitivity between beta blockers can occur). Sick-sinus syndrome. Severe peripheral arterial circulatory disorders. Myocardial Infarction Metoprolol Tartrate Tablets USP is contraindicated in patients with a heart rate of less than 45 beats/min; second- and third-degree heart block; significant first-degree heart block (P-R interval no less than 0.24 sec); systolic blood pressure less than 100 mmHg; or moderate to severe cardiac failure (see WARNINGS). Warnings Heart Failure Beta blockers, like Metoprolol Tartrate Tablets USP, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. If signs or symptoms of heart failure develop, treat the patient according to recommended guidelines. It may be necessary to lower the dose of Metoprolol Tartrate Tablets USP or to discontinue it. Ischemic Heart Disease Do not abruptly discontinue Metoprolol Tartrate Tablets USP therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with beta-blockers. When discontinuing chronically administered Metoprolol Tartrate Tablets USP, particularly in patients with coronary artery disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, Metoprolol Tartrate Tablets USP administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue Metoprolol Tartrate Tablets USP therapy abruptly even in patients treated only for hypertension. Use During Major Surgery Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. Bradycardia Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Metoprolol Tartrate Tablets USP. Patients with first-degree atrioventricular block, sinus node dysfunction or conduction disorders may be at increased risk. Monitor heart rate and rhythm in patients receiving Metoprolol Tartrate Tablets USP. If severe bradycardia develops, reduce or stop Metoprolol Tartrate Tablets USP. Exacerbation of Bronchospastic Disease Patients with bronchospastic disease, should, in general, not receive beta-blockers, including Metoprolol Tartrate Tablets USP. Because of its relative beta1 selectivity, however, Metoprolol Tartrate Tablets USP may be used in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Because beta1 selectivity is not absolute use the lowest possible dose of Metoprolol Tartrate Tablets USP and consider administering Metoprolol Tartrate Tablets USP in smaller doses 3 times daily, instead of larger doses two times daily, to avoid the higher plasma levels associated with the longer dosing interval (see DOSAGE AND ADMINISTRATION). Bronchodilators, including beta2 agonists, should be readily available or administered concomitantly. Diabetes and Hypoglycemia Beta-blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. Pheochromocytoma If Metoprolol Tartrate Tablets USP is used in the setting of pheochromocytoma, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated. Administration of beta blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle. Thyrotoxicosis Metoprolol Tartrate Tablets USP may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Avoid abrupt withdrawal of beta-blockade, which might precipitate a thyroid storm. Precautions Risk of Anaphylactic Reactions While taking beta blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. Information for Patients Advise patients to take Metoprolol Tartrate Tablets USP regularly and continuously, as directed, with or immediately following meals. If a dose should be missed, the patient should take only the next scheduled dose (without doubling it). Patients should not discontinue Metoprolol Tartrate Tablets USP without consulting the physician. Advise patients (1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient’s response to therapy with Metoprolol Tartrate Tablets USP have been determined; (2) to contact the physician if any difficulty in breathing occurs; (3) to inform the physician or dentist before any type of surgery that he or she is taking Metoprolol Tartrate Tablets USP. Drug Interactions Catecholamine-Depleting Drugs Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents or monoamine oxidase (MAO) inhibitors. Observe patients treated with Metoprolol Tartrate Tablets USP plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension. In addition, possibly significant hypertension may theoretically occur up to 14 days following discontinuation of the concomitant administration with an irreversible MAO inhibitor. Digitalis Glycosides and Beta-Blockers Both digitalis glycosides and beta blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Monitor heart rate and PR interval. Calcium Channel Blockers Concomitant administration of a beta-adrenergic antagonist with a calcium channel blocker may produce an additive reduction in myocardial contractility because of negative chronotropic and inotropic effects. CYP2D6 Inhibitors Potent inhibitors of the CYP2D6 enzyme may increase the plasma concentration of Metoprolol Tartrate Tablets USP which would mimic the pharmacokinetics of CYP2D6 poor metabolizer (see PHARMACOKINETICS section). Increase in plasma concentrations of metoprolol would decrease the cardioselectivity of metoprolol. Known clinically significant potent inhibitors of CYP2D6 are antidepressants such as fluvoxamine, fluoxetine, paroxetine, sertraline, bupropion, clomipramine and desipramine; antipsychotics such as chlorpromazine, fluphenazine, haloperidol and thioridazine; antiarrhythmics such as quinidine or propafenone; antiretrovirals such as ritonavir; antihistamines such as diphenhydramine; antimalarials such as hydroxychloroquine or quinidine; antifungals such as terbinafine. Hydralazine Concomitant administration of hydralazine may inhibit presystemic metabolism of metoprolol leading to increased concentrations of metoprolol. Alpha-Adrenergic Agents Antihypertensive effect of alpha-adrenergic blockers such as guanethidine, betanidine, reserpine, alpha-methyldopa or clonidine may be potentiated by beta-blockers including Metoprolol Tartrate Tablets USP. Beta-adrenergic blockers may also potentiate the postural hypotensive effect of the first dose of prazosin, probably by preventing reflex tachycardia. On the contrary, beta adrenergic blockers may also potentiate the hypertensive response to withdrawal of clonidine in patients receiving concomitant clonidine and beta-adrenergic blocker. If a patient is treated with clonidine and Metoprolol Tartrate Tablets USP concurrently, and clonidine treatment is to be discontinued, stop Metoprolol Tartrate Tablets USP several days before clonidine is withdrawn. Rebound hypertension that can follow withdrawal of clonidine may be increased in patients receiving concurrent beta-blocker treatment. Ergot Alkaloid Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids. Dipyridamole In general, administration of a beta-blocker should be withheld before dipyridamole testing, with careful monitoring of heart rate following the dipyridamole injection. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have been conducted to evaluate carcinogenic potential. In a 2-year study in rats at three oral dosage levels of up to 800 mg/kg per day, there was no increase in the development of spontaneously occurring benign or malignant neoplasms of any type. The only histologic changes that appeared to be drug related were an increased incidence of generally mild focal accumulation of foamy macrophages in pulmonary alveoli and a slight increase in biliary hyperplasia. In a 21-month study in Swiss albino mice at three oral dosage levels of up to 750 mg/kg per day, benign lung tumors (small adenomas) occurred more frequently in female mice receiving the highest dose than in untreated control animals. There was no increase in malignant or total (benign plus malignant) lung tumors, or in the overall incidence of tumors or malignant tumors. This 21-month study was repeated in CD-1 mice, and no statistically or biologically significant differences were observed between treated and control mice of either sex for any type of tumor. All mutagenicity tests performed (a dominant lethal study in mice, chromosome studies in somatic cells, a Salmonella/mammalian-microsome mutagenicity test, and a nucleus anomaly test in somatic interphase nuclei) were negative. Reproduction toxicity studies in mice, rats and rabbits did not indicate teratogenic potential for metoprolol tartrate. Embryotoxicity and/or fetotoxicity in rats and rabbits were noted starting at doses of 50 mg/kg in rats and 25 mg/kg in rabbits, as demonstrated by increases in preimplantation loss, decreases in the number of viable fetuses per dose, and/or decreases in neonatal survival. High doses were associated with some maternal toxicity, and growth delay of the offspring in utero, which was reflected in minimally lower weights at birth. The oral NOAELs for embryo-fetal development in mice, rats and rabbits were considered to be 25, 200, and 12.5 mg/kg. This corresponds to dose levels that are approximately 0.3 times, 4 times, and 0.5 times, respectively, when based on surface area, the maximum human oral dose (8 mg/kg/day) of metoprolol tartrate. Metoprolol tartrate has been associated with reversible adverse effects on spermatogenesis starting at oral dose levels of 3.5 mg/kg in rats (a dose that is only 0.1 times the human dose, when based on surface area), although other studies have shown no effect of metoprolol tartrate on reproductive performance in male rats. Pregnancy Category C Upon confirming the diagnosis of pregnancy, women should immediately inform the doctor. Metoprolol Tartrate Tablets USP has been shown to increase postimplantation loss and decrease neonatal survival in rats at doses up to 11 times the maximum daily human dose of 450 mg, when based on surface area. Distribution studies in mice confirm exposure of the fetus when Metoprolol Tartrate Tablets USP is administered to the pregnant animal. These limited animal studies do not indicate direct or indirect harmful effects with respect to teratogenicity (see CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY). There are no adequate and well-controlled studies in pregnant women. The amount of data on the use of metoprolol in pregnant women is limited. The risk to the fetus/ mother is unknown. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Metoprolol Tartrate Tablets USP is excreted in breast milk in a very small quantity. An infant consuming 1 liter of breast milk daily would receive a dose of less than 1 mg of the drug. Fertility The effects of Metoprolol Tartrate Tablets USP on the fertility of human have not been studied. Metoprolol Tartrate Tablets USP showed effects on spermatogenesis in male rats at a therapeutic dose level, but had no effect on rates of conception at higher doses in animal fertility studies (see CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY). Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical trials of Metoprolol Tartrate Tablets USP in hypertension did not include sufficient numbers of elderly patients to determine whether patients over 65 years of age differ from younger subjects in their response to Metoprolol Tartrate Tablets USP. Other reported clinical experience in elderly hypertensive patients has not identified any difference in response from younger patients. In worldwide clinical trials of Metoprolol Tartrate Tablets USP in myocardial infarction, where approximately 478 patients were over 65 years of age (0 over 75 years of age), no age-related differences in safety and effectiveness were found. Other reported clinical experience in myocardial infarction has not identified differences in response between the elderly and younger patients. However, greater sensitivity of some elderly individuals taking Metoprolol Tartrate Tablets USP cannot be categorically ruled out. Therefore, in general, it is recommended that dosing proceed with caution in this population. Adverse Reactions Hypertension and Angina Most adverse effects have been mild and transient. Central Nervous System Tiredness and dizziness have occurred in about 10 of 100 patients. Depression has been reported in about 5 of 100 patients. Mental confusion and short-term memory loss have been reported. Headache, nightmares, and insomnia have also been reported. Cardiovascular Shortness of breath and bradycardia have occurred in approximately 3 of 100 patients. Cold extremities; arterial insufficiency, usually of the Raynaud type; palpitations; congestive heart failure; peripheral edema; and hypotension have been reported in about 1 of 100 patients. Gangrene in patients with preexisting severe peripheral circulatory disorders has also been reported very rarely (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS). Respiratory Wheezing (bronchospasm) and dyspnea have been reported in about 1 of 100 patients (see WARNINGS). Rhinitis has also been reported. Gastrointestinal Diarrhea has occurred in about 5 of 100 patients. Nausea, dry mouth, gastric pain, constipation, flatulence, and heartburn have been reported in about 1 of 100 patients. Vomiting was a common occurrence. Post-marketing experience reveals very rare reports of hepatitis, jaundice and nonspecific hepatic dysfunction. Isolated cases of transaminase, alkaline phosphatase, and lactic dehydrogenase elevations have also been reported. Hypersensitive Reactions Pruritus or rash have occurred in about 5 of 100 patients. Very rarely, photosensitivity and worsening of psoriasis has been reported. Miscellaneous Peyronie’s disease has been reported in fewer than 1 of 100,000 patients. Musculoskeletal pain, blurred vision, and tinnitus have also been reported. There have been rare reports of reversible alopecia, agranulocytosis, and dry eyes. Discontinuation of the drug should be considered if any such reaction is not otherwise explicable. There have been very rare reports of weight gain, arthritis, and retroperitoneal fibrosis (relationship to Metoprolol Tartrate Tablets USP has not been definitely established). The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with Metoprolol Tartrate Tablets USP. Myocardial Infarction Central Nervous System Tiredness has been reported in about 1 of 100 patients. Vertigo, sleep disturbances, hallucinations, headache, dizziness, visual disturbances, confusion, and reduced libido have also been reported, but a drug relationship is not clear. Cardiovascular In the randomized comparison of Metoprolol Tartrate Tablets USP and placebo described in the CLINICAL PHARMACOLOGY section, the following adverse reactions were reported: Metoprolol Tartrate Tablets, USP    Placebo Hypotension (systolic BP of less than 90 mmHg)    27.4%    23.2% Bradycardia (heart rate of less than 40 beats/min)    15.9%    6.7% Second- or third-degree heart block    4.7%    4.7% First-degree heart block (P-R of no less than 0.26 sec)    5.3%    1.9% Heart failure    27.5%    29.6% Respiratory Dyspnea of pulmonary origin has been reported in fewer than 1 of 100 patients Gastrointestinal Nausea and abdominal pain have been reported in fewer than 1 of 100 patients. Dermatologic Rash and worsened psoriasis have been reported, but a drug relationship is not clear. Miscellaneous Unstable diabetes and claudication have been reported, but a drug relationship is not clear. Potential Adverse Reactions A variety of adverse reactions not listed above have been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to Metoprolol Tartrate Tablets USP. Central Nervous System Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emo- tional lability, slightly clouded sensorium, and decreased performance on neuropsy- chometrics. Cardiovascular Intensification of AV block (see CONTRAINDICATIONS). Hematologic Agranulocytosis, nonthrombocytopenic purpura and thrombocytopenic purpura. Hypersensitive Reactions Fever combined with aching and sore throat, laryngospasm and respiratory distress. Post-Marketing Experience The following adverse reactions have been reported during post-approval use of Metoprolol Tartrate Tablets USP: confusional state, an increase in blood triglycerides and a decrease in High Density Lipoprotein (HDL). Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency. Overdosage Acute Toxicity Several cases of overdosage have been reported, some leading to death. Oral LD50’s (mg/kg): mice, 1,158 to 2,460; rats, 3,090 to 4,670. Signs and Symptoms Potential signs and symptoms associated with overdosage with Metoprolol Tartrate Tablets USP are bradycardia, hypotension, bronchospasm, myocardial infarction, cardiac failure and death. Management There is no specific antidote. In general, patients with acute or recent myocardial infarction may be more hemodynamically unstable than other patients and should be treated accordingly (see WARNINGS, MYOCARDIAL INFARCTION). On the basis of the pharmacologic actions of Metoprolol Tartrate Tablets USP, the following general measures should be employed: Elimination of the Drug Gastric lavage should be performed. Other clinical manifestations of overdose should be managed symptomatically based on modern methods of intensive care. Hypotension Administer a vasopressor, e.g., levarterenol or dopamine. Bronchospasm Administer a beta2-stimulating agent and/or a theophylline derivative. Cardiac Failure Administer digitalis glycoside and diuretic. In shock resulting from inadequate cardiac contractility, consider administration of dobutamine, isoproterenol or glucagon. Metoprolol Tartrate Tablet Dosage and Administration Hypertension Individualize the dosage of Metoprolol Tartrate Tablets USP. Metoprolol Tartrate Tablets USP should be taken with or immediately following meals. The usual initial dosage of Metoprolol Tartrate Tablets USP is 100 mg daily in single or divided doses, whether used alone or added to a diuretic. Increase the dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after one week of therapy. The effective dosage range of Metoprolol Tartrate Tablets USP is 100 mg to 450 mg per day. Dosages above 450 mg per day have not been studied. While once-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Beta1 selectivity diminishes as the dose of Metoprolol Tartrate Tablets USP is increased. Angina Pectoris The dosage of Metoprolol Tartrate Tablets USP should be individualized. Metoprolol Tartrate Tablets USP should be taken with or immediately following meals. The usual initial dosage of Metoprolol Tartrate Tablets USP is 100 mg daily, given in two divided doses. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is pronounced slowing of the heart rate. The effective dosage range of Metoprolol Tartrate Tablets USP is 100 mg to 400 mg per day. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, gradually decrease the dosage over a period of 1 to 2 weeks (see WARNINGS). Myocardial Infarction Early Treatment During the early phase of definite or suspected acute myocardial infarction, initiate treatment with Metoprolol Tartrate Tablets USP as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized. Begin treatment in this early phase with the intravenous administration of three bolus injections of 5 mg of Metoprolol Tartrate Tablets USP each; give the injections at approximately 2-minute intervals. During the intravenous administration of Metoprolol Tartrate Tablets USP, monitor blood pressure, heart rate, and electrocardiogram. In patients who tolerate the full intravenous dose (15 mg), initiate Metoprolol Tartrate Tablets USP, 50 mg every 6 hours, 15 minutes after the last intravenous dose and continue for 48 hours. Thereafter, the maintenance dosage is 100 mg twice daily (see LATE TREATMENT below). Start patients who appear not to tolerate the full intravenous dose on Metoprolol Tartrate Tablets USP either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, discontinue Metoprolol Tartrate Tablets USP (see WARNINGS). Late Treatment Start patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason on Metoprolol Tartrate Tablets USP, 100 mg twice daily, as soon as their clinical condition allows. Continue therapy for at least 3 months. Although the efficacy of Metoprolol Tartrate Tablets USP beyond 3 months has not been conclusively established, data from studies with other beta-blockers suggest that treatment should be continued for 1 to 3 years. Special Populations Pediatric Patients No pediatric studies have been performed. The safety and efficacy of Metoprolol Tartrate Tablets USP in pediatric patients have not been established. Renal Impairment No dose adjustment of Metoprolol Tartrate Tablets USP is required in patients with renal impairment. Hepatic Impairment Metoprolol Tartrate Tablets USP blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, Metoprolol Tartrate Tablets USP should be initiated at low doses with cautious gradual dose titration according to clinical response. Geriatric Patients (greater than 65 Years) In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Method of Administration For oral treatment, the tablets should be swallowed unchewed with a glass of water. Metoprolol Tartrate Tablets USP should always be taken in standardized relation with meals. If the physician asks the patient to take Metoprolol Tartrate Tablets USP either before breakfast or with breakfast, then the patient should continue taking Metoprolol Tartrate Tablets USP with the same schedule during the course of therapy. How is Metoprolol Tartrate Tablet Supplied Metoprolol Tartrate Tablets, USP are available containing 25 mg, 50 mg or 100 mg of metoprolol tartrate USP. The 25 mg tablets are white film-coated, round, scored tablets debossed with Y over 25 on one side of the tablet and scored on the other side. They are available as follows: NDC 69445-004-04 bottles of 100 tablets NDC 69445-004-03 bottles of 500 tablets The 50 mg tablets are pink film-coated, round, scored tablets debossed with Y over 50 on one side of the tablet and scored on the other side. They are available as follows: NDC 69445-005-04 bottles of 100 tablets NDC 69445-005-05 bottles of 1,000 tablets The 100 mg tablets are light blue film-coated, round, scored tablets debossed with Y over 100 on one side of the tablet and scored on the other side. They are available as follows: NDC 69445-006-04 bottles of 100 tablets NDC 69445-006-05 bottles of 1,000 tablets Store at 20° to 25°C (68° to 77°F), excursions permitted to 15- 30°C (59- 86°F). [See USP Controlled Room Temperature.] Protect from moisture and heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Yabao Pharmaceutical Co., Ltd. Beijing 101111, China For: YoungTech Pharmaceuticals, Inc. Cranbury, NJ 08512, USA Rev: Nov 2019 METOPROLOL TARTRATE Metoprolol Tartrate Tablet, coated Product Information Product Type    HUMAN PRESCRIPTION DRUG LABEL    Item Code (Source)    NDC:69445-004 Route of Administration    ORAL    DEA Schedule     Active Ingredient/Active Moiety Ingredient Name    Basis of Strength    Strength METOPROLOL TARTRATE (METOPROLOL)    METOPROLOL TARTRATE    25 mg Inactive Ingredients Ingredient Name    Strength ANHYDROUS LACTOSE     SILICON DIOXIDE     CROSCARMELLOSE SODIUM     MAGNESIUM STEARATE     CELLULOSE, MICROCRYSTALLINE     POLYETHYLENE GLYCOL, UNSPECIFIED     POLYVINYL ALCOHOL     STARCH, CORN     SODIUM STARCH GLYCOLATE TYPE A CORN     TALC     TITANIUM DIOXIDE     Product Characteristics Color    WHITE (WHITE)    Score    2 pieces Shape    ROUND (ROUND, DEBOSSED)    Size    6mm Flavor        Imprint Code    Y;25 Contains     Packaging #    Item Code    Package Description 1    NDC:69445-004-04    100 TABLET, COATED in 1 BOTTLE 2    NDC:69445-004-03    500 TABLET, COATED in 1 BOTTLE Marketing Information Marketing Category    Application Number or Monograph Citation    Marketing Start Date    Marketing End Date ANDA    ANDA208955    08/01/2020     METOPROLOL TARTRATE Metoprolol Tartrate Tablet, coated Product Information Product Type    HUMAN PRESCRIPTION DRUG LABEL    Item Code (Source)    NDC:69445-005 Route of Administration    ORAL    DEA Schedule     Active Ingredient/Active Moiety Ingredient Name    Basis of Strength    Strength METOPROLOL TARTRATE (METOPROLOL)    METOPROLOL TARTRATE    50 mg Inactive Ingredients Ingredient Name    Strength ANHYDROUS LACTOSE     SILICON DIOXIDE     CROSCARMELLOSE SODIUM     MAGNESIUM STEARATE     CELLULOSE, MICROCRYSTALLINE     POLYETHYLENE GLYCOL, UNSPECIFIED     POLYVINYL ALCOHOL     STARCH, CORN     SODIUM STARCH GLYCOLATE TYPE A CORN     TALC     TITANIUM DIOXIDE     FD&C RED NO. 40     Product Characteristics Color    PINK (PINK)    Score    2 pieces Shape    ROUND (ROUND, DEBOSSED)    Size    8mm Flavor        Imprint Code    Y;50 Contains     Packaging #    Item Code    Package Description 1    NDC:69445-005-04    100 TABLET, COATED in 1 BOTTLE 2    NDC:69445-005-05    1000 TABLET, COATED in 1 BOTTLE Marketing Information Marketing Category    Application Number or Monograph Citation    Marketing Start Date    Marketing End Date ANDA    ANDA208955    08/01/2020     METOPROLOL TARTRATE Metoprolol Tartrate Tablet, coated Product Information Product Type    HUMAN PRESCRIPTION DRUG LABEL    Item Code (Source)    NDC:69445-006 Route of Administration    ORAL    DEA Schedule     Active Ingredient/Active Moiety Ingredient Name    Basis of Strength    Strength METOPROLOL TARTRATE (METOPROLOL)    METOPROLOL TARTRATE    100 mg Inactive Ingredients Ingredient Name    Strength ANHYDROUS LACTOSE     SILICON DIOXIDE     CROSCARMELLOSE SODIUM     MAGNESIUM STEARATE     CELLULOSE, MICROCRYSTALLINE     POLYETHYLENE GLYCOL, UNSPECIFIED     POLYVINYL ALCOHOL     STARCH, CORN     SODIUM STARCH GLYCOLATE TYPE A CORN     TALC     TITANIUM DIOXIDE     FD&C BLUE NO. 1     FD&C BLUE NO. 2     Product Characteristics Color    BLUE (BLUE)    Score    2 pieces Shape    ROUND (ROUND, DEBOSSED)    Size    10mm Flavor        Imprint Code    Y;100 Contains     Packaging #    Item Code    Package Description 1    NDC:69445-006-04    100 TABLET, COATED in 1 BOTTLE 2    NDC:69445-006-05    1000 TABLET, COATED in 1 BOTTLE Marketing Information Marketing Category    Application Number or Monograph Citation    Marketing Start Date    Marketing End Date ANDA    ANDA208955    08/01/2020     Labeler - Youngtech Pharmaceuticals, Inc. (078622595) Registrant - Youngtech Pharmaceuticals, Inc. (078622595) Establishment Name    Address    ID/FEI    Operations Yabao Pharmaceutical Co. Ltd.        421252976    manufacture(69445-004, 69445-005, 69445-006) Establishment Name    Address    ID/FEI    Operations Zhejiang Yongtai Pharmaceutical Co., Ltd.        544302778    API MANUFACTURE(69445-004, 69445-005, 69445-006) Youngtech Pharmaceuticals, Inc.

Nebivolol tablet

Blood Pressure / Heart

What is nebivolol? Nebivolol is a beta-blocker that is used to treat hypertension (high blood pressure). Lowering blood pressure may lower your risk of a stroke or heart attack. Nebivolol may also be used for purposes not listed in this medication guide. Warnings Do not skip doses or stop taking nebivolol without first talking to your doctor. Before taking this medicine You should not take nebivolol if you are allergic to it, or if you have: a serious heart condition such as heart failure, "AV block" (2nd or 3rd degree), or sick sinus syndrome (unless you have a pacemaker); very slow heartbeats; severe liver disease; or if your heart cannot pump blood properly. Tell your doctor if you have ever had: asthma, bronchitis, emphysema; a heart attack; problems with circulation (especially in your feet and legs); diabetes (taking nebivolol can make it harder for you to tell when you have low blood sugar); a thyroid disorder; liver or kidney disease; allergies; or pheochromocytoma (tumor of the adrenal gland). Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether nebivolol will harm an unborn baby. However, having high blood pressure during pregnancy may cause complications such as diabetes or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating hypertension may outweigh any risks to the baby. You should not breastfeed while using nebivolol. How should I take nebivolol? Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. You may take nebivolol with or without food. Your blood pressure will need to be checked often. If you need surgery, tell the surgeon ahead of time that you are using nebivolol. You should not skip doses or stop using nebivolol suddenly. Stopping suddenly may make your condition worse or cause serious heart problems, including heart attack. Follow your doctor's instructions about tapering your dose. Keep using nebivolol as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life. Store at room temperature away from moisture and heat. What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include slow heart rate, dizziness, vomiting, trouble breathing, or feeling like you might pass out. What should I avoid while taking nebivolol? Avoid driving or hazardous activity until you know how nebivolol will affect you. Your reactions could be impaired. Nebivolol side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: a light-headed feeling, like you might pass out; rapid weight gain; shortness of breath; slow or uneven heartbeats; or numbness or cold feeling in your hands and feet. Common side effects may include: dizziness; swelling in your legs; slow heartbeats; tiredness; or headache. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Nebivolol dosing information Usual Adult Dose for Hypertension: Initial dose: 5 mg orally once a day Dose adjustment: Titrate dose at 2-week intervals up to 40 mg once a day as needed. Maximum dose: 40 mg per day Comments: -Titrating doses more frequently than every 2 weeks is unlikely to be beneficial. -The dose should be individualized to patient requirements. Use: For the management of hypertension, alone or with another antihypertensive agent.   What other drugs will affect nebivolol? Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Many drugs can affect nebivolol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Nifedipine capsule

Blood Pressure / Heart

What is nifedipine? Nifedipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels. Nifedipine is used to treat hypertension (high blood pressure) and angina (chest pain). Nifedipine may also be used for purposes not listed in this medication guide. What is the most important information I should know about nifedipine? You should not use nifedipine if you have severe coronary artery disease, or if you have had a heart attack within the past 2 weeks. Before taking nifedipine, tell your doctor if you have kidney or liver disease, a blockage in your digestive tract (stomach or intestines), a history of stomach surgery, coronary artery disease, underactive thyroid, diabetes, or congestive heart failure. If you need surgery, tell the surgeon ahead of time that you are using nifedipine. You may need to stop using the medicine for a short time. Do not stop taking nifedipine without first talking to your doctor, even if you feel fine. Stopping suddenly may make your condition worse. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Before taking this medicine You should not use this medicine if you are allergic to nifedipine, if you have severe coronary artery disease, or if you have had a heart attack within the past 2 weeks. To make sure nifedipine is safe for you, tell your doctor if you have: severe COPD (chronic obstructive pulmonary disease); kidney disease; congestive heart failure; or if you take other medications, especially an antibiotic or antifungal medicine, an antidepressant, heart or blood pressure medicine, or drugs to treat HIV/AIDS or hepatitis C. It is not known whether nifedipine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Nifedipine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby. The nifedipine extended-release tablet may contain lactose. Talk to your doctor before using this form of nifedipine if you have galactose intolerance, or severe problems with lactose (milk sugar). How should I take nifedipine? Take nifedipine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended. You may need to take an extended-release tablet on an empty stomach. Follow the directions on your medicine label about taking this medication with or without food. Do not crush, chew, or break a nifedipine extended-release tablet. Swallow it whole. Your blood pressure will need to be checked often and you may need other blood tests at your doctor's office. Some tablet forms of nifedipine are made with a shell that is not absorbed or melted in the body. Part of the tablet shell may appear in your stool. This is a normal side effect of nifedipine and will not make the medication less effective. If you need surgery, tell the surgeon ahead of time that you are using nifedipine. You may need to stop using the medicine at least 36 hours before surgery. You may have very low blood pressure while taking this medication. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. If you are also taking a beta-blocker (atenolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, sotalol, and others) you should not stop using the beta-blocker suddenly or you could have serious heart problems that will not be prevented by nifedipine. Follow your doctor's instructions about tapering your beta-blocker dose. You should not stop using nifedipine suddenly. Stopping suddenly may make your condition worse. If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture, heat, and light.   What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid? Grapefruit and grapefruit juice may interact with nifedipine and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Nifedipine side effects Get emergency medical help if you have any signs of an allergic reaction to nifedipine: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: worsening angina; a light-headed feeling, like you might pass out; pounding heartbeats or fluttering in your chest; chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling; swelling in your ankles or feet; or upper stomach pain, jaundice (yellowing of the skin or eyes). Common nifedipine side effects may include: mild dizziness; flushing (warmth, redness, or tingly feeling); weakness, headache, mood changes; heartburn, nausea; tremors, muscle cramps; or cough, wheezing, sore throat, stuffy nose. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What other drugs will affect nifedipine? Other drugs may interact with nifedipine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Nifedipine ER Tablet

Blood Pressure / Heart

What is nifedipine? Nifedipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels. Nifedipine is used to treat hypertension (high blood pressure) and angina (chest pain). Nifedipine may also be used for purposes not listed in this medication guide. What is the most important information I should know about nifedipine? You should not use nifedipine if you have severe coronary artery disease, or if you have had a heart attack within the past 2 weeks. Before taking nifedipine, tell your doctor if you have kidney or liver disease, a blockage in your digestive tract (stomach or intestines), a history of stomach surgery, coronary artery disease, underactive thyroid, diabetes, or congestive heart failure. If you need surgery, tell the surgeon ahead of time that you are using nifedipine. You may need to stop using the medicine for a short time. Do not stop taking nifedipine without first talking to your doctor, even if you feel fine. Stopping suddenly may make your condition worse. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Before taking this medicine You should not use this medicine if you are allergic to nifedipine, if you have severe coronary artery disease, or if you have had a heart attack within the past 2 weeks. To make sure nifedipine is safe for you, tell your doctor if you have: severe COPD (chronic obstructive pulmonary disease); kidney disease; congestive heart failure; or if you take other medications, especially an antibiotic or antifungal medicine, an antidepressant, heart or blood pressure medicine, or drugs to treat HIV/AIDS or hepatitis C. It is not known whether nifedipine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Nifedipine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby. The nifedipine extended-release tablet may contain lactose. Talk to your doctor before using this form of nifedipine if you have galactose intolerance, or severe problems with lactose (milk sugar). How should I take nifedipine? Take nifedipine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended. You may need to take an extended-release tablet on an empty stomach. Follow the directions on your medicine label about taking this medication with or without food. Do not crush, chew, or break a nifedipine extended-release tablet. Swallow it whole. Your blood pressure will need to be checked often and you may need other blood tests at your doctor's office. Some tablet forms of nifedipine are made with a shell that is not absorbed or melted in the body. Part of the tablet shell may appear in your stool. This is a normal side effect of nifedipine and will not make the medication less effective. If you need surgery, tell the surgeon ahead of time that you are using nifedipine. You may need to stop using the medicine at least 36 hours before surgery. You may have very low blood pressure while taking this medication. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. If you are also taking a beta-blocker (atenolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, sotalol, and others) you should not stop using the beta-blocker suddenly or you could have serious heart problems that will not be prevented by nifedipine. Follow your doctor's instructions about tapering your beta-blocker dose. You should not stop using nifedipine suddenly. Stopping suddenly may make your condition worse. If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture, heat, and light.   What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid? Grapefruit and grapefruit juice may interact with nifedipine and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Nifedipine side effects Get emergency medical help if you have any signs of an allergic reaction to nifedipine: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: worsening angina; a light-headed feeling, like you might pass out; pounding heartbeats or fluttering in your chest; chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling; swelling in your ankles or feet; or upper stomach pain, jaundice (yellowing of the skin or eyes). Common nifedipine side effects may include: mild dizziness; flushing (warmth, redness, or tingly feeling); weakness, headache, mood changes; heartburn, nausea; tremors, muscle cramps; or cough, wheezing, sore throat, stuffy nose. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What other drugs will affect nifedipine? Other drugs may interact with nifedipine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Olmesartan Medoxomil tablet

Blood Pressure / Heart

What is olmesartan? Olmesartan is an angiotensin II receptor blocker (sometimes called an ARB). Olmesartan is used to treat high blood pressure (hypertension) in adults and children at least 6 years old. It is sometimes given together with other blood pressure medications. Olmesartan may also be used for purposes not listed in this medication guide. Warnings Do not use if you are pregnant. Stop using olmesartan and tell your doctor right away if you become pregnant. If you have diabetes, do not take olmesartan with any medication that contains aliskiren (a blood pressure medicine). Before taking this medicine You should not take olmesartan if you are allergic to it. If you have diabetes, do not use olmesartan together with any medication that contains aliskiren (a blood pressure medicine). You may also need to avoid taking olmesartan with aliskiren if you have kidney disease. Tell your doctor if you have ever had: a heart condition other than one being treated with olmesartan; kidney disease; or if you are on a low salt diet. Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Olmesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. If you plan to get pregnant, ask your doctor for a safer medicine to use before and during pregnancy. Having high blood pressure during pregnancy may cause complications in the mother and the baby. You should not breastfeed while using olmesartan. How should I take olmesartan? Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. You may take olmesartan with or without food. For a child who cannot swallow a tablet whole, a pharmacist can mix the medicine into a liquid. Shake the liquid before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). Olmesartan doses are based on weight in children and/or teenagers. Your child's dose needs may change if the child gains or loses weight. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking olmesartan. It may take up to 2 weeks before your blood pressure is under control. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life. Treatment may also include diet, exercise, lowering cholesterol, not smoking, and controlling diabetes. Your blood pressure will need to be checked often. Your kidney function may also need to be checked. Store tablets at room temperature away from moisture and heat. Store the liquid in a refrigerator. Throw away any liquid leftover after 4 weeks. What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include fast heartbeats or fainting. What should I avoid while taking olmesartan? Do not use potassium supplements or salt substitutes, unless your doctor has told you to. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Olmesartan side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: a light-headed feeling, like you might pass out; little or no urination; severe diarrhea and weight loss; or high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement. Common side effects may include: dizziness. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Olmesartan dosing information Usual Adult Dose for Hypertension: 20 mg orally once a day; may increase dose to 40 mg in two weeks if further blood pressure reduction is needed. Maximum dose: 40 mg orally once a day Comments: -For patients with possible intravascular volume depletion (e.g., patients treated with diuretics, especially those with impaired renal function), initiate this drug under close supervision and give consideration to a lower starting dose. -Twice daily dosing offers no additional benefit over the same total dose give once daily. Usual Pediatric Dose for Hypertension: 6 to 16 years: -20 to less than 35 kg: 10 mg orally once a day; may increase dose to 20 mg in two weeks if further blood pressure reduction is needed -35 kg or more: 20 mg orally once a day; may increase dose to 40 mg in two weeks if further blood pressure reduction is needed Comments: -For children who cannot swallow tablets, the same dose can be given using an extemporaneous suspension.   What other drugs will affect olmesartan? If you take colesevelam, take your olmesartan dose 4 hours before you take colesevelam. Tell your doctor about all your other medicines, especially: lithium; a diuretic (water pill) or other medicines that lower blood pressure; or NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others. This list is not complete. Other drugs may affect olmesartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Propranolol HCL ER capsule

Blood Pressure / Heart

What is propranolol? Propranolol is a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins). Propranolol is used to treat tremors, angina (chest pain), hypertension (high blood pressure), heart rhythm disorders, and other heart or circulatory conditions. It is also used to treat or prevent heart attack, and to reduce the severity and frequency of migraine headaches. Hemangeol (propranolol oral liquid 4.28 milligrams) is given to infants 5 weeks to 1 year old to treat a genetic condition called infantile hemangiomas. Hemangiomas are caused by blood vessels grouping together in an abnormal way. These blood vessels form benign (non-cancerous) growths that can develop into ulcers or red marks on the skin. Hemangiomas can also cause more serious complications inside the body (in the liver, brain, or digestive system). Warnings You should not use propranolol if you have asthma, very slow heart beats, or a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker). Babies who weigh less than 4.5 pounds should not be given Hemangeol oral liquid. Before taking this medicine You should not use propranolol if you are allergic to it, or if you have: asthma; history of slow heart beats that have caused you to faint; severe heart failure (that required you to be in the hospital); or a serious heart condition such as "sick sinus syndrome" or heart block (2nd or 3rd degree, unless you have a pacemaker). You should not use Hemangeol if you have pheochromocytoma (tumor of the adrenal gland). propranolol also should not be used in babies who weigh less than 4.4 pounds. To make sure propranolol is safe for you, tell your doctor if you have ever had: slow heartbeats, congestive heart failure; bronchitis, emphysema, or other breathing disorders; diabetes (propranolol can make it harder for you to tell when you have low blood sugar); liver or kidney disease; a thyroid disorder; pheochromocytoma (tumor of the adrenal gland); problems with circulation (such as Raynaud's syndrome); or if you smoke. Tell your doctor if you are pregnant or breastfeeding. What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include feeling light-headed or restless, tremors, fast or slow heartbeats, and trouble breathing. What should I avoid while taking propranolol? Avoid drinking alcohol. It may increase your blood levels of propranolol. Propranolol side effects Get emergency medical help if you have signs of an allergic reaction to propranolol (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). Call your doctor at once if you have: slow or uneven heartbeats; a light-headed feeling, like you might pass out; wheezing or trouble breathing; sudden weakness, vision problems, or loss of coordination (especially in a child with hemangioma that affects the face or head); cold feeling in your hands and feet; depression, confusion, hallucinations; heart problems - swelling, rapid weight gain, feeling short of breath; low blood sugar - headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or low blood sugar in a baby - pale skin, blue or purple skin, sweating, fussiness, crying, not wanting to eat, feeling cold, drowsiness, weak or shallow breathing (breathing may stop for short periods), seizure (convulsions), or loss of consciousness.

Propranolol tablet

Blood Pressure / Heart

What is propranolol? Propranolol is a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins). Propranolol is used to treat tremors, angina (chest pain), hypertension (high blood pressure), heart rhythm disorders, and other heart or circulatory conditions. It is also used to treat or prevent heart attack, and to reduce the severity and frequency of migraine headaches. Hemangeol (propranolol oral liquid 4.28 milligrams) is given to infants 5 weeks to 1 year old to treat a genetic condition called infantile hemangiomas. Hemangiomas are caused by blood vessels grouping together in an abnormal way. These blood vessels form benign (non-cancerous) growths that can develop into ulcers or red marks on the skin. Hemangiomas can also cause more serious complications inside the body (in the liver, brain, or digestive system). Warnings You should not use propranolol if you have asthma, very slow heart beats, or a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker). Babies who weigh less than 4.5 pounds should not be given Hemangeol oral liquid. Before taking this medicine You should not use propranolol if you are allergic to it, or if you have: asthma; history of slow heart beats that have caused you to faint; severe heart failure (that required you to be in the hospital); or a serious heart condition such as "sick sinus syndrome" or heart block (2nd or 3rd degree, unless you have a pacemaker). You should not use Hemangeol if you have pheochromocytoma (tumor of the adrenal gland). propranolol also should not be used in babies who weigh less than 4.4 pounds. To make sure propranolol is safe for you, tell your doctor if you have ever had: slow heartbeats, congestive heart failure; bronchitis, emphysema, or other breathing disorders; diabetes (propranolol can make it harder for you to tell when you have low blood sugar); liver or kidney disease; a thyroid disorder; pheochromocytoma (tumor of the adrenal gland); problems with circulation (such as Raynaud's syndrome); or if you smoke. Tell your doctor if you are pregnant or breastfeeding. What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include feeling light-headed or restless, tremors, fast or slow heartbeats, and trouble breathing. What should I avoid while taking propranolol? Avoid drinking alcohol. It may increase your blood levels of propranolol. Propranolol side effects Get emergency medical help if you have signs of an allergic reaction to propranolol (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). Call your doctor at once if you have: slow or uneven heartbeats; a light-headed feeling, like you might pass out; wheezing or trouble breathing; sudden weakness, vision problems, or loss of coordination (especially in a child with hemangioma that affects the face or head); cold feeling in your hands and feet; depression, confusion, hallucinations; heart problems - swelling, rapid weight gain, feeling short of breath; low blood sugar - headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or low blood sugar in a baby - pale skin, blue or purple skin, sweating, fussiness, crying, not wanting to eat, feeling cold, drowsiness, weak or shallow breathing (breathing may stop for short periods), seizure (convulsions), or loss of consciousness.

Quinapril Tablet

Blood Pressure / Heart

What is quinapril? Quinapril is an ACE inhibitor. ACE stands for angiotensin converting enzyme. Quinapril is used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack. Quinapril is also used together with other medications to treat heart failure. Quinapril may also be used for purposes not listed in this medication guide. Warnings Do not use if you are pregnant. If you become pregnant, stop taking quinapril and tell your doctor right away. You should not use quinapril if you have ever had angioedema. Do not take quinapril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto). If you have diabetes, do not use quinapril together with any medication that contains aliskiren (a blood pressure medicine). Before taking this medicine You should not use quinapril if you are allergic to it, or if: you have a history of angioedema; you recently took a heart medicine called sacubitril; or if you are allergic to any other ACE inhibitor, such as benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, ramipril, or trandolapril. Do not take quinapril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto). If you have diabetes, do not use quinapril together with any medication that contains aliskiren (a blood pressure medicine). You may also need to avoid taking quinapril with aliskiren if you have kidney disease. Tell your doctor if you have ever had: kidney disease (or if you are on dialysis); liver disease; a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, lupus, scleroderma, or rheumatoid arthritis; heart disease or congestive heart failure (unless you are taking quinapril for this condition); or if you are on a low-salt diet. Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Quinapril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. Quinapril is not approved for use by anyone younger than 18 years old. How should I take quinapril? Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. Your blood pressure will need to be checked often. Your kidney or liver function may also need to be tested. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking quinapril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure. If you need surgery, tell the surgeon ahead of time that you are using quinapril. You may need to stop using the medicine for a short time. If you are being treated for high blood pressure, keep using quinapril even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life. Store at room temperature away from moisture, heat, and light. What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking quinapril? Drinking alcohol can further lower your blood pressure and may increase certain side effects of quinapril. Do not use salt substitutes or potassium supplements while taking quinapril, unless your doctor has told you to. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Quinapril side effects Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: a light-headed feeling, like you might pass out; fast or pounding heartbeats, fluttering in your chest; little or no urination; pain or burning when you urinate; jaundice (yellowing of the skin or eyes); numbness, tingling, or burning pain in your hands or feet; fever, chills, cold or flu symptoms; high potassium--nausea, chest pain, irregular heartbeats, loss of movement; or low sodium--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady. Common side effects may include: headache; cough; or dizziness, tired feeling. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Quinapril dosing information Usual Adult Dose for Hypertension: Initial dose: 10 or 20 mg orally once a day in patients not on diuretics Maintenance dose: 20 to 80 mg orally per day, administered as a single dose or in two equally divided doses Use: -Treatment of hypertension Usual Adult Dose for Congestive Heart Failure: Initial dose: 5 mg orally twice a day Maintenance dose: 20 to 40 mg orally per day administered in two equally divided doses Comments: -This dose may improve symptoms of heart failure, but increases in exercise duration have generally required higher doses. -If the initial dosage is well tolerated, patients should then be titrated at weekly intervals until an effective dose. Use: -Management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis Usual Geriatric Dose for Congestive Heart Failure: 10 mg orally once a day Comments: Dose should be titrated the same way as for other adult patients. Uses: -Treatment of hypertension -Management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis Usual Geriatric Dose for Hypertension: 10 mg orally once a day Comments: Dose should be titrated the same way as for other adult patients. Uses: -Treatment of hypertension -Management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis   What other drugs will affect quinapril? Tell your doctor about all your other medicines, especially: lithium; a diuretic or "water pill"; gold injections to treat arthritis; or NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others. This list is not complete. Other drugs may affect quinapril, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Ramipril Capsule

Blood Pressure / Heart

What is ramipril? Ramipril (Altace) is an ACE inhibitor. ACE stands for angiotensin converting enzyme. Ramipril is used to treat high blood pressure (hypertension) or congestive heart failure, and to improve survival after a heart attack. Ramipril may also be used for purposes not listed in this medication guide. Warnings Do not use ramipril if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. You should not use ramipril if you have ever had angioedema. Do not take this medicine within 36 hours before or after taking medicine that contains sacubatril (such as Entresto). If you have diabetes, do not use ramipril together with any medication that contains aliskiren (such as Tekturna or Tekamlo). Before taking this medicine You should not use ramipril if you are allergic to it, or if: you have a history of angioedema; you recently took a heart medicine called sacubatril; or if you are allergic to any other ACE inhibitor, such as benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, or trandolapril. Do not take ramipril within 36 hours before or after taking medicine that contains sacubatril (such as Entresto). If you have diabetes, do not use ramipril together with any medication that contains aliskiren (such as Tekturna or Tekamlo). You may also need to avoid taking ramipril with aliskiren if you have kidney disease. To make sure this medicine is safe for you, tell your doctor if you have ever had: kidney disease (or if you are on dialysis); liver disease; a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, lupus, scleroderma, or rheumatoid arthritis; or if you are also taking telmisartan (Micardis). Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Ramipril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control. It is not known whether ramipril passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine. How should I take ramipril? Take ramipril exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended. Ramipril can be taken with or without food. Swallow the tablet whole. You may open the capsule and sprinkle the medicine into a half-cup (4 ounces) of water, apple juice, or applesauce to make swallowing easier. Swallow without chewing. You may store the mixture for up to 24 hours at room temperature, or up to 48 hours in a refrigerator. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking ramipril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure. Your blood pressure will need to be checked often, and you may need frequent blood tests to check your potassium levels. Drink plenty of water each day while you are taking this medication. If you need surgery, tell the surgeon ahead of time that you are using this medicine. If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.   What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid? Do not use salt substitutes or potassium supplements while taking ramipril, unless your doctor has told you to. Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of ramipril. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Ramipril side effects Get emergency medical help if you have any signs of an allergic reaction to ramipril: hives; severe stomach pain; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: a light-headed feeling, like you might pass out; jaundice (yellowing of your skin or eyes); little or no urination; fever, chills, sore throat, cold or flu symptoms; or high potassium - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement. Common ramipril side effects may include: headache; cough; or dizziness, weakness, tired feeling. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Terazosin Capsule

Blood Pressure / Heart

What is terazosin? Terazosin is in a group of drugs called alpha-adrenergic blockers. Terazosin relaxes your veins and arteries so that blood can more easily pass through them. It also relaxes the muscles in the prostate and bladder neck, making it easier to urinate. Terazosin is used to treat hypertension (high blood pressure), or to improve urination in men with benign prostatic hyperplasia (enlarged prostate). Terazosin may also be used for other purposes not listed in this medication guide. Warnings Terazosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. You may wish to take this medication only at bedtime if it causes you to feel light-headed. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. You should not use this medication if you are allergic to terazosin. If you stop taking terazosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment. Terazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using terazosin. Do not stop using terazosin before surgery unless your surgeon tells you to. Tell your doctor about all other medications you use, especially other blood pressure medications including diuretics (water pills). Before taking this medicine You should not use this medication if you are allergic to terazosin. If you have a history of prostate cancer, you may need a dose adjustment or special tests to safely take terazosin. Terazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using terazosin before surgery unless your surgeon tells you to. FDA pregnancy category C. It is not known whether terazosin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether terazosin passes into breast milk or if it could harm a nursing baby. Do not use terazosin without telling your doctor if you are breast-feeding a baby. Terazosin pregnancy and breastfeeding warnings (more detail) How should I take terazosin? Take terazosin exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your terazosin dose to make sure you get the best results. Terazosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. You may wish to take this medication only at bedtime if it causes you to feel light-headed. Call your doctor if you have severe dizziness or feel like you might pass out. You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position. If you stop taking terazosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment. Your blood pressure or prostate will need to be checked often. Visit your doctor regularly. If you are being treated for high blood pressure, keep using terazosin even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting. Store terazosin at room temperature away from moisture, heat, and light. What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. If you miss your doses for several days in a row, contact your doctor before restarting the medication. You may need a lower dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include extreme dizziness or fainting. What should I avoid? Terazosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Drinking alcohol can increase certain side effects of terazosin. Terazosin side effects Get emergency medical help if you have any of these signs of an allergic reaction to terazosin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: fast or pounding heartbeats or fluttering in your chest; feeling like you might pass out; swelling in your hands, ankles, or feet; or penis erection that is painful or lasts 4 hours or longer. Less serious terazosin side effects may include: mild dizziness; weakness, drowsiness; blurred vision; nausea; or headache. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Terazosin side effects (more detail) Dosing information Usual Adult Dose for Hypertension: Initial dose: 1 mg orally once a day at bedtime Maintenance dose: 1-5 mg orally once a day. Maximum dose: 20 mg per day. Usual Adult Dose for Benign Prostatic Hyperplasia: Initial dose: 1 mg orally once a day at bedtime. Maintenance dose: Increased in a stepwise fashion to 2 mg, 5 mg, or 10 mg once a day to achieve desired improvement of symptoms. Detailed Terazosin dosage information What other drugs will affect terazosin? Tell your doctor about all other medications you use, especially: sildenafil (Viagra, Revatio); tadalafil (Cialis); vardenafil (Levitra); verapamil (Calan, Covera, Isoptin, Verelan); or other blood pressure medications, including diuretics (water pills). This list is not complete and other drugs may interact with terazosin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Trandolapril Tablet

Blood Pressure / Heart

What is trandolapril? Trandolapril is an ACE inhibitor. ACE stands for angiotensin converting enzyme. Trandolapril is used to treat high blood pressure (hypertension), and to improve survival after a heart attack. Trandolapril may also be used for purposes not listed in this medication guide. Warnings Do not use if you are pregnant, and tell your doctor right away if you become pregnant. If you have diabetes, do not use trandolapril together with any medication that contains aliskiren (a blood pressure medicine). Do not take trandolapril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto). Before taking this medicine You should not use trandolapril if you are allergic to it, or if you: have a history of angioedema; recently took a heart medicine called sacubitril; or are allergic to any other ACE inhibitor, such as benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, or ramipril. Do not take trandolapril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto). If you have diabetes, do not use trandolapril together with any medication that contains aliskiren (a blood pressure medicine). You may also need to avoid taking trandolapril with aliskiren if you have kidney disease. Tell your doctor if you have ever had: kidney disease (or if you are on dialysis); liver disease; heart disease or congestive heart failure; diabetes; or if you are on a low-salt diet. Do not use if you are pregnant, and tell your doctor right away if you become pregnant. Trandolapril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. You should not breastfeed while using trandolapril. How should I take trandolapril? Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. Trandolapril can be taken with or without food. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking trandolapril. This can lead to very low blood pressure, a serious electrolyte imbalance, or kidney failure. Your blood pressure will need to be checked often. Your kidney function and electrolytes may also need to be checked. If you need surgery, tell the surgeon ahead of time that you are using trandolapril. If you have high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life. Store at room temperature away from moisture and heat. Detailed Trandolapril dosage information What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking trandolapril? Do not use potassium supplements or salt substitutes, unless your doctor has told you to. Trandolapril side effects Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American. Call your doctor at once if you have: a light-headed feeling, like you might pass out; upper stomach pain, and jaundice (yellowing of the skin or eyes); chest pain, pounding heartbeats or fluttering in your chest; high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; low white blood cell counts--fever, chills, feeling light-headed, mouth sores, skin sores, sore throat, cough, trouble breathing; or lung problems--anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus. Common side effects may include: cough; dizziness; or diarrhea. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Trandolapril side effects (more detail) What other drugs will affect trandolapril? Tell your doctor about all your current medicines and any you start or stop using, especially: a diuretic or "water pill"; gold injections to treat arthritis; insulin or oral diabetes medicine; lithium; or NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others. This list is not complete. Other drugs may affect trandolapril, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here

Verapamil ER capsule

Blood Pressure / Heart

What is verapamil? Verapamil is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels. Verapamil is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Verapamil injection is used to rapidly or temporarily restore normal heartbeats in people with certain heart rhythm disorders. Warnings You should not use verapamil if you have a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker), severe heart failure, Wolff-Parkinson-White, Lown-Ganong-Levine syndrome, or slow heartbeats that have caused you to faint. Before taking this medicine You should not use verapamil if you are allergic to it, or if you have a serious heart condition such as: "sick sinus syndrome" or "AV block" (unless you have a pacemaker); very low blood pressure; or if your heart cannot pump blood properly. You may not be able to use verapamil if you have: severe congestive heart failure; certain heart rhythm disorders (such as "Afib," Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome); a heart condition that causes you to have very rapid heartbeats; or if you are receiving an intravenous beta-blocker (such as atenolol, metoprolol, or propranolol). To make sure verapamil is safe for you, tell your doctor if you have ever had: congestive heart failure; kidney disease; liver disease; or a nerve-muscle disorder such as myasthenia gravis or muscular dystrophy. It is not known whether verapamil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. You should not breastfeed while using this medicine. Verapamil oral is not approved for use by anyone younger than 18 years old. How should I use verapamil? Verapamil injection is given as an infusion into a vein, usually in an emergency situation. A healthcare provider will give you this injection. Your heart rate will be constantly monitored to help determine when your heartbeats have returned to normal. Oral verapamil is taken by mouth. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended. Do not use the injection if it looks cloudy or has particles in it. Call your pharmacist for new medicine. Swallow a capsule or tablet whole and do not crush, chew, break, or open it. Your blood pressure will need to be checked often. Your liver function may also need to be checked. If you need surgery, tell the surgeon ahead of time that you take verapamil. If you have high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life. Store at room temperature away from moisture, heat, and light.   What happens if I miss a dose? Verapamil injection: Call your doctor for instructions if you miss a dose. Verapamil oral: Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of verapamil can be fatal. What to avoid Drinking alcohol with verapamil can cause side effects. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Grapefruit may interact with verapamil and lead to unwanted side effects. Avoid the use of grapefruit products. Verapamil side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: chest pain, fast or slow heart rate; a light-headed feeling, like you might pass out; shortness of breath (even with mild exertion), swelling, rapid weight gain; fever, upper stomach pain, not feeling well; or lung problems--anxiety, sweating, pale skin, wheezing, gasping for breath, cough with foamy mucus. Common side effects may include: nausea, constipation; headache, dizziness; or low blood pressure. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What other drugs will affect verapamil? Many drugs can interact with verapamil. Some drugs can raise or lower your blood levels of verapamil, which may cause side effects or make it less effective. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially: aspirin, imatinib, lithium, nefazodone, St. John's wort; all other heart or blood pressure medicines, especially clonidine, digoxin, flecainide, ivabradine, nicardipine, or quinidine; an antibiotic - clarithromycin, telithromycin; antifungal medicine - itraconazole, ketoconazole, posaconazole, voriconazole; antiviral medicine to treat hepatitis or HIV/AIDS - atazanavir, boceprevir, cobicistat, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir; a beta blocker - atenolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, sotalol, and others; cholesterol lowering medicine - atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin; drugs to treat high blood pressure or a prostate disorder - alfuzosin, doxazosin, prazosin, terazosin, silodosin, tamsulosin; seizure medicine - carbamazepine, phenobarbital, phenytoin; or tuberculosis medicine - isoniazid, rifampin. This list is not complete and many other drugs can interact with verapamil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

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