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Estradiol 0.01% Cream

Hormones

What is estradiol? Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body. It is available as an oral tablet, a topical gel or patch, vaginal cream, or as an injection. Estradiol is used to treat menopause symptoms such as hot flashes and vaginal changes, and to prevent osteoporosis (bone loss) in menopausal women. Estradiol is also used to treat low estrogen levels in women with ovarian failure. It is also indicated to treat certain types of breast cancer and prostate cancer. Estradiol may also be used for purposes not listed in this medication guide. Warnings You should not use estradiol if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina. Do not use estradiol if you are pregnant. Estradiol may increase your risk of developing uterine cancer. Report any unusual vaginal bleeding right away. Using this medicine can increase your risk of blood clots, stroke, or heart attack, or cancer of the breast, uterus, or ovaries. Estradiol should not be used to prevent heart disease, stroke, or dementia. Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using this medicine. Before taking this medicine You should not use this medicine if you are allergic to estradiol, or if you have: unusual vaginal bleeding that has not been checked by a doctor; liver disease; a history of heart attack, stroke, or blood clot; an increased risk of having blood clots due to a heart problem or a hereditary blood disorder; or a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina. Do not use estradiol if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke. Estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions. To make sure this medicine is safe for you, tell your doctor if you have ever had: heart disease; liver problems, or prior jaundice caused by pregnancy or taking hormones; kidney disease; cancer; gallbladder disease; asthma; epilepsy or other seizure disorder; migraines; lupus; endometriosis or uterine fibroid tumors; hereditary angioedema; porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); a thyroid disorder; or high levels of calcium in your blood. Using estradiol may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk. Estradiol lowers the hormone needed to produce breast milk and can slow breast milk production. Tell your doctor if you are breast-feeding. How should I take estradiol? Take estradiol exactly as it was prescribed for you. Follow all directions on your prescription label. Do not take this medicine in larger amounts or for longer than recommended. Estradiol may increase your risk of developing uterine cancer. To help lower this risk, your doctor may also want you to take a progestin. Report any unusual vaginal bleeding to your doctor immediately. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis and have a mammogram every year while using estradiol. If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using this medicine. Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use. If you are taking injectable estrogen, dispose of any needles and syringes in an appropriate sharps container per your state laws. Do not throw away used needles into the garbage. If you are using estradiol spray, avoid fire, flame, or smoking until the spray has dried. Do not apply lotion or sunscreen over the area for at least one hour.   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. Overdose can result in nausea, vomiting and vaginal bleeding. What to avoid Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using this medicine. Grapefruit and grapefruit juice may interact with estradiol and lead to unwanted side effects. Avoid the use of grapefruit products. Estradiol side effects Get emergency medical help if you have signs of an allergic reaction to estradiol: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; signs of a blood clot - sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs; swelling or tenderness in your stomach; jaundice (yellowing of the skin or eyes); memory problems, confusion, unusual behavior; unusual vaginal bleeding, pelvic pain; a lump in your breast; or nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy. Common estradiol side effects may include: nausea, vomiting, diarrhea, stomach cramps; mood changes, sleep problems (insomnia); cold symptoms such as stuffy nose, sinus pain, sore throat; weight gain; headache, back pain, dizziness; breast pain; darkening of the skin or skin rash; thinning scalp hair; or vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding. 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 estradiol? 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 interact with estradiol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Estradiol Tablet

Hormones

What is estradiol? Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body. It is available as an oral tablet, a topical gel or patch, vaginal cream, or as an injection. Estradiol is used to treat menopause symptoms such as hot flashes and vaginal changes, and to prevent osteoporosis (bone loss) in menopausal women. Estradiol is also used to treat low estrogen levels in women with ovarian failure. It is also indicated to treat certain types of breast cancer and prostate cancer. Estradiol may also be used for purposes not listed in this medication guide. Warnings You should not use estradiol if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina. Do not use estradiol if you are pregnant. Estradiol may increase your risk of developing uterine cancer. Report any unusual vaginal bleeding right away. Using this medicine can increase your risk of blood clots, stroke, or heart attack, or cancer of the breast, uterus, or ovaries. Estradiol should not be used to prevent heart disease, stroke, or dementia. Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using this medicine. Before taking this medicine You should not use this medicine if you are allergic to estradiol, or if you have: unusual vaginal bleeding that has not been checked by a doctor; liver disease; a history of heart attack, stroke, or blood clot; an increased risk of having blood clots due to a heart problem or a hereditary blood disorder; or a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina. Do not use estradiol if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke. Estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions. To make sure this medicine is safe for you, tell your doctor if you have ever had: heart disease; liver problems, or prior jaundice caused by pregnancy or taking hormones; kidney disease; cancer; gallbladder disease; asthma; epilepsy or other seizure disorder; migraines; lupus; endometriosis or uterine fibroid tumors; hereditary angioedema; porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); a thyroid disorder; or high levels of calcium in your blood. Using estradiol may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk. Estradiol lowers the hormone needed to produce breast milk and can slow breast milk production. Tell your doctor if you are breast-feeding. How should I take estradiol? Take estradiol exactly as it was prescribed for you. Follow all directions on your prescription label. Do not take this medicine in larger amounts or for longer than recommended. Estradiol may increase your risk of developing uterine cancer. To help lower this risk, your doctor may also want you to take a progestin. Report any unusual vaginal bleeding to your doctor immediately. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis and have a mammogram every year while using estradiol. If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using this medicine. Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use. If you are taking injectable estrogen, dispose of any needles and syringes in an appropriate sharps container per your state laws. Do not throw away used needles into the garbage. If you are using estradiol spray, avoid fire, flame, or smoking until the spray has dried. Do not apply lotion or sunscreen over the area for at least one hour.   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. Overdose can result in nausea, vomiting and vaginal bleeding. What to avoid Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using this medicine. Grapefruit and grapefruit juice may interact with estradiol and lead to unwanted side effects. Avoid the use of grapefruit products. Estradiol side effects Get emergency medical help if you have signs of an allergic reaction to estradiol: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; signs of a blood clot - sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs; swelling or tenderness in your stomach; jaundice (yellowing of the skin or eyes); memory problems, confusion, unusual behavior; unusual vaginal bleeding, pelvic pain; a lump in your breast; or nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy. Common estradiol side effects may include: nausea, vomiting, diarrhea, stomach cramps; mood changes, sleep problems (insomnia); cold symptoms such as stuffy nose, sinus pain, sore throat; weight gain; headache, back pain, dizziness; breast pain; darkening of the skin or skin rash; thinning scalp hair; or vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding. 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 estradiol? 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 interact with estradiol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Medroxyprogesterone Tablet

Hormones

What is medroxyprogesterone? Medroxyprogesterone is a progestin (a form of progesterone), a female hormone that helps regulate ovulation (the release of an egg from an ovary) and menstrual periods. Medroxyprogesterone is used to treat conditions such as absent or irregular menstrual periods, or abnormal uterine bleeding. Medroxyprogesterone is also used to decrease the risk of endometrial hyperplasia (a condition that may lead to uterine cancer) while taking estrogens. Medroxyprogesterone is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy Warnings You should not use medroxyprogesterone if you are pregnant, or if you have liver disease, a hormone-related cancer such as breast or uterine cancer, a history of stroke or blood clot, or abnormal vaginal bleeding that has not been checked by a doctor. Medroxyprogesterone should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions. Long-term use of medroxyprogesterone may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risk. Before taking this medicine You should not use this medicine if you are allergic to medroxyprogesterone, or if you have: abnormal vaginal bleeding that has not been checked by a doctor; liver disease; a history of heart attack, stroke, or blood clot; or a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina. Medroxyprogesterone may cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant. Medroxyprogesterone should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions. To make sure medroxyprogesterone is safe for you, tell your doctor if you have: heart problems; liver problems; asthma; migraine headaches; a thyroid disorder; endometriosis (severe pelvic pain); jaundice caused by pregnancy or birth control pills; kidney disease; high or low blood levels of calcium; a seizure; diabetes; or lupus. Using this medicine can increase your risk of blood clots, stroke, or heart attack, especially if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke. Long-term use of medroxyprogesterone may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk. Do not breastfeed. How should I take medroxyprogesterone? Take medroxyprogesterone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Medroxyprogesterone is usually given for only a few days in a row each month. Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using this medicine. If you need major surgery or will be on long-term bed rest, you may need to stop using medroxyprogesterone for a short time. This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using medroxyprogesterone. Store at room temperature away from moisture and heat. Dosing information Usual Adult Dose for Endometrial Hyperplasia -- Prophylaxis: Oral tablets: 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16 th day of the cycle Comments: -Postmenopausal woman with a uterus taking estrogens should also initiate progestin therapy to reduce the risk of endometrial cancer. -Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration. Starting dose should be the lowest. -Periodically re-evaluation (e.g., 3 to 6 month intervals) to determine if treatment is still necessary is recommended. -In women with uterus, endometrial sampling should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. Use: Prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets Usual Adult Dose for Abnormal Uterine Bleeding: Oral tablets: -5 or 10 mg daily for 5 to 10 days, beginning on the 16 th or 21 st day of the menstrual cycle -Dose to produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen: 10 mg daily for 10 days beginning on the 16 th day of the cycle Comments: -Withdrawal bleeding usually occurs within 3 to 7 days after discontinuing therapy with the oral tablets. -Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with the oral tablets. Use: Abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer Usual Adult Dose for Amenorrhea: Oral tablets: -5 or 10 mg daily for 5 to 10 days Dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen: -10 mg daily for 10 day Comments: -Therapy may be started at any time. -Withdrawal bleeding usually occurs within 3 to 7 days after discontinuing therapy with this drug. Use: Treatment of secondary amenorrhea due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer   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 medroxyprogesterone? Avoid smoking while you are taking medroxyprogesterone. Smoking greatly increases your risk of blood clots. Medroxyprogesterone side effects Get emergency medical help if you have signs of an allergic reaction to medroxyprogesterone: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medicine and call your doctor at once if you have: signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; signs of a blood clot - sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs; heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; liver problems - loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); unusual vaginal bleeding; confusion, memory problems; a breast lump; or symptoms of depression - sleep problems, weakness, tired feeling, mood changes. Common medroxyprogesterone side effects may include: spotting or breakthrough bleeding; changes in your menstrual periods; vaginal itching or discharge; headache, dizziness, feeling nervous or depressed; breast tenderness or discharge; stomach discomfort, bloating, nausea, vomiting; itching, rash, acne, hair growth, hair loss; premenstrual type symptoms (bloating, fluid retention, mood changes); weight gain; bruising or swelling of your veins; tiredness, trouble sleeping; or vision changes and difficulty wearing contact lenses. 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 medroxyprogesterone? Other drugs may interact with medroxyprogesterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Testosterone Gel packet (CS)

Hormones

What is testosterone? Testosterone is a naturally occurring sex hormone that is produced in a man's testicles. Small amounts of testosterone are also produced in a woman's ovaries and adrenal system. Testosterone injection is used in men and boys to treat conditions caused by a lack of this hormone, such as delayed puberty or growth. It is only recommended for males with a known medical condition, such as a genetic disorder, problem with certain brain structures (called the hypothalamus and pituitary) or previous chemotherapy. Testosterone injection is also used in women to treat certain types of breast cancer that have spread to other parts of the body. Testosterone should not be used to enhance athletic performance or to treat normal male aging. Testosterone injection is also used "off-label" for the treatment of gender dysphoria. Injections are typically administered weekly by the user in a home setting. Warnings Do not use this medicine if you are pregnant or may become pregnant. You should not receive testosterone if you have prostate cancer, male breast cancer, a serious heart condition, or severe liver or kidney disease. Misuse of testosterone can cause dangerous or irreversible effects. Testosterone injections should be given only by a healthcare professional. Testosterone can lead to serious problems with the heart, brain, liver, endocrine, and mental health systems. Stopping testosterone may also lead to unpleasant withdrawal symptoms. Testosterone injections have also been linked to a condition called pulmonary oil microembolism (POME), or a blood clot in the lung that can be fatal. Seek medical help immediately for symptoms including chest pain, dizziness, trouble breathing, urge to cough, throat tightening and fainting. Before taking this medicine You should not receive testosterone if you are allergic to it, or if you have: prostate cancer; male breast cancer; a serious heart condition; severe liver disease; severe kidney disease; or if you are pregnant or may become pregnant. To make sure testosterone is safe for you, tell your doctor if you have: heart disease or coronary artery disease; a history of heart attack, stroke, or blood clot; diabetes; enlarged prostate; high cholesterol or triglycerides (a type of fat in the blood); breast cancer (in men, or in women who have hypercalcemia); liver or kidney disease; high calcium levels; if you are bedridden or otherwise debilitated; or if you take a blood thinner (warfarin, Coumadin, Jantoven). This medicine can harm an unborn baby. Do not use testosterone if you are pregnant or may become pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are receiving this medicine. It is not known whether testosterone passes into breast milk or if it could harm a nursing baby. You should not breastfeed while using this medicine. How is testosterone injection given? Testosterone is injected into a muscle. The injection is usually given every 2 to 4 weeks. Testosterone injections should be given only by a healthcare professional. Misuse can lead to serious side effects or death. The length of treatment will depend on the condition being treated. Testosterone will not enhance athletic performance and should not be used for that purpose. While receiving this medicine, you will need frequent blood tests. Testosterone can affect bone growth in boys who are treated for delayed puberty. Bone development may need to be checked with x-rays every 6 months during treatment.   What happens if I miss a dose? Call your doctor for instructions if you miss an appointment for your testosterone injection. What happens if I overdose? Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. What should I avoid while receiving testosterone injection? Follow your doctor's instructions about any restrictions on food, beverages, or activity. Testosterone side effects Get emergency medical help if you have any signs of an allergic reaction to testosterone: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Get emergency medical help if you have any signs of a blood clot in the lung after using testosterone. These symptoms include chest pain, dizziness, trouble breathing, urge to cough, throat tightening and fainting. Misuse of testosterone can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence. Call your doctor at once if you have: chest pain or pressure, pain spreading to your jaw or shoulder; swelling in your ankles or feet, rapid weight gain; chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; pain, swelling, warmth, or redness in one or both legs; nausea or vomiting; changes in skin color; increased or ongoing erection of the penis; impotence, ejaculation problems, decreased amounts of semen, decrease in testicle size; painful or difficult urination; shortness of breath (even with mild exertion); stomach pain, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless; or upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Women receiving testosterone may develop male characteristics, which could be irreversible if treatment is continued. Call your doctor at once if you notice any of these signs of excess testosterone: acne; changes in menstrual periods; male-pattern hair growth (such as on the chin or chest); hoarse or deepened voice; or enlarged clitoris. Common testosterone side effects (in men or women) may include: breast swelling; headache, anxiety; increased facial or body hair growth, male-pattern baldness; increased or decreased interest in sex; numbness or tingly feeling; or pain or swelling where the medicine was injected. 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 testosterone? Certain drugs may interact with testosterone, including; Blood thinners (including warfarin, Coumadin, Jantoven) Anti-inflammatory drugs, such as oxyphenbutazone Other prescription and over-the-counter medicines, vitamins, and herbal products may also react with testosterone. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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