Atropine affects the body in many different ways, such as reducing spasms in the bladder, stomach, and intestines.
Diphenoxylate is an antidiarrheal medication.
Atropine and diphenoxylate is a combination medicine used to treat diarrhea in adults and children who are at least 13 years old.
Atropine and diphenoxylate may also be used for purposes not listed in this medication guide.
Do not use atropine and diphenoxylate if you have diarrhea that is caused by bacteria or by taking an antibiotic. You should not use atropine and diphenoxylate if you have a bile duct disorder causing jaundice (yellowing of your skin or eyes).
Keep this medicine where a child cannot reach it. An overdose can be fatal to a child.
You should not use this medicine if you are allergic to atropine or diphenoxylate, or if you have:
obstructive jaundice (a bile duct disorder that may cause yellowing of your skin or eyes);
diarrhea that is caused by bacteria; or
diarrhea caused by using antibiotic medication.
Atropine and diphenoxylate is not approved for use by anyone younger than 6 years old. This medicine has not been proven safe or effective in children younger than 13 years old.
Tell your doctor if you have ever had:
a blockage in your intestines;
ulcerative colitis;
asthma or other breathing problems;
glaucoma;
urination problems;
liver or kidney disease;
Down's syndrome; or
if you are dehydrated.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.
It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.
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.
Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
Drink plenty of liquids to keep from getting dehydrated while you have diarrhea. Your doctor may recommend an electrolyte supplement such as Gatorade or Pedialyte. Carefully follow all care instructions.
It may take up to 48 hours before your symptoms improve. Keep using the medication as directed. Call your doctor if you still have diarrhea after 10 days, or if you have a fever.
Store at room temperature away from moisture and heat.
Keep atropine and diphenoxylate where a child cannot reach it. An overdose of atropine and diphenoxylate can be fatal to a child.
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.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of atropine and diphenoxylate can cause breathing problems and may result in death or permanent brain damage.
Early overdose symptoms include weakness, blurred vision, slurred speech, feeling hot, fast heartbeats, slowed breathing, fainting, seizure, or coma. Report any early overdose symptoms to your doctor as soon as possible.
Avoid driving or hazardous activity until you know how atropine and diphenoxylate will affect you. Your reactions could be impaired.
Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor's instructions about the type and amount of liquids you should drink.
Drinking alcohol with this medicine can cause 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.
Some side effects may occur up to 30 hours after you take this medicine.
Stop using this medicine and call your doctor at once if you have:
severe constipation, stomach pain or bloating;
ongoing or worsening diarrhea;
diarrhea that is watery or bloody;
severe pain in your upper stomach spreading to your back;
fever, flushing (warmth, redness, or tingly feeling);
hallucinations, seizure;
rapid breathing, weak or shallow breathing;
fast heart rate; or
dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.
Common side effects may include:
drowsiness, dizziness, feeling restless;
headache;
numbness in your hands or feet;
depression, not feeling well;
confusion, feelings of extreme happiness;
red or swollen gums;
dry mouth, nose, or throat;
nausea, vomiting, upset stomach, loss of appetite; or
skin rash, dryness, or itching.
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.
Usual Adult Dose for Diarrhea:
Initial dose: 2 tablets or 10 mL (5 mg of diphenoxylate), orally, 4 times a day
Maintenance dose: Once control is achieved, reduce dose to individual requirements, to as little as 2 tablets or 10 mL once a day
Maximum dose: 20 mg diphenoxylate per day
Comments:
-Clinical improvement is usually seen within 48 hours.
-If no improvement is seen within 10 days, symptoms are unlikely to respond to further administration.
Usual Pediatric Dose for Diarrhea:
2 years and older:
Initial dose: 0.3 to 0.4 mg/kg of diphenoxylate, orally, in 4 divided doses
Maintenance dose: Once control is achieved, reduce dose to individual requirements, to as little as one quarter of the initial daily dosage
Maximum dose: 20 mg diphenoxylate per day
Comments:
-These doses are approximate; adjust downward according to nutritional status and degree of dehydration.
-Reduce dose as soon as initial control of symptoms has been achieved.
-If no response within 48 hours, this medicine is unlikely to be effective.
-Use only the liquid medication in children under 13 years old; do not use tablets.
Using atropine and diphenoxylate with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, cold or allergy medicine, or medicine for anxiety, depression, or seizures.
Tell your doctor about all your other medicines. Some may affect atropine and diphenoxylate, especially:
medicine to treat Parkinson's disease;
medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;
bladder or urinary medicines;
a bronchodilator; or
an MAO inhibitor--isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
This list is not complete. Other drugs may affect atropine and diphenoxylate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.