Difenoxin and atropine

MOTOFEN® is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.

Difenoxin and atropine combination medicine is used along with other measures to treat severe diarrhea in adults. Difenoxin helps stop diarrhea by slowing down the movements of the intestines.

Since difenoxin is chemically related to some narcotics, it may be habit-forming if taken in doses that are larger than prescribed. To help prevent possible abuse, atropine (an anticholinergic) has been added. If higher-than-normal doses of the combination are taken, the atropine will cause unpleasant effects, making it unlikely that such doses will be taken again.

Difenoxin and atropine combination medicine should not be used in children. Children with diarrhea should be given solutions of carbohydrates (sugars) and electrolytes (important salts) to replace the water and important salts that are lost from the body during diarrhea.

difenoxin and atropine is available only with your doctor's prescription.

If difenoxin and atropine upsets your stomach, your doctor may want you to take it with food.

Take difenoxin and atropine only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming.

Importance of diet and fluids while treating diarrhea:

• In addition to using medicine for diarrhea, it is very important that you replace the fluid lost by the body and follow a proper diet. For the first 24 hours you should eat gelatin and drink plenty of caffeine-free clear liquids, such as ginger ale, decaffeinated cola, decaffeinated tea, and broth. During the next 24 hours you may eat bland foods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables, fried or spicy foods, bran, candy, caffeine, and alcoholic beverages may make the condition worse.
• If too much fluid has been lost by the body due to the diarrhea a serious condition may develop. Check with your doctor as soon as possible if any of the following symptoms of too much fluid loss occur:
  • Decreased urination
  • Dizziness and lightheadedness
  • Dryness of mouth
  • Increased thirst
  • Wrinkled skin

Dosing

The dose of difenoxin and atropine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of difenoxin and atropine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For severe diarrhea:
    • Adults and teenagers—The first dose is usually 2 milligrams (mg). After that, the dose is 1 mg taken after each loose stool or every three or four hours as needed. Do not take more than 8 mg in any twenty-four-hour period.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of difenoxin and atropine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dizziness.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Atropine and Difenoxin

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, oral:

Motofen: Difenoxin hydrochloride 1 mg and atropine sulfate 0.025 mg [dye free]

• Antidiarrheal

Hypersensitivity to difenoxin, atropine, or any component of the formulation; jaundice; diarrhea associated with organisms that penetrate the intestinal mucosa (eg, toxigenic E. coli, Salmonella spp., Shigella) and pseudomembranous colitis associated with broad-spectrum antibiotics; children <2 years of age.

Store at 20°C to 25°C (68°F to 77°F).

There are no data on the excretion of atropine-difenoxin into human milk. The effects in the nursing infant are unknown. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.