Drug Facts

How The Drug Works

Difenoxin and diphenoxylate, related to the narcotic pain reliever meperidine, act on intestinal tract muscles and slow intestinal motility. Atropine is present to discourage deliberate misuse of these drugs.

Uses

To relieve diarrhea.

Pregnancy: Adequate studies have not been done in pregnant women. Use only if clearly needed and potential benefits outweigh the possible hazards to the fetus.

Breastfeeding: Difenoxin and diphenoxylate may appear in breast milk.

Atropine appears in breast milk. Because of the potential for serious side effects in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Children: Do not use difenoxin tablets or diphenoxylate liquid in children under 2 years of age. Do not use diphenoxylate tablets in children under 13 years of age. Safety and effectiveness of difenoxin tablets have not been established in children under 12 years of age. Use with caution in children with Down syndrome due to presence of atropine.

Drug Interactions

Tell your doctor or pharmacist if you are taking or if you are planning to take any over-the-counter or prescription medications or dietary supplements with antidiarrheals containing difenoxin, diphenoxylate, or atropine sulfate. Doses of one or both drugs may need to be modified or a different drug may need to be prescribed. The following drugs and drug classes interact with antidiarrheals containing difenoxin, diphenoxylate, or atropine sulfate.

Side Effects

Every drug is capable of producing side effects. Many antidiarrheal users experience no, or minor, side effects. The frequency and severity of side effects depend on many factors including dose, duration of therapy, and individual susceptibility. Possible side effects include:

Both: Nausea; vomiting; dizziness; drowsiness; headache.

Difenoxin Only: Constipation; lightheadedness; dry mouth; stomach pain.

Diphenoxylate Only: Stomach ache; appetite loss; toxic megacolon; paralyticileus; pancreatitis; restiessness; confusion; depression; exaggerated sense of well-being; itching; hives; swelling of gums; numbness of arms or legs; general body discomfort; allergic reaction.

Atropine Only: Dry skin; flushing; fever; fast heartbeat; urinary retention.

Guidelines for Use

• Difenoxin - Starting dose in adults is 2 mg by mouth, then 1 mg after each loose stool or 1 mg every 3 to 4 hours as needed. Total dose in any 24-hour period should not exceed 8 mg.
• Diphenoxylate - Initial dosage in adults is 2 tablets by mouth 4 times daily or 10 ml (2 tsp) of liquid 4 times daily (20 mg/day). Once control of diarrhea is achieved, reduce the dose to the lowest possible level (eg, 2 tablets daily) to maintain control.
• Do not use tablets for children under 13 years of age. Only use the plastic dropper included with the liquid to measure doses for children. Doses for children must be carefully determined. Talk to your doctor or pharmacist about the correct dose for your child.
• If clinical improvement of acute diarrhea is not observed within 48 hours, do not continue the medication. If improvement of chronic diarrhea is not seen within 10 days of using diphenoxylate (with a maximum daily dose of 20 mg), symptoms are unlikely to be controlled by further administration.
• Do not take more than the prescribed dose.
• Appropriate fluid and electrolyte therapy should be used in conjunction with diphenoxylate therapy in the treatment of diarrhea in children.
• Avoid alcohol and other sedatives that may cause drowsiness.
• May cause drowsiness or dizziness. Use caution when performing tasks requiring alertness, coordination, or physical dexterity.
• May cause dry mouth. Chew sugarless gum or suck sugarless hard candies if desired.
• Keep out of reach of children because accidental overdose may result in severe, even fatal, breathing problems.
• Notify your doctor if diarrhea persists or if fever, rapid heart rate, or stomach swelling occur.
• Store at room temperature (59^o to 86°F) in a child resistant container.
• Protect diphenoxylate from light.

Tagged under:dietary supplements, dizziness, drug interactions, intestinal tract narcotic pain reliever