section name header

Indications

REMS

Contraind./Precautions

Contraindicated in:

Use Cautiously in:

Adv. Reactions/Side Effects

CV: tachycardia.

Derm: flushing.

EENT: blurred vision, dry eyes.

GI: constipation, dry mouth, epigastric distress, ileus, nausea, vomiting.

GU: urinary retention.

Neuro: dizziness, confusion, drowsiness, headache, insomnia, nervousness.

Interactions

Drug-Drug:

Drug-Natural Products:

Availability

Difenoxin/Atropine

Diphenoxylate/Atropine

(generic available)

Route/Dosage

see Calculator

Difenoxin/Atropine

Doses given are in terms of difenoxin—each tablet contains 1 mg difenoxin with 0.025 mg of atropine

Diphenoxylate/Atropine

Adult doses given are in terms of diphenoxylate—each tablet contains 2.5 mg diphenoxylate with 0.025 mg of atropine; pediatric doses are given in mg of diphenoxylate and in mL of diphenoxylate/atropine liquid; each 5 mL of liquid contains 2.5 mg diphenoxylate with 0.025 mg of atropine

US Brand Names

Lomotil

difenoxin/atropine: Motofen

Action

Therapeutic Effects:

Classifications

Therapeutic Classification: antidiarrheals

Pharmacologic Classification: anticholinergics

Pharmacokinetics

Absorption: Well absorbed from the GI tract.

Distribution: Enters breast milk.

Metabolism/Excretion: Diphenoxylate: mostly metabolized by the liver with some conversion to an active antidiarrheal compound (difenoxin). Difenoxin: metabolized by the liver. Minimal excretion in urine.

Half-life: Diphenoxylate: 2.5 hr; difenoxin: 4.5 hr.

Contr. Subst. Schedule


Schedule V (C-V)(diphenoxylate/atropine)
Schedule IV (C-IV)(difenoxin/atropine)

Time/Action Profile

(antidiarrheal action)

ROUTEONSETPEAKDURATION
Difenoxin–PO45–60 min2 hr3–4 hr
Diphenoxylate–PO45–60 min2 hr3–4 hr

Patient/Family Teaching

Pronunciation

dye-fen-OX-i-late/A-troe-peen

difenoxin/atropine: dye-fen-OX-in/A-troe-peen audio

Code

NDC Code*