| DIPHENOXYLATE HYDROCHLORIDE WITH ATROPINE SULFATE
Diphenatol, Lofene, Lomanate, Lomotil, Lonox, Lo-Trol, Low-Quel, Nor-Mil
Classifications: antidiarrheal; Therapeutic: antidiarrheal
Pregnancy Category: C
Controlled Substance: Schedule V
2.5 mg tablets; 2.5 mg/5 mL liquid
Diphenoxylate is a synthetic narcotic opiate agonist. Commercially available only with atropine sulfate, added in subtherapeutic
doses to discourage deliberate overdosage. Inhibits mucosal receptors responsible for peristaltic reflex, thereby reducing
Reduces GI motility. Has little or no analgesic activity or risk of dependence, except in high doses.
Adjunct in symptomatic management of diarrhea.
Hypersensitivity to diphenoxylate or atropine; severe dehydration or electrolyte imbalance, advanced liver disease, obstructive
jaundice, diarrhea caused by pseudomembranous enterocolitis associated with use of broad-spectrum antibiotics; diarrhea
associated with organisms that penetrate intestinal mucosa; diarrhea induced by poisons until toxic material is eliminated
from GI tract; glaucoma; children <2 y of age; pregnancy (category C), lactation.
Advanced hepatic disease, abnormal liver function tests; renal function impairment, MAOI therapy; patients receiving addicting
drugs, addiction-prone individuals, or those whose history suggests drug abuse; ulcerative colitis; young children (particularly
patients with Down syndrome).
Route & Dosage
Adult: PO 12 tablets or 12 teaspoons full (5 mL) 34 times/d (each tablet or 5 mL contains 2.5 mg diphenoxylate HCl
and 0.025 mg atropine sulfate)
Child (212 y): PO 0.30.4 mg/kg/d of liquid in divided doses
- Crush tablet if necessary and give with fluid of patient's choice.
- Reduce dosage as soon as initial control of symptoms occurs.
- Withhold drug in presence of severe dehydration or electrolyte imbalance until appropriate corrective therapy has been initiated.
- Note: Treatment is generally continued for 2436 h before it is considered ineffective.
- Store in tightly covered, light-resistant container, preferably 15°30° C (59°86° F), unless
otherwise directed by manufacturer.
Adverse Effects (≥1%)Body as a Whole:
Hypersensitivity (pruritus, angioneurotic edema, giant urticaria, rash). CNS:
Headache, sedation, drowsiness, dizziness, lethargy, numbness of extremities; restlessness, euphoria, mental depression
weakness, general malaise. CV:
Flushing, palpitation, tachycardia. Special Senses:
Nystagmus, mydriasis, blurred vision, miosis (toxicity). GI:
Nausea, vomiting, anorexia, dry mouth, abdominal discomfort or distension, paralytic ileus, toxic megacolon. Other:
Urinary retention, swelling of gums.
InteractionsDrug: mao inhibitors
may precipitate hypertensive crisis; alcohol
and other cns depressants
may enhance CNS effects; also see atropine.
Readily absorbed from GI tract. Onset:
4560 min. Peak:
2 h. Duration:
34 h. Distribution:
Distributed into breast milk. Metabolism:
Rapidly metabolized to active and inactive metabolites in liver. Elimination:
Slowly through bile into feces; small amount in urine. Half-Life:
Assessment & Drug Effects
- Assess GI function; report abdominal distention and signs of decreased peristalsis.
- Monitor for S&S of dehydration (see Appendix F). It is essential to monitor young children closely; dehydration occurs more
rapidly in this age group and may influence variability of response to diphenoxylate and predispose patient to delayed toxic
- Monitor frequency and consistency of stools.
Patient & Family Education
- Take medication only as directed by physician.
- Notify physician if diarrhea persists or if fever, bloody stools, palpitation, or other adverse reactions occur.
- Do not drive or engage in other potentially hazardous activities until response to drug is known.