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Diphenoxylate HCl/Atropine Sulfate Oral Solution
Diarrhea
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Drug Name:

Diphenoxylate HCl/Atropine Sulfate Oral Solution CV

Generic Name and Formulations:
Diphenoxylate HCl 2.5mg, atropine sulfate 0.025mg; per 5mL liq; alcohol 15%.

Company:
Hikma Pharmaceuticals

Therapeutic Use:

Indications for Diphenoxylate HCl/Atropine Sulfate Oral Solution:

Adjunct therapy in the management of diarrhea.

Adult:

10mL 4 times daily until diarrhea is controlled; max 20mg/day. Maintenance: 10mL daily. Discontinue if no improvement within 10 days after treatment with max dose.

Children:

See full labeling. <2yrs: not recommended. 2–12yrs: initially 0.3–0.4mg/kg in 4 divided doses until diarrhea is controlled. Maintenance: 25% of initial dose; max 48hrs.

Contraindications:

Obstructive jaundice. Diarrhea associated with pseudomembranous enterocolitis or other enterotoxin-producing bacteria.

Warnings/Precautions:

Dehydration. Electrolyte imbalance. Acute ulcerative colitis; discontinue if toxic megacolon occurs. Hepatic or renal impairment. Drug abusers. Pregnancy (Cat.C). Nursing mothers.

Pharmacological Class:

Opioid + anticholinergic.

Interactions:

Concomitant MAOIs may cause hypertensive crisis; avoid use. Potentiates sedation with alcohol, CNS depressants (eg, barbiturates, tranquilizers). May delay elimination of other drugs metabolized by CPY450.

Adverse Reactions:

Nausea, vomiting, abdominal discomfort, paralytic ileus, toxic megacolon, dizziness, drowsiness, headache, euphoria, tachycardia, numbness of extremities, pruritus, urticaria, angioneurotic edema, anticholinergic effects; respiratory depression (overdosage), atropinism (esp in pediatrics with Down's syndrome).

How Supplied:

Soln—60mL


Data provided by MPR.

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