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Diphenoxylate Hcl/atropine Sulfate Oral Solution Generic Name & Formulations
Legal Class
CV
General Description
Diphenoxylate HCl 2.5mg, atropine sulfate 0.025mg; per 5mL liq; alcohol 15%.
Pharmacological Class
Opioid + anticholinergic.
How Supplied
Soln—60mL
Manufacturer
Diphenoxylate Hcl/atropine Sulfate Oral Solution Indications
Indications
Adjunct therapy in the management of diarrhea.
Diphenoxylate Hcl/atropine Sulfate Oral Solution Dosage and Administration
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.
Diphenoxylate Hcl/atropine Sulfate Oral Solution Contraindications
Contraindications
Obstructive jaundice. Diarrhea associated with pseudomembranous enterocolitis or other enterotoxin-producing bacteria.
Diphenoxylate Hcl/atropine Sulfate Oral Solution Boxed Warnings
Not Applicable
Diphenoxylate Hcl/atropine Sulfate Oral Solution Warnings/Precautions
Warnings/Precautions
Dehydration. Electrolyte imbalance. Acute ulcerative colitis; discontinue if toxic megacolon occurs. Hepatic or renal impairment. Drug abusers. Pregnancy (Cat.C). Nursing mothers.
Diphenoxylate Hcl/atropine Sulfate Oral Solution Pharmacokinetics
See Literature
Diphenoxylate Hcl/atropine Sulfate Oral Solution Interactions
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.
Diphenoxylate Hcl/atropine Sulfate Oral Solution Adverse Reactions
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).
Diphenoxylate Hcl/atropine Sulfate Oral Solution Clinical Trials
See Literature
Diphenoxylate Hcl/atropine Sulfate Oral Solution Note
Not Applicable
Diphenoxylate Hcl/atropine Sulfate Oral Solution Patient Counseling
See Literature
