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Donnatal Elixir Generic Name & Formulations
Legal Class
Rx
General Description
Phenobarbital 16.2mg, hyoscyamine sulfate 0.1037mg, atropine sulfate 0.0194mg, scopolamine HBr 0.0065mg; per 5mL; contains alcohol; grape flavor.
Pharmacological Class
Barbiturate + anticholinergics.
See Also
How Supplied
Tabs—100, 1000; Elixir—4oz, pt
Manufacturer
Donnatal Elixir Indications
Indications
Adjunct in irritable bowel syndrome, enterocolitis, duodenal ulcer.
Donnatal Elixir Dosage and Administration
Adult
5–10mL 3–4 times daily.
Children
<10lb (4.5kg): not recommended. 10lb (4.5kg): Initially 0.5mL every 4hrs or 0.75mL every 6hrs. 20lb (9.1kg): 1mL every 4hrs or 1.5mL every 6hrs. 30lb (13.6kg): 1.5mL every 4hrs or 2mL every 6hrs. 50lb (22.7kg): 2.5mL every 4hrs or 3.75mL every 6hrs. 75lb (34kg): 3.75mL every 4hrs or 5mL every 6hrs. 100 lb (45.4kg): 5mL every 4hrs or 7.5mL every 6hrs.
Donnatal Elixir Contraindications
Contraindications
Glaucoma. Porphyria. Unstable cardiovascular status. GI or GU obstruction. Paralytic ileus or intestinal atony. Toxic megacolon. Severe ulcerative colitis. Myasthenia gravis. Hiatal hernia. History of paradoxical reactions to phenobarbital.
Donnatal Elixir Boxed Warnings
Not Applicable
Donnatal Elixir Warnings/Precautions
Warnings/Precautions
Renal or hepatic impairment. Autonomic neuropathy. Cardiovascular disease. Hypertension. Hyperthyroidism. Drug abusers. High environmental temperature. Gastric ulcer. Diarrhea. Elderly. Debilitated. Pregnancy (Cat.C). Nursing mothers.
Donnatal Elixir Pharmacokinetics
See Literature
Donnatal Elixir Interactions
Interactions
Potentiated CNS depression with alcohol, other CNS depressants. Additive anticholinergic effects with other anticholinergics, narcotics, type I antiarrhythmics, antihistamines, phenothiazines, tricyclics. May antagonize anticoagulants, CYP450 substrates.
Donnatal Elixir Adverse Reactions
Adverse Reactions
Drowsiness, anticholinergic effects, paradoxical excitement.
Donnatal Elixir Clinical Trials
See Literature
Donnatal Elixir Note
Not Applicable
Donnatal Elixir Patient Counseling
See Literature
