Monograph Details
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Gastrointestinal Tract
> Hyperacidity, GERD, and ulcers
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DONNATAL ELIXIR |
| Manufacturer |
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PBM Pharmaceuticals, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Barbiturate + anticholinergics. |
| Generic Name |
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Phenobarbital 16.2mg, hyoscyamine sulfate 0.1037mg, atropine sulfate 0.0194mg, scopolamine HBr 0.0065mg; per 5mL; contains alcohol; grape flavor. |
| Also |
• DONNATAL EXTENTABS
• DONNATAL TABLETS
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| Indications |
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Adjunct in irritable bowel syndrome, enterocolitis, duodenal ulcer. |
| Children |
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<10 lb (4.5 kg): not recommended. 10 lb (4.5 kg): Initially 0.5mL every 4 hours or 0.75mL every 6 hours. 20 lb (9.1 kg): 1mL every 4 hours or 1.5mL every 6 hours. 30 lb (13.6 kg): 1.5mL every 4 hours or 2mL every 6 hours. 50 lb (22.7 kg): 2.5mL every 4 hours or 3.75mL every 6 hours. 75 lb (34 kg): 3.75mL every 4 hours or 5mL every 6 hours. 100 lb (45.4 kg): 5mL every 4 hours or 7.5mL every 6 hours. |
| Adults |
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5–10mL 3–4 times daily. |
| Contraindications |
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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. |
| Precautions |
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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. |
| Interactions |
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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. |
| Adverse Reactions |
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Drowsiness, anticholinergic effects, paradoxical excitement. |
| How Supplied |
Tabs—100, 1000
Extentabs—100, 500
Elixir—4oz, pt |
| Additional Resources |
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• Related Prescribing Note |
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