hyoscyamine, atropine, scopolamine and phenobarbital, Donnatal

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Pharmacy Author:

Omudhome Ogbru, PharmD

Omudhome Ogbru, PharmD

Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

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Medical and Pharmacy Editor:

Jay W. Marks, MD

Jay W. Marks, MD

Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

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GENERIC NAME: hyoscyamine sulfate, atropine sulfate, scopolamine sulfate and phenobarbital

BRAND NAME: Donnatal, Donnatal Extentabs

DRUG CLASS AND MECHANISM: Belladonna/phenobarbital is an oral medication which combines naturally occurring belladonna alkaloids (atropine, scopolamine [Transderm-Scop], and hyoscyamine) with phenobarbital. It is used for treating abdominal discomfort that is thought to be due to muscular spasm of the intestinal muscles. Belladonna alkaloids block the action of acetylcholine, a chemical that nerves to use to communicate with other nerves and muscles. Acetylcholine stimulates the muscles of the intestines that propels digesting food through the intestine. It also affects the secretion of fluids by salivary glands and the stomach. By blocking acetylcholine, belladonna alkaloids relax intestinal muscles, slow passage of digesting food through the intestines, and reduce gastric secretion. Phenobarbital produces sedation. The FDA classifies Belladonna/phenobarbital as possibly effective for its stated uses.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

PREPARATIONS:

• Tablets: 16.2 mg phenobarbital, 0.1037 mg hyoscyamine sulfate, 0.0194 mg atropine sulfate, and 0.065 mg scopolamine hydrobromide
• Sustained release tablets: 48.6 mg phenobarbital, 0.311 mg hyoscyamine sulfate, 0.0582 mg atropine sulfate, and 0.0195 mg scopolamine hydrobromide.
• Elixir (per 5ml): 16.2 mg phenobarbital, 0.1037 mg hyoscyamine sulfate, 0.0194 mg atropine sulfate, and 0.0065 mg scopolamine hydrobromide.

STORAGE: Belladonna/phenobarbital should be stored at controlled room temperature between 15-30 C (59-86 F)

PRESCRIBED FOR: Belladonna/phenobarbital is used in the treatment of abdominal pain, bloating and cramps in patients with irritable bowel syndrome. It is also used in patients with acute inflammation of the stomach and intestines (gastroenteritis) to reduce pain and diarrhea. It is used occasionally as additional therapy in patients with duodenal ulcer.

DOSING: May be taken with or without food. The dosage is adjusted to the individual patient to assure control of symptoms with a minimum of side effects. The usual doses are 1-2 regular tablets 3 to 4 times daily or 1 extended release tablet every 8 or 12 hours or 5-10 ml of the elixir, 3 or 4 times daily.

DRUG INTERACTIONS: Phenobarbital reduces the blood levels of several drugs by increasing their breakdown in the body. Examples include voriconazole (Vfend), bocepravir (Victrelis), ranolazine (Ranexa), and protease inhibitors (for example, atazanavir [Reyataz], indinavir [Crixivan], saquinavir [Invirase], ritonavir [Norvir]). Belladonna/phenobarbital should not be combined with potassium tablets because belladonna/phenobarbital slows the passage of potassium tablets through the gastrointestinal tract, leading to potassium-induced ulcers and high potassium levels in the blood.

PREGNANCY: Use during pregnancy has not been adequately evaluated. Pregnant women should use belladonna alkaloid/phenobarbital only when the expected benefit outweighs the potential but unknown risks.

NURSING MOTHERS: Belladonna/phenobarbital are secreted in breast milk and may also reduce milk production.

SIDE EFFECTS: Adverse reactions include constipation, dry eyes, dry mouth and urinary hesitancy and retention (difficulty urinating, particularly in men). Blurred vision, rapid heart rate, and palpitations also may occur. Headache, nervousness, drowsiness, and dizziness can be seen. Caution is advised in patients with glaucoma, myasthenia gravis and urinary obstruction since symptoms of these conditions may worsen with the use of belladonna/phenobarbital. Patients with an unstable cardiac status, severe ulcerative colitis and acute intermittent porphyria should avoid belladonna/phenobarbital. Elderly patients may experience confusion, depression, and excitement even from small doses.

Reference: FDA Prescribing Information

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