B-Donna Tablets
Generic name:phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
Dosage form: tablet
Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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DESCRIPTION:
Each B-Donna™ Tablet contains:
Phenobarbital, USP..... 16.2 mg
Hyoscyamine Sulfate, USP..... 0.1037 mg
Atropine Sulfate, USP .....0.0194 mg
Scopolamine Hydrobromide, USP .....0.0065 mg
INACTIVE INGREDIENTS:
Anhydrous Lactose, Calcium Stearate, Colloidal Silicon Dioxide, Corn Starch, and Microcrystalline Cellulose.
CLINICAL PHARMACOLOGY:
This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.
INDICATIONS AND USAGE:
Based on a review of this drug by the National Academy of Sciences–National Research Council and/or other information, FDA has classified the following indications as: “possibly” effective:
For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
May also be useful as adjunctive therapy in the treatment of duodenal ulcer.
IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.
CONTRAINDICATIONS:
Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; myasthenia gravis; hiatal hernia associated with reflux esophagitis.
B-Donna™ is contraindicated in patients with k
