From the FDA Drug Label
INDICATIONS AND USAGE Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon,mucous colitis) and functional gastrointestinal disorders The recommended use of Donnatal (belladonna and phenobarbital) for gastrointestinal disorders is as an adjunctive therapy in the treatment of:
- Peptic ulcer
- Spastic colitis
- Functional intestinal disorders
- Irritable bowel syndrome 1
From the Research
Donnatal, a combination of belladonna alkaloids and phenobarbital, is recommended as an adjunctive therapy for irritable bowel syndrome (IBS) and acute enterocolitis when other first-line treatments have failed, with a typical adult dosage of one tablet or 5-10 mL of elixir taken three to four times daily before meals and at bedtime, as supported by the most recent and highest quality study available 2. The treatment duration should be limited, generally not exceeding a few weeks due to the potential for dependence on the phenobarbital component. Donnatal works through dual mechanisms: the anticholinergic belladonna alkaloids reduce smooth muscle spasms in the gastrointestinal tract, while phenobarbital provides mild sedative effects that can help reduce anxiety-related GI symptoms. However, Donnatal is no longer considered a first-line treatment due to limited evidence supporting its efficacy and potential side effects including dry mouth, urinary retention, blurred vision, and drowsiness, as noted in various studies 3, 4, 5, 6. It should be used cautiously in elderly patients and is contraindicated in those with glaucoma, prostatic hypertrophy, or myasthenia gravis. Patients should avoid alcohol while taking this medication as it can enhance the sedative effects. Some studies suggest that other treatments, such as low dose naltrexone, may be effective in treating gastrointestinal disorders, but the evidence is limited and more research is needed 4. In general, the use of Donnatal should be approached with caution and patients should be closely monitored for potential side effects and interactions with other medications. Key considerations for the use of Donnatal include:
- Limited evidence supporting its efficacy
- Potential for dependence on the phenobarbital component
- Side effects including dry mouth, urinary retention, blurred vision, and drowsiness
- Contraindications in patients with glaucoma, prostatic hypertrophy, or myasthenia gravis
- Need for cautious use in elderly patients
- Potential interactions with other medications, including alcohol.