Monograph Details

Gastrointestinal Tract > Hyperacidity, GERD, and ulcers
BELLERGAL-S
Manufacturer
Novartis Pharmaceuticals Corp
Legal Classification
Rx
Pharmacological Class
Barbiturate + ergot alkaloid + anticholinergic.
Generic Name
Phenobarbital 40mg, ergotamine tartrate 0.6mg, levorotatory alkaloids of belladonna 0.2mg; scored tabs; contains tartrazine.
Indications
GI disorders where simultaneous adrenergic and cholinergic inhibition and sedation are indicated.
Children
Not recommended.
Adults
1 tab twice daily; max 16 tabs weekly.
Contraindications
Coronary or peripheral vascular disease. Hypertension. Impaired hepatic or renal function. Sepsis. Glaucoma. Porphyria. Paradoxidal reactions to phenobarbital. Pregnancy (Cat.X). Nursing mothers.
Precautions
GI or urinary tract obstruction. Paralytic ileus or intestinal atony. Toxic megacolon. Severe ulcerative colitis. Myasthenia gravis. Reflux esophagitis. Avoid prolonged use. Autonomic neuropathy. Hyperthyroidism. High environmental temperature. Diarrhea. Asthma. Drug abusers. Elderly. Debilitated.
Interactions
Avoid other vasoconstrictors (e.g., dopamine). Drowsiness potentiated by other CNS depressants, alcohol. Concomitant antacids may inhibit absorption. May antagonize anticoagulants. Barbiturates induce hepatic drug-metabolizing enzymes. Monitor patients on concomitant β-blockers. Additive anticholinergic effects with tricyclic antidepressants.
Adverse Reactions
Drowsiness, vasoconstrictive complications (ergotism), tachycardia or bradycardia, nausea, vomiting, localized edema, itching, paresthesias, anticholinergic effects, paradoxical excitement.
How Supplied
Tabs—100
Additional Resources
Related Prescribing Note