International generic name Combined product
Drug form and composition Coated tablets. One coated tablet contains: 0.1 mg Belladonna Alkaloids; 0.3 mg Ergotamine tartrate; 20 mg Phenobarbital.
Indications Neuroses; insomnia; climacteric symptom complex; cardiovascular diseases with neuro-vegetative symptoms; Meniere syndrome; vertigo; kinesias; migraine; neurodermitis and pruritus; ulcer; gastrointestinal diseases accompanies with hypermotility and hypersecretion.
Dosage and administration The recommended dose is 1 tablet, 3-4 times daily. In lack of satisfactory therapeutic effect, the daily dose may be increased.
Contraindications Hypersensitivity to some components of the preparation; arterial hypertension; stenocardia; myocardial infarction; atrial fibrillation; peripheral vascular spastic diseases; pregnancy and lactation; liver porphyria and other severe liver and renal diseases; narrow angle glaucoma; high degree hypertrophy of prostate; sepsis.
Special warnings and precautions The obstructive uropathy with various etiology requires a special attention in the use of preparation. In case of mechanical obstacles along gastrointestinal tract of various etiology, pyloro-duodenal stenosis, in megacolon, the administration of Bellergamin may lead to retention of gastrointestinal content, meteorism, intoxication. In a long-term treatment the preparation may lead to visual disturbances (mydriasis and cycloplegia). There are no data on the therapeutic efficacy and safety of the preparation in pediatric practice. The long-term therapy with high doses requires an exact precision of daily doses of phenobarbital administration due to a danger of development of tolerance and drug interaction. Its administration by drivers and persons working with machines is not desirable due to failing of active attention and reflexes.
Drug interactions The phenothiazine preparations, the antiparkinsonics, and the tricyclic antidepressants potentiate atropine effects. Ergotamine toxicity is increased at the simultaneous administration with macrolide antibiotics and non-selective beta-blockers. Phenobarbital decreases the activity of dicumarol and increases toxicity of phenytoin and halothan. Alcohol and narcotic analgesics increase the sedative effect of phenobarbital.
Adverse reactions Xerostomia; sense of fatigue; drowsiness; visual disturbances (mydriasis and cycloplegia); glaucoma attack at higher doses; reduced gastrointestinal motility and constipation; gastrointestinal discomfort (nausea, vomiting, colics); tachycardia; urine retention.
Pharmacological mechanisms Bellergamin possesses cholinolytic ganglioplegic and sedative action and has a regulation effect on the functions of vegetative nervous system. Alkaloids of Atropa belladonna, exerting a manifested peripheral and a certain central M-cholinolytic action, suppress the spasms of smooth muscles of gastrointestinal and urogenital tract, inhibit the secretion of exocrine glands, at therapeutic doses manifest a sedative effect. Ergotamine exerts adrenolytic effect, weakly inhibits metabolism, exerts a manifested antiserotonine action, has a manifested uterotonic and vasospastic effect. Phenobarbital exerts a central sedative effect, suppresses insomnia, has a manifested anticonvulsive action.
Supplied 20 or 800 coated tablets.
Expiry 2 years. |