| BELLERGAL® SPACETABS® |
|Novartis Pharmaceuticals |
|Belladonna - Ergotamine Tartrate - Phenobarbital |
|Anticholinergic - Antispasmodic - Sedative |
|Indications And Clinical Uses: Functional symptoms such as hot flushes, perspiration, palpitations, dizzy spells, restlessness, apprehension, fatigue, insomnia, headache, for example in patients with anxiety-tension states associated with menopause.
Menopausal women who are treated with Bellergal, exhibiting atrophic vaginitis and/or osteoporosis, require specific therapy for these conditions if indicated.
Contra-Indications: Narrow-angle glaucoma, sepsis, occlusive vascular disease, hypertension, peripheral vascular disease, severe coronary insufficiency, myocardial lesions, pregnancy and lactation, severe disorders of renal or hepatic function, porphyria, malnutrition, prostatic hypertrophy, hypersensitivity to any of the components.
Precautions: Administer with caution to patients with pyloric obstruction or angina pectoris. Excessive dryness of the mouth and visual disturbances are signs of overdosage or sensitivity to belladonna alkaloids. Reduction of dosage may be necessary. If excessive or prolonged dosage is contemplated, the physician should be alert to possible peripheral vascular complications in patients highly sensitive to ergot. Due to presence of a barbiturate, Bellergal may be habit forming.
Occupational Hazards: Barbiturate containing preparations may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery.
Interactions : The concomitant use of alcohol or other CNS depressants may have an additive effect. Warn patients accordingly.
The prolonged ingestion of barbiturates gives rise to enzyme induction. This increases the rate of metabolism of certain drugs, including oral anticoagulants and oral contraceptives, thus reducing their effectiveness.
See also phenobarbital general monograph.
There is some evidence that the concomitant use of triacetyloleandomycin (troleandomycin) or erythromycin and ergotamine may lead to an elevated concentration of ergotamine in the plasma, thereby causing untoward peripheral vasoconstriction.
Like all drugs, Bellergal Spacetabs should be kept out of the reach of children.
Adverse Reactions: Visual disturbances, dry mouth, flushing, drowsiness may occur.
Children: In children, behavioral disturbances and cognitive impairment may occur, due to the presence of phenobarbital.
Symptoms And Treatment Of Overdose: Symptoms: 1) Nausea, vomiting and abdominal discomfort, usually after an acute overdose of ergotamine (these symptoms may be masked by the action of the belladonna). 2) Numbness, tingling, pain and cyanosis of the extremities, with diminished or absent peripheral pulses. 3) Drowsiness, confusion, incoordination and coma (convulsions, while a feature of acute ergotamine and belladonna poisoning, may be masked by the depressant action of the barbiturate and hence may not be common in a theoretical Bellergal intoxication). 4) Respiratory depression, which may be early in onset, pronounced and persistent. 5) Hypotension, followed by a typical shock like state in more severe cases. 6) Respiratory complications and renal failure, which are not uncommon late sequelae of severe barbiturate intoxication. 7) Hypothermia or hyperthermia.
The danger of Bellergal intoxication is increased when the drug is ingested in the presence of alcohol, phenothiazines, minor tranquilizers and/or narcotics.
Treatment: Elimination of the drug by gastric lavage and administration of activated charcoal. Supportive symptomatic treatment with close monitoring of cardiovascular and respiratory systems. In the event of vasospasm, vasodilators such as nitroprusside sodium are indicated.
Special Features due to Ergotamine Overdosage: Marked peripheral vasospasm with coldness and poor or absent pulses in the hands and feet are commonly associated with acute ergotamine poisoning. Warmth, but not heat, and protection must be afforded the ischemic limbs. Vasopressors should be avoided.
Vasodilators, such as sodium nitroprusside or tolazoline, may be used with benefit.
Dosage: One Spacetab in the morning and 1 in the evening. Weekly maximum: 16 tablets.
Availability And Storage: Each compressed tablet, speckled dark green, orange and light lemon yellow, embossed "
" on one side and double-scored on the other, contains: levorotatory belladonna alkaloids 0.2 mg, ergotamine tartrate USP 0.6 mg and phenobarbital USP 40 mg. Nonmedicinal ingredients: cornstarch, lactose and tartrazine. Bottles of 100.
(Shown in Product Recognition Section)