Brand Name: Bellaspas, Bellergal Spacetabs
Generic Name: Belladonna
Functional symptoms such as hot flashes, 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.
Coadministration of ergotamine with potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities, with some cases resulting in amputation. There have been rare reports of cerebral ischemia in patients on protease or reverse transcriptase inhibitor therapy when ergotamine was coadministered, at least one resulting in death. Because of the increased risk for ergotism and other serious vasospastic adverse events, ergotamine use is contraindicated with these drugs and other potent inhibitors of CYP 3A4 (e.g., ketoconazole, itraconazole) .
Concomitant treatment with vasocontrictor agents (including ergot alkaloids, sumatriptan and other 5HT1 receptor agonists) is contraindicated.
Narrow-angle glaucoma, septic conditions, shock, obliterative vascular disease, inadequately controlled hypertension, peripheral vascular disease, coronary heart disease, temporal arteritis, hemiplegic or basilar migraine, severe disorders of renal or hepatic function, porphyria, malnutrition, prostatic hypertrophy, known hypersensitivity to ergot alkaloids, caffeine, or any other components of the formulation.
Pregnancy
BELLERGAL Spacetabs are contraindicated during pregnancy because ergotamine has oxytocic and vasoconstrictor effects on the placenta and umbilical cord.
Lactation
Ergotamine is excreted in breast milk and may cause symptoms of vomiting, diarrhea, weak pulse and unstable blood pressure in infants. Thus, BELLERGAL Spacetabs are contraindicated in nursing mothers.
CYP 3A4 Inhibitors
(e.g. Macrolide Antibiotics and Protease Inhibitors): Coadministration of ergotamine with potent CYP 3A4 inhibitors such as HIV protease or reverse transcriptase inhibitors, azole antifungals, or macrolide antibiotics, has been associated with serious adverse events; for this reason, these drugs should not be given concomitantly with ergotamine. While these reactions have not been reported with less potent CYP 3A4 inhibitors, there is a potential risk for serious toxicity including vasospasm when these drugs are used with ergotamine. Examples of less potent CYP 3A4 inhibitors include: saquinavir, nefazodone, fluconazole, fluoxetine, grapefruit juice, fluvoxamine, zileuton, metronidazole, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP3A4 of other agents being considered for concomitant use with ergotamine.
Fibrotic Complications
There have been a few reports of patients using ergotamine therapy on a long term period or in an excessive way, who developed retroperitoneal and/or pleuropulmonary fibrosis. There have also been rare reports of fibrotic thickening of the aortic, mitral, tricuspid, and/or pulmonary valves with long-term continuous use of ergotamine-containing products.
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. Symptoms such as tingling in the fingers or toes should be reported to the physician immediately and the drug should be discontinued at once. Due to presence of a barbiturate, BELLERGAL may be habit-forming.
Patients who are being treated with BELLERGAL Spacetabs should be informed of the maximum doses allowed and of the first symptoms of overdosage: paresthesia (e.g. numbness, tingling) in the fingers and toes, non-migraine-related nausea and vomiting, and symptoms of myocardial ischemia (e.g. precordial pain).
Patients with mild to moderate hepatic impairment, especially cholestatic patients should be appropriately monitored.
Excessive use of ergotamine-containing drugs over the years may induce fibrotic changes, in particular of the pleura and the retroperitoneum. There have also been rare reports of fibrotic changes of the cardiac valves.
Like all drugs, BELLERGAL Spacetabs should be kept out of the reach of children.
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