Product Description.:
SZ 183
tablet , film-coated , tan , round round
Debossed
(ergotamine tartrate and caffeine) Tablets, USP
WARNING: Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of CAFERGOT? with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of CAFERGOT?, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated (see also CONTRAINDICATIONS and WARNINGS section).
DESCRIPTION
Each tablet for oral administration contains 1 mg ergotamine tartrate, USP, and 100 mg caffeine, USP.
Inactive ingredients include acacia, calcium carbonate, compressible sugar, confectioner's sugar (sucrose and corn starch), magnesium stearate, methylparaben, microcrystalline cellulose, povidone, propylparaben, sodium benzoate, sodium starch glycolate, starch (potato), sucrose, synthetic iron oxide, titanium dioxide and other ingredients.
INDICATIONS
CAFERGOT? (ergotamine tartrate and caffeine tablets, USP) are indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants, or so-called histaminic cephalalgia.
DOSAGE AND ADMINISTRATION
Procedure: For the best results, dosage should start at the first sign of an attack. Adults: Take 2 tablets at the start of attack 1 additional tablet every 1/2 hour, if needed for full relief (maximum 6 tablets per attack, 10 per week).
Maximum Adult Dosage: Total dose for any one attack should not exceed 6 tablets. Total weekly dosage should not exceed 10 tablets. Ergotamine tartrate and caffeine tablets should not be used for chronic daily administration. In carefully selected patients, with due consideration of maximum dosage recommendations, administration of the drug at bedtime may be an appropriate short-term preventive measure.
HOW SUPPLIED
CAFERGOT? (ergotamine tartrate and caffeine tablets, USP) for oral administration are available as:
1 mg/100 mg: round tablets, sugar coated beige and imprinted CAFERGOT in black ink.
Bottles of 100...................................................NDC 0078-0349-05
Store at controlled room temperature 15? -30? C (59? -86? F).
Dispense in a tight, light-resistant container.
