ERGOMAR SUBLINGUAL

Ergomar ® Sublingual Tablets Ergotamine Tartrate Sublingual Tablets USP ... 2 mg Inactive Ingredients: Microcrystalline Cellulose NF, Natural Peppermint Flavor Powder, Crospovidone NF, Saccharin Sodium USP Powder, D&C Yellow #10 Lake, Magnesium Stearate NF, FD&C Blue #1 Aluminum Lake.

Ergomar ® is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called "histaminic cephalalgia".

Procedure For best results, dosage should start at the first sign of an attack. Early Administration Gives Maximum Effectiveness. At the first sign of an attack or to relieve symptoms after onset of an attack, one 2 mg tablet is placed under the tongue. Another tablet should be taken at half-hour intervals thereafter, if necessary, but dosage must not exceed three tablets in any 24 hour period. Total weekly dosage should not exceed five tablets (10 mg) in any one week. Ergomar ® Sublingual Tablets should not be used for chronic daily administration.

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 ( See PRECAUTIONS: Drug Interactions ), with some cases resulting in amputation. There have been rare reports of cerebral ischemia in patients on protease 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) (See WARNINGS: CYP 3A4 Inhibitors ). Ergomar ® Sublingual Tablets may cause fetal harm when administered to pregnant women. Ergomar ® Sublingual Tablets are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this product, the patient should be apprised of the potential hazard to the fetus. Peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function and sepsis. Hypersensitivity to any of the components.

Cardiovascular: Vasoconstrictive complications of a serious nature may occur at times. These include ischemia, cyanosis, absence of pulse, cold extremities, gangrene, precordial distress and pain, EKG changes and muscle pains. Although these effects occur most commonly with long-term therapy at relatively high doses, they have also been reported with short-term or normal doses. Other cardiovascular adverse effects include transient tachycardia or bradycardia and hypertension. Gastrointestinal: Nausea and vomiting. Neurological: paresthesias, numbness, weakness, and vertigo. Allergic: Localized edema and itching. Fibrotic Complications: ( See WARNINGS ).

CYP 3A4 Inhibitors (e.g., Macrolide Antibiotics and Protease inhibitors) See CONTRAINDICATIONS and WARNINGS . Ergomar ® Sublingual Tablets (Ergotamine Tartrate Sublingual Tablets USP) should not be administered with other vasoconstrictors. Use with sympathomimetics (pressor agents) may cause extreme elevation of blood pressure. The beta-blocker Inderal (propranolol) has been reported to potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine. Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy. The blood levels of ergotamine-containing drugs are reported to be elevated by the concomitant administration of macrolide antibiotics and vasospastic reactions have been reported with therapeutic doses of the ergotamine-containing drugs when coadministered with these antibiotics.

STORE AND DISPENSE Store at 20°- 25°C (68° - 77°F) [see USP Controlled Room Temperature]; excursions permitted to 15° - 30°C (59° - 86°F). Protect from light and heat. Keep out of reach of children.