Ergomar Sublingual Ergotamine Tartrate 2 mg Tablet, 20-count — NDC 81279-104-20 (Billing 81279-0104-20)

WARNINGS CYP 3A4 Inhibitors (e.g., Macrolide Antibiotics and Protease Inhibitors) Coadministration of ergotamine with potent CYP 3A4 inhibitors such as protease inhibitors or macrolide antibiotics has been associated with serious adverse events; for this reason, these drugs should not be given concomitantly with ergotamine ( See CONTRAINDICATIONS ). 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 CYP 3A4 of other agents being considered for concomitant use with ergotamine. Fibrotic Complications There have been a few reports of patients on ergotamine tartrate and caffeine therapy developing 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 tartrate and caffeine. Ergomar ® Sublingual Tablets should not be used for chronic daily administration (See DOSAGE AND ADMINISTRATION ).

ADVERSE REACTIONS 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 ).

Drug Interactions 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.

PRECAUTIONS General Although signs and symptoms of ergotism rarely develop even after long term intermittent use of the drug, care should be exercised to remain within the limits of recommended dosage. Ergotism is manifested by intense arterial vasoconstriction, producing signs and symptoms of peripheral vascular ischemia. Ergotamine induces vasoconstriction by a direct action on vascular smooth muscle.

In chronic intoxication with ergot derivatives, headache, intermittent claudication, muscle pains, numbness, coldness and pallor of the digits may occur. If the condition is allowed to progress untreated, gangrene can result. While most cases of ergotism associated with ergotamine treatment result from frank overdosage, some cases have involved apparent hypersensitivity.

There are few reports of ergotism among patients taking doses within the recommended limits or for brief periods of time. In rare instances, patients, particularly those who have used the medication indiscriminately over long periods of time, may display withdrawal symptoms consisting of rebound headache upon discontinuation of the drug. Information for Patients Patients should be advised that one Ergomar ® Sublingual Tablet should be taken at the first sign of a migraine headache.

No more than 2 tablets should be taken for any single migraine attack. No more than 5 tablets should be taken during any 7-day period. Administration of Ergomar ® Sublingual Tablets should not exceed the dosing guidelines and should not be used for chronic daily administration ( See DOSAGE AND ADMINISTRATION ).

Ergomar ® Sublingual Tablets should be used only for migraine headaches. It is not effective for other types of headaches and it lacks analgesic properties. Patients should be advised to report to the physician immediately any of the following: numbness or tingling in the fingers and toes, muscle pain in the arms and legs, weakness in the legs, pain in the chest or temporary speeding or slowing of the heart rate, swelling or itching.

Drug Interactions 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.

Pregnancy Teratogenic Effects Pregnancy Category X: There are no studies on the placental transfer or teratogenicity of Ergomar ® . Ergotamine crosses the placenta in small amounts, although it does not appear to be embryotoxic in this quantity. However, prolonged vasoconstriction of the uterine vessels and/or increased myometrial tone leading to reduced myometrial and placental blood flow may have contributed to fetal growth retardation observed in animals.

(See CONTRAINDICATIONS ) Nonteratogenic Effects Ergomar ® is contraindicated in pregnancy due to its oxytocic effects of ergotamine (See CONTRAINDICATIONS ) Labor and Delivery Ergomar ® is contraindicated in pregnancy due to its oxytocic effect which is maximal in the third trimester. (See CONTRAINDICATIONS ) Nursing Mothers Ergot drugs are known to inhibit prolactin but there are no reports of decreased lactation with Ergomar ® . Ergotamine is excreted in breast milk and may cause symptoms of vomiting, diarrhea, weak pulse and unstable blood pressure in nursing infants.

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DRUG ABUSE AND DEPENDENCE There have been reports of drug abuse and psychological dependence in patients on ergotamine tartrate therapy. Due to the chronicity of vascular headaches, it is imperative that patients be advised not to exceed recommended dosages with long-term use to avoid ergotism. ( See PRECAUTIONS )