Rx only

Each tablet for oral administration contains 1 mg ergotamine tartrate, USP, and 100 mg caffeine, USP.

ERGOTAMINE TARTRATE:

Ergotaman-3',6',18-trione, 12'-hydroxy-2'-methyl-5'-(phenyl-methyl)-,(5' α)-, [R-(R*,R*)]-2,3-dihydroxy-butanedioate (2:1) (salt).

CAFFEINE:

1H-Purine-2,6-dione, 3,7-dihydro-1,3,7-trimethyl-.

Inactive ingredients include black iron oxide, compressible sugar, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

Ergotamine is an alpha adrenergic blocking agent with a direct stimulating effect on the smooth muscle of peripheral and cranial blood vessels and produces depression of central vasomotor centers. The compound also has the properties of serotonin antagonism. In comparison to hydrogenated ergotamine, the adrenergic blocking actions are less pronounced and vasoconstrictive actions are greater.

Caffeine, also a cranial vasoconstrictor, is added to further enhance the vasoconstrictive effect without the necessity of increasing ergotamine dosage.

Many migraine patients experience excessive nausea and vomiting during attacks, making it impossible for them to retain any oral medication. In such cases, therefore, the only practical means of medication is through the rectal route where medication may reach the cranial vessels directly, evading the splanchnic vasculature and the liver.

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".

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 CAFERGOT® (ergotamine tartrate and caffeine tablets, USP) 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).

CAFERGOT® (ergotamine tartrate and caffeine tablets, USP) may cause fetal harm when administered to pregnant women. CAFERGOT® (ergotamine tartrate and caffeine tablets, USP) is 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).

There have been reports of drug abuse and psychological dependence in patients on CAFERGOT® (ergotamine tartrate and caffeine tablets, USP) 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).

The toxic effects of an acute overdosage of CAFERGOT® (ergotamine tartrate and caffeine tablets, USP) are due primarily to the ergotamine component. The amount of caffeine is such that its toxic effects will be overshadowed by those of ergotamine. Symptoms include vomiting, numbness, tingling, pain and cyanosis of the extremities associated with diminished or absent peripheral pulses; hypertension or hypotension; drowsiness, stupor, coma, convulsions and shock. A case has been reported of reversible bilateral papillitis with ring scotomata in a patient who received five times the recommended daily adult dose over a period of 14 days.

Treatment consists of removal of the offending drug by induction of emesis, gastric lavage, and catharsis. Maintenance of adequate pulmonary ventilation, correction of hypotension and control of convulsions and blood pressure are important considerations. Treatment of peripheral vasospasm should consist of warmth, but not heat, and protection of the ischemic limbs. Vasodilators may be beneficial but caution must be exercised to avoid aggravating an already existent hypotension.

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).

CAFERGOT® (ergotamine tartrate and caffeine tablets, USP) for oral administration are available as:

1 mg/100 mg: round tablets, film coated beige, debossed SZ 183 on one side and plain on the reverse side and supplied as:

NDC 0781-5405-01 bottles of 100

02-2008M

7336

Sandoz Inc.

Princeton, NJ 08540

NDC 0781-5405-01

Cafergot®

(ergotamine tartrate

and caffeine

tablets, USP)

1 mg/100 mg

Rx only 100 Tablets