Please see below for Important Safety Information and Boxed Warning
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WARNING: CYP 3A4 Inhibitors
Serious and/or life-threatening peripheral ischemia has been associated with the co-administration of ergotamine tartrate and caffeine with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate and caffeine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated.
INDICATIONS AND USAGE
MIGERGOT® (ergotamine tartrate and caffeine suppositories) is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called “histaminic cephalalgia”.
Ergotamine tartrate and caffeine suppositories should only be used for migraine headaches as they are not effective for other types of headaches and they lack analgesic properties.
The safety and effectiveness of MIGERGOT in pediatric patients has not been established.
IMPORTANT SAFETY INFORMATION
- Do not administer MIGERGOT with potent CYP 3A4 inhibitors such as protease inhibitors or macrolide antibiotics as this 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 inhibitor therapy when ergotamine tartrate and caffeine was coadministered, at least one resulting in death.
- Do not use MIGERGOT in women who are, or may become, pregnant, or who are nursing, as it may cause harm to the fetus or nursing infant.
- Do not use MIGERGOT in patients with peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function, or sepsis.
- Do not use MIGERGOT in patients with known hypersensitivity to any of its components.
WARNINGS AND PRECAUTIONS
- 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. 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.
- There have been 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. Ergotamine tartrate suppositories should not be used for chronic daily administration.
- Ergotamine tartrate and caffeine should not be administered with other vasoconstrictors. Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy.
- While most cases of ergotism results from frank overdosage, some have involved apparent hypersensitivity. Care should be exercised to the patient remains within the limits of the recommended dosage.
- In rare instances, patients may display withdrawal symptoms consisting of rebound headaches upon discontinuation of the drug.
- Rare cases of solitary rectal or anal ulcer have occurred from product abuse. Spontaneous healing occurs within usually 4-8 weeks after drug withdrawal.
- No more than 2 suppositories should be taken for any single migraine attack. No more than 5 suppositories should be taken during any 7-day period.
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; rectal or anal ulcer (from overuse of suppositories).
Neurological: Paresthesias, numbness, weakness, and vertigo.
Allergic: Localized edema and itching.
Fibrotic Complications: (See WARNINGS AND PRECAUTIONS).
Please see the Prescribing Information, including Boxed Warning, for more information
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch