Ergomar® (Ergotamine Tartrate Sublingual Tablets, USP)
WARNING
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate, 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
Ergomar is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called “histaminic cephalalgia.”
Important Safety Information
CONTRAINDICATIONS
- Do not administer Ergomar 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 inhibitors when ergotamine was coadministered, at least one resulting in death.
- Ergomar Sublingual Tablets should not be administered to pregnant women, nursing mothers or women who may become pregnant.
- Ergomar Sublingual Tablets should not be given to patients with peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function or sepsis.
- Ergomar Sublingual Tablets should not be given to patients with hypersensitivity to ergotamine.
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 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 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 associated with ergotamine treatment result from frank overdosage, some cases have involved apparent hypersensitivity. Care should be exercised to ensure that the patient stays within the limits of recommended dosage.
- In rare instances, patients may display withdrawal symptoms consisting of rebound headache upon discontinuation of treatment.
- There have been reports of drug abuse and psychological dependence in patients on ergotamine tartrate therapy.
- Ergomar Sublingual Tablets should not be used for chronic daily administration. Total daily 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.
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 PRECAUTIONS)
Please see the Prescribing Information, including Boxed Warning, for more information.
Individual patient results may vary.
To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also contact TerSera Therapeutics at 844-334-4035 or medicalinformation@tersera.com.