에르고타민타르타르산염

Ergomar ® is 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 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 …

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 ).

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 )