Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ERGOTAMINE TARTRATE (UNII: MRU5XH3B48) (ERGOTAMINE - UNII:PR834Q503T), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Cosette Pharmaceuticals, Inc.
Ergotamine Tartrate
Ergotamine Tartrate 2 mg
RECTAL
PRESCRIPTION DRUG
Ergotamine Tartrate and Caffeine 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 tartrate and caffeine 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). Ergotamine tartrate and caffeine may caus
HOW SUPPLIED: Ergotamine Tartrate and Caffeine Suppositories USP are supplied in boxes of 12 foil wrapped suppositories. NDC 0713-0166-12
Abbreviated New Drug Application
MIGERGOT- ERGOTAMINE TARTRATE AND CAFFEINE SUPPOSITORY COSETTE PHARMACEUTICALS, INC. ---------- ERGOTAMINE TARTRATE AND CAFFEINE SUPPOSITORIES USP (FOR RECTAL ADMINISTRATION) RX ONLY WARNING SERIOUS AND/OR LIFE-THREATENING PERIPHERAL ISCHEMIA HAS BEEN ASSOCIATED WITH THE COADMINISTRATION 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. _(SEE_ _ALSO CONTRAINDICATIONS AND WARNINGS SECTION)_ DESCRIPTION: ERGOTAMINE TARTRATE AND CAFFEINE SUPPOSITORY ergotamine tartrate USP 2 mg caffeine USP 100 mg _Inactive Ingredients: _tartaric acid NF, and hard fat NF Ergotamine Tartrate and Caffeine Suppositories are for rectal administration only. Ergotamine Tartrate and Caffeine Suppositories are sealed in foil to afford protection from leakage. If an unavoidable period of exposure to heat softens the suppository, it should be chilled in ice-cold water to solidify it before removing the foil. CLINICAL PHARMACOLOGY 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 re Přečtěte si celý dokument