MIGERGOT- ergotamine tartrate and caffeine suppository

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

ERGOTAMINE TARTRATE (UNII: MRU5XH3B48) (ERGOTAMINE - UNII:PR834Q503T), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Доступна с:

Horizon Pharma Inc.

ИНН (Международная Имя):

ERGOTAMINE TARTRATE

состав:

ERGOTAMINE TARTRATE 2 mg

Администрация маршрут:

RECTAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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 cause fetal harm when administered to preg

Обзор продуктов:

Ergotamine Tartrate and Caffeine Suppositories USP are supplied in boxes of 12 foil wrapped suppositories. NDC 75987-090-11 The suppositories should be refrigerated at 2°-8°C (36°-46°F). Distributed by: Horizon Pharma USA, Inc.                                    Revised: 01/2018       Lake Forest, IL 60045                              

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

MIGERGOT- ERGOTAMINE TARTRATE AND CAFFEINE SUPPOSITORY
HORIZON PHARMA INC.
----------
ERGOTAMINE TARTRATE AND CAFFEINE SUPPOSITORIES USP
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