MIGERGOT- ergotamine tartrate and caffeine suppository

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Cosette Pharmaceuticals, Inc.

INN (nume internaţional):

Ergotamine Tartrate

Compoziție:

Ergotamine Tartrate 2 mg

Calea de administrare:

RECTAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

HOW SUPPLIED: Ergotamine Tartrate and Caffeine Suppositories USP are supplied in boxes of 12 foil wrapped suppositories. NDC 0713-0166-12

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

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