MIGERGOT ergotamine tartrate and caffeine suppository

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

ERGOTAMINE TARTRATE (UNII: MRU5XH3B48) (ERGOTAMINE - UNII:PR834Q503T)

Dostupné s:

Crealta Pharmaceuticals LLC

INN (Mezinárodní Name):

ERGOTAMINE TARTRATE

Složení:

ERGOTAMINE TARTRATE 2 mg

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

MIGERGOT- ERGOTAMINE TARTRATE AND CAFFEINE SUPPOSITORY
CREALTA PHARMACEUTICALS LLC
----------
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 reach