ERGOTAMINE- ergotamine tartrate and caffeine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

West-Ward Pharmaceutical Corp

INN (International Name):

ERGOTAMINE TARTRATE

Composition:

ERGOTAMINE TARTRATE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 drug 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 pregnant women. Ergotamine tartrate and ca

Product summary:

Ergotamine Tartrate and Caffeine Tablets USP, 1 mg/100 mg are round, film coated buff colored tablet; printed "WW 120" in black ink and are available in: Bottles of 30 tablets. Bottles of 100 tablets. Bottles of 500 tablets. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured By: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised November 2004

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERGOTAMINE- ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED
WEST-WARD PHARMACEUTICAL CORP
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ERGOTAMINE TARTRATE AND CAFFEINE
ERGOTAMINE TARTRATE AND CAFFEINE
TABLETS, USP
1MG/100 MG
Rev. 11/04Rx 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 SECTIONS)
DESCRIPTION:
Ergotamine Tartrate and Caffeine Tablets USP
ergotamine tartrate USP . . . . . . . . . . . . . . . . . .1 mg
caffeine USP . . . . . . . . . . . . . . . . . . . . . . . . . . .100
mg
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
compressible sugar, corn starch, magnesium stearate, mannitol,
microcrystalline cellulose, sodium
starch glycolate, sugar, and tartaric acid. Polishing and Film Coating
Solutions may contain the
following: FD&C Blue Lake #2, FD&C Yellow Lake #6, hydroxypropyl
methylcellulose, polyethylene
glycol, and titanium dioxide. The printing ink contains: amide resin,
black pigment, natural resin, and
wax.
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 exc