CAFERGOT- 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:

Sandoz Inc

INN (International Name):

ERGOTAMINE TARTRATE

Composition:

ERGOTAMINE TARTRATE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cafergot (ergotamine tartrate and caffeine tablets, USP) is 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 Cafergot (ergotamine tartrate and caffeine tablets, USP) 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 ) . Cafergot (ergotamine tart

Product summary:

Cafergot (ergotamine tartrate and caffeine tablets, USP) for oral administration are available as: 1 mg/100 mg: round tablets, film coated beige, debossed SZ 183 on one side and plain on the reverse side and supplied as: NDC 0781-5405-01 bottles of 100 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. KEEP OUT OF THE REACH OF CHILDREN. Cafergot® is a registered trademark of NOVARTIS PHARMACEUTICALS CORPORATION.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CAFERGOT- ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED
SANDOZ INC
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CAFERGOT® (ERGOTAMINE TARTRATE AND CAFFEINE TABLETS, USP)
RX ONLY
WARNING
SERIOUS AND/OR LIFE-THREATENING PERIPHERAL ISCHEMIA HAS BEEN
ASSOCIATED
WITH THE COADMINISTRATION OF CAFERGOT (ERGOTAMINE TARTRATE AND
CAFFEINE
TABLETS, USP) WITH POTENT CYP 3A4 INHIBITORS INCLUDING PROTEASE
INHIBITORS AND MACROLIDE ANTIBIOTICS. BECAUSE CYP 3A4 INHIBITION
ELEVATES
THE SERUM LEVELS OF CAFERGOT (ERGOTAMINE TARTRATE AND CAFFEINE
TABLETS,
USP), 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
Each tablet for oral administration contains 1 mg ergotamine tartrate,
USP, and 100 mg
caffeine, USP.
ERGOTAMINE TARTRATE:
Ergotaman-3',6',18-trione, 12'-hydroxy-2'-methyl- 5'-(phenyl-methyl)
-,(5' α) -, [ R-
(R*,R*)] -2,3-dihydroxy-butanedioate (2:1) (salt).
CAFFEINE:
1_H_-Purine-2,6-dione, 3,7-dihydro-1,3,7- trimethyl-.
Inactive ingredients include black iron oxide, compressible sugar,
iron oxide red,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
polyvinyl alcohol,
sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.
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, ther