CAFERGOT ergotamine tartrate and caffeine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

KAISER FOUNDATION HOSPITALS

INN (International Name):

ERGOTAMINE TARTRATE

Composition:

ERGOTAMINE TARTRATE 1 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CAFERGOT- ERGOTAMINE TARTRATE AND CAFFEINE TABLET
KAISER FOUNDATION HOSPITALS
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CAFERGOT (ERGOTAMINE TARTRATE AND CAFFEINE) TABLETS, USP
1 MG/ 100 MG
RX ONLY
WARNING
SERIOUS AND/OR LIFE-THREATENING PERIPHERAL ISCHEMIA HAS BEEN
ASSOCIATED WITH THE
COADMINISTRATION OF CAFERGOT WITH POTENT CYP 3A4 INHIBITORS INCLUDING
PROTEASE
INHIBITORS AND MACROLIDE ANTIBIOTICS. BECAUSE CYP 3A4 INHIBITION
ELEVATES THE SERUM LEVELS
OF CAFERGOT , 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:
(C
H N O ) • C H O M.W. 1313.41
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:
C H N O (anhydrous) M.W. 194.19
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,
®
®
®
33
35
5
5 2
4
6
6
8
10
4
2
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 m