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

ERGOTAMINE TARTRATE AND CAFFEINE- ERGOTAMINE TARTRATE AND CAFFEINE
TABLET
KAISER FOUNDATION HOSPITALS
----------
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 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
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 colloidal silicon dioxide, crospovidone,
magnesium stearate, and
33
35
5
5 2
4
6
6
8
10
4
2
microcrystalline cellulose. Film coating includes the following
ingredients: macrogol/PEG 3350,
polyvinyl alcohol, purified water, talc, titanium dioxide, FD&C blue
#2 aluminum lake, FD&C red #40
aluminum lake, and FD&C yellow #5 tartrazine aluminum lake.
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 i