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:

Mikart, LLC

INN (International Name):

ERGOTAMINE TARTRATE

Composition:

ERGOTAMINE TARTRATE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ergotamine tartrate and caffeine tablets are 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 tablets was coadministered, at least one resulting in death. Because of the increased risk of 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 ). Er

Product summary:

Ergotamine tartrate and caffeine tablets, USP for oral administration are available as: 1 mg/100 mg: beige (film coated), round, convex face tablets, debossed “123” on one side and “MH” on the other side. Bottles of 100......NDC 46672-198-01 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. Manufactured by: MIKART, LLC Atlanta, GA 30318 Code 928Z00 Rev. 04/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERGOTAMINE TARTRATE AND CAFFEINE- ERGOTAMINE TARTRATE AND CAFFEINE
TABLET, FILM
COATED
MIKART, LLC
----------
ERGOTAMINE TARTRATE AND CAFFEINE TABLETS, USP 1 MG/100 MG
WARNING
SERIOUS AND/OR LIFE-THREATENING PERIPHERAL ISCHEMIA HAS BEEN
ASSOCIATED WITH THE
COADMINISTRATION OF ERGOTAMINE TARTRATE AND CAFFEINE TABLETS WITH
POTENT CYP 3A4 INHIBITORS
INCLUDING PROTEASE INHIBITORS AND MACROLIDE ANTIBIOTICS. BECAUSE CYP
3A4 INHIBITION
ELEVATES THE SERUM LEVELS OF ERGOTAMINE TARTRATE AND CAFFEINE TABLETS,
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
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 inc