ERGOTAMINE TARTRATE, CAFFEINE tablet

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:

KMM Pharmaceuticals, LLC

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 ). Ergotamine tartrate and caffeine tablets may cause fetal

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 52187-555-10 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. Distributed by KMM Pharmaceuticals LLC Wilmington, DE 19801 Manufactured by MIKART, LLC Atlanta, GA 30318 Code 1098D00 Rev. 01/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERGOTAMINE TARTRATE, CAFFEINE- ERGOTAMINE TARTRATE, CAFFEINE TABLET
KMM PHARMACEUTICALS, LLC
----------
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 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
33
35
5
5
2
4
6
6
8
10
4
2
1 _H_-Purine-2,6-dione, 3,7-dihydro-1,3,7-trimethyl-
Inactive ingredients include colloidal silicon dioxide, crospovidone,
magnesium stearate,
and 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