ERGOTAMINE TARTRATE AND CAFFEINE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

ERGOTAMINE TARTRATE (UNII: MRU5XH3B48) (ERGOTAMINE - UNII:PR834Q503T), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

זמין מ:

Cintex Services, LLC

INN (שם בינלאומי):

ERGOTAMINE TARTRATE

הרכב:

ERGOTAMINE TARTRATE 1 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 cau

leaflet_short:

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 24470-917-10 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 Cintex Services, LLC Dallas, TX 75243 Manufactured by: MIKART, LLC Atlanta, GA 30318 Code 1098C00 Rev. 10/20

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

ERGOTAMINE TARTRATE AND CAFFEINE- ERGOTAMINE TARTRATE AND
CAFFEINE TABLET, FILM COATED
CINTEX SERVICES, 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)
33
35
5
5
2
4
6
6
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 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 incr