Drug Catalog - Product Detail
ERGOTAMINE/CAFFEINE 1MG/100MG TAB 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 24470-0917-10 | CINTEX | 100 | 1-100MG | TABLET |
PACKAGE FILES
Generic Name
ERGOTAMINE TARTRATE AND CAFFEINE
Substance Name
CAFFEINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA040590
Description
DESCRIPTION Each tablet for oral administration contains 1 mg ergotamine tartrate, USP, and 100 mg caffeine, USP. ERGOTAMINE TARTRATE: (C 33 H 35 N 5 O 5 ) 2 • C 4 H 6 O 6 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 8 H 10 N 4 O 2 (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. ergotamine structure.jpg caffeine structure.jpg
How Supplied
HOW SUPPLIED 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
Indications & Usage
INDICATIONS AND USAGE 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.”
Dosage and Administration
DOSAGE AND ADMINISTRATION Procedure: For the best results, dosage should start at the first sign of an attack. Adults: Take 2 tablets at the start of attack; 1 additional tablet every ½ hour, if needed for full relief (maximum 6 tablets per attack, 10 per week). Maximum Adult Dosage: Total daily dose for any one attack should not exceed 6 tablets. Total weekly dosage should not exceed 10 tablets. Ergotamine tartrate and caffeine tablets should not be used for chronic daily administration. In carefully selected patients, with due consideration of maximum dosage recommendations, administration of the drug at bedtime may be an appropriate short-term preventive measure.