ergotamine tartrate 1 MG / caffeine 100 MG Oral Tablet
WARNINGS
CYP 3A4 Inhibitors (e.g.
Macrolide Antibiotics and Protease Inhibitors) Coadministration of ergotamine with potent CYP 3A4 inhibitors such as protease inhibitors or macrolide antibiotics has been associated with serious adverse events, for this reason, these drugs should not be given concomitantly with ergotamine (see CONTRAINDICATIONS ).
While these reactions have not been reported with less potent CYP 3A4 inhibitors, there is a potential risk for serious toxicity including vasospasm when these drugs are used with ergotamine.
Examples of less potent CYP 3A4 inhibitors include: saquinavir, nefazodone, fluconazole, fluoxetine, grapefruit juice, fluvoxamine, zileuton, metronidazole, and clotrimazole.
These lists are not exhaustive, and the prescriber should consider the effects on CYP3A4 of other agents being considered for concomitant use with ergotamine.
Fibrotic Complications There have been a few reports of patients on ergotamine tartrate and caffeine therapy developing retroperitoneal and/or pleuropulmonary fibrosis.
There have also been rare reports of fibrotic thickening of the aortic, mitral, tricuspid, and/or pulmonary valves with long-term continuous use of ergotamine tartrate and caffeine.
Ergotamine tartrate should not be used for chronic daily administration (see DOSAGE AND ADMINISTRATION ).
DRUG INTERACTIONS
Drug Interactions CYP 3A4 Inhibitors (e.g.
Macrolide Antibiotics and Protease Inhibitors) See CONTRAINDICATIONS and WARNINGS .
Ergotamine tartrate and caffeine should not be administered with other vasoconstrictors.
Use with sympathominetics (pressor agents) may cause extreme elevation of blood pressure.
The beta-blocker Inderal (propranolol) has been reported to potentiate the vasoconstrictive action of ergotamine tartrate and caffeine by blocking the vasodilating property of epinephrine.
Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy.
The blood levels of ergotamine-containing drugs are reported to be elevated by the concomitant administration of macrolide antibiotics and vasospastic reactions have been reported with therapeutic doses of the ergotamine-containing drugs when coadministered with those antibiotics.
OVERDOSAGE
The toxic effects of an acute overdosage of ergotamine tartrate and caffeine are due primarily to the ergotamine component.
The amount of caffeine is such that its toxic effects will be overshadowed by those of ergotamine.
Symptoms include vomiting, numbness, tingling, pain and cyanosis of the extremities associated with diminished or absent peripheral pulses, hypertension or hypotension, drowsiness, stupor, coma, convulsion and shock.
A case has been reported of reversible bilateral papillitis with ring scotomata in a patient who received five times the recommended daily adult dose over a period of 14 days.
Treatment consists of removal of the offending drug by induction of emesis.
Maintenance of adequate pulmonary ventilation, correction of hypotension, and control of convulsions and blood pressure are important considerations.
Treatment of peripheral vasospasm should consist of warmth, but not heat, and protection of the ischemic limbs.
Vasodilators may be beneficial but caution must be exercised to avoid aggravating an already existent hypotension.
DESCRIPTION
: Ergotamine Tartrate and Caffeine Tablets USP ergotamine tartrate USP .
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.1 mg caffeine USP .
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.100 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, sugar, and tartaric acid.
Polishing and Film Coating Solutions may contain the following: FD&C Blue Lake #2, FD&C Yellow Lake #6, hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.
The printing ink contains: amide resin, black pigment, natural resin, and wax.
HOW SUPPLIED
Ergotamine Tartrate and Caffeine Tablets USP, 1 mg/100 mg are round, film coated buff colored tablet; printed “WW 120” in black ink and are available in: Bottles of 30 tablets.
Bottles of 100 tablets.
Bottles of 500 tablets.
Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Manufactured By: West-ward Pharmaceutical Corp.
Eatontown, NJ 07724 Revised November 2004
INDICATIONS AND USAGE
Ergotamine Tartrate and Caffeine Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called “histaminic cephalalgia”.
PEDIATRIC USE
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
PREGNANCY
Pregnancy
NUSRING MOTHERS
Nursing Mothers Ergot drugs are known to inhibit prolactin but there are no reports of decreased lactation with ergotamine tartrate and caffeine.
Ergotamine is excreted in breast milk and may cause symptoms of vomiting, diarrhea, weak pulse and unstable blood pressure in nursing infants.
Because of the potential for serious adverse reactions in nursing infants from ergotamine tartrate and caffeine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
BOXED WARNING
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 sections)
INFORMATION FOR PATIENTS
Information for Patients Patients should be advised that two tablets of ergotamine tartrate and caffeine should be taken at the first sign of a migraine headache.
No more than 6 tablets should be taken for any single migraine attack.
No more than 10 tablets should be taken during any 7-day period.
Administration of ergotamine tartrate and caffeine tablets should not exceed the dosing guidelines and should be used for chronic daily administration (see DOSAGE AND ADMINISTRATION ).
Ergotamine tartrate and caffeine should be used only for migraine headaches.
It is not effective for other types of headaches and it lacks analgesic properties.
Patients should be advised to report to the physician immediately any of the following: numbness or tingling in the fingers and toes, muscle pain in the arms and legs, weakness in the legs, pain in the chest or temporary speeding or slowing of the heart rate, swelling or itching.
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).
Early Administration Gives Maximum Effectiveness.
Maximum Adult Dosage: Six tablets is the maximum dose for an individual attack.
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.