ergotamine tartrate and caffeine 100 mg/1
ergotamine tartrate and caffeine · TABLET, FILM COATED · Cintex Services, LLC
ergotamine tartrate and caffeine is a tablet, film coated containing ergotamine tartrate and caffeine at 100 mg/1, taken oral. Manufactured by Cintex Services, LLC.
Key Facts
- Brand Name
- ergotamine tartrate and caffeine
- Generic Name
- ergotamine tartrate and caffeine
- NDC Code (Product)
24470-917- Manufacturer
- Cintex Services, LLC
- Strength
- 100 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA040590
- Drug Class
- Central Nervous System Stimulant [EPC]; Methylxanthine [EPC]
- Marketing Start
- 11/23/2016
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 & 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.
Warnings
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 CYP 3A4 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 ergot…
Contraindications
CONTRAINDICATIONS 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 harm when administered to pregnant women. Ergotamine tartrate and caffeine tablets is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this product, the patient should be apprised of the potential hazard to the fetus. Peripheral vascular disease…
Drug Interactions
Drug Interactions CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors) See CONTRAINDICATIONS and WARNINGS . Ergotamine tartrate and caffeine tablets should not be administered with other vasoconstrictors. Use with sympathomimetics (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 tablets 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 these antibiotics.
Adverse Reactions
ADVERSE REACTIONS Cardiovascular: Vasoconstrictive complications of a serious nature may occur at times. These include ischemia, cyanosis, absence of pulse, cold extremities, gangrene, precordial distress and pain, EKG changes and muscle pains. Although these effects occur most commonly with long-term therapy at relatively high doses, they have also been reported with short-term or normal doses. Other cardiovascular adverse effects include transient tachycardia or bradycardia and hypertension. Gastrointestinal: Nausea and vomiting Neurological: Paresthesias, numbness, weakness, and vertigo Allergic: Localized edema and itching. Fibrotic Complications: (see WARNINGS ). To report SUSPECTED ADVERSE REACTIONS, call 1-855-899-4237, or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is ergotamine tartrate and caffeine used for?
ergotamine tartrate and caffeine contains ergotamine tartrate and caffeine. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is ergotamine tartrate and caffeine a controlled substance?
ergotamine tartrate and caffeine is not classified as a controlled substance by the DEA.
What is the generic name for ergotamine tartrate and caffeine?
The generic name for ergotamine tartrate and caffeine is ergotamine tartrate and caffeine. There are 2 other brand versions of ergotamine tartrate and caffeine.
What is the NDC code for ergotamine tartrate and caffeine 100 mg/1?
The NDC (National Drug Code) for ergotamine tartrate and caffeine 100 mg/1 is 24470-917, listed by Cintex Services, LLC.