Ergotamine Tartrate + Caffeine Suppositories Generic Name & Formulations
Refrigerate at 2° to 8°C (36° to 46°F).
Ergotamine Tartrate + Caffeine Suppositories Indications
Ergotamine Tartrate + Caffeine Suppositories Dosage and Administration
1 supp rectally at onset of attack, then 1 supp after 1 hour if needed; max 2 supps/attack, 5 supps/week.
Ergotamine Tartrate + Caffeine Suppositories Contraindications
Peripheral vascular disease. Coronary heart disease. Hypertension. Hepatic or renal dysfunction. Sepsis. Concomitant potent CYP3A4 inhibitors (eg, ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) or other vasoconstrictors. Pregnancy. Labor and delivery.
Ergotamine Tartrate + Caffeine Suppositories Boxed Warnings
Peripheral ischemia following coadministration with strong CYP3A4 inhibitors.
Ergotamine Tartrate + Caffeine Suppositories Warnings/Precautions
- Manifested by intense arterial vasoconstriction, producing signs and symptoms of peripheral vascular ischemia.
- Most cases have been associated with overdosage, though some have involved hypersensitivity.
- Headache intermittent claudication, muscle pain, numbness, coldness and pallor of the digits may develop with chronic intoxication of ergot derivatives.
- Do not exceed recommended dosages with long-term use.
Contraindicated in pregnancy due to oxytocic effects of ergotamine.
Contraindicated during labor and delivery due to its oxytocic effect which is maximal in the third trimester.
Nursing Mother Considerations
Ergotamine is excreted in the breast milk and may cause vomiting, diarrhea, weak pulse, and unstable blood pressure in nursing infants. A decision should be made to either discontinue nursing or discontinue the drug.
Safety and effectiveness in pediatric patients have not been established.
Other Considerations for Specific Populations
There have been reports of drug abuse and psychological dependence in patients on ergotamine tartrate and caffeine therapy.
Ergotamine Tartrate + Caffeine Suppositories Pharmacokinetics
Ergotamine Tartrate + Caffeine Suppositories Interactions
Ergotamine Tartrate + Caffeine Suppositories Adverse Reactions
Ergotamine Tartrate + Caffeine Suppositories Clinical Trials
Ergotamine Tartrate + Caffeine Suppositories Note
Ergotamine Tartrate + Caffeine Suppositories Patient Counseling
Do not exceed the dosing guidelines.
Use only to treat migraine headaches; ergotamine/caffeine is not effective for other types of headaches and the product lacks analgesic properties.
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: Report immediately.