Ergotamine

Ergotamine Tartrate and Caffeine Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called “histaminic cephalalgia”.

• Procedure For best results, dosage should start at the first sign of an attack
• Rectally Two suppositories is the maximum dose for an individual attack
• Total weekly dosage should not exceed 5 suppositories
• Ergotamine Tartrate and Caffeine Suppositories 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
• Maximum Adult Dosage: One suppository at start of attack; second suppository after 1 hour, if needed for full relief
• Early administration gives maximum effectiveness

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. …

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. …

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; rectal or anal ulcer (from overuse of suppositories). Neurological: Paresthesias, numbness, weakness, and vertigo. Allergic: Localized edema and itching. …

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, convulsions and shock. …

There have been reports of drug abuse and psychological dependence in patients on ergotamine tartrate and caffeine therapy. Due to the chronicity of vascular headaches, it is imperative that patients be advised not to exceed recommended dosages with long-term use to avoid ergotism. (See PRECAUTIONS )

Store and Dispense The suppositories should be refrigerated at 2° to 8°C (36° to 46°F). Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0166CPLNC1 Iss. 06/2020 VC7420

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.