Ergotamine

FDA label

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Renal Contraindicated in impaired renal function

Hepatic Contraindicated in impaired hepatic function

Patient-information section advises no more than 2 tablets per single attack (DOSAGE section allows 3/24 h); weekly max 5 tablets.

Instructions

• Place tablet under the tongue at first sign of attack — early administration gives maximum effectiveness
• Not for chronic daily administration
• Use only for migraine — not effective for other headache types; lacks analgesic properties
• Report numbness/tingling, limb muscle pain, leg weakness, chest pain, heart-rate changes, swelling or itching immediately

Contraindications

• Potent CYP3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) — acute ergotism with vasospasm/ischemia
• Pregnancy (women who are or may become pregnant)
• Peripheral vascular disease
• Coronary heart disease
• Hypertension
• Impaired hepatic or renal function
• Sepsis

Cautions

• Ergotism — intense arterial vasoconstriction and peripheral ischemia; can progress to gangrene; remain within recommended dosage
• Potential vasospasm risk even with less potent CYP3A4 inhibitors (saquinavir, nefazodone, fluconazole, fluoxetine, fluvoxamine, grapefruit juice, zileuton, metronidazole, clotrimazole)
• Fibrotic complications with long-term continuous use — retroperitoneal, pleuropulmonary, cardiac valve thickening
• Rebound headache (withdrawal) after long-term indiscriminate use

Adverse reactions

• Vasoconstrictive complications: ischemia, cyanosis, absent pulse, cold extremities, gangrene, precordial pain, EKG changes, muscle pain
• Transient tachycardia or bradycardia; hypertension
• Nausea and vomiting
• Paresthesias, numbness, weakness, vertigo
• Localized edema and itching

Pregnancy Category X — contraindicated; oxytocic effects (maximal 3rd trimester) and fetal growth retardation in animals.

Lactation Excreted in breast milk — may cause vomiting, diarrhea, weak pulse, unstable blood pressure in nursing infants; discontinue nursing or the drug.