Usual Adult Dose for Migraine

Oral: Ergotamine 1 mg-caffeine 100 mg per tablet:
Initial dose: 2 tablets orally at first sign of an attack; 1 additional tablet every half-hour as needed not to exceed maximum doses
Maximum doses: 6 tablets per attack; 10 tablets per 7-day period

Rectal: Ergotamine 2 mg-caffeine 100 mg per suppository:
Initial dose: 1 suppository rectally at first sign of a migraine attack; 1 additional suppository may be administered after 1 hour if needed for full relief
Maximum dose: 2 suppositories per attack; 5 suppositories per 7-day period

Comments:

• Early administration at onset provides maximum effectiveness.
• This drug should not be used for chronic daily administration.

Renal Dose Adjustments

Contraindicated

Liver Dose Adjustments

Contraindicated

Precautions

US BOXED WARNING: CONCOMITANT ADMINISTRATION WITH POTENT CYP450 3A4 INHIBITORS:

• Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of this drug with potent CYP450 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP450 3A4 inhibition elevates the serum levels of this drug, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased.

Dialysis

Data not available, however this drug is contraindicated in patients with renal impairment

Other Comments

Administration advice:

• Tablets: Take orally at first sign of a migraine headache; do not exceed 6 tablets per attack OR 10 tablets per 7-day period
• Suppository: Administer rectally at first sign of a migraine headache; do not exceed 2 suppositories per attack OR 5 suppositories in a 7-day period

• Tablets: Protect from light; store between 68F and 77F (20C to 25C)
• Suppositories: Store in refrigerator (36F to 46F [2C to 8C])

• This drug should only be used when a clear diagnosis of migraine headache has been established.
• Safe administration of ergot alkaloids require patients at risk of coronary artery disease (CAD) have a satisfactory cardiovascular (CV) evaluation prior to starting therapy; due to the possibility of CV testing not detecting underlying CAD, it is strongly recommended that first dose administration occur in a medically equipped facility and an ECG be obtained after dosing.

• Consider ECG monitoring following the first dose in patients with risk factors for coronary artery disease (CAD) who have satisfactorily completed a cardiovascular evaluation; patients with cardiovascular risk factors and those who acquire risk factors predictive of CAD should undergo periodic cardiovascular evaluation

• Patients should report to their healthcare provider any numbness or tingling in toes or fingers, muscle pain in the arms and legs, weakness in legs, chest pain, changes in heart rate, swelling, or itching.
• Patients should be advised to talk with their doctor or pharmacist before taking any new medications or supplements.
• Patients should be aware of the risk of serious cardiovascular side effects and the importance of seeking medical advice promptly if they occur.
• Patients should be instructed not to take more than the prescribed amount of medication without talking to their healthcare provider.
• This drug cause dizziness; have patient avoid driving or operating machinery until adverse effects are determined.
• Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.