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Trade Names:
Ergomar
- Tablets, sublingual 2 mg

Mechanism of Action

Pharmacology

Reduces extracranial blood flow, causes decline in amplitude of pulsation in the cranial arteries and decreases hyperperfusion of the territory of the basilar artery; produces constriction of both arteries and veins.

Pharmacokinetics

Absorption

Poorly absorbed following GI and SL administration.

Metabolism

Metabolized by the liver.

Elimination

T _½ is approximately 2 h; 90% of metabolites are excreted in the bile. Unmetabolized ergotamine is erratically excreted in the saliva and trace amounts are excreted in the feces and urine.

Indications and Usage

Abort or prevent vascular headache (eg, migraine).

Contraindications

Peripheral vascular disease; coronary heart disease; hypertension; hepatic or renal function impairment; severe pruritus; sepsis; hypersensitivity to any component of the product; pregnancy.

Dosage and Administration

SL 2 mg under tongue at first sign of attack or to relieve symptoms after onset of an attack; another tablet should be taken at 30-min intervals thereafter, if necessary (max, 6 mg/24 h and 10 mg in any 1 wk).

General Advice

For SL administration only. Do not crush, chew, or swallow tablet.

Storage/Stability

Store at controlled room temperature (59° to 86°F). Protect from light and heat.

Drug Interactions

May elevate ergotamine plasma levels, increasing the pharmacologic effects and adverse reactions.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Transient changes in heart rate.

GI

Nausea; vomiting.

Miscellaneous

Weakness of legs, limb muscle pain; numbness and tingling of the fingers and toes; precordial pain; localized edema; itching.

Precautions

Pregnancy

Category X .

Lactation

Excreted in breast milk.

Ergotism

Signs and symptoms are rare; however, remain within limits of recommended dosage.

Dependency

Prolonged use may result in dependency and increase the dose requirement for relief of vascular headaches and to prevent dysphoria following withdrawal of the drug.

Overdosage

Symptoms

Nausea, vomiting, weakness of the legs, pain in limb muscles, numbness, itching of fingers and toes, precordial pain, tachycardia, bradycardia, hypertension, hypotension, localized edema, itching together with signs and symptoms of ischemia caused by vasoconstriction of peripheral arteries and arterioles, cold, pale and numb feet and hands, muscle pain while walking and later at rest, gangrene, confusion, depression, drowsiness, convulsions.

Patient Information

• Explain that drug is to be used only during migraine and does not prevent or reduce the number of attacks. Emphasize that drug is used only to treat actual migraine attack.
• Instruct patient in proper use of SL tablet. Caution patient not to chew, crush, or swallow tablet.
• Advise patient that drug is to be taken as soon as symptoms of migraine appear, and that the dose may be repeated every 30 min if needed but that no more than 3 tablets should be used in any 24-h period or 5 tablets used in any 1-wk period.
• Caution patient not to exceed the dosing guidelines because of the risk of toxic effects developing.
• Advise patient to stop taking the drug and notify their health care provider if any of the following occur: numbness, tingling, coldness, or paleness in the fingers or toes; muscle pain in arms or legs; weakness in the legs; chest pain, tightness or pressure; changes in heart rate; sudden worsening of headache; swelling; itching.
• Instruct patient that if they have migraine prophylactic medications prescribed to take daily as directed.
• Advise patient that if not currently taking a migraine prophylactic drug to discuss the use of such drugs with health care provider.