Safety and efficacy not established for management of cluster headaches.
Dosage and Administration
Administration
Administer orally or intranasally.
Oral Administration
Administer orally as conventional or orally disintegrating tablets without regard to meals.
To achieve a dose <2.5 mg, manually break the scored 2.5-mg conventional tablet in half. Do not break orally disintegrating tablets.
Just prior to administration of orally disintegrating tablet, remove tablet from blister package; peel open blister package, place tablet on tongue to dissolve, and swallow with saliva.
Administration of orally disintegrating tablet with liquid is not necessary.
Intranasal Administration
Administer intranasally as a single spray into 1 nostril.
Do not spray contents into eyes.
To administer, blow nose gently and remove protective cap just before use. Hold nasal spray device gently and do not press plunger until tip is placed into nostril. Block one nostril by pressing firmly on side of nose and put tip into other nostril as far as feels comfortable. Tilt head slightly back and breathe gently through nose while pressing plunger firmly with thumb; a click may be heard. Keep head tilted slightly back and remove tip of device from nose; breathe gently through mouth for 5–10 seconds. Liquid may be felt in nose or back of throat. Consult manufacturer’s patient information for complete directions.
Single-use spray pump; discard after use.
Dosage
Due to similarity in systemic exposure, dosage adjustments with oral and intranasal formulations should be similar; doses <5 mg can be achieved only through use of oral formulations.
Adults
Vascular Headaches
Migraine
Oral
Initially, ≤2.5 mg. In clinical studies, single oral doses of 1 (not commercially available in US), 2.5, or 5 mg were effective, but the 2.5- and 5-mg doses were effective in a greater proportion of patients. The 5-mg dose appears to offer little additional benefit and is associated with increased risk of adverse effects.
If headache recurs, dose may be repeated after ≥2 hours.
Following failure to respond to first dose, reconsider diagnosis of migraine prior to administration of a second dose.
Intranasal
5 mg (1 spray) as a single dose; individualize selection of dosage and administration route.
If headache recurs, dose may be repeated after 2 hours.
Following failure to respond to first dose, reconsider diagnosis of migraine prior to administration of a second dose.
Prescribing Limits
Adults
Vascular Headaches
Migraine
Oral
Maximum 10 mg in any 24-hour period.
Safety of treating an average of >3 headaches per 30-day period has not been established.
Intranasal
Maximum 10 mg in any 24-hour period.
Safety of treating an average of >4 headaches per 30-day period has not been established.
Special Populations
Hepatic Impairment
Generally use <2.5 mg as a single oral dose in patients with moderate to severe hepatic impairment; concurrent BP monitoring recommended.
Recommended doses can be achieved only with oral formulations; use of intranasal formulation not recommended.
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