Acute Treatment of Migraine Attacks

ZOMIG (zolmitriptan nasal spray) Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults.

Important Limitations

ZOMIG (zolmitriptan nasal spray) should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with ZOMIG (zolmitriptan nasal spray) , the diagnosis of migraine should be reconsidered before ZOMIG (zolmitriptan nasal spray) is administered to treat any subsequent attacks.

ZOMIG (zolmitriptan nasal spray) is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine [see CONTRAINDICATIONS]. Safety and effectiveness of ZOMIG (zolmitriptan nasal spray) have not been established for cluster headache, which is present in an older, predominantly male population.

Acute Treatment of Migraine Attacks

Administer one dose of ZOMIG (zolmitriptan nasal spray) Nasal Spray 5 mg for the treatment of acute migraine. If the headache returns, the dose may be repeated after 2 hours. The effectiveness of a second dose has not been established in placebo-controlled trials. The maximum daily dose should not exceed 10 mg in any 24-hour period.

In controlled clinical trials, single doses of 5 mg of zolmitriptan nasal spray were administered into one nostril and were effective for the treatment of acute migraines in adults.

Individuals may vary in response to ZOMIG (zolmitriptan nasal spray) Nasal Spray. The pharmacokinetics of a 5 mg nasal spray dose is similar to the 5 mg oral formulations. Doses lower than 5 mg can only be achieved through the use of an oral formulation. The choice of dose, and route of administration should therefore be made on an individual basis.

The safety of treating an average of more than four headaches in a 30-day period has not been established.

Hepatic Impairment

Patients with moderate to severe hepatic impairment have decreased clearance of zolmitriptan and significant elevation in blood pressure was observed in some patients. Use of doses less than 2.5 mg of an alternate formulation with blood pressure monitoring is recommended [see CLINICAL PHARMACOLOGY and WARNINGS AND PRECAUTIONS].

Dosage Forms And Strengths

Nasal Spray 5 mg

Storage And Handling

The ZOMIG (zolmitriptan nasal spray) Nasal Spray device is a blue colored plastic device with a gray protection cap, labeled to indicate the nominal dose. Each ZOMIG (zolmitriptan nasal spray) Nasal Spray device administers a single dose of ZOMIG (zolmitriptan nasal spray) .

ZOMIG (zolmitriptan nasal spray) Nasal Spray is supplied as a clear to pale yellow solution of zolmitriptan, buffered to a pH 5.0. Each ZOMIG Nasal Spray device contains 5 mg of zolmitriptan in a 100-μL unit dose aqueous buffered solution containing citric acid, anhydrous, USP, disodium phosphate dodecahydrate USP and purified water USP.

5 mg ZOMIG® (zolmitriptan nasal spray) Nasal Spray is supplied in boxes of 6 single use nasal spray units. (NDC 310-0208-60).

Each ZOMIG® Nasal Spray single dose unit spray supplies 5 mg of zolmitriptan. The ZOMIG® (zolmitriptan nasal spray) Nasal Spray unit must be discarded after use.

Store at controlled room temperature, 20-25°C (68-77°F) [see USP].

Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, Delaware 19850. By: AstraZeneca UK Limited, Macclesfield, Cheshire UK. Made in the United Kingdom. Rev. 10/08. FDA revision date: 10/14/2008

Last reviewed on RxList: 12/22/2008
This monograph has been modified to include the generic and brand name in many instances.