Zomig Nasal Spray
"Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The me"...
Zomig Nasal Spray
Limitations of Use
- Only use ZOMIG if a clear diagnosis of migraine has been established.If a patient has no response to ZOMIG treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG is administered to treat any subsequent attacks.
- ZOMIG is not indicated for the prevention of migraine attacks.
- Safety and effectiveness of ZOMIG have not been established for cluster headache.
- Not recommended in patients with moderate or severe hepatic impairment [see DOSAGE AND ADMINISTRATION].
DOSAGE AND ADMINISTRATION
The recommended starting dose for ZOMIG nasal spray is 2.5 mg. As the individual response to ZOMIG Nasal spray may vary, the dose should be adjusted on an individual basis. The maximum recommended single dose of ZOMIG is 5 mg.
In controlled clinical trials, a greater proportion of patients had headache response following a 2.5 mg or 5 mg dose than following a 1 mg dose. There was little added benefit from the 5 mg dose compared to the 2.5 mg dose, but adverse reactions were more frequent with the 5 mg dose.
If the migraine has not resolved by 2 hours after taking ZOMIG, or returns after a transient improvement, another dose may be administered at least 2 hours after the previous dose.
The maximum daily dose should not exceed 10 mg in any 24-hour period.
The safety of ZOMIG in the treatment of an average of more than four headaches in a 30-day period has not been established.
Dosing in Patients with Hepatic Impairment
ZOMIG nasal spray is not recommended in patients with moderate to severe hepatic impairment because of increased zolmitriptan blood levels in these patients and elevation of blood pressure in some of these patients. The recommended dosage of ZOMIG nasal spray in patients with mild hepatic impairment is the same as for patients with normal hepatic function [see WARNINGS AND PRECAUTIONS, Use in Specific Populations and CLINICAL PHARMACOLOGY].
Dosing in Patients taking Cimetidine
Dosage Forms And Strengths
Nasal Spray 2.5 mg and 5 mg.
Storage And Handling
The ZOMIG Nasal Spray device is a blue colored plastic device with a gray protection cap, labeled to indicate the nominal dose. Each ZOMIG Nasal Spray device administers a single dose of ZOMIG.
ZOMIG 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 2.5 mg or 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.
2.5 mg ZOMIG® Nasal Spray is supplied in boxes of 6 single-use nasal spray units. (NDC 64896-682-51)
5 mg ZOMIG® Nasal Spray is supplied in boxes of 6 single-use nasal spray units. (NDC 64896-681-51).
Each ZOMIG® Nasal Spray single dose unit spray supplies 2.5 and 5 mg, respectively, of zolmitriptan. The ZOMIG® Nasal Spray unit must be discarded after use.
Store at controlled room temperature, 20-25°C (68-77°F) [see USP].
Distributed by: Impax Pharmaceuticals, a division of Impax Laboratories, Inc., Hayward, CA 94544. Revised 09-2013
Last reviewed on RxList: 9/30/2013
This monograph has been modified to include the generic and brand name in many instances.
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