Pediatric Indication for Zomig Nasal Spray
June 16, 2015 – The U.S. Food and Drug Administration (FDA) approved a new indication for Impax Specialty Pharma’s Zomig® Nasal Spray (zolmitriptan). The new indication is for treating acute migraine headaches in patients between 12 years and 18 years of age. Zolmitriptan is a 5-HT1B/1D receptor agonist (triptan) that previously was approved for treating patients age 18 and older who experience migraines. Zolmitriptan can be used whether or not the migraine is accompanied by an aura — sensory disturbances, such as flashing lights, buzzing sounds or intensified smells, that may happen before or during the migraine. Zolmitriptan is not indicated to prevent migraines or to treat cluster headaches.
For pediatric patients, the recommended beginning dose of Zomig Nasal Spray is 2.5mg and no more than 5mg is recommended for any single dose and no more than 10mg should be used in any 24-hour period. Brand-only Zomig Nasal Spray is dispensed in cartons of six disposable, single-dose sprayers each containing either 2.5mg or 5mg of zolmitriptan. Both branded and generic zolmitriptan also are available in tablets and orally disintegrating tablets (both in 2.5mg and 5mg strengths). Several other oral and injected triptans are FDA approved, most with generic equivalents. Marketed as both brand and generic, Imitrex® (sumatriptan) is the only other triptan with a nasal dosage form, but it is not approved for patients younger than 18.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.