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Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
ZOMIG Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.
Limitations of Use
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- 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.
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- ZOMIG is not indicated for the prevention of migraine attacks.
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- Safety and effectiveness of ZOMIG have not been established for cluster headache.
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- Not recommended in patients with moderate or severe hepatic impairment [ see Dosage and Administration (2.2)].
History
There is currently no drug history available for this drug.
Other Information
ZOMIG® (zolmitriptan) Nasal Spray contains zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure:
The empirical formula is C16H21N3O2, representing a molecular weight of 287.36. Zolmitriptan is a white to almost white powder that is readily soluble in water. ZOMIG Nasal Spray is supplied as a clear to pale yellow solution of zolmitriptan, buffered to a pH 5.0. Each ZOMIG Nasal Spray 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.
ZOMIG Nasal Spray is hypertonic. The osmolarity of ZOMIG Nasal Spray for 2.5 mg is 360 to 420 mOsmol, and for 5 mg is 420 to 470 mOsmol.
Sources
Hourglass Illusion Tinted Moisturizer Sand Spf 15 Manufacturers
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Kingdom Animalia, Llc Dba Hourglass Cosmetics
Hourglass Illusion Tinted Moisturizer Sand Spf 15 | Impax Laboratories, Inc.
2.1 Dosing InformationThe recommended starting dose for ZOMIG nasal spray in adult and pediatric patients 12 years of age and older 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.
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.
2.2 Dosing in Patients with Hepatic ImpairmentZOMIG 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 Dosage and Administration (2.1),Warnings and Precautions (5.8),Use in Specific Populations (8.6)andClinical Pharmacology (12.3)].
2.3 Dosing in Patients taking CimetidineIf ZOMIG is co‑administered with cimetidine, limit the maximum single dose of ZOMIG to 2.5 mg, not to exceed 5 mg in any 24‑hour period [see Drug Interactions (7.4)andClinical Pharmacology (12.3)].
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