ZOLMITRIPTAN spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW)

Available from:

Amneal Pharmaceuticals

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZOLMITRIPTAN 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 Zolmitriptan is contraindicated in patients with: Risk Summary There are no adequate data on the developmental risk associated with the use of zolmitriptan in pregnant women. In reproductive toxicity studies in rats and rabbits, oral administration of zolmitriptan to pregnant animals resulted in embryolethality and fetal abnormalities (malformations and variations) at clinically relevant exposures. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated rates of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data ha

Product summary:

The ZOLMITRIPTAN NASAL SPRAY device is a blue-colored plastic device with a gray protection cap, labeled to indicate the nominal dose. Each ZOLMITRIPTAN NASAL SPRAY device administers a single dose of ZOLMITRIPTAN NASAL SPRAY. ZOLMITRIPTAN NASAL SPRAY is supplied as a clear to pale yellow solution of zolmitriptan, buffered to a pH 5.0. Each ZOLMITRIPTAN 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 ZOLMITRIPTAN NASAL SPRAY is supplied in boxes of 6 single‑use nasal spray units. (NDC 69238-2006-6) 5 mg ZOLMITRIPTAN NASAL SPRAY is supplied in boxes of 6 single‑use nasal spray units. (NDC 69238-2007-6) Each ZOLMITRIPTAN NASAL SPRAY single dose unit spray supplies 2.5 and 5 mg, respectively, of zolmitriptan. The ZOLMITRIPTAN NASAL SPRAY unit must be discarded after use. Store at controlled room temperature, 20‑25°C (68‑77°F) [see USP].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

ZOLMITRIPTAN- ZOLMITRIPTAN SPRAY, METERED
AMNEAL PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLMITRIPTAN NASAL SPRAY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLMITRIPTAN NASAL
SPRAY.
ZOLMITRIPTAN NASAL SPRAY
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
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LIMITATIONS OF USE:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Nasal Spray: 2.5 mg and 5 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (≥5% and > placebo) were:
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ZOLMITRIPTAN NASAL SPRAY is a serotonin (5 HT)
receptor agonist (triptan) indicated for the acute
treatment of migraine with or without aura in adults and pediatric
patients 12 years and older (1)
1B/1D
Use only after a clear diagnosis of migraine has been established (1)
Not intended for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
Not recommended in patients with moderate to severe hepatic impairment
(1)
Recommended starting dose: 2.5 mg (2.1)
Maximum single dose: 5 mg (2.1)
May repeat dose after 2 hours if needed; not to exceed 10 mg in any 24
hour period (2.1)
History of ischemic heart disease or coronary artery vasospasm (4)
Symptomatic Wolff-Parkinson-White syndrome or other cardiac accessory
conduction pathway disorders (4)
History of stroke, transient ischemic attack, or hemiplegic or basilar
migraine (4)
Peripheral Vascular Disease (4)
Ischemic bowel disease (4)
Uncontrolled hypertension (4)
Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another
triptan) or of an ergot-type medication (4)
MAO-A inhibitor used in past 2 weeks (4)
Hypersensitivity to zolmitriptan (4)
Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina:
Perform cardiac evaluation in patients with
multiple cardiovascular risk factors (5.1)
Arrhythmias: Discontinue dosing i