ZOLMITRIPTAN spray

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Padagis Israel Pharmaceuticals Ltd

Calea de administrare:

NASAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 (see Data) . 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 Publ

Rezumat produs:

The Zolmitriptan Nasal Spray device is a white plastic device, labeled to indicate the nominal dose. Each Zolmitriptan Nasal Spray device administers a single dose of zolmitriptan. Zolmitriptan Nasal Spray, USP 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, benzalkonium chloride solution NF and purified water USP. 2.5 mg Zolmitriptan Nasal Spray is supplied in boxes of 6 single-use nasal spray units. (NDC 45802-606-91) 5 mg Zolmitriptan Nasal Spray is supplied in boxes of 6 single-use nasal spray units. (NDC 45802-711-91) 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 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

ZOLMITRIPTAN- ZOLMITRIPTAN SPRAY
PADAGIS ISRAEL PHARMACEUTICALS LTD
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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 indicated 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-HT agonist (e.g., another
triptan) or of an ergot-type
medication (4)
1
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 dos