NARATRIPTAN HYDROCHLORIDE tablet film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

NARATRIPTAN HYDROCHLORIDE (UNII: 10X8X4P12Z) (NARATRIPTAN - UNII:QX3KXL1ZA2)

Հասանելի է:

Paddock Laboratories, LLC

INN (Միջազգային անվանումը):

NARATRIPTAN HYDROCHLORIDE

Կազմը:

NARATRIPTAN 1 mg

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

NARATRIPTAN HYDROCHLORIDE- NARATRIPTAN HYDROCHLORIDE TABLET, FILM
COATED
PADDOCK LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NARATRIPTAN TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NARATRIPTAN TABLETS,
USP.
NARATRIPTAN (NARATRIPTAN HYDROCHLORIDE) TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Naratriptan Tablets, USP are a serotonin (5-HT
) receptor agonist (triptan) indicated for the acute treatment of
migraine with or without aura in adults. (1) (1)
Limitations of Use: (1)
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg and 2.5 mg (3, 16) (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (≥2% and >placebo) were paresthesias,
nausea, dizziness, drowsiness, malaise/fatigue,
and throat/neck symptoms. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at
1-866-634-9120 or FDA at 1-800-FDA-1088 or
www.fda.gov/me dwatch.
1B/1D
Use only if a clear diagnosis of migraine has been established. (1)
Not indicated for the prophylactic therapy of migraine attacks. (1)
Not indicated for the treatment of cluster headache. (1)
Recommended dose: 1 mg or 2.5 mg. (2.1)
May repeat dose after 4 hours if needed; not to exceed 5 mg in any
24-hour period. (2.1)
Mild or moderate renal or hepatic impairment: recommended starting
dose is 1 mg not to exceed 2.5 mg in any 24-
hour period. (2.2, 2.3)
History of coronary artery disease or coronary artery vasospasm (4)
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 an ergotamine-containing medica