NARATRIPTAN 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:

Sun Pharmaceutical Industries Limited

INN (Միջազգային անվանումը):

NARATRIPTAN HYDROCHLORIDE

Կազմը:

NARATRIPTAN 2.5 mg

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

NARATRIPTAN - NARATRIPTAN TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NARATRIPTAN TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR NARATRIPTAN TABLETS.
NARATRIPTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Naratriptan is a serotonin (5-HT
) receptor agonist (triptan) indicated for the acute treatment of
migraine with or
without aura in adults. (1)
Limitations of Use:
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)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
Tablets : 2.5 mg (3, 16)
CONTRAINDICATIONS
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-HT1 agonist (e.g., another
triptan) or an ergotamine-containing medication
(4)
Hypersensitivity to naratriptan (angioedema and anaphylaxis seen) (4)
Severe renal or hepatic impairment (4)
WARNINGS AND PRECAUTIONS
Myocardial ischemia/infarction and Prinzmetal's angina: Perform
cardiac evaluation in patients with multiple cardiovascular
risk factors. (5.1)
Arrhythmias: Discontinue naratriptan if occurs. (5.2)
Chest/throat/neck/jaw pain, tightness, pressure, or heaviness:
Generally not associated with myocardial ischemia; evaluate
for CAD in patients at high risk. (5.3