AZILECT- rasagiline mesylate tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

RASAGILINE MESYLATE (UNII: LH8C2JI290) (RASAGILINE - UNII:003N66TS6T)

Disponibil de la:

Aphena Pharma Solutions - Tennessee, LLC

INN (nume internaţional):

RASAGILINE MESYLATE

Compoziție:

RASAGILINE 1 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

AZILECT (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD). AZILECT is contraindicated for use with meperidine, tramadol, methadone, propoxyphene and MAO inhibitors (MAOIs), including other selective MAO-B inhibitors, because of risk of serotonin syndrome [See Warnings and Precautions (5.2)] . At least 14 days should elapse between discontinuation of AZILECT and initiation of treatment with these medications. AZILECT is contraindicated for use with St. John’s wort and with cyclobenzaprine. AZILECT is contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior. Pregnancy Category C There are no adequate and well-controlled studies of rasagiline in pregnant women. AZILECT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In a combined mating/fertility and embryo-fetal development study in pregnant rats, no effect on embryo-fetal development was observed at oral doses up to 3 mg/kg/da

Rezumat produs:

AZILECT 0.5 mg Tablets: White to off-white, round, flat, beveled tablets, debossed with “GIL 0.5” on one side and plain on the other side. Supplied as bottles of 30 tablets (NDC 68546-142-56). AZILECT 1 mg Tablets: White to off-white, round, flat, beveled tablets, debossed with “GIL 1” on one side and plain on the other side. Supplied as bottles of 30 tablets (NDC 68546-229-56). Storage: Store at 25°C (77°F) with excursions permitted to 15°-30°C (59°-86°F).

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

AZILECT- RASAGILINE MESYLATE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZILECT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AZILECT.
AZILECT (RASAGILINE MESYLATE) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
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05/2014
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05/2014
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05/2014
INDICATIONS AND USAGE
AZILECT, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated
for the treatment of Parkinson’s disease (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
Concomitant use of meperidine, tramadol, methadone, propoxyphene
dextromethorphan, St. John’s wort,
cyclobenzaprine, or another (selective or non-selective) MAO inhibitor
(4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence 3% or greater than placebo):
®
Indications and Usage (1)
Dosage and Administration (2.1)
Warnings and Precautions (5.2, 5.3, 5.6, 5.8, 5.9)
Monotherapy: AZILECT 1 mg once daily (2.1)
As adjunct without levodopa: AZILECT 1 mg once daily (2.1)
As adjunct to levodopa: AZILECT 0.5 mg once daily. Increase dose to 1
mg daily as needed for sufficient clinical
response (2.1)
Patients taking ciprofloxacin or other CYP1A2 inhibitors: AZILECT 0.5
mg once daily (2.2, 5.4)
Patients with mild hepatic impairment: AZILECT 0.5 mg once daily.
AZILECT should not be used in patients with
moderate or severe hepatic impairment (2.3, 5.5)
AZILECT 0.5 mg tablets (containing, as the active ingredient,
rasagiline mesylate equivalent to 0.5 mg of rasagiline
base) (3)
AZILECT 1 mg tablets (containing, as the active ingredient, rasagiline
mesylate equivalent to 1 mg of rasagiline base)
(3)
May cause hypertension (including severe hypertensive syndromes) at
recommended doses (5.1)
May cause serotonin syndrome when used with antidepressants (5.2)
May cause falling asleep during activities of daily living, daytime
drowsine