AZILECT- rasagiline mesylate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Neuroscience, Inc.

INN (International Name):

RASAGILINE MESYLATE

Composition:

RASAGILINE 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Risk Summary There are no adequate data on the developmental risks associated with the use of AZILECT in pregnant women. In animal studies, oral administration of rasagiline to rats during gestation and lactation resulted in decreased survival and reduced body weight in the offspring at doses similar to those used clinically. When administered to pregnant animals in combination

Product summary:

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).

Authorization status:

New Drug Application

Summary of Product characteristics

AZILECT- RASAGILINE MESYLATE TABLET
TEVA NEUROSCIENCE, INC.
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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) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
AZILECT, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated
for the treatment of Parkinson’s
disease (1)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
AZILECT 0.5 mg tablets (3)
AZILECT 1 mg tablets (3)
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
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
drowsiness, and somnolence (5.3)
May cause hypotension, especially orthostatic (5.6)
May cause or exacerbate dyskinesia. Decreasing the levodopa dose may
lessen or eliminate this side
effect (5.7)
May cause hallucinations and psychotic-like behavior (5.8)
May cause impulse control/compulsive behaviors (5.9)
May cause withdrawal-emergent hyperpyrexia and confusion (5.10)
ADVERSE REACTIONS
Most common adverse reactions (incidence 3% or greater than placebo):
AZILECT monotherapy: flu syndrome, arthralgia, depression, dyspepsia
(6.1)
AZILECT used as a