RASAGILINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ascend Laboratories, LLC

INN (International Name):

RASAGILINE MESYLATE

Composition:

RASAGILINE 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Rasagiline tablets are indicated for the treatment of Parkinson's disease (PD) Rasagiline 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 rasagiline and initiation of treatment with these medications. Rasagiline is contraindicated for use with St. John’s wort and with cyclobenzaprine. Rasagiline 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 rasagiline 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 comb

Product summary:

Rasagiline Tablets, 0.5 mg White to off-white, uncoated round, flat, beveled tablets, debossed with “RAS” on one side and “0.5” on the other side. Supplied as: NDC 67877-259-30                  Bottles of 30 tablets Rasagiline Tablets, 1 mg  White to off white, uncoated round, flat, beveled tablets debossed with "RAS" on one side and "1" on other side. Supplied as: NDC 67877-260-30                 Bottles of 30 tablets Storage: Store at 25°C (77°F) with excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RASAGILINE - RASAGILINE TABLET
ASCEND LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RASAGILINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RASAGILINE TABLETS.
RASAGILINE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
Rasagiline tablets, a monoamine oxidase (MAO)-B inhibitor (MAOI), is
indicated for the treatment of
Parkinson’s disease (1)
DOSAGE AND ADMINISTRATION
Monotherapy: Rasagiline tablets 1 mg once daily (2.1)
As adjunct without levodopa: Rasagiline tablets 1 mg once daily (2.1)
As adjunct to levodopa: Rasagiline tablets 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: Rasagiline
tablets 0.5 mg once daily (2.2, 5.4)
Patients with mild hepatic impairment: Rasagiline tablets 0.5 mg once
daily. Rasagiline tablets should
not be used in patients with moderate or severe hepatic impairment
(2.3, 5.5)
DOSAGE FORMS AND STRENGTHS
· Rasagiline tablets 0.5 mg tablets (3)
· Rasagiline tablets 1 mg tablets (3) (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% o