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:

Avet Pharmaceuticals Inc.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

Rasagiline tablets 0.5 mg: White to off-white, round, flat, beveled tablets, debossed with “31” on one side and “I” on the other side. Supplied as bottles of 30 tablets with child-resistant cap (NDC 23155-746-03). Rasagiline tablets 1 mg: White to off-white, round, flat, beveled tablets, debossed with “32” on one side and “I” on the other side. Supplied as bottles of 30 tablets with child-resistant cap (NDC 23155-747-03).      Storage: Store at 25°C (77°F) with excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

RASAGILINE MESYLATE - RASAGILINE MESYLATE TABLET
AVET PHARMACEUTICALS INC.
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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)
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