RASAGILINE 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:

Teva Pharmaceuticals USA, Inc.

INN (nume internaţional):

RASAGILINE MESYLATE

Compoziție:

RASAGILINE 0.5 mg

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 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 combin

Rezumat produs:

Rasagiline 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 0093-3060-56). Rasagiline 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 0093-3061-56). Storage: Store at 25°C (77°F) with excursions permitted to 15°-30°C (59°-86°F).

Statutul autorizaţiei:

New Drug Application Authorized Generic

Caracteristicilor produsului

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