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:

Mylan Pharmaceuticals Inc.

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 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. 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 preg

Product summary:

Rasagiline Tablets are available containing 0.5 mg or 1 mg of rasagiline equivalent to 0.78 mg or 1.56 mg of rasagiline mesylate, respectively. The 0.5 mg tablets are white to off-white, round tablets debossed with M on one side of the tablet and RA over 5 on the other side. They are available as follows: NDC 0378-1270-93 bottles of 30 tablets The 1 mg tablets are white to off-white, round tablets debossed with M on one side of the tablet and RA over 1 on the other side. They are available as follows: NDC 0378-1271-93 bottles of 30 tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RASAGILINE MESYLATE - RASAGILINE MESYLATE TABLET
MYLAN 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), are
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):
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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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)
Rasagiline 0.5 mg tablets (3)
Rasagiline 1 mg tablets (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
drowsiness, and somnolence (5.3)
May cause hypotension, especially orthostatic (5.6)
May cause or exacerbate d