ZELAPAR- selegiline hydrochloride tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SELEGILINE HYDROCHLORIDE (UNII: 6W731X367Q) (SELEGILINE - UNII:2K1V7GP655)

Available from:

Bausch Health US, LLC

INN (International Name):

SELEGILINE HYDROCHLORIDE

Composition:

SELEGILINE HYDROCHLORIDE 1.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZELAPAR is indicated as an adjunct in the management of patients with Parkinson’s disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that ZELAPAR has any beneficial effect in the absence of concurrent levodopa therapy [see Clinical Studies (14) ]. ZELAPAR is contraindicated in patients with: Risk Summary There are no adequate data on the developmental risk associated with the use of ZELAPAR in pregnant women. In animal studies, administration of selegiline during pregnancy was associated with developmental toxicity (decreased embryofetal and postnatal offspring growth and survival) at doses greater than those used clinically. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage in the indicated population is u

Product summary:

ZELAPAR Orally Disintegrating Tablets are available containing 1.25 mg selegiline hydrochloride in a Zydis® formulation. Each pale yellow tablet is imprinted with a stylized “V”. Ten tablets in a blister card are provided in a sachet pouch. The sachet pouch is stored inside a clear child-resistant outer pouch and is packaged in a carton. The blister card and sachet pouch are not child-resistant. The clear outer pouch is child-resistant. ZELAPAR (selegiline hydrochloride) is available as: Store at controlled room temperature, 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Use within 3 months of opening pouch and immediately upon opening individual blister. Store blister tablets in sachet pouch at all times. Keep sachet pouch sealed or closed inside clear child-resistant pouch provided. Potency cannot be guaranteed after 3 months of opening the sachet pouch.

Authorization status:

New Drug Application

Summary of Product characteristics

ZELAPAR- SELEGILINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING
BAUSCH HEALTH US, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZELAPAR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZELAPAR.
ZELAPAR (SELEGILINE HYDROCHLORIDE) ORALLY DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Contraindications (4) 6/2021
Warnings and Precautions,
INDICATIONS AND USAGE
ZELAPAR, a monoamine oxidase type B (MAO-B) inhibitor, is indicated as
an adjunct in the management
of patients with Parkinson’s disease being treated with
levodopa/carbidopa who exhibit deterioration in the
quality of their response to this therapy (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Orally Disintegrating Tablets: 1.25 mg (3)
CONTRAINDICATIONS
ZELAPAR is contraindicated in patients using the following drugs:
opioid drugs (e.g., meperidine, tramadol,
methadone), MAO inhibitors including selective MAO-B inhibitors,
dextromethorphan, St. John’s wort, and
cyclobenzaprine (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (incidence at least 3% greater than
on placebo) are constipation,
skin disorders, vomiting, dizziness, dyskinesia, insomnia, dyspnea,
myalgia, and rash (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAUSCH HEALTH US, LLC
AT 1-800-321-
4576 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
®
Melanoma-removal (5.9) 6/2021
Risk for Patients with Phenylketonuria (5.10) 6/2021
Initiate treatment with 1.25 mg given once a day for at least 6 weeks;
after 6 weeks, the dose may be
escalated to 2.5 mg once a day (2.1)
Place tablet on top of the tongue where the tablet will disintegrate
in seconds; avoid food and liquid
intake 5 minutes before and after each dose (2.1)
In patients with mild or moderate hepatic impairment, the dose should
be reduced to 1.25 mg;