Drug Catalog - Product Detail
SELEGILINE HCL CP 5MG 60
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 67253-0700-06 | PAR PHARMACEUTICAL | 60 | 5MG | CAPSULE |
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Description
DESCRIPTION: Selegiline hydrochloride, USP is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl. The chemical name is: (R)-(-)- N ,2-dimethyl- N -2-propynylphenethylamine hydrochloride. It is a white to near white crystalline powder, freely soluble in water, chloroform, and methanol, and has a molecular weight of 223.75. The structural formula is as follows: Each white opaque capsule is band printed with S 700. Each capsule contains 5 mg selegiline hydrochloride, USP. Inactive ingredients are citric acid, lactose, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin and titanium dioxide and are imprinted with red ink. The ink contains pharmaceutical glaze and synthetic red iron oxide. Chemical Structure for: (R)-(-)-N,2-dimethyl-N-2propynyphenethylamine hydrochloride
How Supplied
HOW SUPPLIED: Selegiline Hydrochloride Capsules, USP are available containing 5 mg of selegiline hydrochloride. Each opaque white capsule is printed with S 700. They are available as: NDC 67253-700-06 bottles of 60 capsules. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] All brand names listed are registered trademarks of their respective owners and are not trademarks of Par Pharmaceutical. Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528 USA Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 Revised: 03/17 300 172 990 140
Indications & Usage
INDICATIONS AND USAGE: Selegiline hydrochloride capsules, USP are indicated as an adjunct in the management of Parkinsonian patients 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 selegiline has any beneficial effect in the absence of concurrent levodopa therapy. Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of ‘off’ time, and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).
Dosage and Administration
DOSAGE AND ADMINISTRATION: Selegiline hydrochloride capsules are intended for administration to Parkinsonian patients receiving levodopa/carbidopa therapy who demonstrate a deteriorating response to this treatment. The recommended regimen for the administration of selegiline hydrochloride is 10 mg per day administered as divided doses of 5 mg each taken at breakfast and lunch. There is no evidence that additional benefit will be obtained from the administration of higher doses. Moreover, higher doses should ordinarily be avoided because of the increased risk of side effects. After two to three days of selegiline treatment, an attempt may be made to reduce the dose of levodopa/carbidopa. A reduction of 10 to 30% was achieved with the typical participant in the domestic placebo controlled trials who was assigned to selegiline treatment. Further reductions of levodopa/carbidopa may be possible during continued selegiline therapy.