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NDC 70954-0504-10

Selegiline Hydrochloride 5 mg/1 CAPSULE

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NDC
70954-0504-10
Generic Name
Selegiline Hydrochloride
Brand Name
Selegiline Hydrochloride
Strength
5 mg/1
Dosage Form
CAPSULE
Route
ORAL
Package Size
Labeler
Novitium Pharma LLC

FDA Drug Information

Indications & Usage

INDICATIONS & 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…

Important Warnings

WARNINGS Selegiline should not be used at daily doses exceeding those recommended (10 mg/day) because of the risks associated with non-selective inhibition of MAO (see CLINICAL PHARMACOLOGY ). The selectivity of selegiline for MAO-B may not be absolute even at the recommended daily dose of 10 mg a day. Rare cases of hypertensive reactions associated with ingestion of tyramine-containing foods have…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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