Selegilinedrug info
selegiline hydrochloride 5 MG Oral Capsule
What it is used for
Selegiline 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).
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective September 22, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Selegiline hydrochloride 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,α-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 molecular formula is C 13 H 17 N. HCI and the structural formula is as follows: Each capsule, for oral administration contains 5 mg of selegiline hydrochloride. In addition, each capsule contains the following inactive ingredients: Anhydrous Lactose NF, Citric Acid Anhydrous USP, Microcrystalline Cellulose NF PH102, Stearic Acid NF and Talc USP. The capsule shell contains Gelatin NF, FD & C Blue #1 and Titanium Dioxide. The capsule logo ink Black SW-9008/SW-9009 contains the following inactive ingredients: Ammonium Hydroxide; Black Iron Oxide, Bacteria Controlled EEC No. 172; n-Butyl NF; Ethyl Alcohol, Anhydrous, 200 Proof; Isopropyl Alcohol USP; Potassium Hydroxide NF; Propylene Glycol USP; Purified Water USP and Shellac NF.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective September 22, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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