FINIDE Film-coated tablet Ref.[50319] Active ingredients: Finasteride

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2020  Publisher: Alphapharm Pty Ltd, Level 1, 30 The Bond, 30 – 34 Hickson Road, Millers Point NSW 2000, www.mylan.com.au

Product name and form

Finide – Finasteride.

Pharmaceutical Form

Finide 5 mg tablets are blue colored, oval shaped, biconvex, film-coated tablets, debossed with ‘FIN’ on one side and ‘5’ on the other side.

Qualitative and quantitative composition

Finide film coated tablets contain 5 mg of finasteride as the active ingredient.

Excipients with known effect: Lactose monohydrate.

For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.

Chemical structure

Chemical name: N-(1,1-dimethylethyl)-3-oxo-4-aza-5-α-androst-1-ene-17-β-carboxamide

Molecular formula: C23H36N2O2

Molecular Weight: 372.55

CAS Number: 98319-26-7

Active Ingredient Description
Finasteride

Finasteride is a competitive inhibitor of human 5α-reductase, an intracellular enzyme which metabolises testosterone into the more potent androgen, dihydrotestosterone (DHT). In benign prostatic hyperplasia (BPH), enlargement of the prostate gland is dependent upon the conversion of testosterone to DHT within the prostate. Finasteride is highly effective in reducing circulating and intraprostatic DHT. Finasteride has no affinity for the androgen receptor.

List of Excipients

Finide also contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinised maize starch, sodium starch glycollate Type A, docusate sodium, magnesium stearate and Opadry complete film-coating system 03B50899 blue.

Pack sizes and marketing

Available in blister packs containing 28 tablets (Al/Al) and 30 tablets (PVC/PE/PVDC/Al).

Some strengths, pack sizes and/or pack types may not be marketed.

Marketing authorization holder

Alphapharm Pty Ltd, Level 1, 30 The Bond, 30 – 34 Hickson Road, Millers Point NSW 2000, www.mylan.com.au

Marketing authorization dates and numbers

18/06/2010

Drugs

Drug Countries
FINIDE Australia, South Africa

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