UROMAX D Film-coated tablet Ref.[50496] Active ingredients: Dutasteride Tamsulosin

Source: Marketing Authorisation Holder  Revision Year: 2013 

Product name and form

URIMAX D Tablets (Tamsulosin hydrochloride + Dutasteride).

Pharmaceutical Form

Oral tablet.

Qualitative and quantitative composition

Each film-coated tablet contains:

Tamsulosin Hydrochloride: 0.4 mg (as modified-release tablets)

Dutasteride: 0.5 mg

The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of two underlying components: static and dynamic. The static component is related to an increase in the prostate size, caused, in part, by a proliferation of smooth muscle cells in the prostatic stroma. The dynamic component is a function of an increase in smooth muscle tone in the prostate and bladder neck, leading to constriction of the bladder outlet.

Tamsulosin hydrochloride, a selective alpha1A-adrenoceptor blocking agent, exhibits selectivity for alpha1A-receptors in the human prostate. Tamsulosin hydrochloride acts by relaxing smooth muscles of the bladder neck, prostatic capsule and prostatic urethra.

Dutasteride is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type I and type II isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to 5 alpha-dihydrotestosterone (DHT). DHT is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland.

Active Ingredient Description
Dutasteride

Dutasteride reduces circulating levels of dihydrotestosterone (DHT) by inhibiting both type 1 and type 2, 5α-reductase isoenzymes which are responsible for the conversion of testosterone to DHT.

Tamsulosin

Tamsulosin binds selectively and competitively to post-synaptic α1-adrenoreceptors, prevailingly their subtypes designated α1A and α1D. Thus relaxation of smooth muscles of the prostate and urethra is achieved, which leads to a reduction of tonus and an improvement of the urinary flow.

List of Excipients

Pack sizes and marketing

URIMAX D Tablets: Pack of 10 tablets.

Drugs

Drug Countries
UROMAX CO South Africa

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