CO-STRIMAX Hard gelatin capsule Ref.[115686] Active ingredients: Dutasteride Tamsulosin

Source: Registered Drug Product Database (NG)  Publisher: Registrant: ANTILA LIFESCIENCE PVT.LTD., 817, 8 th Floor Devpath, B/H Lal Bunglow, Off. C.G.ROAD, Ahmedabad, Gujarat, India Manufacturer: ANTILA LIFESCIENCE PVT.LTD., MFG. AT: Block No. 2244, At & Post-Santej, Tal-Kalol. Dist-Gandhinagar

Product name and form

1.1 (Invented) Name of the medicinal product

CO-STRIMAX.

1.2 Strength

Each Hard Gelatin Capsule contains:

Tamsulosin Hydrochloride USP 0.4 mg (As modified release pellets)

Dutasteride 0.5 mg

Excipients Q.S.

Approved colour used for capsule shells.

1.3 Pharmaceutical Form

Hard Gelatin Capsule.

Pharmaceutical Form

Pink/CT colored hard gelatin capsules of size '1' containing multi colored Pellets.

Qualitative and quantitative composition

Batch Size: 100,000 Capsules.

Sr. No.Name of IngredientSpecificationQuantity/
capsule
in mg
Quantity/
Batch in kg
Functions
1.Tamsulosin Hydrochloride
USP (As modified release
pellets) and Dutasteride ready
mix pellets
In house400.0 mg40.00 kgAlpha-
adrenoreceptor
antagonists
Total Weight of Pellets400.0 mg40.00 kg 
2.Pink/CT colored hard gelatin
capsules size '1'
In house1 No.100,000
Nos.
Capsule Shell
Active Ingredient

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 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

Not applicable.

Pack sizes and marketing

CO-STRIMAX is packed in 3 X 10 Capsules Alu-Alu blister pack in a printed carton along with package insert.

Marketing authorization holder

Registrant: ANTILA LIFESCIENCE PVT.LTD., 817, 8th Floor Devpath, B/H Lal Bunglow, Off. C.G.ROAD, Ahmedabad, Gujarat, India

Manufacturer: ANTILA LIFESCIENCE PVT.LTD., MFG. AT: Block No. 2244, At & Post-Santej, Tal-Kalol. Dist-Gandhinagar

Drugs

Drug Countries
CO-STRIMAX Nigeria

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