Tamsumax 200mcg Sustained-Release Capsule

Country: Philippines

Language: English

Source: FDA (Food And Drug Administration)

Active ingredient:

Tamsulosin Hydrochloride

Available from:

Pharmabest Incorporated; Distributor: Pharmabest Incorporated

INN (International Name):

Tamsulosin Hydrochloride

Dosage:

200mcg

Pharmaceutical form:

Sustained-Release Capsule

Units in package:

Clear PVC/PVDC -Alu Blister Pack x 10's (Box of 10's), Clear PVC/PVDC-Alu Blister pack x 10's (box of 10's)

Manufactured by:

Hangzhou Conba Pharmaceutical Co., Ltd., China

Authorization date:

2022-02-16

Summary of Product characteristics

TAMSUMAX (TAMSULOSIN HCL)
200mcg and 400mcg Sustained Release Capsule
Alpha-1-Adrenoceptor Blocker
FORMULATION
Each Tamsulosin HCl (Tamsumax) sustained release capsule for oral
administration contains
tamsulosin hydrochloride 200mcg or 400mcg.
DESCRIPTION
Tamsulosin HCl is an antagonist of alpha1A adrenoceptors in the
prostate.
Tamsulosin Hydrochloride, is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]
amino] propyl]-2-
methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride
is a white or almost
white crystalline powder that melts with decomposition at
approximately 230°C. It is slightly soluble in
water, freely soluble in formic acid, slightly soluble in anhydrous
ethanol, sparingly soluble in
methanol, slightly soluble in glacial acetic acid, and practically
insoluble in ether.
The molecular formula of Tamsulosin hydrochloride is C
20
H
28
N
2
O
5
S•HCl. The molecular weight of
Tamsulosin hydrochloride is 444.98. Its structural formula is:
CLINICAL PHARMACOLOGY
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 prostate size caused, in part,
by a proliferation of smooth muscle
cells in the prostatic stroma. However, the severity of BPH symptoms
and the degree of urethral
obstruction do not correlate well with the size of the prostate. 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. Smooth muscle tone is mediated by the sympathetic
nervous stimulation of alpha1
adrenoceptors, which are abundant in the prostate, prostatic capsule,
prostatic urethra, and bladder
neck. Blockade of these adrenoceptors can cause smooth muscles in the
bladder neck and prostate to
relax, resulting in an improvement in urine flow rate and a reduction
in symptoms of BPH.
Tamsulosin, an alpha1 adrenoceptor blocking agent, exhibits
selectivity for alph