Tamsulosin Hydrochloride

What it is and how it works

Mechanism of Action 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.

Indications

Tamsulosin hydrochloride capsules are an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension Tamsulosin hydrochloride capsules, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) . Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.

Dosage and administration (summary)

0.4 mg once daily taken approximately one-half hour following the same meal each day. Tamsulosin capsules should not be crushed, chewed or opened. Can be increased to 0.8 mg once daily for patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing If discontinued or interrupted for several days, therapy should start again with the 0.4 mg once-daily dose Tamsulosin hydrochloride capsules, 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour following the same meal each day. Tamsulosin hydrochloride capsules should not be crushed, chewed or opened.

Contraindications

Contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules ( 4 , 6.2 ) Tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. Reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms .

Warnings and precautions

Advise patients about the possibility of symptoms related to postural hypotension and to avoid situations where injury could result should syncope occur Should not be used in combination with strong inhibitors of CYP3A4. Use with caution in combination with moderate inhibitors of CYP3A4, with strong or moderate inhibitors of CYP2D6, in patients known to be CYP2D6 poor metabolizers, or in combination with other cytochrome P450 inhibitors.

Pregnancy

Pregnancy Risk Summary Tamsulosin hydrochloride capsules are not indicated for use in women. There are no adequate data on the developmental risk associated with the use of Tamsulosin hydrochloride capsules in pregnant women.

Storage and supply

Tamsulosin Hydrochloride Capsules USP, 0.4 mg are white to off-white free flowing pellets filled in size '2' empty hard gelatin capsules with green colored cap printed with "ZA-18" in black ink and peach colored body printed with "0.4 mg" in black ink and are supplied as follows: NDC 82009-025-10 in bottle of 1000 capsules Storage: Store at 20°C to…

Source: Tamsulosin Hydrochloride (Tamsulosin Hydrochloride) — US FDA prescribing information, 2023-09-18, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.