Focusin (tamsulosin) capsules with modified release 0.4 mg. №30

Description

Focusin №30 Storage
active substance: tamsulosin;

1 capsule contains tamsulosin hydrochloride 0.4 mg;

excipients: methacrylate copolymer dispersion, microcrystalline cellulose, dibutyl sebacate, polysorbate 80, colloidal aqueous silicon dioxide, calcium stearate; capsule composition: gelatin, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), iron oxide black (E 172), indigotine (E 132).

Focusin №30 Dosage form
Hard-release capsules with modified release.

Main physical and chemical properties: hard gelatin capsules size № 3 with olive lid and orange body. Capsule contents: white or almost white pellets.

Focusin №30 Pharmacotherapeutic group
Remedies used in benign prostatic hypertrophy. Α1-adrenergic receptor antagonists. ATX code G04C A02.

Pharmacological properties

Pharmacodynamics.

Tamsulosin selectively and competitively blocks postsynaptic α1-adrenoceptors, in particular α1A and α1D, which are located in the smooth muscles of the prostate, bladder neck and prostatic urethra. This reduces the tone of the smooth muscles of the prostate, bladder neck and prostatic urethra and improves urine output. Simultaneously, the symptoms of obstruction and irritation associated with benign prostatic hyperplasia (difficulty starting to urinate, weakening of urine flow, dripping after urination, feeling of incomplete emptying of the bladder, frequent urge to urinate, urge to urinate) .

These effects persist for a long time with long-term treatment and significantly constrain surgery or catheterization.

Α1-adrenoceptor antagonists have the ability to lower blood pressure by reducing peripheral vascular tone. No clinically significant reduction in blood pressure was observed during drug trials.

Pharmacokinetics.

Absorption: Tamsulosin is well absorbed from the gastrointestinal tract, and its bioavailability is almost 100%. Absorption of tamsulosin is somewhat slower after a meal. Uniformity of absorption is achieved when the patient takes the drug at the same time after a meal. The pharmacokinetics of tamsulosin are linear.

After a single dose after a meal, peak plasma concentrations of tamsulosin are reached after approximately 6 hours, and a stable concentration is formed on the fifth day after daily administration of the drug. Cmax is approximately two-thirds higher than that formed after a single dose.

Indication
Treatment of functional disorders of the lower urinary tract in benign prostatic hyperplasia.

Contraindication
Hypersensitivity to tamsulosin hydrochloride, including drug-induced angioneurotic edema, or to any of the excipients; presence of a history of orthostatic hypotension; severe liver failure.