Tamsulosin-Vertex, 0.4 mg capsules 90 pcs

Tamsulosin is a specific blocker of postsynaptic α1-adrenoreceptors located in the smooth muscles of the prostate, bladder neck and prostatic part of the urethra. Blockade of α1-adrenoreceptors by tamsulosin leads to decrease of tone of the smooth muscles of the prostate, bladder neck and prostatic part of the urethra and improves outflow of urine.

The severity of symptoms of filling and emptying associated with increased smooth muscle tone and detrusor hyperactivity in benign prostatic hyperplasia are simultaneously reduced. < br>

The ability of tamsulosin to affect α1A subtype of adrenoreceptors is 20 times greater than its ability to interact with α1B subtype of adrenoreceptors located in vascular smooth muscle. < br>

Owing to its high selectivity, tamsulosin does not cause clinically significant reduction of systemic arterial pressure (BP) both in patients with arterial hypertension and in patients with normal baseline BP.

< br>.

Indications

Treatment of dysuric disorders in benign prostatic hyperplasia.

Active ingredient

Composition

Prolonged release capsules.

1 sustained release capsule contains:

Tamsulosin hydrochloride pellet substance 0.2% – 200.0 mg [active ingredient: tamsulosin hydrochloride – 0.4 mg; excipients: sugar spheres (sucrose – 99 %, hypromellose – 1 %) – 190.0 mg, methacrylic acid copolymer – 4.8 mg, ethylcellulose – 4.0 mg, polyethylene glycol – 0.8 mg].

Capsules are hard gelatin:

titanium dioxide – 1.0%,

iron oxide yellow (iron oxide) – 0.27%,

Patented blue dye – 0.015 %,

Gelatin – up to 100%.

How to take, the dosage

Ingestion.

Tamsulosin capsules should be taken after breakfast, without chewing, with plenty of water.

The drug is taken 1 capsule (0.4 mg) once daily.

Interaction

No interaction has been observed when concomitant use of tamsulosin with atenolol, enalapril, nifedipine or theophylline. When concomitant use with cimetidine, plasma concentrations of tamsulosin are increased, and when concomitant use of tamsulosin with furosemide is decreased.

However, no dose adjustment is required, since tamsulosin concentrations remain within the therapeutic range.

In vitro diazepam, propranolol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the level of free fraction of tamsulosin in plasma. In turn, tamsulosin does not change the plasma levels of free fractions of diazepam, propranolol, trichloromethiazide and chlormadinone.

The interaction of tamsulosin with amitriptyline, salbutamol, glibenclamide and finasteride was not found in in vitro studies. Simultaneous use of diclofenac or warfarin with tamsulosin may increase the elimination rate of tamsulosin.

Concomitant administration of tamsulosin with drugs that reduce blood pressure, including other alpha1 -adrenoblockers and anesthetics, may increase the hypotensive effect.

Special Instructions

At the first signs of orthostatic hypotension (dizziness, weakness), one should sit or lie down until these symptoms disappear.
Before treatment with tamsulosin, the patient should be examined to exclude other diseases that may cause the same symptoms as benign prostatic hyperplasia.

Before treatment with the drug and during therapy, regular examination of the prostate gland and, if necessary, determination of prostatic specific antigen (PSA) should be performed. Due to the possibility of complications during surgical treatment of cataracts, it is not recommended to prescribe tamsulosin treatment to patients with cataracts if surgery is planned.

Drowsiness, visual impairment, dizziness and fainting may occur while taking tamsulosin; therefore, the drug should be used with caution while driving vehicles and people whose profession requires increased concentration.

Impact on driving and operating machinery

At the time of treatment, one must refrain from engaging in potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

With caution:
Severe renal insufficiency (decreased creatinine clearance below 10 ml/min).

Side effects

Nervous system disorders: frequently – dizziness, infrequently – headache, rarely – fainting; sleep disturbance (drowsiness or insomnia);

Cardiovascular system disorders: infrequent – tachycardia, orthostatic hypotension; pain in the chest;

Respiratory system: infrequent – rhinitis.

Digestive system: infrequent – constipation, diarrhea, nausea, vomiting.

Skin and skin: infrequent – rash, itching, urticaria; rarely – angioedema.

Urogenital system: infrequent – retrograde ejaculation, very rare – priapism; decreased libido;

Others: occasionally – asthenia, back pain, small pupil syndrome during cataract surgery

Overdose

There have been no cases of overdose described; theoretically, acute hypotension is possible.

Treatment: in case of overdose it is recommended to put the patient in horizontal position and perform measures aimed at maintaining cardiovascular function (restoration of blood pressure and heart rate); gastric lavage, administration of activated charcoal and osmotic laxatives such as sodium sulfate.

If there is no effect, a circulating blood volume booster should be given and, if necessary, vasoconstrictors. Renal function should be monitored and measures taken to maintain it. Dialysis is of little use in tamsulosin overdose because the drug is largely bound to plasma proteins.

Similarities