Universal reference book for medicines
Name of the drug: TAMSULOSIN RETARD (TAMSULOSIN RETARD)

Active substance: tamsulosin

Type: A drug used for urination disorders associated with benign prostatic hyperplasia.
Alpha 1- adrenoblocker
Manufacturer: ФП ОБОЛЕНСКОЕ (Russia)
Composition, form of production and packaging
Long-acting tablets coated with a film membrane
from yellow to brownish-yellow color, round, biconvex;
Two layers are visible on the cross-section.
1 tab.

tamsulosin hydrochloride 400 μg

[PRING] hypromellose (hydroxymethylcellulose) 41.25 mg, silicon colloidal dioxide (aerosil) 0.625 mg, microcrystalline cellulose 82.1 mg, magnesium stearate 0.625 mg.

Sheath composition: Opadrai II - series 85 (alcohol polyvinyl partially hydrolyzed, macrogol 3350, talc, titanium dioxide, iron oxide yellow, iron oxide red, iron oxide black) 3 mg.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
14 pcs.
- blisters (1) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
14 pcs.
- blisters (3) - packs of cardboard.
15 pcs.
- blisters (1) - packs of cardboard.
15 pcs.
- blisters (2) - packs of cardboard.
15 pcs.
- blisters (3) - packs of cardboard.
20 pcs.
- blisters (1) - packs of cardboard.
20 pcs.
- blisters (2) - packs of cardboard.
20 pcs.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Tamsulosin is a specific blocker of postsynaptic alpha-adrenergic receptors located in the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra.
Blockade of alpha-adrenergic receptors with tamsulosin leads to a decrease in the tone of the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra and to improve the outflow of urine. Simultaneously, both emptying symptoms and filling symptoms are reduced, due to the increased tone of smooth muscles and detrusor hyperactivity in benign prostatic hyperplasia (BPH).
The ability of tamsulosin to affect the alpha A subtype of adrenoreceptors is 20 times greater than its ability to interact with the alpha B subtype of adrenoreceptors that are located in the smooth muscle of the vessels.
Due to its high selectivity, tamsulosin does not cause a clinically significant reduction in systemic BP in both patients with arterial hypertension and in patients with normal initial BP.
PHARMACOKINETICS

Tamsulosin is well absorbed in the intestine and has almost 100% bioavailability.
Absorption of tamsulosin somewhat slows down after eating. The same level of absorption can be achieved if the patient takes the drug every time after a normal breakfast. Tamsulosin is characterized by linear kinetics. After a single oral intake of 0.4 mg of the drug, its C max is reached after 6 hours. After repeated intake of 0.4 mg per day, C ss is reached by day 5, while its value is about 2/3 higher than the value of this parameter after taking a single dose.
Binding to plasma proteins is 99%, V d is small (about 0.2 l / kg).

Tamsulosin is slowly metabolized in the liver with the formation of less active metabolites.
Most of the tamsulosin is present in plasma in unchanged form.
In the experiment, the ability of tamsulosin to induce insignificantly the activity of microsomal liver enzymes was revealed.
With a slight and moderate degree of hepatic insufficiency, there is no need for correction of the dosing regimen. Tamsulosin and its metabolites are mainly excreted in the urine, with approximately 9% of the drug excreted unchanged.
T 1/2 of the drug with a single intake of 0.4 mg after a meal is 10 hours, with a multiple of 13 hours. In renal failure, there is no need to reduce the dose, if the patient has severe renal failure (creatinine clearance less than 10 ml / min), the appointment tamsulosin should be administered with caution.

INDICATIONS

- treatment of dysuric disorders in benign prostatic hyperplasia.

DOSING MODE

Inside, after breakfast, washed down with water, take 1 tab.
prolonged action, film-coated (0.4 mg), 1 time / day. Tablet is not recommended to chew, tk. this can affect the release rate of the drug.
SIDE EFFECT

The incidence of side effects developing with tamsulosin is classified according to WHO recommendations: very often - at least 10%;
often - not less than 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%, including individual reports.
Rarely - dizziness, retrograde ejaculation, very rarely - orthostatic hypotension, tachycardia / palpitation, asthenia, headache, nausea, vomiting, diarrhea, constipation, hypersensitivity reactions - skin rash, itching, angioedema.

CONTRAINDICATIONS

- Orthostatic hypotension (including in the anamnesis);

- severe hepatic impairment;

- hypersensitivity to tamsulosin or any other component of the drug.

With caution: chronic renal failure (CC below 10 ml / min).

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution: chronic renal failure (CC below 10 ml / min).

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in severe hepatic insufficiency.

SPECIAL INSTRUCTIONS

As with other alpha-blockers, when treated with Tamsulosin retard, in some cases, a decrease in blood pressure may occur, which can sometimes lead to a fainting condition.
At the first signs of orthostatic hypotension (dizziness, weakness), the patient must sit or lie down and remain in this position until the signs disappear.
With surgical interventions for cataracts against the background of taking the drug, the development of intraoperative irrosis syndrome (narrow pupil syndrome) is possible, which should be taken into account by the surgeon for preoperative preparation of the patient and during the operation.

Before starting therapy with Tamsulosin retard, the patient should be examined to exclude the presence of other diseases that can cause the same symptoms as BPH.

Before the start of treatment and regularly during therapy, a digital rectal examination and, if necessary, the determination of a prostatic specific antigen should be performed.

Impact on the ability to drive vehicles and manage mechanisms

Care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, due to the possible development of dizziness.

OVERDOSE

There are no reports of cases of acute overdose with tamsulosin.
However, theoretically, with an overdose, it is possible to develop an acute decrease in blood pressure and compensatory tachycardia, in which case symptomatic therapy is necessary. Blood pressure and heart rate can be restored when a person takes a horizontal position. In the absence of effect, it is possible to use agents that increase the volume of circulating blood and, if necessary, vasoconstrictors. It is necessary to monitor kidney function. It is unlikely that dialysis will be effective. tamsulosin is strongly associated with plasma proteins.
To prevent further absorption of the drug, it is advisable to wash the stomach, taking activated charcoal or osmotic laxative, for example sodium sulfate.

DRUG INTERACTION

When tamsulosin was prescribed, no interactions were found with atenolol, enalapril or nifedipine.

With the simultaneous use of tamsulosin with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was noted, and with furosemide a decrease in the concentration was noted, but this does not require a change in the dose of Tamsulosin retard since the drug concentration remains within the normal range.

Diazepam, propranolol, trichloromethiazide, chloromadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the free tamsulosin fraction in human plasma in vitro.
In turn, tamsulosin also does not change the free fractions of diazepam, propranolol, trichloromethiazide and chloromadinone.
In studies in vitro, no interaction was found at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide, and finasteride.

Diclofenac and warfarin can increase the rate of excretion of tamsulosin.
Simultaneous administration of other antagonists of alpha 1- adrenoreceptors can lead to a decrease in blood pressure.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Keep the drug in a dry, dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children. Shelf life 2 years.
Do not use after the expiration date printed on the package.

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