Tamzelin - instructions for use, dose, side effects, contraindications

Sucrose 143.36 mg, starch 95.58 mg, ethyl cellulose 3.74 mg, hypromellose 2.56 mg, povidone K-30 1.5 mg, copovidone S-630) - 2.54 mg, hypromellose phthalate - 10.4 mg, cetyl alcohol - 1.0 mg, diethyl phthalate - 0.35 mg, talc - 5.47 mg

The composition of the gelatin capsule:

Gelatin.......................................62.306655 mg

Cap

Dyes:

Diamond black ............ 0.0065 mg

Blue patented .............. 0.00715 mg

Quinoline yellow ............... 0.00871 mg

Iron oxide yellow.................0.071175 mg

Titanium dioxide ............................ 1.3 mg

Base

Dyes:

Titanium dioxide ............................ 1.3 mg

Description:Gelatin capsules No. 2 with a white casing, light green lid. Contents of capsules - white or almost, white spherical pellets.

Pharmacotherapeutic group:alpha 1-blocker

ATX: & nbsp

G.04.C.A.02 Tamsulosin

Pharmacodynamics:Selectively and competitively blocks postsynaptic alpha 1a-adrenergic receptors, located in the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra.Reduces the tone of the smooth musculature of the prostate gland, the neck of the bladder and the prostatic part of the urethra, improving the outflow of urine. Simultaneously, the symptoms of obstruction and irritation of the urinary tract are associated with benign prostatic hyperplasia. Therapeutic effect occurs 2 weeks after the start of treatment. Tropism to alpha-adrenoreceptors located in the bladder is 20 times greater than its ability to interact with alpha 1b-adrenoceptors, which are located in the smooth muscles of the vessels. Due to this high selectivity, does not cause any clinically significant decrease in systemic blood pressure in patients with arterial hypertension, or in patients with normal initial arterial pressure.

Pharmacokinetics:

Absorption is high (more than 90%). The maximum concentration in the plasma after a single oral intake of 0.4 mg is achieved after 6 hours. The connection with plasma proteins is 94-99%. The volume of distribution is insignificant - 0.2 l / kg.

Slowly metabolized in the liver with the formation of pharmacologically active metabolites. Most of it is present in the blood in unchanged form.It is excreted by the kidneys (4-9% unchanged). Half-lead period10-12 hours.

Indications:Benign prostatic hyperplasia (treatment of dysuric disorders).

Contraindications:

Hypersensitivity to tamsulosin or another component of the drug. Age to 18 years.

Carefully:Chronic renal failure (creatinine clearance below 10 ml / min), arterial hypotension (including orthostatic), severe hepatic insufficiency.

Pregnancy and lactation:The drug is not used in women.

Dosing and Administration:

Inside, at 0.4 mg / day, with plenty of water. Capsules take whole, not liquid, after the first meal.

Side effects:

Headache, dizziness, asthenia, sleep disturbances (drowsiness or insomnia), retrograde ejaculation, decreased libido, priapism, back pain, rhinitis; Orthostatic hypotension, fainting, tachycardia, palpitations, chest pain; nausea, vomiting, constipation, or diarrhea; allevric reactions (skin rash, itching, hives, angioedema edema).

Overdose:

Symptoms: marked reduction in blood pressure, tachycardia.

Treatment: gastric lavage, taking activated charcoal or osmotic laxative (sodium sulfate), symptomatic therapy (horizontal position of the patient, drugs that increase the volume of circulating blood, vasoconstrictive drugs), control of kidney function. Dialysis is ineffective (intensely associated with plasma proteins).

Interaction:

With the simultaneous use of the drug with cimetidine,the concentration of tamsulosin in the blood plasma, and with furosemide -is avoided.

Diclofenac and indirect anticoagulants slightly increase the rate of excretion of tamsulosin.

Diazepam, propranolol, trichloromethiazide, chloromadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the free fraction of tamsulosin in human plasma in vitro. In its turn tamsulosin also does not change 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.

Other alpha 1-adrenoblockers, acetylcholinesterase inhibitors, alprostedil, anesthetics, diuretics, levodopa, antidepressants, beta-adrenoblockers, blockers of "slow" calcium channels, nitrates and ethanol can increase the severity of the hypotensive effect.

Special instructions:

As with the use of other alpha 1-blockers, when treated with the drug in some cases, there may be a decrease in blood pressure, which can sometimes lead to a fainting condition. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down, and remain in this position until the signs disappear.

Before starting therapy with the drug, the patient should be examined in order to rule out the presence of other diseases that can cause the same symptoms as benign prostatic hyperplasia. Before the start of treatment and regularly during therapy, a digital rectal examination and, if required, the determination of a specific prostate antigen (PSA).

In patients with impaired renal function, a change in the dosing regimen is not required.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Capsules of prolonged dementia0.4 mg.

For 10 or 20 capsules in a contour cell packaging.

1, 3, 6 contour squaresforging 10 capsules or 3, 5 contourscell packs of 20 drops eachsul with instructions for use put in a pack of cardboard.

For 60, 100 capsules in cans of polydimensional. Each bank with instructionsshe is put into a pack for use from cardboard.

Packaging:(10) - Contour pack (1) / Instruction for use / - Cardboard package
(10) - Contour pack (3) / Instruction for use / - Cardboard package

Storage conditions:

In the dark place at temperature not higher than 30 ° С.

Keep out of reach of children.

Shelf life:

3 years. Do not use after the expiration date. shelf life.

Terms of leave from pharmacies:On prescription

Registration number:LP-000620

Date of registration:21.09.2011

The owner of the registration certificate:VELFARM, LLC VELFARM, LLC Republic of San Marino

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Information update date: & nbsp30.08.2015

Illustrated instructions

Instructions

Tamzelin® (Tamzelin®)