Hyperprost - instructions for use, doses, side effects, contraindications

Description:Hard gelatin capsules number 1, the case is blue, the lid is blue. The contents of the capsules are pellets of white or almost white color.

Pharmacotherapeutic group:Alpha-blocker

ATX: & nbsp

G.04.C.A.02 Tamsulosin

Pharmacodynamics:

Tamsulosin selectively and competitively blocks postsynaptic α1- adrenergic receptors located in the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra, and α_1D-adrenoreceptors, mainly located in the body of the bladder. This leads to a decrease in the tone of the smooth muscles of the prostate gland, the neck of the bladder, the prostatic part of the urethra and the improvement of the detrusor function, thereby reducing the symptoms of urinary tract obstruction and irritation associated with benign prostatic hyperplasia.

The therapeutic effect usually develops 2 weeks after the start of the drug, although in a number of patients the decrease in the severity of symptoms is already observed after taking the first dose. The ability of tamsulosin to affect α_1A-adrenoceptors are 20 times higher than its ability to interact with α_1B- adrenoreceptors, which are located in the smooth muscles of the vessels. Due to this high selectivity, the drug does not cause a clinically significant decrease in systemic blood pressure (BP) both in patients with normal initial BP and in patients with arterial hypertension.

Pharmacokinetics:

Bioavailability of the drug is about 100%. After oral administration tamsulosin quickly and almost completely absorbed in the digestive tract: with a single admission of 0.4 mg of the drug, the maximum concentration of tamsulosin in the blood plasma is reached after 6 hours. In a state of equilibrium concentration (after 5 days of course administration), the maximum level of tamsulosin in the blood plasma is 60-70% higher than after a single dose of the drug. Binding to plasma proteins - 99%. The volume of distribution is 0.2 l / kg. The drug is not affected by the "first pass effect" and slowlymetabolized in the liver with the formation of pharmacologically active metabolites, also having a high selectivity to α_1A adrenoreceptors. Most of the tamsulosin is present in the blood in unchanged form. The drug and its metabolites are excreted by the kidneys, while about 9% of the drug is excreted unchanged. The half-life for a single dose is 10-12 hours.

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

Contraindications:

- increased sensitivity to tamsulosin or other components of the drug;

- severe hepatic impairment;

- orthostatic hypotension (including in the anamnesis);

- children's age (under 18 years).

The drug is not used in women.

Carefully:

Chronic renal failure (decrease in creatinine clearance below 10 ml / min).

Pregnancy and lactation:The use during pregnancy and during lactation is contraindicated, because the drug is used only in men.

Dosing and Administration:

Inside, 1 capsule (0.4 mg) per day. Capsules are taken after the first meal, with plenty of water.It is not recommended to chew the capsule, as this can affect the release rate of tamsulosin.

Side effects:

Frequency distribution of side effects is made in accordance with the following gradation: very often (≥10%), often (≥1% and <10%), infrequently (≥0.1% and <1%), rarely (≥0.01% and <0.1%), very rarely (<0.01%).

Disorders from the cardiovascular system: infrequently - tachycardia, palpitation, orthostatic hypotension.

Disorders from the central and peripheral nervous system: often - dizziness; infrequently - a headache; rarely - fainting, asthenia, sleep disturbance (drowsiness or insomnia).

Disorders from the gastrointestinal tract: infrequently - constipation, diarrhea, nausea, vomiting.

Disorders from the urogenital system: infrequently - retrograde ejaculation; very rarely - priapism, decreased libido.

Allergic reactions: infrequently - skin rash, hives; rarely - angioedema.

Other: infrequently - rhinitis; rarely - back pain; very rarely - pain in the chest.

Overdose:

There were no cases of acute drug overdose.

Symptoms: it is theoretically possible the occurrence of orthostatic hypotension.

Treatment: Carry out cardiotropic therapy.If symptoms persist, replace vasoconstrictive solutions or vasoconstrictors. To prevent further absorption of tamsulosin, it is possible to wash the stomach, taking activated charcoal or osmotic laxative.

Interaction:

With the simultaneous use of tamsulosin with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was observed, and with furosemide a decrease in concentration was noted, but this did not require a change in the dose of tamsulosin.

Diclofenac and warfarin can slightly increase the rate of elimination of tamsulosin. The simultaneous use of tamsulosin with other ss-adrenergic blockers can lead to a marked increase in the hypotensive effect.

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.

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

Special instructions:

Hyperprost should be used with caution in patients with a predisposition to orthostatic hypotension. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should be seated or laid. In patients with impaired renal function, no dose reduction is required.

Before starting therapy with tamsulosin, the patient should be examined to exclude other diseases that can cause the same symptoms as benign prostatic hyperplasia. Before and during treatment, a rectal examination and, if necessary, the definition of a prostatic specific antigen (PSA) should be performed.

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 action, 0,4 mg.

Packaging:10 capsules are packed in a contour squad packaging (blister) from a polyvinylchloride film and aluminum foil.

1 or 3 blisters together with instructions for use are placed in a pack of cardboard.

Storage conditions:

In a dry, protected from light 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 expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001345

Date of registration:20.06.2011

Expiration Date:Unlimited

The owner of the registration certificate:Nizhny Novgorod Chemical and Pharmaceutical Plant, OJSCNizhny Novgorod Chemical and Pharmaceutical Plant, OJSC

Manufacturer: & nbsp

HETERO DRUGS Limited India

Representation: & nbspMAKIZ-PHARMA, LLCMAKIZ-PHARMA, LLCRussia

Information update date: & nbsp17.04.2017

Illustrated instructions

Instructions

Hyperprost (Hyperprost)