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

Auxiliary substances of pellets: sugar granule [sucrose, molasses starch] 91.33 mg, ethylcellulose 0.8 mg, methylacrylic acid and ethyl acrylate copolymer [1: 1] 7.05 mg, macrogol-6000 0.62 mg

Excipients: sugar grits [sucrose, molasses starch] 160.0 mg

Capsule cap: gelatin 20,1157 mg, water 3,4800 mg, iron dye oxide red 0.1440 mg, iron dye oxide yellow 0.0799 mg, titanium dioxide 0.11612 mg, sodium lauryl sulfate 0.0190 mg

Capsule body: gelatin 32.6880 mg, water 5.6550 mg, iron dye oxide red 0.2340 mg, iron dye oxide yellow 0.1299 mg, titanium dioxide 0.2619 mg, sodium lauryl sulfate 0.0312 mg

Inks for applying the inscription on the capsule shell: ethanol 30-34%, 2-propanol 3-6%, butanol 3-6%, propylene glycol 0.5-2%, polysorbate 80 0-1%. shellac 20-25%, titanium dioxide 30-34%

Dosage of 0.4 mg:

Active substance: tamsulosin hydrochloride pellets 0.2% * - 200 mg containing tamsulosin hydrochloride - 0.4 mg

Auxiliary substances of pellets: sugar granule [sucrose, molasses starch] 182.66 mg, ethyl cellulose 1.6 mg, methylacrylic acid and ethyl acrylate copolymer [1: 1] 14.1 mg, macrogol-6000 1.24 mg

Excipients: sugar grits [sucrose, molasses starch] 60.0 mg

Capsule cap: gelatin 20.4792 mg, water 3.4800 mg, azorubin dye 0,0216 mg, sodium lauryl sulfate 0.0190 mg

Capsule body: gelatin 33.3138 mg, water 5.6550 mg, sodium lauryl sulfate 0.0312 mg

Inks for applying the inscription on the capsule shell: ethanol 30-34%, 2-propanol 3-6%, butanol 3-5%, propylene glycol 0.5-2%, shellac 20-24%, dye iron oxide black 20-24%

* 2-propanol is used as solvents in the production of pellets (USP) and water (BP), which are not contained in the finished product.

Description:

Dosage of 0.2 mg: Hard gelatin capsule No. 2, body and cap of brown color, with a white inscription "HiGlance" on the lid.

Dosage 0,4 mg: Hard gelatin capsule No. 2, transparent body, pink lid, with a black inscription "HiGlance" on the lid.

The contents of capsules are white or almost white pellets.

Pharmacotherapeutic group:α1-blocker

ATX: & nbsp

G.04.C.A.02 Tamsulosin

Pharmacodynamics:

Tamsulosin is a specific blocker of postsynaptic α₁-adrenoreceptors, located in the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra. Blockade α₁adrenoreceptor 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 improve the outflow of urine. Simultaneously, both emptying symptoms and bladder filling symptoms due to increased tone of smooth muscle and detrusor hyperactivity in benign prostatic hyperplasia decrease.

The ability of tamsulosin to affect α_1A subtype adrenoreceptors is 20 times greater than its ability to interact with α_1B subtype of adrenoreceptors, which are located in the smooth muscles of blood vessels. Due to its high selectivity, the drug does not cause a clinically significant decrease in systemic blood pressure (BP) in patients with arterial hypertension, or in patients with normal initial BP. The drug has a prolonged effect (modified release).

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 characterized by linear kinetics. After a single oral administration of fasting capsules 0.4 mg maximum concentration (C_max) tamsulosin in blood plasma is reached after 6 hours. When administered inside the capsule 0.4 mg per day for several days, the equilibrium concentration is reached by the 5th day, while its value is about 2/3 higher than the value of this parameter after taking a single dose. Binding to plasma proteins 99%. The volume of distribution is insignificant and is about 0.2 l / kg. Tamsulosin It is slowly metabolized in the liver with the formation of less active metabolites. Most of tamsulosin is present in the blood plasma unchanged. With mild and moderate severity of liver failure, dosage adjustment is not required.

Tamsulosin and its metabolites are mainly excreted in the urine, while about 9% of the drug is excreted unchanged. The half-life of the drug with a single dose of a capsule of tamsulosin 0.4 mg after a meal is 10 hours, with a reception for several days - 13 hours.

When renal failure is not required to reduce the dose, if the patient has severe renal failure (creatinine clearance less than 10 ml / min), tamsulosin should be administered with caution.

Indications:

Treatment of dysuric disorders in benign prostatic hyperplasia (including treatment of urinary disorders).

Contraindications:

Hypersensitivity to tamsulosin or any other component of the drug; deficiency of sugar / isomaltase; intolerance to fructose; glucose-galactose malabsorption; orthostatic hypotension (including in the anamnesis); severe hepatic impairment, children under 18 years of age.

Carefully:

Tsevere renal failure (creatinine clearance less than 10 ml / min); Arterial hypotension, when used simultaneously with α₁adrenoblockers.

Pregnancy and lactation:

The drug Glansin is intended for use only in males.

Dosing and Administration:

Inside for 0.4 mg (1 capsule) 1 time per day after the first meal (the time interval between taking the drug should be 24 hours).The capsule should be swallowed whole (it can not be chewed or grinded, as this can affect the release rate of tamsulosin). With mild and moderate violations of the liver, as well as in cases of impaired renal function, dose adjustment is not required. When intolerance dose 0.4 mg, a dose of 0.2 mg per day is prescribed. If taking the drug at a dose of 0.2 mg or 0.4 mg was interrupted for two weeks (for any reason), then the treatment should be started again with the same dosage. Duration of use is not limited, the drug is prescribed in the form of continuous therapy.

Side effects:

Grading frequency of side effects:

very often> 1/10

often from> 1/100 to <1/10

infrequently from > 1/1000 to <1/100

rarely from >1/10 000 to <1/1000

very rarely from <1/10 000, including individual messages.

From the side of the cardiovascular system: infrequently - a feeling of palpitations, postural hypotension, rarely - atrial fibrillation, dyspnea, arrhythmia. From the gastrointestinal tract: infrequently - constipation, diarrhea, nausea, vomiting, rarely - dry mouth.

From the nervous system: often - dizziness; infrequently - headache, rarely - fainting, drowsiness.

From the side of the reproductive system: often - impaired ejaculation, rarely - priapism.

On the part of the respiratory, thoracic and mediastinal organs: infrequently - rhinitis, rarely - nose bleed.

Disturbances from the skin and subcutaneous tissue: infrequently - rash, itching, hives; rarely - angioedema (including Quincke's edema); rarely - Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis.

General condition disorders: infrequently - asthenia.

Other: intraoperative iris instability (narrow pupil syndrome) in cataract surgery in patients taking tamsulosin.

Overdose:

There were no cases of acute drug overdose.

Symptoms. Perhaps the emergence of acute arterial hypotension and compensatory tachycardia.

Treatment. Conduct symptomatic therapy: giving the patient a horizontal position, if necessary - the introduction of plasma-substituting solutions or vasoconstrictive drugs. It is necessary to monitor kidney function. It is unlikely that dialysis will be effective, since tamsulosin 99% associated with plasma proteins.

To prevent further absorption of tamsulosin, it is possible to wash the stomach, taking activated charcoal or osmotic laxative.

Interaction:

With simultaneous use with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was noted, with furosemide a decrease in the concentration of tamsulosin, but this does not require a change in the dose of tamsulosin, since the drug concentration remains within the normal range. Diclofenac and warfarin can slightly increase the rate of excretion of tamsulosin. The simultaneous use of tamsulosin with other antagonists of α₁-adrenoceptors can lead to a decrease in blood pressure. At simultaneous admission with atenolol, enalapril, nifedipine, drug interaction was not found. Diazepam, propranolol, trichloromethiazide, chloromadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the free fraction of tamsulosin in human plasma in vitro. Tamsulosin 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.

Simultaneous use of tamsulosin with potent inhibitors of isoenzyme CYP3A4 can lead to an increase in the action of tamsulosin. When used simultaneously with ketoconazole (a known potent inhibitor CYP3A4) the area under the "concentration-time" curve increases (AUC) C_max tamsulosin with a coefficient of 2.8 and 2.2, respectively. Tamsulosin Do not use simultaneously with powerful inhibitors CYP3A4 in patients with a phenotype of slow isoenzyme metabolism CYP2D6. With the simultaneous use of tamsulosin with paroxetine (a potent inhibitor of isoenzyme CYP2D6) AUC and C_maxtamsulosin increased by 1.3 and 1.6 times, respectively, but this increase was not clinically significant.

Special instructions:

Caution should be given to the drug for renal failure of severe severity (creatinine clearance less than 10 ml / min), as with other α₁adrenoblockers. The drug should be used with caution in patients with a predisposition to orthostatic hypotension.At the first signs of orthostatic hypotension (dizziness, weakness), the patient must sit or lie down and remain in this position until the above signs disappear. Before using the drug, it is necessary to verify the diagnosis and exclude the presence of other diseases that can cause similar symptoms.

Before and during the therapy, a digital rectal examination and, if necessary, the determination of a specific antigen of the prostate (PSA) should be performed.

It is advisable to stop taking the drug 1-2 weeks before the surgery for cataract and glaucoma (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). There are reports of cases of development of prolonged erection and priapism against the background of therapy with alpha-adrenoblagacoram. If the erection persists for 4 hours, you should immediately seek medical help. If priapism therapy has not been carried out immediately, it can lead to damage to the tissues of the penis and an irreversible loss of potency.

In one capsule (0.2 mg or 0.4 mg) contains 0.26 g of carbohydrates, which corresponds to 0.026 XE (1 XE (bread) - 10 g of carbohydrates). The maintenance of the minimum amount of carbohydrates allows to prescribe the drug to patients with diabetes mellitus.

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 requiring increased concentration of attention and speed of psychomotor reactions. the drug may cause dizziness and other side effects that may affect these abilities.

Form release / dosage:Capsules with modified release 0.2 mg, 0.4 mg.

Packaging:

For pharmacies: Capsules with a modified release of 0.2 mg, 0.4 mg. Po 10 capsules in Al / Al blister and / or in PVDC / PVC / Al blister. By 1,3,6 or 9 blisters for 10 (№ 10, № 30, № 60 or № 90) capsules with instructions for medical use in a cardboard box.

For hospitals: Capsules with a modified release of 0.2 mg, 0.4 mg. For 100, 500 or 1000 capsules per package of PVC, a package with instructions for use in a jar of high-density polyethylene.

Storage conditions:

In a dry place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:4 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003820

Date of registration:05.09.2016

Expiration Date:05.09.2021

The owner of the registration certificate:Highgans Laboratories Pvt. Ltd.Highgans Laboratories Pvt. Ltd. India

Manufacturer: & nbsp

HIGLANCE LABORATORIES Pvt. Ltd. India

Representation: & nbspPharma Group, LLCPharma Group, LLCRussia

Information update date: & nbsp25.04.2017

Illustrated instructions

Instructions

Glansin (Glancin)