Glansin caps 0.4mg #90

Instruction for Glansin

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Glansin is an alpha1-blocker.

Release form and composition

Dosage form - capsules with modified release: hard gelatinous, size No. 2, with a body and a brown cap (dosage 0.2 mg) or a transparent body and a pink cap (dosage 0.4 mg), the cap bears the inscription "HiGlance" ( on capsules with a dosage of 0.2 mg - white, on capsules with a dosage of 0.4 mg - black); the contents of the capsules are white or almost white pellets (10 pcs. in blisters, in a cardboard box of 1, 3, 6 or 9 blisters and instructions for the use of Glansin; packing for hospitals - 100, 500 and 1000 pcs. in PVC bags , in a plastic jar 1 package).
Composition of 1 capsule:
    active substance: tamsulosin hydrochloride pellets * 0.2% - 100 or 200 mg, which corresponds to the content of tamsulosin hydrochloride 0.2 or 0.4 mg;
    auxiliary components of pellets: sugar crumbs (sucrose, starch syrup), macrogol-6000, methacrylic acid and ethyl acrylate copolymer (1: 1), ethyl cellulose;
    excipients: sugar crumbs (sucrose, starch syrup);
    capsule cap: gelatin, water, sodium lauryl sulfate; capsules with a dosage of 0.2 mg also contain titanium dioxide, iron dye yellow oxide and iron dye red oxide, in capsules with a dosage of 0.4 mg - azorubin dye;
    capsule body: gelatin, water, sodium lauryl sulfate; the capsules with a dosage of 0.2 mg also contain titanium dioxide, iron dye yellow oxide and iron dye red oxide;
    ink for writing on the capsule shell: ethanol, propylene glycol, butanol, 2-propanol, shellac; the capsules with a dosage of 0.2 mg also contain titanium dioxide and polysorbate 80, in capsules with a dosage of 0.4 mg - the dye iron oxide black.
* In the process of pellet production, water (BP) and 2-propanol (USP) are used as solvents, which are absent in the finished product.

Pharmacodynamics

The active substance of Glansin is tamsulosin, a specific blocker of postsynaptic α1-adrenergic receptors located in the smooth muscles of the prostate gland, the bladder neck and the prostatic urethra. By blocking α1-adrenergic receptors, the drug reduces their tone. At the same time, symptoms of filling and emptying of the bladder, caused by increased muscle tone and detrusor hyperactivity in benign prostatic hyperplasia, decrease.
The effect of tamsulosin on the α1A subtype of adrenergic receptors is 20 times higher than its interaction with the α1B subtype of adrenergic receptors located in vascular smooth muscles. Due to its high selectivity, Glansin does not have a clinically significant decrease in systemic blood pressure, regardless of its initial value.
Glansin is available in the form of modified release capsules, which provides a prolonged action of the drug.

Pharmacokinetics

After oral administration, tamsulosin is well absorbed in the intestine. Almost 100% bioavailable. Simultaneous food intake slows down the absorption process somewhat. To achieve the same level of absorption, it is recommended to take Glansin in the morning after your usual breakfast.
The kinetics of tamsulosin is linear. After a single dose of 0.4 mg on an empty stomach, the maximum plasma concentration (Cmax) is observed after 6 hours. When Glansin is taken in the same dose for several days, the equilibrium concentration (Css) is reached by the fifth day, its indicator is about ⅔ higher than after a single dose.
Tamsulosin is characterized by a high binding to plasma proteins (99%) and a small volume of distribution (0.2 l / kg). It undergoes a slow metabolism in the liver, as a result of which less active metabolites are formed. Most of the drug is present in blood plasma unchanged. In patients with mild to moderate hepatic impairment, dosage adjustment is not required.
Tamsulosin and its metabolites are excreted mainly by the kidneys; approximately 9% of the dose is excreted unchanged. The half-life (T½) in the case of a single dose of 0.4 mg after meals is 10 hours, with multiple doses over several days - 13 hours.
With mild to moderate renal impairment, a dose reduction of Glansin is not required. In severe renal failure [creatinine clearance (CC) <10 ml / min], treatment should be performed with caution.

Indications for use

Glansin is used to treat dysuric disorders (including urinary disorders) caused by benign prostatic hyperplasia.

Contraindications

Absolute:
    severe liver failure;
    glucose-galactose malabsorption, fructose intolerance, sucrase / isomaltase deficiency;
    orthostatic hypotension (including history);
    age under 18;
    hypersensitivity to any component of the drug.
Glansin should be used with caution in severe renal failure (CC <10 ml / min), arterial hypotension, as well as in the case of the simultaneous use of α1-blockers.

Glansin, instructions for use: method and dosage

Glansin capsules should be taken orally, once a day after a morning meal: swallow whole with sufficient water. The capsules should not be crushed or chewed as this will alter the release rate of tamsulosin.
Glansin 0.4 mg is usually prescribed for adults. In case of poor tolerance of the drug - Glansin 0.2 mg.
The duration of therapy is determined individually. The duration of use is not limited.
If the drug is interrupted for 2 or more weeks, treatment should be restarted with the same dose.

Side effects

Possible side reactions (according to the frequency of development, they are classified as follows: 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 - <1/10,000, including individual messages):
    on the part of the skin and subcutaneous tissue: infrequently - itching, skin rashes, urticaria; rarely - angioedema; very rarely - erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis;
    from the nervous system: often - dizziness; infrequently - headache; rarely - drowsiness, fainting;
    from the gastrointestinal tract: infrequently - nausea, diarrhea, constipation, vomiting; very rarely - dry mouth;
    on the part of the cardiovascular system: infrequently - postural hypotension, palpitations; very rarely - arrhythmia, shortness of breath, atrial fibrillation;
    from the respiratory system: infrequently - rhinitis; very rarely - nosebleeds;
    from the reproductive system: often - ejaculation disorders; very rarely - priapism;
    others: infrequently - asthenia; during cataract surgery - intraoperative instability of the iris of the eye (narrow pupil syndrome).

Overdose

No cases of acute overdose of Glansin have been reported. Development of acute arterial hypotension and compensatory tachycardia is possible.
The patient should take a horizontal position. To prevent further absorption of tamsulosin, gastric lavage and intake of activated charcoal or osmotic laxatives may be recommended. Treatment is symptomatic. If necessary, plasma-substituting solutions or vasoconstrictor agents are administered. Monitoring of renal function is required. Dialysis is ineffective.

Special instructions

Before the appointment of the drug, it is recommended to conduct a thorough examination to exclude other diseases that may manifest similar symptoms.
Before taking the drug and periodically during treatment, it is necessary to regularly conduct a digital rectal examination, if necessary, determine the specific antigen of the prostate gland (PSA).
Particular care should be taken during treatment in patients with a predisposition to orthostatic hypotension. In the event of the first signs of its development (weakness and dizziness), the patient must sit down or lie down and remain in this position until the symptoms disappear completely.
Alpha1-blockers rarely cause prolonged erection and priapism. If an erection persists for 4 hours, you should immediately consult a doctor. Priapism requires urgent treatment, otherwise it can cause damage to the tissues of the penis and irreversible loss of potency.
In connection with the risk of developing narrow pupil syndrome, if it is necessary to undergo surgery for glaucoma and cataracts, you should stop taking Glansin within 1-2 weeks. It is also advisable to inform the surgeon about taking the drug, so that he would take this into account during preoperative preparation and operation.
Each capsule contains 0.26 g of carbohydrates, which corresponds to 0.026 XE (Bread Units). The content of carbohydrates in the preparation is minimal, so it can be prescribed for patients with diabetes mellitus.

Influence on the ability to drive vehicles and complex mechanisms

Against the background of therapy, dizziness and drowsiness may develop, therefore, patients are advised to be careful when driving a car and other potentially dangerous activities that require quick reactions and increased attention.

Application during pregnancy and lactation

According to registered indications, Glansin is not used in women.

Childhood use

Glansin is not intended for use in children and adolescents under 18 years of age.

With impaired renal function

The drug is excreted mainly by the kidneys, therefore, it should be used with caution in patients with severe renal insufficiency (CC <10 ml / min).

For violations of liver function

Glansin is metabolized in the liver, therefore it is contraindicated in patients with severe hepatic impairment.

Drug interactions

    other antagonists of α1-adrenergic receptors: blood pressure may decrease;
    diclofenac, warfarin: a slight increase in the rate of elimination of tamsulosin is possible;
    furosemide: the concentration of tamsulosin decreases slightly (dose adjustment is not required);
    cimetidine: the plasma concentration of tamsulosin increases slightly (there is no need to adjust the dose);
    potent inhibitors of the CYP3A4 isoenzyme (for example, ketoconazole, paroxetine): the effect of tamsulosin is enhanced (this combination is contraindicated in patients with a slow metabolism phenotype of the CYP2D6 isoenzyme);
    trichloromethiazide, propranolol, chlormadinone, glibenclamide, diclofenac, simvastatin, amitriptyline, warfarin, diazepam: there was no change in the free fraction of tamsulosin in human blood plasma in vitro;
    salbutamol, finasteride, glibenclamide, amitriptyline: no interaction at the level of hepatic metabolism was found in in vitro studies;
    enalapril, atenolol, nifedipine: no drug interactions have been identified;
    diazepam, chlormadinone, trichloromethiazide, propranolol: their free fractions remain unchanged.

Terms and conditions of storage

Store at a temperature not exceeding 25 ° C in a dry place out of the reach of children.
Shelf life is 4 years.

Reviews

On specialized forums and sites, reviews of Glansin from patients are few. According to doctors, tamsulosin is an affordable and effective remedy that helps to solve the problem of urination disorders caused by benign prostatic hyperplasia. The drug is well tolerated and rarely causes side effects. Its additional advantage includes the possibility of long-term use.

Terms of sell

You don't need a prescription to buy Glansin.