Composition, form of production and packaging
Capsules with modified release gelatin; size number 2; opaque, with a casing of light orange color and a lid of gray-green color; on the body and the lid is applied on one black line, on the lid is marked "TSLO.4"; the contents of capsules - pellets from white to almost white.
1 caps.
tamsulosin hydrochloride 400 Ојg
Excipients: microcrystalline cellulose - 276.9 mg, methacrylic acid and ethyl acrylate copolymer (1: 1) - 16.5 mg, triethyl citrate - 1.65 mg, talc - 16.5 mg.
The composition of the pellet shell: a copolymer of methacrylic acid and ethyl acrylate (1: 1) - 21.63 mg, talc - 8.65 mg, triethyl citrate - 2.16 mg.
The composition of the capsule body: iron oxide red oxide - 0.0239 mg, titanium dioxide - 0.53 mg, iron oxide, yellow oxide - 0.258 mg, gelatin - 38.938 mg.
The composition of the capsule capsule: indigocarmine - 0.00152 mg, iron oxide, black oxide - 0.0107 mg, titanium dioxide - 0.356 mg, iron oxide, yellow oxide - 0.114 mg, gelatin 23.889 mg.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
PHARMACHOLOGIC EFFECT
Does Tamsulosin selectively and competitively block postsynaptic? 1A- adrenoreceptors, located in the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra. 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 an improvement in the outflow of urine.
Blockers of? -adrenoceptors can reduce blood pressure (BP) by decreasing peripheral vascular resistance. However, in the clinical studies of tamsulosin, in patients with normal blood pressure, there was no clinically significant reduction in blood pressure.
PHARMACOKINETICS
Suction
After ingestion, tamsulosin is rapidly and almost completely absorbed from the digestive tract. Absorption of tamsulosin somewhat slows down after eating. After a single dose of the drug inside at a dose of 0.4 mg, the maximum concentration (C max ) of tamsulosin in the blood plasma is reached after about 6 hours.
Distribution
The connection with blood plasma proteins is about 99%, the volume of distribution is small - 0.2 l / kg.
Metabolism
Tamsulosin is not exposed to the "first pass" effect and is slowly metabolized in the liver with the formation of less active metabolites. Most of the tamsulosin is present in the blood in unchanged form. In the experiment, the ability of tamsulosin to induce insignificantly the activity of microsomal liver enzymes was revealed.
Excretion
Tamsulosin and its metabolites are excreted mainly in the urine, 9% of the drug is excreted unchanged. The half-life (T 1/2 ) of tamsulosin is approximately 10 hours (with a single intake after meals), with a regular intake of -13 hours.
INDICATIONS
- benign prostatic hyperplasia (treatment of dysuric disorders).
DOSING MODE
Inside, 1 capsule 1 time per day after breakfast or first meal. The capsule should be swallowed whole, without chewing, squeezed with enough water. Capsule can not be divided into parts or broken, as this can affect the release rate of the active substance. Duration of use is not limited.
SIDE EFFECT
Possible side effects when using the drug are given below on the descending frequency of occurrence: often (<1/10,> 1/100), infrequently (<1/100,> 1/1000), rarely (<1/1000,> 1/10000 ), very rarely (<1/10000), including individual messages.
Disturbances from the nervous system: often - dizziness; infrequently - a headache; rarely - fainting.
Disorders from the CCC: infrequently - tachycardia, orthostatic hypotension.
Disorders from the digestive tract: infrequent - constipation, diarrhea, nausea, vomiting.
Disorders from the reproductive system: infrequently - ejaculation disorder; very rarely - priapism.
Disturbances from the skin and subcutaneous tissues: infrequent - rash, itching, hives; rarely - angioedema.
Other: in some cases - development of atonic iris syndrome (narrow pupil syndrome) during an operation to remove cataracts, asthenia, rhinitis.
CONTRAINDICATIONS
- hypersensitivity to tamsulosin or other components of the drug;
- Orthostatic hypotension (including in the anamnesis);
severe hepatic insufficiency.
With caution: chronic renal failure (CC less than 10 ml / min); arterial hypotension.
PREGNANCY AND LACTATION
The drug is prescribed only to men.
APPLICATION FOR FUNCTIONS OF THE LIVER
Use the drug with caution in chronic kidney disease (CC less than 10 ml / min).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe hepatic insufficiency.
SPECIAL INSTRUCTIONS
At the first signs of orthostatic hypotension (dizziness, weakness), the patient should be seated or laid.
Before starting therapy with the drug Proflosin В® , the patient should be excluded from the presence of diseases and conditions capable of causing symptoms similar to that of benign prostatic hyperplasia.
Before the start of treatment and regularly during therapy, a digital rectal examination and, if necessary, determination of the concentration of a specific prostatic antigen (PSA) should be performed.
In case of angioedema development, therapy with Proflosin should be stopped immediately. Repeated administration of the drug is contraindicated. With surgery for cataracts against the background of taking the drug, it is possible to develop a syndrome of atonic iris, which must be taken into account by the surgeon for preoperative preparation of the patient and during the operation.
Impact on the ability to drive a vehicle and other complex 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 have been no cases of overdose with taking the drug to date. However, theoretically, there is a possibility of a sharp drop in blood pressure and tachycardia, which may require appropriate measures. To restore blood pressure (including orthostatic hypotension) and heart rate to normal patient values, it is necessary to pack.Conduction of hemodialysis is inexpedient, since tamsulosin has a high affinity for plasma proteins.
To prevent further absorption of tamsulosin, it is advisable to wash the stomach, taking activated charcoal or osmotic laxative (eg sodium sulfate).
DRUG INTERACTION
Tamsulosin does not interact with atenolol, enalapril, nifedipine and theophylline.
With simultaneous use with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was noted; with furosemide - a decrease in concentration, but this does not require a correction of the dose of the drug Proflosin В® , since the drug concentration remains within the normal range.
Diclofenac and warfarin can increase the rate of excretion of tamsulosin.
Simultaneous administration of tamsulosin with other ai-adrenoreceptor blockers can lead to a decrease in blood pressure.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
At a temperature of no higher than 30 В° C. Keep out of the reach of children! Shelf life - 3 years.
