Tamsulosin-OBL capsules 0.4mg N30
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Active ingredients
Tamsulosin
Release form
Capsules
Composition
Tamsulosin hydrochloride 0.400 mg, based on tamsulosin 0.367 mg; Auxiliary substances: microcrystalline cellulose (101), methacrylic acid and ethyl acrylate copolymer (1: 1), triethyl citrate, talc, water, sodium hydroxide / hydrochloric acid.
Pharmacological effect
Tamsulosin selectively and competitively blocks postsynaptic alpha1A adrenoreceptors found in the smooth muscles of the prostate gland, bladder neck and prostatic part of the urethra, as well as alpha1D adrenoreceptors, mainly in the body of the bladder. This leads to a decrease in the tone of the smooth muscles of the prostate gland, bladder neck, prostatic urethra, improves urine flow, reduces the symptoms of obstruction and irritation of the urinary tract in benign prostatic hyperplasia. alpha1A-adrenoreceptors located in the smooth muscles of the vessels. Due to such high selectivity, the drug does not cause any clinically significant systemic lowering of blood pressure (BP) in patients with arterial hypertension, and in patients with normal baseline blood pressure. As a rule, the therapeutic effect is achieved 2 weeks after the start of the drug.
Pharmacokinetics
Tamsulosin is well absorbed in the intestines and has almost 100% bioavailability. Tamsulosin absorption slows down somewhat after eating. The same level of absorption can be achieved if the patient takes the drug each time after a normal breakfast. Tamsulosin is characterized by linear kinetics. After a single oral dose of 0.4 mg of the drug, its maximum plasma concentration (Cmax) is reached after 6 hours. After repeated ingestion of 0.4 mg per day, the equilibrium concentration (Сss) 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. Communication with plasma proteins is 99%, the volume of distribution small (about 0.2 l / kg). Tamsulosin is slowly metabolized in the liver to form less active metabolites.Most tamsulosin is present in plasma in unchanged form. The experiment revealed the ability of tamsulosin to slightly induce the activity of microsomal liver enzymes. With a slight and moderate degree of liver failure, no dosage regimen needs to be adjusted. Tamsulosin and its metabolites are mainly excreted in the urine, with about 9% of the drug being excreted unchanged. The half-life of the drug (T1 / 2) with a single dose of 0.4 mg after eating is 10 hours, with multiple - 13 hours. In case of renal insufficiency, a dose reduction is not required, if the patient has severe renal insufficiency (creatinine clearance (QC) less than 10 ml / min), the administration of tamsulosin should be carried out with caution.
Indications
Treatment of functional symptoms of benign prostatic hyperplasia (BPH).
Contraindications
Hypersensitivity to tamsulosin hydrochloride or other components of the drug Tamsulosin; Orthostatic hypotension (including history); Severe hepatic insufficiency. With caution: Severe renal insufficiency (reduced creatinine clearance below 10 ml / min).
Dosage and administration
Tamsulosin is taken orally, 1 capsule (0.4 mg) at the same time after meals once a day. The capsule must be swallowed whole, in a sitting or standing position, not crushing or chewing, as this may interfere with the gradual release of the active ingredient.
Side effects
Since the cardiovascular system: infrequently - tachycardia, orthostatic hypotension; pain in the chest; On the part of the respiratory system: infrequently - rhinitis. On the part of the digestive system: rarely - constipation, diarrhea, nausea, vomiting. On the side of the skin and skin: infrequent - rash, itching, rash; rarely - angioedema. From the urogenital system: infrequently - retrograde ejaculation, very rarely - priapism; decrease in libido; Others: sometimes - asthenia, back pain, small pupil syndrome during cataract surgery
Overdose
Cases of overdose are not described, theoretically possible acute hypotension. Treatment: in case of overdose, it is recommended to transfer the patient to a horizontal position and take measures,aimed at maintaining the function of the cardiovascular system (restoration of blood pressure and heart rate); gastric lavage, the introduction of activated carbon and osmotic laxatives, such as sodium sulfate. In the absence of effect, you should enter substances that increase the volume of circulating blood, and, if necessary, vasoconstrictor agents. Kidney function should be monitored and activities aimed at maintaining it. Dialysis is not very effective in overdosing tamsulosin, since the drug is largely bound to plasma proteins.
Interaction with other drugs
No interaction was noted with simultaneous administration of tamsulosin with atenolol, enalapril, nifedipine, or theophylline. When taken simultaneously with cimetidine, the concentration of tamsulosin in the blood plasma increases, and when taken simultaneously with tamsulosin with furosemide, it decreases. However, dose adjustment is not required, because the concentration of tamsulosin remains in the therapeutic range. In vitro, diazepam, propranolol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not alter the level of free fraction of tamsulosin in plasma. In turn, tamsulosin does not change the content of free fractions of diazepam, propranolol, trichloromethiazide and chlormadinone in the blood plasma. No tamsulozin interactions with amitriptyline, salbutamol, glibenclamide and finasteride were found in in vitro studies. While taking diclofenac or warfarin with tamsulosin, it is possible to increase the rate of elimination of tamsulosin. If you take tamsulosin with drugs that lower blood pressure, including other alpha1-blockers and anesthetics, it is possible that the hypotensive effect may increase.
special instructions
At the first signs of orthostatic hypotension (dizziness, weakness), you should sit down or lie down until these symptoms disappear. Before starting treatment with tamsulosin, it is necessary to examine the patient to rule out other diseases that can cause the same symptoms as benign prostatic hyperplasia.Before starting treatment with the drug and during therapy, it is necessary to regularly examine the prostate gland and, if necessary, determine the prostate specific antigen (PSA). Due to the possibility of complications during cataract surgery, it is not recommended to administer tamsulosin to patients with cataracts if surgery is planned. When taking tamsulozin, drowsiness, vision loss, dizziness and fainting are possible, therefore the drug should be used with caution while working for drivers of vehicles and people whose profession requires increased concentration of attention. The effect on the ability to drive vehicles and control mechanisms In the period of treatment Dimo refrain from activities potentially hazardous activities that require high concentration and psychomotor speed reactions.