Omnic modified release capsules 0.4mg #10×3

Name:
Omnik. Release formCapsules with modified release. Dosage 0.4 mg. Pack quantity: 30 pcs. Manufacturer Astellas Pharma Inc. MNN Tamsulosin. FTGα1 is an adrenoblocker. Composition Tamsulosin hydrochloride 0.4 mg, microcrystalline cellulose, methyl acrylic acid copolymer (type C), polysorbate 80, sodium lauryl sulfate, triacetin, calcium stearate, talc, gelatin, indigotine, titanium dioxide, yellow iron oxide, red iron oxide.
Description:
Size #2 hard gelatin capsules with an orange body marked 701 with trademark graphic and an olive green cap marked 0.4. Capsules contain granules from white to white with a light yellow tint. Pharmacological group Means for the treatment of benign prostatic hyperplasia. Antagonists of alpha-adrenergic receptors. ATC code: G04CA02 Pharmacological properties Pharmacodynamics Tamsulosin is a specific competitive blocker of postsynaptic α1-adrenergic receptors, especially α1A and α1D subtypes, responsible for relaxing the smooth muscles of the prostate, bladder neck and prostatic urethra. Omnic at a dosage of 0.4 mg increases the maximum rate of urination, and also reduces the tone of the smooth muscles of the prostate and urethra, improving the outflow of urine and thus reducing the severity of emptying symptoms. Omnic also reduces the severity of filling symptoms, in the development of which detrusor overactivity plays an important role. With long-term therapy, the effect on the severity of symptoms of filling and emptying remains, reducing the risk of developing acute urinary retention and the need for surgical intervention. α1A-adrenergic antagonists can lower blood pressure by reducing peripheral resistance. When using the drug Omnic in a daily dose of 0.4 mg, there were no cases of a clinically significant decrease in blood pressure. Pharmacokinetics Absorption: Tamsulosin is well absorbed from the intestine and has almost 100% bioavailability. The absorption of tamsulosin slows down somewhat after a meal. The same level of absorption can be achieved if the patient takes the drug every 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 is reached after 6 hours. After repeated oral administration of 0.4 mg per day, the equilibrium concentration is reached by the 5th day, while its value is approximately 2/3 higher than the value of this parameter after taking a single dose. Distribution: Communication with plasma proteins – 99%, the volume of distribution is small (about 0.2 l / kg). Metabolism: Tamsulosin is slowly metabolized in the liver to less active metabolites. Most of tamsulosin is present in plasma in unchanged form. The experiment revealed the ability of tamsulosin to slightly induce the activity of microsomal liver enzymes. The results of in vitro studies have shown that CYP3A4 and CYP2D6 isoenzymes are involved in the metabolism of tamsulosin hydrochloride with a minor contribution of other CYP isoenzymes. Inhibition of CYP3A4 and CYP2D6 enzymes can lead to an increase in the concentration of tamsulosin hydrochloride. With a slight and moderate degree of hepatic insufficiency, no correction of the dosing regimen is required. Elimination: Tamsulosin and its metabolites are primarily excreted in the urine, with approximately 9% of the drug excreted unchanged. The half-life of the drug with a single dose of 0.4 mg after meals is 10 hours, with multiple doses – 13 hours. In case of renal insufficiency, a dose reduction is not required; if the patient has severe renal insufficiency (creatinine clearance less than 10 ml / min), the appointment of tamsulosin should be carried out with caution. Indications for use Benign prostatic hyperplasia (treatment of urinary disorders). Contraindications Hypersensitivity to tamsulosin or any other component of the drug. Orthostatic hypotension (including history). Severe liver failure. Childhood. With caution – severe renal failure (creatinine clearance less than 10 ml / min) Dosage and administration Adults over 18 years of age, as well as elderly patients Inside, after breakfast, with water, take 1 capsule (0.4 mg) 1 time per day . The capsule is not recommended to be chewed, as this may affect the release rate of the drug. In patients with impaired liver and kidney function In case of renal insufficiency, as well as in mild and moderate hepatic insufficiency, no dosage adjustment is required. Side effect The evaluation of undesirable adverse reactions is based on the following data on the frequency of occurrence: very often (≥1/10), often (≥1/100 to <1/10), infrequently (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data). Common Uncommon Rare Very rare Unknown Cardiovascular disorders palpitations, orthostatic hypotension Gastrointestinal disorders constipation, diarrhoea, nausea, vomiting Dry mouth * General condition asthenia Nervous system disorders dizziness (1.3%) headache pain fainting Visual disturbances blurred vision* visual impairment* Reproductive system disorders ejaculatory disorders, incl. retrograde ejaculation and anejaculation priapism Respiratory, thoracic and mediastinal disorders rhinitis epistaxis* Skin and subcutaneous tissue disorders rash, pruritus, urticaria angioedema Stevens-Johnson syndrome erythema multiforme* exfoliative dermatitis**Noted in the post-registration period. Cases of intraoperative instability of the iris (small pupil syndrome) during cataract surgery in patients who have been taking tamsulosin for a long time have been described. The frequency has not been set. Post-marketing use of the drug: in addition to the side effects described above, atrial fibrillation, arrhythmia, tachycardia and dyspnea have been observed with the use of tamsulosin. Due to the fact that the data were obtained by the method of spontaneous reports in the period after registration, it is difficult to determine the frequency and causal relationship of these events with the use of tamsulosin. OverdoseSymptoms: An overdose of tamsulosin hydrochloride has the potential to lead to a decrease in blood pressure, compensatory tachycardia. Treatment: Treatment is symptomatic. Blood pressure and heart rate can be restored when the patient takes a horizontal position. In the absence of effect, you can use drugs that increase the volume of circulating blood and, if necessary, vasoconstrictors. It is necessary to monitor kidney function. It is unlikely that dialysis will be effective, since tamsulosin is highly bound to plasma proteins. To prevent further absorption of the drug, it is advisable to wash the stomach, take activated charcoal and an osmotic laxative, such as sodium sulfate. Interaction with other medicinal products When prescribing the drug Omnic® together with atenolol, enalapril or theophylline, no interactions were found. With the simultaneous use of Omnic with cimetidine, there was a slight increase in the concentration of tamsulosin in the blood plasma, and with furosemide - a decrease in concentration, but this does not require a change in the dose of Omnic, since the concentration of the drug remains within the normal range. Diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin, and warfarin do not alter the free fraction of tamsulosin in human plasma in vitro. In turn, tamsulosin also does not change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone. Diclofenac and warfarin may increase the rate of elimination of tamsulosin. Simultaneous administration of tamsulosin with strong inhibitors of the CYP3A4 isoenzyme can lead to an increase in the concentration of tamsulosin. Co-administration with ketoconazole (a strong inhibitor of CYP3A4) led to an increase in AUC and Cmax of tamsulosin by 2.8 and 2.2 times, respectively. Tamsulosin hydrochloride should not be used in combination with strong CYP3A4 inhibitors in patients with impaired metabolism of the CYP2D6 isoenzyme. The drug should be used with caution in combination with strong and moderate inhibitors of CYP3A4. The simultaneous administration of tamsulosin and paroxetine, a strong inhibitor of CYP2D6, led to an increase in Cmax and AUC of tamsulosin by 1.3 and 1.6 times, respectively, but this increase was recognized as clinically insignificant. The simultaneous appointment of other α1-adrenergic antagonists can lead to a decrease in blood pressure. Precautions As with the use of other α1-blockers, in the treatment of Omnic®, in some cases, a decrease in blood pressure may be observed, which can sometimes lead to fainting. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down and remain in this position until these symptoms disappear. Before starting therapy with Omnic®, the patient should be examined to exclude other diseases that can cause the same symptoms as benign prostatic hyperplasia. Before starting treatment and regularly during therapy, a digital rectal examination and, if necessary, the determination of prostate specific antigen (PSA) should be performed. Treatment with Omnic® in patients with severe renal insufficiency (creatinine clearance < 10 ml / min) requires caution, because. no studies have been conducted in this category of patients. During surgical interventions for cataracts while taking the drug, the syndrome of intraoperative instability of the iris of the eye (small pupil syndrome) may develop, which must be taken into account by the surgeon for preoperative preparation of the patient and during the operation. The feasibility of discontinuing tamsulosin hydrochloride therapy 1-2 weeks before cataract surgery has not yet been proven. Cases of intraoperative instability of the iris occurred in patients who stopped taking the drug and at an earlier time before surgery. It is not recommended to start tamsulosin hydrochloride therapy in patients who are scheduled for cataract surgery. During the preoperative examination of patients, the surgeon and ophthalmologist should consider whether the patient is taking or has taken tamsulosin. This is necessary to prepare for the possibility of developing intraoperative iris instability syndrome during surgery. Tamsulosin hydrochloride should not be co-administered with strong inhibitors of CYP3A4 in patients with impaired metabolism of the CYP2D6 isoenzyme. The drug should be used with caution in combination with strong and moderate inhibitors of CYP3A4. Pregnancy and lactationOmnic® 0.4 mg capsules are for use in males only. Influence on the ability to drive vehicles and mechanisms Studies on the effect of the drug on the ability to drive a car and mechanisms have not been conducted. Patients should be aware that dizziness may occur when taking the drug. Release form Modified release capsules 0.4 mg. Blisters of 10 capsules, 1 or 3 blisters in a cardboard box. Storage conditionsAt a temperature not higher than 25°C. Keep out of the reach of children. Shelf life 4 years. Do not use after the expiration date. Conditions for dispensing from pharmaciesBy prescription. Buy Omnic capsules with modified release 0.4mg No. 10x3 Price for Omnic capsules with modified release 0.4mg No. 10x3