Omnic capsules. with modif.vysv. 0.4mg 30 pc

Description

Composition
Active substance:
1 capsule contains: 0.4 mg of tamsulosin hydrochloride.
Excipients:
Microcrystalline cellulose, copolymer of methyl acrylic acid, polysorbate 80, sodium lauryl sulfate, triacetin, calcium stearate, talc, gelatin solid, indigotine E132, titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172).
Description:
Hard gelatin capsules having orange colored casing with marks 701 and the graphic image. Comrade. sign and olive-green cap marked 0.4. The capsules contain granules from white to white with a light yellow color.
Product form:
Blisters 10 capsules of 1 or 3 in the blister cardboard pack.
Contraindications
Hypersensitivity to tamsulosin or any other component of the formulation.
Orthostatic hypotension (including history).
Severe hepatic insufficiency.
Precautions – severe renal impairment (creatinine clearance less than 10 mL / min).
Dosage
0.4 mg
Indications
Treatment dizuricheskih disorders in benign prostatic hyperplasia.
Interaction with other drugs
In appointing the drug Omnik® with atenolol, enalapril or nifedipine interactions were found. When applied simultaneously with Omnic cimetidine was a slight increase in the concentration of tamsulosin in blood plasma and furosemide – reduction in the concentration, however this does not require a dose change Omnic as the drug concentration is within the normal range. Diazepam, propranolol, trichloromethiazide, chlormadinone amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin does not alter the tamsulosin free fraction in human plasma in vitro. In turn, tamsulosin also serves free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone.
In in vitro studies have not revealed interaction on the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide and finasteride. Diclofenac and warfarin may increase the rate of excretion of tamsulosin.
Simultaneous administration of other alpha1-adrenergic antagonists may lead to blood pressure reduction.
Overdose
There are no reports of acute overdose tamsulosin. However, it is theoretically possible to overdose of acute BP reduction and compensatory tachycardia, in which case you need to symptomatic therapy. Blood pressure and heart rate can be restored at the adopting person horizontal position. If no effect is possible to apply means which increase blood volume and, if necessary, vasoconstrictors. It is necessary to monitor renal function. It is unlikely that dialysis would be effective as tamsulosin is strongly bound to plasma proteins.
To prevent further absorption of the drug expedient gastric lavage, activated charcoal or osmotic laxative, such as sodium sulfate.
pharmachologic effect
Pharmacological group:
Alpha-blocker.
Pharmacodynamics:
Tamsulosin is a specific blocker of postsynaptic alpha1-adrenergic receptors located in the smooth muscle of the prostate, bladder neck and prostatic urethra. The blockade of alpha1-adrenoceptor tamsulosin reduces the tone of smooth muscles of the prostate, bladder neck and prostatic urethra and improve urine flow. At the same time decrease as the emptying of the symptoms and signs of filling due to increased tone of smooth muscle and detrusor overactivity in benign prostatic hyperplasia.
The ability to influence the tamsulosin in 20 times alpha1 adrenoceptor subtype exceeds its ability to interact with adrenoceptor subtype alfa1V which are located in vascular smooth muscle. Due to their high selectivity, tamsulosin does not cause a clinically significant decrease in systemic blood pressure (BP) both in hypertensive patients and in patients with normal blood pressure source.
Pharmacokinetics:
Absorption: Tamsulosin is well absorbed in the gut and has almost 100% bioavailability. Absorption of tamsulosin slows down somewhat after a meal. The same level of absorption can be achieved if the patient takes the drug each time, after the usual breakfast. Tamsulosin is characterized by linear kinetics. After a single oral administration of 0.4 mg dose of its maximum concentration achieved within 6 hours of plasma. Following multiple oral administration of 0.4 mg per day equilibrium concentration achieved by the 5th day, and its value is approximately 2/3 above this value, after a single dose.
Distribution Communication plasma protein – 99%, the volume of distribution is small (about 0.2 l / kg).
Metabolism: Tamsulosin slowly metabolized in the liver with the formation of less active metabolites. Most of tamsulosin represented in the blood plasma in unchanged form.
The experiment revealed the ability of tamsulosin slightly induce the activity of microsomal liver enzymes.
At low and moderate hepatic failure is not required dosing regime correction.
Excretion: Tamsulosin and its metabolites are mainly excreted in urine, with about 9% of the drug is released in unaltered form.
The half life of the drug in single dose of 0.4 mg once a meal is 10 hours after repeated – 13 hours.
In renal insufficiency does not require dose reduction, if the patient has severe renal failure (creatinine clearance less than 10 mL / min) tamsulosin assignment must be done with caution.
Pregnancy and breast-feeding
No data.
Conditions of supply of pharmacies
By prescription.
side effects
Rarely – dizziness, retrograde ejaculation; in rare cases – orthostatic hypotension, tachycardia / palpitations, fatigue, headache.
On the part of the gastrointestinal tract, in rare cases – nausea, vomiting, diarrhea, constipation.
In very rare cases there may be a hypersensitivity reaction – skin rash, itching, angioedema.
special instructions
As with the other * 1-blockers in the treatment of drug Omnik® in some cases, decrease in blood pressure may occur, which can sometimes lead to fainting. At the first signs of orthostatic hypotension (dizziness, weakness) the patient must sit or lie down and to remain in this position as long as the symptoms disappear.
Before starting therapy with Omnik®, the patient should be examined in order to exclude the presence of other diseases, which can cause the same symptoms as benign prostatic hyperplasia. Before beginning treatment and at regular intervals during treatment should be performed digital rectal examination and, if required, the determination of prostate specific antigen (PSA).
Storage conditions
At temperatures above 25 ° C.
Dosing and Administration
Inside, after lunch, drinking water, taking 1 capsule (0.4 mg), 1 time per day. Chew the capsule is not recommended because this may affect the release rate of the drug.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist