Vazotenz of N

General characteristics. Structure:

1 tablet, film coated, 50 mg +12.5 mg contains:
active agents: лозартан potassium of 50 mg and hydrochlorothiazide of 12,5 mg;
excipients: Mannitolum of 82,5 mg, cellulose of microcrystallic 40,0 mg, sodium of a kroskarmelloz of 8,0 mg, povidone of 4,0 mg, magnesium stearate of 3,0 mg, Opadray of white 4,0 mg (gipromelloz of ZSR of 1,4 mg, hydroxypropyl cellulose of 1,2 mg, titanium dioxide of 0,8 mg, macrogoal of 0,4 mg, gipromelloza 50 Wednesday of 0,2 mg).

1 tablet, film coated, 100 mg +25 mg contains:
active agents: лозартан potassium of 100 mg and hydrochlorothiazide of 25 mg;
excipients: Mannitolum of 165,0 mg, cellulose of microcrystallic 80,0 mg, sodium of a kroskarmelloz of 16,0 mg, povidone of 8,0 mg, magnesium stearate of 6,0 mg, Opadray of white 6,0 mg (gipromelloz of ZSR of 2,8 mg, hydroxypropyl cellulose of 2,4 mg, titanium dioxide of 1,6 mg, macrogoal of 0,8 mg, gipromelloza 50 Wednesday of 0,4 mg).

Description 
Tablets of 50 mg + 12,5 mg Round, biconvex tablets, white color, film coated, from a tablet, risky from two parties, and side risks, with the designation "LH" on the one hand from risks and "1" on the other hand from risks.
Tablets of 100 mg + 25 mg Round, biconvex tablets, white color, film coated, from a tablet, risky from two parties, and side risks, with the designation "LH" on the one hand from risks and "2" on the other hand from risks.

Pharmacological properties:

Pharmacodynamics. The combined drug, has hypotensive effect. Contains лозартан potassium – the antagonist of receptors of angiotensin II (AT1 subtype) and a hydrochlorothiazide – diuretic.
Lozartan is a specific antagonist of receptors of angiotensin II (AT1 subtype). Does not suppress a kinase of II – the enzyme destroying bradykinin. Reduces the general peripheric resistance (OPSS), concentration in blood of adrenaline and Aldosteronum, the arterial pressure (AP), pressure in a small circle of blood circulation; reduces an afterload, renders diuretic effect. Interferes with development of a hypertrophy of a myocardium, increases tolerance to an exercise stress at patients with chronic heart failure.
Hydrochlorothiazide – thiazide diuretic. Reduces a reabsorption of ions of sodium, strengthens allocation with urine of potassium ions, a hydrocarbonate and phosphates. Lowers the ABP due to reduction of the volume of the circulating blood (VCB), change of reactivity of a vascular wall, decrease in pressor influence of vasoconstrictive substances and strengthening of depressor influence on a ganglion.

Pharmacokinetics. Lozartan is quickly absorbed from digestive tract. Bioavailability – about 33%. Has effect of "the first passing" through a liver, it is metabolized by a carboxylation with formation of an active metabolite. Communication with proteins of a blood plasma – 99%. Time of achievement of the maximum concentration in a blood plasma of a lozartan makes 1 h, an active metabolite of 3-4 h, after intake. Elimination half-life of 1,5 - 2 h, and its main metabolite of 3-4 h, respectively. About 35% of a dose are removed with urine, about 60% - through intestines.
The hydrochlorothiazide is quickly absorbed from digestive tract. The elimination half-life makes 5,8-14,8 h. It is not metabolized by a liver. About 61% are removed by kidneys in not changed look.

Indications to use:

Arterial hypertension (at patients for whom the combination therapy is optimum).

Route of administration and doses:

Inside, regardless of meal.
The usual initial and maintenance dose of drug makes 50 mg of a lozartan + 12,5mg a hydrochlorothiazide (1 tablet) in day. For those patients from whom at this dosage it is not possible to achieve adequate control of the ABP the dose can be increased to 2 tablets (50 mg / 12,5 by mg) or 1 tablets (100 mg / 25 in mg) once a day. The maximum dose makes 2 tablets (50 mg / 12,5 mg) or 1 tablet (100 mg / 25 mg) once a day.
In general, the maximum hypotensive effect is reached within 3 weeks after an initiation of treatment.
There is no need for special selection of an initial dose to patients of advanced age.

Features of use:

It is possible to appoint together with other antihypertensives.
There is no need for special selection of an initial dose by the patient of advanced age.
Drug can increase concentration of urea and creatinine in a blood plasma at patients with a bilateral stenosis of renal arteries or a renal artery stenosis of the only kidney.
The hydrochlorothiazide can strengthen arterial hypotension and disturbances of water and electrolytic balance (reduction of volume of the circulating blood, a hyponatremia, a gipokhloremichesky alkalosis, a hypomagnesiemia, a hypopotassemia), to break tolerance to glucose, to reduce removal of calcium with urine and to cause passing, slight increase of concentration of calcium in a blood plasma, to increase concentration of cholesterol and triglycerides, to provoke emergence of a hyperuricemia and/or gout.
Reception of the medicines which are directly operating on system a renin angiotensin during II and III trimesters of pregnancy can lead to death of a fruit. At emergence of pregnancy drug withdrawal is shown.
Use of diuretics usually is not recommended to pregnant women in connection with risk of developing of jaundice at a fruit and the newborn, thrombocytopenia of mother. Therapy by diuretics does not prevent development of toxicosis of pregnancy.
There is no information on influence on ability to drive the car and other mechanisms.

Side effects:

Side reactions are limited observed earlier at use of a lozartan of potassium and/or a hydrochlorothiazide.
At treatment of essential hypertensia refer dizziness to the most frequent side effects.
Allergic reactions: anaphylactoid reactions, a Quincke's disease, including hypostasis of a throat and/or language that led to obstruction of respiratory tracts, and/or a face edema, lips, the drinks and/or language which were occasionally noted at reception of a lozartan. Some of these patients had a Quincke's disease earlier at use of other drugs including APF inhibitors. Extremely seldom, at reception of a lozartan manifestations of a vasculitis, including Shenlyayn-Genokh's disease were noted.
From cardiovascular system: decrease in the ABP.
From a digestive tract: at reception of a lozartan were registered rare (<1%) hepatitis cases, diarrhea.
From a respiratory organs: at reception of a lozartan – cough.
From integuments: small tortoiseshell.
Laboratory indicators: seldom (<1%) hyperpotassemia (serum potassium more than 5,5 mmol/l), increase in activity of "hepatic" enzymes.

Interaction with other medicines:

Lozartan strengthens effect of other antihypertensives. Clinically significant interaction with a hydrochlorothiazide, digoxin, indirect anticoagulants, Cimetidinum, phenobarbital, ketokonazoly, erythromycin is noted. There are messages that rifampicin and флуконазол reduce the level of an active metabolite. Clinical value of these interactions is not studied.
As well as other drugs blocking angiotensin II or its effect, co-administration of kaliysberegayushchy diuretics (for example, Spironolactonum, Triamterenum, amiloride), drugs of potassium or the deputies of salt containing potassium can lead to a hyperpotassemia.
Non-steroidal anti-inflammatory drugs (NPVP), including the selection inhibitors of cyclooxygenase-2 (SOH-2 inhibitors) can reduce effect of diuretics and other antihypertensives.
At some patients with an impaired renal function receiving therapy of NPVP (including cyclooxygenase-2 inhibitors), treatment by antagonists of receptors of angiotensin II can cause further deterioration in function of kidneys, including an acute renal failure which is usually reversible.
The hypotensive effect of a lozartan, as well as other anti-hypertensive means, can be weakened at reception of non-steroidal anti-inflammatory drug of indometacin.

Hydrochlorothiazide
The following medicines can interact with thiazide diuretics at appointment, simultaneous with them:
Barbiturates, drugs, ethanol – there can be a potentiation of orthostatic hypotension.
Hypoglycemic means (peroral means and insulin) – dose adjustment of hypoglycemic means can be required.
Other antihypertensives – the additive effect is possible.
Colestyraminum and колестипол reduces absorption of a hydrochlorothiazide.
Corticosteroids, AKTG – strengthening of loss of electrolytes, in particular potassium.
Pressor amines – perhaps insignificant decrease in effect of pressor amines which is not interfering their use.
Not depolarizing muscle relaxants (for example, Tubocurarini chloridum) – strengthening of action of muscle relaxants is possible.
Lithium drugs - diuretics reduce renal clearance of Li + and increase risk of intoxication lithium therefore simultaneous use is not recommended.
Non-steroidal anti-inflammatory drugs (NPVP), including the selection inhibitors of cyclooxygenase-2 (SOH-2 inhibitors) – at some patients are reception of NPVP, including cyclooxygenase-2 inhibitors, can reduce diuretic, natriuretic and anti-hypertensive effect of diuretics.
Impact on results of laboratory researches
Thanks to impact on excretion of calcium, a tiazida can influence results of the analysis of function of epithelial bodies.

Contraindications:

• hypersensitivity to drug components, hypersensitivity to other derivatives of sulfonamides;
• anury;
• the expressed arterial hypotension;
• the expressed abnormal liver functions;
• the expressed renal failures (clearance of creatinine of ≤30 ml/min.)
• a hypovolemia (including against the background of high doses of diuretics)
• pregnancy and period of a lactation;
• age up to 18 years (efficiency and safety are not established).

With care: to patients with a bilateral stenosis of renal arteries or a stenosis of an artery of the only kidney, with disturbances of water and electrolytic balance of blood (dehydration, a hyponatremia, a gipokhloremichesky alkalosis, a hypomagnesiemia, a hypopotassemia).

With care drug is appointed at patients with a diabetes mellitus, hypercalcemia, hyperuricemia and/or gout, and also to patients with the burdened allergological anamnesis and bronchial asthma, and also at general diseases of connecting fabric (including a system lupus erythematosus), at co-administration with non-steroidal anti-inflammatory drugs (NPVP), including cyclooxygenase-II inhibitors (SOH-2 inhibitors).

Overdose:

Symptoms: лозартан - the expressed decrease in the ABP, tachycardia, bradycardia (as a result of vagal stimulation). A hydrochlorothiazide – loss of electrolytes (a hypopotassemia, a hyperchloremia, a hyponatremia), and also dehydration arising owing to an excess diuresis.
Treatment: symptomatic and maintenance therapy. If drug is accepted recently, it is necessary to wash out a stomach; if necessary carry out correction of water and electrolytic disturbances.
Lozartan and his active metabolites are not removed by means of a hemodialysis.

Storage conditions:

At a temperature not above 30 °C. To store in the place, unavailable to children! Period of validity 3 years. Not to use after a period of validity.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated 50 mg +12,5 mg; 100 mg +25 mg.
On 7, 10 or 14 tablets in the blister from PVC/PVDH / aluminum foil; on 2, 4 blisters (on 7 tablets) or on 1, 3 blisters (on 10 tablets), or on 1, 2 blisters (on 14 tablets) together with the application instruction in a cardboard pack.
On 10, 30, 60 blisters (on 10 tablets) together with application instructions in a cardboard box (for hospitals).