Vasotenz N, 100 mg+25 mg 30 pcs

Combination drug, has a hypotensive effect. It contains potassium losartan – angiotensin II receptor antagonist (AT1 subtype) and hydrochlorothiazide – diuretic.

Lozartan is a specific angiotensin II receptor antagonist (AT1 subtype). It does not inhibit kinase II, an enzyme that degrades bradykinin.

Limits total peripheral resistance (TPR), blood concentrations of adrenaline and aldosterone, blood pressure (BP), pressure in the small circle of the circulation; reduces post-load, has a diuretic effect. It prevents the development of myocardial hypertrophy and increases exercise tolerance in patients with chronic heart failure.
Hydrochlorothiazide is a thiazide diuretic.

Reduces reabsorption of sodium ions, increases urinary excretion of potassium ions, bicarbonate and phosphate.

Lowers BP by reducing the volume of circulating blood (RBC), changing the reactivity of the vascular wall, reducing the pressor effect of vasoconstrictors and increasing the depressor effect on the ganglia.

Indications

– Arterial hypertension (in patients for whom combination therapy is optimal).

Composition

White film-coated tablets, round, biconvex, rimmed on both sides of the tablet and marked with “LH” on one side of the rim and “1” on the other side of the rim.

1 tablet losartan potassium 50 mg hydrochlorothiazide 12.5 mg

Excipients:

Mannitol – 82.5 mg,

microcrystalline cellulose – 40 mg,

croscarmellose sodium – 8 mg,

povidone – 4 mg,

magnesium stearate – 3 mg,

opadray white – 4 mg (hypromellose 3cP – 1.4 mg, hydroxypropyl cellulose – 1.2 mg, titanium dioxide – 0.8 mg, macrogol – 0.4 mg, hypromellose 50cP – 0.2 mg).

How to take, the dosage

Intentionally, regardless of meals.

The usual starting and maintenance dose is 50 mg losartan/12.5 mg hydrochlorothiazide (1 tablet) daily.

For those patients in whom adequate BP control is not achieved at this dosage, the dose may be increased to 2 tablets (50 mg/12.5 mg) or 1 tablet (100 mg/25 mg) once daily.

The maximum dose is 2 tablets (50 mg/12.5 mg) or 1 tablet (100 mg/25 mg) once daily.

In general, the maximum hypotensive effect is achieved within 3 weeks after the start of treatment.

There is no need for special selection of the initial dose in elderly patients.

Interaction

Lozartan enhances the effect of other hypotensive agents. No clinically significant interaction with hydrochlorothiazide, digoxin, indirect anticoagulants, cimetidine, phenobarbital, ketoconazole, erythromycin has been noted. There are reports that rifampicin and fluconazole reduce the level of active metabolite. The clinical significance of these interactions has not been studied.
Like other drugs that block angiotensin II or its effects, simultaneous administration of potassium-saving diuretics (e.g., spironolactone, triamterene, amiloride), potassium drugs or potassium salt substitutes may lead to hyperkalemia.

NSAIDs, including selective cyclooxygenase-2 inhibitors may decrease the effect of diuretics and other hypotensive agents.
In some patients with impaired renal function treated with NSAIDs (including COX-2 inhibitors), treatment with angiotensin II receptor antagonists may cause further impairment of renal function, including acute renal failure, which is usually reversible.

The hypotensive effect of losartan, as well as other antihypertensive agents, may be impaired by administration of indomethacin.
Hydrochlorothiazide.

The following drugs may interact with thiazide diuretics when taken concomitantly:
Barbiturates, narcotics, ethanol – potentiation of orthostatic hypotension may occur.

Hypoglycemic agents (oral agents and insulin) – correction of the dose of hypoglycemic agents may be required.
Other hypotensive agents – additive effect is possible.

Colestyramine and colestipol reduces absorption of hydrochlorothiazide.

GCS, ACTH – increased loss of electrolytes, especially potassium.

Pressor amines – a slight decrease in the effect of pressor amines is possible, not preventing their use.
Non-depolarizing myorelaxants (e.g., tubocurarine chloride) – possible enhancement of myorelaxant action.

Lithium drugs – Diuretics decrease renal clearance of lithium and increase the risk of lithium intoxication, so concomitant use is not recommended.

NSAIDs, including selective COX-2 inhibitors: may decrease diuretic, natriuretic and antihypertensive effects of diuretics.

Impact on laboratory results.

Particularly because of its effect on calcium excretion, thiazides may affect the results of parathyroid function tests.
Pregnancy and lactation.

It is contraindicated for use in pregnancy and lactation.

The administration of drugs acting directly on the renin/angiotensin system during the second and third trimesters of pregnancy can lead to fetal death. If pregnancy occurs, withdrawal of the drug is indicated.

The use of diuretics in pregnant women is generally not recommended due to the risk of jaundice in the fetus and the newborn, thrombocytopenia of the mother. Diuretic therapy does not prevent the development of toxemia of pregnancy.

Special Instructions

Can be administered together with other hypotensive agents.

There is no need for special selection of the initial dose in elderly patients.

The drug may increase plasma urea and creatinine concentrations in patients with bilateral renal artery stenosis or artery stenosis of the single kidney.

. Hydrochlorothiazide may increase arterial hypotension and water-electrolyte balance disorders (decreased circulating blood volume, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypokalemia), impair glucose tolerance, decrease urinary calcium excretion and cause transient, slight increase in plasma calcium concentrations, increase cholesterol and triglyceride concentrations, provoke the occurrence of hyperuricemia and/or gout.

Impact on the ability to drive and operate machinery

There is no information about the effect on the ability to drive vehicles and other mechanisms.

Contraindications

– hypersensitivity to the components of the drug, hypersensitivity to other sulfonamide derivatives;

– anuria;

p> – significant arterial hypotension;

– significant hepatic impairment;

– significant renal impairment (CK ≤30 ml/min.);

– hypovolemia (including with high doses of diuretics);

– pregnancy and lactation;

– age less than 18 years (effectiveness and safety are not established).

With caution: patients with bilateral renal artery stenosis or stenosis of the artery of the only kidney, with disorders of water-electrolyte balance of the blood (dehydration, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypokalemia).

With cautiousness .The drug is used in patients with diabetes mellitus, hypercalcemia, hyperuricaemia and/or gout as well as in patients with a history of allergy and bronchial asthma, also in case of systemic connective tissue diseases (including systemic lupus erythematosus), when simultaneously prescribed with NSAIDs, including COP inhibitors.COX-2 inhibitors).

Side effects

The adverse reactions are limited to those previously observed with potassium losartan and/or hydrochlorothiazide.

The most frequent side effects with treatment of essential hypertension include dizziness.

Allergic reactions: anaphylactoid reactions, angioedema, including swelling of the larynx and/or tongue resulting in airway obstruction, and/or swelling of the face, lips, pharynx, and/or tongue occasionally noted while taking losartan. Some of these patients had previously experienced angioedema with other drugs, including ACE inhibitors. Rarely, vasculitis, including Schoenlein-Henoch disease, has been reported while taking losartan.

Cardiovascular system: decreased BP.

Gastrointestinal disorders: rare (1%) cases of hepatitis and diarrhea have been reported while taking losartan.

Respiratory disorders: cough when taking losartan.

Skin disorders: urticaria.

Laboratory disorders: rarely (1%) – hyperkalemia (serum potassium over 5.5 mmol/l), increased liver enzymes activity.

Overdose

Symptoms due to losartan overdose: marked BP decrease, tachycardia, bradycardia (as a result of vagus stimulation).

Symptoms due to hydrochlorothiazide overdose: loss of electrolytes (hypokalemia, hyperchloremia, hyponatremia), and dehydration due to excessive diuresis.

Treatment: symptomatic and supportive therapy. If the drug was taken recently, the stomach should be flushed; if necessary, correction of water-electrolyte disturbances is carried out.

Lozartan and its active metabolites are not eliminated by hemodialysis.