Vasotenz N, 12.5mg+50 mg 30 pcs

Prevention of heart attacks and strokes, Edema, Hypertension (high blood pressure)

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

Composition

Active ingredients:

Potassium losartan 50 mg;

Hydrochlorothiazide 12.5 mg.

Auxiliary substances:

Mannitol,

Microcrystalline cellulose,

How to take, the dosage

The usual starting and maintenance dose of Vasotenz N 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 of starting treatment.
No special selection of the initial dose is necessary 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 substitute salts containing potassium 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 the administration of indomethacin.
Hydrochlorothiazide
The following drugs may interact with thiazide diuretics when taken simultaneously:
Barbiturates, narcotic drugs, ethanol – potentiation of orthostatic hypotension may occur.
Hypoglycemic agents (oral agents and insulin) – may require correction of the dose of hypoglycemic agents.
Other hypotensive agents – possible additive effect.
Colestiramine 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 that does not prevent their use.
Non-depolarizing muscle relaxants (such as tubocurarine chloride) – possible increase in the effect of muscle relaxants.
Lithium drugs – diuretics decrease renal clearance of lithium and increase the risk of lithium intoxication, therefore simultaneous use is not recommended.
NSAIDs, including selective COX-2 inhibitors: may decrease the diuretic, natriuretic and antihypertensive effect of diuretics.
Impact on laboratory results
Due to the effect on calcium excretion, thiazides may affect the results of parathyroid function tests.

Special Instructions

Can be administered together with other hypotensive agents.

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

Vasotenz N may increase plasma urea and creatinine concentrations in patients with bilateral renal artery stenosis or arterial stenosis of the sole 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.

Influence on driving and operating machinery

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

Contraindications

Hypersensitivity to the components of the drug or to other sulfonamide derivatives, anuria, severe arterial hypotension, severe hepatic impairment, severe renal impairment (creatinine Cl ≤30 ml/min), hypovolemia (including with high doses of diuretics), pregnancy, breast-feeding, age under 18 years (effectiveness and safety are not established).

. With caution – bilateral stenosis of the renal arteries or stenosis of the artery of the only kidney, disorders of the water-electrolyte balance (dehydration, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypokalemia), diabetes, hypercalcemia, hyperuricemia and/or gout, aggravated allergic history and bronchial asthma, as well as in systemic connective tissue diseases (including systemic lupus erythematosus).including systemic lupus erythematosus), when concomitantly prescribed with NSAIDs, including COX 2 inhibitors.

Side effects

Adverse reactions are limited to those previously observed with potassium losartan and/or hydrochlorothiazide.
The most common adverse effects in the 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 when taking losartan.

Some of these patients have had previous angioedema with other drugs, including ACE inhibitors. Rarely, vasculitis, including Schoenlein-Henoch disease, has been reported with losartan.

Cardiovascular system: decreased BP.

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

Respiratory system: when taking losartan – cough.

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 Vasotenz N has been taken recently, the stomach should be flushed; correction of water-electrolyte disturbances should be performed, if necessary.

Lozartan and its active metabolites are not eliminated by hemodialysis.