Nolaxen
(Spironolactone Hydrochlorothiazide)




COMPOSITION

Each film coated tablet contains 25 mg of spironolactone and 25 mg of hydrochlorothiazide.

THERAPEUTIC INDICATIONS

- Soft and moderate arterial hypertension;
- Edematic syndrome of different genesis (chronic cardiac insufficiency, hepatic and renal disease).

CONTRAINDICATIONS

- Hypersensitivity to any drug compounds;
- Acute renal impairment, anuria;
- Apparent hepatic dysfunction (precoma and hepatic coma);
- Unregulated electrolyte metabolic disbalance: hypokaliemia, hyperkaliemia, hypercalcemia, hyponatremia;
- Hypersensitivity to sulfonamides (because of risk of crossed allergic reactions);
- Pregnancy (I trimester), lactation.

DOSAGE AND ADMINISTRATION

Nolaxen should be used orally.
Children, in converting to spironolactone: 1.66-3.3 mg/kg/daily divided into 2-4 doses.
Adults: 1-8 tablets of Nolaxen (in converting to spironolactone: 100-200 mg, rarely 300 mg daily) in 1-2 dose every day within 14-21 days. If it is necessary the course is repeated in every 10-14 days.

ADVERSE EFFECTS

- Effects from water-electrolytic balance and acid-base balance: dry mouth and thirst.
- In prolonged administration: hyponatremia, hypomagnesemia, hypochloremia, hypo- and hyperkalemia. Seldom: hypercalcemia, hyperuricemy.
- Possible: nausea, vomiting, headaches, palpitation, orthostatic disturbances of hemodynamics, allergic reactions.
- Seldom: increasing of glucose level, urea and creatinine in blood.

PRECAUTIONS

Nolaxen should be cautiously prescribed for patients with podagra, pancreatic diabetes, hepatic and renal disorder and for patients with a high risk of respiratory and metabolic acidosis.
In case of prolonged administration of Nolaxen the content of electrolytes in serum as well as urea, glucose, creatinine and uric acid should be occasionally monitored. During pregnancy and lactation Nolaxen is prescribed only under strict indications.

DRUG INTERACTIONS

The co-administration of Nolaxen with other antihypertensive drugs (especially inhibitors of ACE), diuretic agents, barbiturates, diazepam, vasodilators and drugs containing ethanol may increase Nolaxen hypotensive effect.
In case of the co-administration of Nolaxen with salts of potassium, potassium-sparring diuretics and indometacin hyperkaliemia may occur.
In case of the co-administration of Nolaxen with glycocorticoids, purgatives in high doses hypokaliemia may occur.
Acetylsalicylic acid, indometacin and mephanamine acid decreases diuretic effect of Nolaxen.
The co-administration of Nolaxen with muscle relaxants may increase and prolong their action.
Nolaxen may increase the concentrations of salts of lithium up to toxic level in blood; may decrease the effect of peroral hypoglycemic agents and the sensibility of vessels to noradrenalin.
Nolaxen may increase the effect of indirect anticoagulants (cumarin derivatives); increase digoxin half-time excretion (therefore in case of their combined administration the reducing of digoxin dosage or dosage interval is required).

Box contains 20 film coated tablets.

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