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Cardiovascular System

Semilact Tablets
(Furosemide / Spironolactone)



CONTENT:
Film coated tablets. Tablet contains spironolactone 50 mg or 100 mg, furosemide 20 mg.
 
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMICS. Semilact - combined diuretic preparation. Its hypotensive action is conditioned by the combination of spironolactone and furosemide. Spironolactone is a potassium-sparing diuretic, specific long-acting antagonist of aldosterone (mineralocorticosteroid hormone of adrenal cortex). Binding with aldosterone receptors spironolactone increases a water excretion, sodium ions and chlorine excretion; it also reduces potassium and urea excretion. Furosemide is potent loop diuretic. It blocks an active reabsorption of sodium, potassium, chlorides and magnesium ions in ascending limb of Henle's loop, as well as proximal and distal convoluted tubules; it increases the water excretion. PHARMACOKINETICS. Spironolactone and Furosemide after oral administration are well absorbed from gastrointestinal tract, and characterized by high bioavailability. Spironolactone is metabolised quickly in liver. The main pharmacologically active metabolites are 7-a-thiospironolactone, 7-a-thiomethylspironolactone and canrenone (about 50%). It has half-life is on average 12.5 h.
Furosemide is metabolised in the organism with glucuronid formation. The elimination half-life is about 2 h.
 
THERAPEUTIC INDICATIONS:
- edema in cardiac insufficiency, nephrotic syndrome (especially, if the other preparations are not sufficiently effective or if hypocalemia caused by diuretics is present);
- edemas or ascites at electrolyte exchange due to hyperaldosteronism;
- ascites at liver cirrhosis;
- arterial hypertension.
 
CONTRAINDICATIONS:
- hypersensitivity to spironolactone, furosemide or sulfonamides; - acute renal insufficiency, anuria;
- highly compromised liverfunction (hepatic precoma and coma); - electrolyte imbalance: hypo-or hyperkaliemia, hypercalcemia, hyponatremia.
 
SIDE EFFECTS:
From water-electrolytic balance: hyponatremia, hypo- or hyperkaliemia, at long term administration; rare-hyperuricemia, hyperglycemia, glucosuria. From central nervous system (CNS): dizziness, drowsiness, headache, ataxy, mental confusion, ringing in the ears, parestesia, hearing loss, and vision irregularity. From gastro-intestinal tract: abdominal pain, nausea, vomiting, diarrhea, pancreatitis, cholestatic jaundice, anorexia, irritation of oral cavity and stomach mucous membrane. From urogenital system: voiding impairment, gynecomastia (in men); pain in mammary gland, dysmenorrhea, amenorea, hirsutism, voice posterization (in women).
Allergic reactions: systemic vasculitis, interstitial nephritis, necrotizing vasculitis, exfoliative dermatitis, multiform erithema, fever, skin eruption, itch, urticaria. From blood system: rare - aplastic anemia, hemolytic anemia, leucopenia, agranulocytosis, thrombocytopenia.
 
DOSAGE AND ADMINISTRATION:
The preparation Semilact is taken as a whole, without chewing, during meal, washing down with enough quantity of liquid.
Dosage regimen is established individually, taken into account nosological form of disease and intensity of water-electrolytic disbalance.
At the first 3-6 days of treatment, the preparation is administrated every day in the average daily dose up to 4 tablets. Maintaining dose is 1 tablet up to 3 times per day. Depending on intensity of clinical effect, this dose is prescribed every day or in a day or in 2 days. The treatment duration is established individually.
 
PACKAGING:
10 tablets in blister.
1 blister with enclosed leaflet in carton box.
 
 
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