 |
| Lasilactone |
Lasilactone® 50 mg Lasilactone® 100 mg Spironolactone / Furosemide sanoFi avents Composition
Each film-coated tablet of Lasilactone SOmg contains, as active ingredients, SO mg spironolactone in micronized form, and 20 mg furosemide.
Each film-coated tablet of Lasilactoneloomg contains, as active ingredients, 100 mg spironolactone in micronized form, and 20 mg furosemide.
Indications Fluid accumulation in tissues (edema) or in body cavities (e.g ascites), with additional electrolyte disturbances due to excessive aldosterone levels (hyperaldosteronism) that have not responded adequately to previous diuretic treatment.
Lasilactone is further indicated in ascites due to liver diseases (e.g cirrhosis), edema in tissues and cor-pulmonale due to heart failure, edema in tissues in nephrotic syndrome.
Contraind ications
Hypersensitivity to spironolactone, furosemide, sulphonamides or sulphonamides derivatives.
Disorders of renal function with a creatinine clearance of less than 30 ml per minute, corresponding to serum creatinine levels of about 1.8 - 2 mgldl (see also under “Special Warnings and Precautions”).
Elevated blood potassium levels (hyperkalemia).
Sodium depletion and/or reduction in blood volume (hypovolemia) with or without hypotension.
Hepatic coma.
Pregnancy and lactation. V Special Warnings and Precautions Severe potassium depletion must be corrected before the start of treatment. If Lasilactone has to be used in nursing mothers, breast-feeding should be stopped. In patients with impaired renal function with serum creatinine values of over 1.5 mg/dl and a creatinine clearance of less than 60 ml /min, the serum potassium level must be frequently monitored during treatment.
During long-term treatment, potassium, sodium and urinary substances containing nitrogen should be regularly monitored.
Patients with hypertension must be regularly monitored while on treatment with I.asilactone.
Adverse Reactions
During long-term treatment, especially in patients with impaired renal function, hyperkalemia may occur, associated with irregular pulse, drowsiness and muscular weakness in the lower limbs.
Owing to its chemical similarity to sex hormones, spironolactone may cause increased tenderness of the nipples and breast enlargement in both sexes and in very rare cases, vocal changes in the form of hoarseness and deepening of the voice in women and heightening of the voice in men. In some patients these voice changes are irreversible, even after discontinuation of the drug. The therapeutic benefit of the drug must be weighed against this possible hazard, especially in patients whose voice is of professional importance (e.g. singers, teachers, etc ).
Menstrual irregularities and abnormal hair growth on face and body in women and disturbances of potency in men are occasionally encountered.
Lethargy and mental confusion after high doses have been reported.
Allergic reactions (e.g. skin rashes -also photosensitively- vasculitis, fever, interstitial nephritis) and changes in blood picture (hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia) may occasionally be observed. A decrease in the number of blood platelets (thrombocytopenia) may become manifest, as an increased tendency to bleeding, a physician should be consulted in such cases.
Serum cholesterol and triglyceride levels may rise under furosemide treatment, but usually returns to normal, under long-term treatment within six months. Gastrointestinal disorders such as nausea, vomiting and diarrhea are possible.
Each film-coated tablet of Lasilactone SOmg contains, as active ingredients, SO mg spironolactone in micronized form, and 20 mg furosemide.
Each film-coated tablet of Lasilactoneloomg contains, as active ingredients, 100 mg spironolactone in micronized form, and 20 mg furosemide.
Indications Fluid accumulation in tissues (edema) or in body cavities (e.g ascites), with additional electrolyte disturbances due to excessive aldosterone levels (hyperaldosteronism) that have not responded adequately to previous diuretic treatment.
Lasilactone is further indicated in ascites due to liver diseases (e.g cirrhosis), edema in tissues and cor-pulmonale due to heart failure, edema in tissues in nephrotic syndrome.
Contraind ications
Hypersensitivity to spironolactone, furosemide, sulphonamides or sulphonamides derivatives.
Disorders of renal function with a creatinine clearance of less than 30 ml per minute, corresponding to serum creatinine levels of about 1.8 - 2 mgldl (see also under “Special Warnings and Precautions”).
Elevated blood potassium levels (hyperkalemia).
Sodium depletion and/or reduction in blood volume (hypovolemia) with or without hypotension.
Hepatic coma.
Pregnancy and lactation. V Special Warnings and Precautions Severe potassium depletion must be corrected before the start of treatment. If Lasilactone has to be used in nursing mothers, breast-feeding should be stopped. In patients with impaired renal function with serum creatinine values of over 1.5 mg/dl and a creatinine clearance of less than 60 ml /min, the serum potassium level must be frequently monitored during treatment.
During long-term treatment, potassium, sodium and urinary substances containing nitrogen should be regularly monitored.
Patients with hypertension must be regularly monitored while on treatment with I.asilactone.
Adverse Reactions
During long-term treatment, especially in patients with impaired renal function, hyperkalemia may occur, associated with irregular pulse, drowsiness and muscular weakness in the lower limbs.
Owing to its chemical similarity to sex hormones, spironolactone may cause increased tenderness of the nipples and breast enlargement in both sexes and in very rare cases, vocal changes in the form of hoarseness and deepening of the voice in women and heightening of the voice in men. In some patients these voice changes are irreversible, even after discontinuation of the drug. The therapeutic benefit of the drug must be weighed against this possible hazard, especially in patients whose voice is of professional importance (e.g. singers, teachers, etc ).
Menstrual irregularities and abnormal hair growth on face and body in women and disturbances of potency in men are occasionally encountered.
Lethargy and mental confusion after high doses have been reported.
Allergic reactions (e.g. skin rashes -also photosensitively- vasculitis, fever, interstitial nephritis) and changes in blood picture (hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia) may occasionally be observed. A decrease in the number of blood platelets (thrombocytopenia) may become manifest, as an increased tendency to bleeding, a physician should be consulted in such cases.
Serum cholesterol and triglyceride levels may rise under furosemide treatment, but usually returns to normal, under long-term treatment within six months. Gastrointestinal disorders such as nausea, vomiting and diarrhea are possible.
