Lasilactone 50/20 mg 30 tablets
Sanofi Egypt
Sanofi Egypt
Composition
Each film-coated tablet contains
- Furosemide 20 mg,
- Spironolactone 50 mg.
Excipients
Maize starch, lactose monohydrate D80 (75.5 mg), povidone 25000, dioctyl sodium sulfosuccinate, sodium starch glycolate, talc, colloidal anhydrous silica, magnesium stearate.
Product Description
Lasilactone is a combination diuretic containing the loop diuretic furosemide and the aldosterone antagonist spironolactone.
It provides effective diuresis and helps correct fluid and electrolyte imbalances associated with hyperaldosteronism.
Indications for Use
Oedema and ascites associated with electrolyte imbalance due to hyperaldosteronism when previous diuretic therapy has been insufficient, including:
- heart failure with oedema and pulmonary congestion;
- ascites due to hepatic disease (e.g. liver cirrhosis);
- oedema in nephrotic syndrome (with treatment of the underlying condition).
Indicated in adults only.
Method of Administration and Dosage
Tablets should be swallowed whole with sufficient liquid, preferably at breakfast or lunch.
Evening administration is not recommended due to increased nocturnal urination.
Initial dose: Usually 2 tablets daily (40 mg furosemide and 100 mg spironolactone).
In hepatic disease: Up to 4 tablets daily (80 mg furosemide and 200 mg spironolactone).
Maintenance dose: 1–2 tablets daily after 3–6 days (20–40 mg furosemide and 50–100 mg spironolactone).
If required: Up to 3 tablets daily (60 mg furosemide and 150 mg spironolactone).
Maximum daily dose: 4 tablets.
Paediatric population: use in children and adolescents under 18 years of age is not recommended.
Contraindications
- Hypersensitivity to furosemide, spironolactone, sulphonamides or excipients.
- Renal failure with anuria unresponsive to furosemide.
- Severe renal impairment (CrCl < 30 ml/min/1.73 m²).
- Hepatic encephalopathy, pre-comatose or comatose states.
- Hyperkalaemia or severe hypokalaemia.
- Severe hyponatraemia.
- Hypovolaemia or dehydration.
- Pregnancy and breast-feeding.
- Hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Precautions
- Regular monitoring of serum electrolytes, renal function, uric acid and blood glucose is required.
- Caution is advised in elderly patients and in those with renal, hepatic or cardiovascular disease.
- Careful dose adjustment is necessary in nephrotic syndrome due to increased risk of adverse reactions and ototoxicity.
- In patients with hepatic cirrhosis and concomitant renal impairment, close monitoring is required.
- Symptomatic hypotension may occur, especially in elderly patients or those receiving other hypotensive medicines.
- Concomitant use with potassium-raising medicinal products may result in severe hyperkalaemia.
- Spironolactone may cause voice changes, which can be irreversible in some cases and should be considered in patients whose profession depends on voice quality.
- Progression of castration-resistant prostate cancer has been observed under spironolactone therapy.
- Long-term furosemide use may require thiamine supplementation.
- This medicine contains lactose and should not be used in patients with rare hereditary disorders of galactose metabolism.
- Body weight loss due to diuresis should not exceed 1 kg per day.
Side Effects
Most common adverse reactions include
- electrolyte disturbances, hypovolaemia and dehydration, increased creatinine and triglycerides, hypotension and orthostatic reactions.
Other possible adverse effects include
- potassium imbalance;
- dizziness, headache;
- gastrointestinal disturbances;
- gynaecomastia, breast tenderness;
- menstrual disorders;
- voice changes;
- allergic skin reactions;
- renal and auditory disorders.
Pregnancy and Lactation
Lasilactone is contraindicated during pregnancy and breast-feeding.
Furosemide crosses the placenta and is excreted into breast milk.
Storage Conditions
Store below 30 °C in a dry place.
Keep out of reach of children
Packaging
Carton box containing 3 blisters of 10 film-coated tablets and a package leaflet.