THERAPEUTIC INDICATIONS

Patients with Oedema due to cardiac, hepatic and renal disease, and patients with adjunctive therapy in acute pulmonary oedema and cerebral oedema where intense and rapid onset of diuresis is desired.

POSOLOGY AND METHOD OF ADMINISTRATION

The initial dose for adults and adolescents of 15 years or over is 20 to 40 mg Lasix (1-2 ampoules) intravenously or, in exceptional cases, intramuscularly. For infants and children under 15 years, parenteral administration (if necessary, continous drip infusion) is indicated only in life threatening conditions. The dosage schedule is 1 mg furosemide pe kg body weight up to a daily maximum of 20 mg Lasix (1 ampoule). Intravenous injection of Lasix 20 mg should be given slowly, not exceeding an injection rate of 4 mg per minute. Intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary oedema.

CONTRAINDICATIONS

Lasix 20 mg is contra-indicated in patients with renal failure accompanied by lack of urine formation (anuria), hepatic coma and precoma, electrolyte deficiencies, decreased volume of blood in the body – with or without reduced blood pressure or dehydration, hypersensitivity to furosemide or any of the excipients.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

During treatment with Lasix 20 mg, output of urine must be secured. Patients whose outflow is obstructed (e.g. those with prostatic hypertrophy, ureterostenosis, or hydronephrosis) require careful monitoring, especially at the beginning of treatment. Particularly careful surveillance is necessary in hypotension, patients at particular risk from a pronounced fall in blood pressure, latent or manifest diabetes mellitus, gout, hepatorenal syndrome, reduced protein content in the blood, premature infants. Hypovolaemia or dehydration, as well as any significant disturbances in electrolyte content and acid-base balance, must be corrected. A temporary discontinuation of treatment with Lasix 20mg may become necessary. For concomitans use with risperidone and Levothyroxine: see full PI.

INTERACTIONS

The simultaneous use of furosemide and glucocorticoids, carbenoxolone or laxatives can lead to increased potassium depletion with the risk of hypokalemia. That may reduce the effect of Furosemide : Non-steroidal antiinflammatory drugs (e.g. indomethacin and acetylsalicylic acid), Probenecid, methotrexate and other medicinal products which, like furosemide, and phenytoin. Furosemide can potentiate the harmful effects of nephrotoxic medicinal products. If cisplatin and furosemide are administered concomitantly, hearing damage may occur. The concomitant administration of furosemide and lithium leads to an increase in the cardiac and neurotoxic effects of lithium via reduced lithium excretion. If other antihypertensive agents, diuretics or medicinal products with blood-pressure-lowering potential are used at the same time as furosemide, a greater drop in blood pressure is to be expected. The effect of theophylline or curare-type muscle relaxants may be increased by furosemide. For other interactions : see full PI.

PREGNANCY AND LACTATION

Lasix 20 mg must not be given during pregnancy unless there are compelling medical reasons, because furosemide can crosses the placental barrier. If lasix 20 mg is given during pregnancy, fetal growth must be monitored. Furosemide passes into breast milk and inhibits lactation, so itmust not be used during breastfeeding.

UNDESIRABLE EFFECTS

Very common : Electrolyte disorders, dehydration, hypovolemia, hypotension, elevated blood Creatinine, elevated triglycerides.

Common : Hemoconcentration, hyponatremia, hypochloremia, hypokalemia, hepatic encephalopathy, increased urine volume.

OVERDOSE

The clinical picture of an acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss, e.g. hypovolaemia. dehydration, haemoconcentration, cardiac arrhythmias.. No specific antidote to furosemide is known.

PHARMACODYNAMIC PROPERTIES

Lasix is a medicine which increase urine excretion (loop diuretic).

Presentation

Boxes of 5 ampoules of 2 mL (20 mg) Reg. No. DKL1521206243A1

Manufactured by

PT. Sydna Farma, Jakarta, Indonesia.

More detailed Information on request

PT Aventis Pharma Jl. Jend. Ahmad Yani, Pulomas, Jakarta 13210 (021) 4892208 - 4895608

Date of revision

08-Dec-2021 (based on BPOM approval 21-Sep-2018)

This information is intended for Health Care Professional only. See local product information for full details information