THERAPEUTIC INDICATIONS

Patients with Oedema due to cardiac, hepatic, or renal disorders (in the presence of nephrotic syndrome, treatment of the basic disorder is the prime concern), and Peripheral oedema due to mechanical obstruction or venous insufficiency and hypertension.

POSOLOGY AND METHOD OF ADMINISTRATION

the usual initial daily dose for adults is 20-80 mg given as single dose. If it is not satisfactory, increase this dose by increments of 20-40 mg not sooner than 6-8 hours after the previous dose until the desired diuretic effect is obtained. As for children, the dosage is based on body weight: 1-2 mg/kg of body weight for a single dose, with a maximum dose is 6 mg/kg of body weight.

CONTRAINDICATIONS

Furosemide 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 Furosemide, 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 Furosemide 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. 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

Furosemide must not be given during pregnancy unless there are compelling medical reasons, because furosemide can crosses the placental barrier. If Furosemide is given during pregnancy, fetal growth must be monitored. Furosemide passes into breast milk and inhibits lactation. so itmust not be used during breastfeeding. 8. 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

Furosemide has a diuretic effect (natrium) depends on the dosis given.

Presentation

Boxes of 10 blisters x 10 tablets of 40 mg Reg. No. DKL0121203710A1

Manufactured by

PT Aventis Pharma, 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