FUROSEMIDE-AFT SOLUTION FOR INJECTION 20MG/2ML [SIN16784P]

Product Info

FUROSEMIDE-AFT SOLUTION FOR INJECTION 20MG/2ML

[SIN16784P]

4.1 THERAPEUTIC INDICATIONS

• Oedema due to cardiac and hepatic diseases (ascites)

• Oedema due to renal disease (in the nephrotic syndrome, therapy of the underlying diseases has precedence)

• Acute cardiac insufficiency, especially in pulmonary oedema (administration in conjunction with other therapeutic measures)

• Reduced urinary output due to gestoses (pregnancy-related nephrosis), after restoring the fluid volume to normal

• Supportive measures in brain oedema

• Oedema due to burns

• Hypertensive crisis (in addition to other antihypertensive measures)

• To support forced diuresis in poisoning

4.2 DOSE AND METHOD OF ADMINISTRATION

Adults

Parenteral therapy with Furosemide – AFT should be used only in patients unable to take oral medication or in emergency situations and should be replaced with oral therapy as soon as practical. To achieve optimum efficacy and suppress counter-regulation, a continuous furosemide (frusemide) infusion is generally preferred to repeat bolus injections.

Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenous administration are feasible. It must be noted that intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary oedema.

Oedema

The usual initial dose of Furosemide – AFT is 20 to 40 mg given as a single dose, injected intramuscularly or intravenously. The intravenous dose should be given slowly (see Section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Ordinarily a prompt diuresis ensues. If needed, another dose may be administered in the same manner 2 hours later, or the dose may be increased. The dose may be raised by 20 mg and given not sooner than 2 hours after the previous dose, until the desired diuretic effect has been obtained. This individually determined single dose should then be given once or twice daily.

Therapy should be individualised according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response. Close medical supervision is necessary. If the physician elects to use high dose parenteral therapy, add the Furosemide – AFT to either Sodium Chloride Injection or Lactated Ringer's Injection, and administer as a controlled intravenous infusion at a rate not greater than 4 mg/min. Furosemide – AFT is a buffered alkaline solution.

Acute Pulmonary Oedema

The usual initial dose of Furosemide – AFT is 40 mg injected slowly intravenously (see Section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If a satisfactory response does not occur, a further dose of 20–40 mg is injected after 20 minutes. If necessary, additional therapy (e.g. digitalis, oxygen) may be administered concomitantly.

Infants and Children

Parenteral therapy should be used only in patients unable to take oral medication or in emergency situations, and should be replaced with oral therapy as soon as practical.

The recommended dose of Furosemide – AFT (intravenously or intramuscularly) in infants and children is 1 mg/kg body weight and should be given slowly under close medical supervision up to a maximum of 20 mg.

Furosemide-AFT Injection should be inspected visually for particulate matter and discolouration before administration. Do not use if solution is discoloured.

Furosemide-AFT is for single use in one patient only. Discard any residue.

Although the chemical stability of diluted Furosemide – AFT (diluted with 0.9 % NaCl or Lactated Ringer's Injection to concentration 1 mg/ml of furosemide) has been demonstrated for storage at 30 °C for 24 hours, the diluted solution should be used as soon as practicable to reduce risk of microbiological hazard. The diluted solution must be protected from light.

4.3 CONTRAINDICATIONS

Known hypersensitivity to furosemide or sulfonamides or any of the inactive ingredients (see Section 6.1 List of excipients description – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients allergic to sulfonamides (e.g. sulfonamide antibiotics or sulfonylureas) may show cross-sensitivity to Furosemide – AFT.

Renal failure with oligoanuria not responding to furosemide. Renal failure as a result of poisoning by nephrotoxic or hepatotoxic agents. If increasing azotaemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.

Severe hypokalaemia, (see Section 4.8 Adverse effects (undesirable effects) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information, hyponatraemia, hypovolaemia, dehydration or hypotension must be regarded as contraindications until serum electrolytes, fluid balance and blood pressure have been restored to normal levels.

In hepatic coma or precoma and conditions producing electrolyte depletion, furosemide therapy should not be instituted until the underlying conditions have been corrected or ameliorated.

In breast-feeding women.

Do not administer furosemide to new-borns presenting jaundice or to infants with conditions which might induce hyperbilirubinemia or kernicterus (e.g. Rhesus incompatibility, familial non-haemolytic jaundice etc.) because of furosemide’s in vitro potential to displace bilirubin from albumin.