- Approval Id
- b63394ed72d5cfa2
- Drug Name
- FUROSEMIDE-BAXTER SOLUTION FOR INJECTION 20 MG/2 ML
- Product Name
- FUROSEMIDE-BAXTER SOLUTION FOR INJECTION 20 MG/2 ML
- Approval Number
- SIN15366P
- Approval Date
- 2017-11-23
- Registrant
- BAXTER HEALTHCARE (ASIA) PTE LTD
- Licence Holder
- BAXTER HEALTHCARE (ASIA) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- **DOSAGE AND ADMINISTRATION**
**Adults**
Parenteral therapy with Furosemide-Baxter Solution for Injection 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.
Oedema:
The usual initial dose of Furosemide-Baxter Solution for Injection is 20 to 40 mg given as a single dose, injected intramuscularly or intravenously. The intravenous dose should be given slowly (see PRECAUTIONS – _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-Baxter Solution for Injection 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-Baxter Solution for Injection is a buffered alkaline solution.
Acute Pulmonary Oedema:
The usual initial dose of Furosemide-Baxter Solution for Injection is 40 mg injected slowly intravenously (see PRECAUTIONS – _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-Baxter Solution for Injection (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-Baxter Solution for Injection should be inspected visually for particulate matter and discolouration before administration. Do not use if solution is discoloured.
Furosemide-Baxter Solution for Injection is for single use in one patient only. Discard any residue.
Although the chemical stability of diluted Furosemide-Baxter Solution for Injection has been demonstrated for storage at 25 °C for 24 hours, the diluted solution should be used as soon as practicable to reduce risk of microbiological hazard. If storage is necessary hold the diluted solution at 2–8 °C for not more than 24 hours.
**Incompatibilities**
Furosemide may precipitate out of solution in fluids of low pH (e.g. dextrose solutions).
**Overdosage**
The clinical picture in acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss; e.g. dehydration, blood volume reduction, hypotension, electrolyte imbalance, cardiac arrhythmias (including A-V block and ventricular fibrillation), hypokalaemia and hypochloraemic alkalosis, and extensions of its diuretic action. Symptoms of these disturbances include severe hypotension (progressing to shock), acute renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion.
The acute toxicity of furosemide has been determined in mice, rats and dogs. In all three, the oral LD50 exceeded 1 000 mg/kg body weight, while the intravenous LD50 ranged from 300 to 680 mg/kg.
The acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats. The concentration of furosemide in biological fluids associated with toxicity or death is not known.
No specific antidote to furosemide is known. If ingestion has only just taken place, attempts may be made to limit further systemic absorption of the active ingredient by measures such as activated charcoal.
Treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses. Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently.
Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy). Haemodialysis does not accelerate furosemide elimination.
- Route Of Administration
- INTRAVENOUS, INTRAMUSCULAR
- Indication Info
- **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
- Contraindications
- **Contraindications**
- Known hypersensitivity to furosemide or sulfonamides or any of the inactive ingredients. Patients allergic to sulfonamides (e.g. sulfonamide antibiotics or sulfonylureas) may show cross-sensitivity to furosemide.
- 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, hyponatraemia, hypovolaemia 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 nonhaemolytic jaundice etc.) because of furosemide's 'in vitro' potential to displace bilirubin from albumin.
- Furosemide 250 mg injection must not be used as a bolus injection. It must only be infused using volume or rate controlled infusion pumps to reduce the risk of accidental overdose.
- Atc Code
- C03CA01
- Atc Item Name
- furosemide
- Pharma Manufacturer Name
- BAXTER HEALTHCARE (ASIA) PTE LTD
- Company Detail Path
- /organization/baxter-healthcare-asia-pte-ltd
