Regulatory Information
GLORIOUS DEXA SINGAPORE PTE. LTD.
GLORIOUS DEXA SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
INJECTION, SOLUTION
**Recommended Dosage:** _**Adults**_ Parenteral therapy with furosemide 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. _Edema:_ The usual initial dose of furosemide 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 **Warnings and 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 individualized 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 solution for injection to either 0.9% sodium chloride, 5% dextrose, or Ringer lactate infusion solution, and administer as a controlled intravenous infusion at a rate not greater than 4 mg/minute. Furosemide solution for injection is a buffered alkaline solution. _Acute pulmonary edema:_ The usual initial dose of furosemide solution for injection is 40 mg injected slowly intravenously (see **Warnings and 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 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.
INTRAVENOUS, INTRAMUSCULAR
Medical Information
**Indications:** - Edema due to cardiac and hepatic diseases (ascites). - Edema due to renal diseases (in the nephrotic syndrome, therapy of the underlying diseases has precedence). - Acute cardiac insufficiency, especially in pulmonary edema (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 edema. - Edema due to burns. - Hypertensive crisis (in addition to other antihypertensive measures). - To support forced diuresis in poisoning.
**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 azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide. - Severe hypokalemia, hyponatremia, hypovolemia, 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 breastfeeding women. - Do not administer furosemide to newborns presenting jaundice or to infants with conditions which might induce hyperbilirubinemia or kernicterus (e.g. Rhesus incompatibility, familial nonhemolytic jaundice etc.) because of furosemide’s 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.
C03EB01
furosemide and potassium-sparing agents
Manufacturer Information
GLORIOUS DEXA SINGAPORE PTE. LTD.
PT. Ferron Par Pharmaceuticals
Active Ingredients
Documents
Package Inserts
Fusetic Injection_Package Insert.pdf
Approved: February 23, 2023