FUROSEMIDE INJECTION USP 20 MG / 2 ML — DIN 02384094

What is FUROSEMIDE INJECTION USP?

FUROSEMIDE INJECTION USP 20 MG / 2 ML contains FUROSEMIDE : 20 MG / 2 ML. It is listed in the Health Canada Drug Product Database under DIN 02384094, held by HIKMA CANADA LIMITED, supplied as SOLUTION for INTRAVENOUS ; INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 29-Apr-2022. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is FUROSEMIDE INJECTION USP used for?

Furosemide Injection USP is indicated when a rapid onset and intense diuresis is desired, e.g. acute pulmonary edema, cerebral edema and when oral therapy is precluded because of interference with intestinal absorption or for other reasons. Generally administered to patients in hospitals or outpatient clinics. In emergencies outside this setting, the recommended dosage should be closely adhered to and the patient should be kept under close observation.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Do not add furosemide into the tubing of a running infusion solution. Changes in blood pressure should be carefully monitored when furosemide is used with other antihypertensive drugs, especially during initial therapy. The dosage of other agents must be reduced by at least 50% as soon as furosemide is added to the regimen to prevent an excessive drop in blood pressure. As blood pressure falls under the potentiating effects of furosemide, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary. Adults Edema: Usual initial dose is 20 to 40 mg injected IM or IV as a single dose. IV injections should be given slowly over a period of 1 to 2 minutes. Ordinarily, a prompt diuresis ensues. If the diuretic response with a single dose of 20 to 40 mg is not satisfactory it may be increased by increments of 20 mg not sooner than 2 hours after the previous dose until the desired diuretic effect has been obtained. Maximum daily dose: 100 mg. Once the effective single dose has been determined, it should then be given once or twice daily. Parenteral furosemide therapy should be replaced by oral therapy as soon as this is practical. Acute Pulmonary Edema: Administer 40 mg IV slowly, followed by another 40 mg IV 1 to 1.5 hours later, as indicated by the patient's condition. Children Institute therapy in the hospital, in carefully selected patients, under close observation with frequent monitoring of serum electrolytes. Do not add furosemide into the tubing of a running infusion solution. The initial dose should be in the range of 0.5 to 1.0 mg/kg body weight. The total daily dose (given in divided doses of 6 to 12 hours apart) should not exceed 2 mg/kg orally or 1 mg/kg parenterally. In the newborn and in premature babies, the daily dose should not exceed 1 mg/kg. Adopt an intermittent dosage schedule as soon as possible using the minimum effective dose at the longest possible intervals. Particular caution with potassium concentrations is always desirable when furosemide is used in infants and children.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

Furosemide Injection USP is contraindicated in patients with complete renal shutdown. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide. In hepatic coma, precoma or in states of electrolyte depletion, furosemide therapy should not be instituted until the underlying condition has been corrected or ameliorated. Furosemide Injection USP is contraindicated in patients with a known history of hypersensitivity to furosemide, sulfonamide-derived drugs or to any ingredient in the formulation or component of the container. Patients allergic to sulfonamides (e.g. sulfonamide antibiotics or sulfonylureas) may show cross-sensitivity to furosemide. Severe hypokalemia, hyponatremia, hypovolemia, dehydration or hypotension must be regarded as contraindications until serum electrolytes, fluid balance and blood pressure have been restored to normal levels. As furosemide may be capable of displacing bilirubin from albumin at least in vitro, it should not be administered to jaundiced newborn infants or to infants suffering from diseases (e.g. Rh incompatibility, familial non-hemolytic jaundice, etc.) with the potential of causing hyperbilirubinemia and possibly kernicterus.

Warnings and precautions

Furosemide Injection USP is to be used under strict medical supervision and only within a hospital setting. Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required; dose and dose schedule have to be adjusted to the individual patient's needs (see DOSAGE AND ADMINISTRATION). Furosemide Injection USP administered in doses up to 100 mg should be injected slowly (1 to 2 minutes) when the intravenous route is used. Cases of tinnitus and reversible deafness have been reported. There have also been some reports of cases, the majority in children undergoing renal transplantation, in which permanent deafness has occurred. In these latter cases, the onset of deafness was usually insidious and gradually progressive up to six months after furosemide therapy. Hearing impairment is more likely to occur in patients with hypoproteinemia or severely reduced renal function who are given large doses of furosemide parenterally, at a rate exceeding 4 mg/minute, or in patients who are also receiving drugs known to be ototoxic. Since this may lead to irreversible damage, these drugs must only be used with furosemide if there are compelling medical reasons. The teratogenic and embryotoxic potential of furosemide in humans is unknown. Because furosemide has been shown to produce fetal abnormalities in animal reproductive studies, it should not be used in pregnant women or in women of childbearing potential unless the benefits to the patient outweigh the possible risk to the fetus. Treatment during pregnancy requires monitoring of fetal growth. Sulfonamide diuretics have been reported to decrease arterial responsiveness to pressor amines and to enhance the effect of tubocurarine. Great caution should be exercised in administering curare or its derivatives to patients undergoing furosemide therapy and it is advisable to discontinue furosemide for one week prior to any elective surgery. Furosemide should be used with caution in patients with hepatic cirrhosis because rapid alterations in fluid and electrolyte balance and diuretic therapy may be related to the development of hepatorenal syndrome. Therefore, strict observation is necessary during the period of diuresis. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis. Renal calcifications have occurred in some severely premature infants treated with intravenous furosemide for edema due to patent ductus arteriosus and hyaline membrane disease. In premature infants furosemide may precipitate nephrocalcinosis/nephrolithiasis. When administered to premature infants with respiratory distress syndrome in the first few weeks of life, diuretic treatment with furosemide may accentuate the risk of a patent ductus arteriosus.