Furosemide Injection 20mg/2mL | Loop Diuretic

Product Description

1. Composition

Each 2 mL contains 20 mg furosemide as the sodium salt.

2. Pharmacological Classification

Diuretics.

3. Pharmacological Action

Furosemide is a loop diuretic acting primarily by inhibiting electrolyte and fluid reabsorption in the thick ascending limb of Henle, as well as in the proximal tubule. Up to 99% of the drug is protein-bound, with a plasma half-life of about 1.5 hours and a duration of action ranging from 4 to 6 hours. It is excreted mainly in the urine and bile.

Loop diuretics increase the excretion of potassium, titratable acid, ammonia, calcium and magnesium, and raise plasma uric acid concentration. In patients with pulmonary oedema, furosemide increases systemic venous capacitance, thereby decreasing left ventricular filling pressure. Furosemide crosses the placental barrier and is excreted in breast milk.

4. Indications

Oedema of cardiac, hepatic or renal origin

Acute pulmonary oedema

Cerebral oedema

Forced diuresis

5. Contraindications

Hypersensitivity to furosemide or sulphonamides

Anuria

Renal failure caused by nephrotoxic drugs

Renal failure associated with hepatic coma

Pre-comatose states related to hepatic cirrhosis

6. Warnings and Precautions

Fluid and electrolyte imbalance should be closely monitored, especially in patients with vomiting or during parenteral fluid therapy.

Furosemide should be used with caution during pregnancy.

Furosemide crosses the placental barrier and is excreted in breast milk. Safety in lactation has not been established.

Use with caution in jaundiced infants.

Use with caution in patients with prostatic hypertrophy or impairment of micturition.

7. Dosage and Directions for Use

Intravenous injection must be administered slowly, at a rate not exceeding 4 mg per minute.

Adults

The recommended intramuscular or intravenous dose is 20–50 mg, which may be repeated if necessary after an interval of not less than 2 hours.

Paediatric patients

The usual dose is 0.5 to 1.5 mg/kg body weight.

Pulmonary oedema

The initial dose is 40 mg, administered slowly intravenously. If necessary, the injection may be repeated after approximately 60 minutes. The dose may be increased to 80 mg, administered slowly intravenously.

8. Side Effects and Special Precautions

The most common adverse reaction associated with furosemide therapy is fluid and electrolyte imbalance, including hyponatraemia, hypokalaemia and hypochloraemic alkalosis, particularly after large doses or prolonged administration.Other side effects are relatively uncommon, and include allergic reactions, nausea, diarrhoea, blurred vision, yellow vision, dizziness, headache, pancreatitis, photosensitivity, skin rashes and hypotension. Skin rashes and hypersensitivity reactions may be severe; hypersensitivity reactions including interstitial nephritis occur less frequently. Bone marrow depression may occur rarely. Agranulocytosis, thrombocytopenia and leucopenia have been reported. Hepatic dysfunction, cholestatic jaundice and paraesthesia have also been reported.

Tinnitus and deafness may occur, particularly during rapid high-dose parenteral furosemide therapy. Deafness may be permanent in some cases, especially when furosemide is co-administered with other ototoxic medicines.

Furosemide may induce hyperglycaemia and glycosuria. It may cause hyperuricaemia and precipitate gout attacks in some patients. Pancreatitis is more common at high doses. Cholestatic jaundice has been reported. Furosemide increases urinary calcium excretion, and renal stone formation has been reported in preterm infants treated with furosemide.

Drug interactions

Furosemide may enhance the nephrotoxicity of cephalosporin antibiotics (such as cephalothin) and aminoglycoside antibiotics.

Concurrent administration of phenytoin or indomethacin may reduce the clinical efficacy of furosemide.

9. Known Symptoms of Overdosage and Its Treatment

Treatment is symptomatic and supportive. Following overdose, there is a risk of dehydration and electrolyte depletion due to excessive diuresis. Excessively rapid mobilisation of oedema may lead to malaise and asthenia. Rapid changes in pressure-flow relationships within the cardiovascular system may give rise to symptoms typically associated with hypovolaemia, even in the presence of expanded extracellular fluid volume. During intensive long-term therapy, diuretic-induced renal loss of sodium chloride may lead to extracellular fluid depletion, with or without hyponatraemia. This condition usually responds to discontinuation of the diuretic and increased dietary sodium chloride intake.

10. Storage Instructions

Store at controlled room temperature (25°C / 77°F) and protect from light. Keep all medicines out of the reach of children.

11. Pack Information

Available in packs containing 10 ampoules of 2 ml per box.