Each tablet contains: Furosemide, USP 20 mg or 40 mg.
Pharmacology: Furosemide is a potent diuretic with a rapid action. Its effect are evident within 1 hour after a dose by mouth and for about 4 to 6 hours; also promote the excretion of water and electrolytes by the kidneys. Used in treating patients with congestive heart failure, renal or pulmonary disease when salt and water retention has resulted in edema and ascites. Furosemide is incompletely but fairly rapidly absorbed from the gastrointestinal tract. It has a biphasic half-life in a plasma with a terminal elimination phase that has been estimated to range to 1 1/2 hours. It is up to 99% bound to plasma protein and is mainly excreted in the urine, largely unchanged, but also in the form of the glucuronide and free amine metabolites. Variable amount are also excreted in the bile, non-renal elimination being considerably increased in the renal failure. Furosemide crosses the placental barrier and is excreted in milk.
For the treatment of edema associated with heart failure, including pulmonary edema, and with renal and hepatic disorders and maybe effective in patients unresponsive to thiazide diuretics. It is also used in high doses in the management of oliguria due to renal failure or insufficiency. Furosemide is also used in the treatment of hypertension, either alone or with other antihypertensives.
For Edema: Adults: Initially 40 mg in the morning; maintenance of 20 mg to 40 mg daily, increased in resistance edema to 80 mg daily or more.
Children: Initially, 1 mg to 3 mg/kg daily, maximum of 40 mg daily.
20 mg tablet: Adult: 20 to 80 mg single dose daily preferably in the morning; dose may be titrated and given in divided doses every 6 to 8 hours.
Children: Start with 2 mg/kg/dose, if diuretic response is not achieved, increase dose by 1-2 mg/kg every 6-8 hours. After initial dose, maximum 6 mg/kg with an interval of at least 2 hours between doses. Or as prescribed by the physician.
For Oliguria in chronic renal impairment: Initially 250 mg daily; If necessary, larger doses, increasing in steps of 250 mg, maybe given every 4 to 6 hours to a maximum of 1.5 g in 24 hours may be given.
Or, as prescribed by the physician.
40 mg tablet: For hypertension: 40 to 80 mg daily, either alone or in conjunction with other antihypertensives.
For Oliguria in chronic renal impairment: An initial dose of 250 mg may be given, increase if necessary in steps of 250 mg every 4 to 6 hours to a maximum of 1.5 g in 24 hours.
Or as prescribed by the physician.
Best avoided during pregnancy. Anuria in patients receiving lithium therapy.
20 mg tablet: This product contains FD&C Yellow #5 (Tartrazine) which may cause allergic reaction including bronchial asthma in certain susceptible persons.
Furosemide should be used with care to patients with prostatic hypertrophy or impairment of micturition, caution in patients with impaired hearing, and pregnancy. Furosemide should not be given in pre-comatose states associated with hepatic cirrhosis.
Best avoided during pregnancy. Caution in patients with impaired hearing, and pregnancy.
The most common adverse effect associated with furosemide therapy is fluid and electrolyte imbalance after either single large doses or prolonged administration. Other side effects are relatively uncommon and include allergy, nausea, diarrhea, blurred vision, dizziness, headache, pancreatitis, photosensitivity, skin rashes, muscle spasm and hypotension. Hyponatremia, hypokalemia, & hypomagnesemia, hypochloremic alkalosis, increased calcium excretion, hypotension; less commonly nausea, gastro-intestinal disturbances, hyperuricemia & gout; hyperglycemia, temporary increase in plasma cholesterol & triglyceride concentrations; rarely rashes, photosensitivity, & bone marrow depression (withdrawal treatment).
Furosemide may enhance the nephrotoxicity of cephalosporin antibacterials such as cefalotin and can enhance the ototoxicity of aminoglycoside antibacterials and other ototoxic drugs. The interactions of furosemide that are due to its effects on fluids and electrolyte balance are similar to those of hydrochlorothiazide. Diuretic-induced hypokalemia may enhance the toxicity of digitalis glycosides and may also increase the risk of arrhythmias with drugs that prolong the QT interval such as astemizole, terfenadine, halofantrine, pimozide, and sotalol.
Store at temperatures not exceeding 30°C. Protect from light.
C03CA01 - furosemide ; Belongs to the class of high-ceiling sulfonamide diuretics.