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    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 and dose schedule must be adjusted to the individual patient’s needs. (See “DOSAGE AND ADMINISTRATION”.)-furfuryl-5-sulfamoylanthranilic acid. Furosemide is a white to slightly yellow, odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows: Each tablet for oral administration contains 20 mg, 40 mg, or 80 mg of furosemide. Furosemide Oral Solution is available in two strengths: 40 mg per 5 m L, and 10 mg per m L. 6, flavors, potassium carbonate 1 1/2 hydrate, propylene glycol, USP, sorbitol solution, USP and water. The tablets contain colloidal silicon dioxide, NF, corn starch, NF, lactose monohydrate, NF, microcrystalline cellulose, NF, pregelatinized starch, NF, sodium lauryl sulfate, NF, sodium starch glycolate, NF and stearic acid, NF. The 10 mg/m L solution is orange flavored and the 40 mg/5 m L solution is pineapple-peach flavored. The 10 mg/m L oral solution also contains saccharin sodium, USP. Investigations into the mode of action of furosemide have utilized micropuncture studies in rats, stop flow experiments in dogs and various clearance studies in both humans and experimental animals. Furosemide is a potent diuretic with a rapid action. Indications for furosemide include: 1) The treatment of oedema associated with congestive heart failure, cirrhosis of the liver, renal disease including nephrotic syndrome. 2) The treatment of peripheral oedema due to mild to moderate hypertension (alone, or in combination with other antihypertensive agents in the treatment of more severe cases). Posology Adults and children over 12 years: Oedema: Initially 40mg daily in the morning; ordinarily a prompt diuresis ensues and the starting dose can then be maintained or even reduced. Diuresis lasts for approximately four hours following administration and hence the time of administration can be adjusted to suit the patient's requirements. Maintenance dose is 20mg daily or 40mg on alternate days, increased in resistant oedema to 80mg daily. Dosage should be titrated until the required response is achieved. Hypertension: 20-40mg twice daily; if 40mg twice daily does not lead to a clinically satisfactory response, the addition of other antihypertensive agents, rather than an increase in the dose of furosemide should be considered. Dosage adjustment may be required (see also section 4.4) Dosage adjustment may be necessary in patients with • hypoproteinaemia • liver congestion/dysfunction Concomitant administration of the following with furosemide should be considered (see section 4.4): Colestyramine and colestipol - Administer 2 to 3 hours apart. Furosemide is contraindicated in the following circumstances • Hypersensitivity to furosemide, any of its excipients, sulphonamides, sulphonamide derivatives/amiloride • Anuria and impaired renal function (creatinine clearance below 30m L/min per 1.73 m2 body surface area) and renal failure resulting from poisoning by nephrotoxic and/or hepatotoxic agents • Electrolyte disturbances (severe hyponatraemia: severe hypokalaemia, hypovolaemia), dehydration and/or hypotension (see section 4.4) • Concomitant potassium supplements or potassium sparing diuretics (see section 4.5) • Pre-coma/coma associated with hepatic cirrhosis or encephalopathy • Addison's disease • Digitalis intoxication (see also section 4.5) • Breast-feeding women (see section 4.6) Hypotension and/or hypovolaemia (see also section 4.3) These and any acid-base disturbances should be corrected before furosemide is started Symptomatic hypotension leading to dizziness, fainting or loss of consciousness can occur in patients treated with furosemide, particularly in the elderly, patients on other medications which can cause hypotension and patients with other medical conditions that are risks for hypotension.

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