Furosemide 20mg Tablets


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Furosemide 20mg Tablets


1. Name Of The Medicinal Product

Furosemide 20mg Tablets.

2. Qualitative And Quantitative Composition

Each tablet contains 20mg furosemide.

For excipients, see 6.1

3. Pharmaceutical Form


Appearance: A white, circular, flat bevelled edge tablet with 'F' scoreline 20' embossed on one face and plain on the reverse.

4. Clinical Particulars 4.1 Therapeutic Indications

In the treatment of oedema associated with congestive heart failure, cirrhosis of the liver, renal disease including nephrotic syndrome.

In 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).

Management of oliguria due to acute or chronic renal insufficiency.

4.2 Posology And Method Of Administration

Adults: The usual initial daily dose is 40mg. This may require adjustment until the effective dose is achieved. In mild cases 20mg daily or 40mg on alternate days may be sufficient, whereas in cases of resistant oedema daily doses of 80mg and above may be used.

In patients with chronic renal insufficiency, an initial daily dose of 250mg is employed. If a satisfactory diuresis is not produced then the dose may be increased in steps of 250mg at four to six hourly intervals up to a maximum daily dose of 1,500 mg in 24 hours. In exceptional cases up to 2,000 mg in 24 hours may be given.

Children: The oral dose for children ranges from 1-3mg/kg body weight daily, up to a maximum total dose of 40mg per day.

Elderly: The usual adult dose, but caution is advised as furosemide is excreted more slowly in the elderly.

Method of administration: Oral – the tablets should be swallowed with water.

4.3 Contraindications

Furosemide is contra-indicated in the presence of anuria, electrolyte deficiency, precoma associated with hepatic cirrhosis, digitalis intoxication, porphyria and hypersensitivity to furosemide or sulphonamides.

4.4 Special Warnings And Precautions For Use

Where indicated, steps should be taken to correct hypotension or hypovolaemia before commencing therapy. Regular monitoring of fluid and electrolyte balance is recommended.

Use with caution in patients with impaired hepatic or renal function, diabetes mellitus or adrenal disease.

Use with care in elderly patients or those with prostatic hypertrophy or impairment of micturition.

Latent diabetes may become manifest or the insulin requirements of diabetic patients may increase.

Hypotension may occur if ACE inhibitors are added to furosemide therapy. The dose of furosemide should be reduced or the drug stopped before initiating the ACE inhibitor.

Use with caution in patients with a history of gout. Discontinue furosemide if bone marrow depression occurs.

This product contains lactose. Patients with rare herditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Furosemide may enhance the toxicity of cardiac glycosides by electrolyte disturbance particularly potassium and magnesium.

The action of antihypertensive agents such as methyldopa may be enhanced by furosemide. The nephrotoxic effect of cephaloridine and the aminoglycoside antibiotics may be increased by furosemide.

The action of diuretics such as furosemide may be antagonised by certain non-steroidal anti-inflammatory agents.

The renal clearance of lithium is decreased by furosemide, resulting in increased and possibly toxic serum levels. Concomitant administration should be avoided unless plasma levels can be monitored.

Concurrent administration of glucocorticoids may cause sodium retention and exacerbate potassium loss.

Furosemide decreases the effects of some drugs (e.g. antidiabetics and pressor amines) and may potentiate the effects of others (e.g. salicylates, theophylline, and curare type muscle relaxants).

Resultant hypokalaemia may potentiate cardiac toxicity of certain drugs such as antihistamines and antiarrythmics. It may also antagonise the action of antiarrhythmics such as lidocaine, mexiletine and tocainide.

4.6 Pregnancy And Lactation

Furosemide has been given after the first trimester of pregnancy for oedema, hypertension and toxaemia of pregnancy without causing foetal or new-born adverse effects. However, it should only be given during pregnancy if strictly indicated and for short-term treatment.

As it may inhibit lactation and passes into breast milk, furosemide should be used with caution in nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Reduced mental alertness and rarely dizziness and blurred vision have been reported. Patients so affected should not drive or operate machines.

4.8 Undesirable Effects

Furosemide is generally well tolerated. Fluid and electrolyte imbalance is the most common side effect. Uncommonly nausea, diarrhoea, blurred vision, dizziness, headache, pancreatitis, photosensitivity, vasculitis and interstitial nephritis have occurred very rarely. The incidence of allergic reactions such as skin rashes is very low, but when these occur treatment should be withdrawn.

A transient rise in creatinine may occur as may hypotension and liver dysfunction. Muscle spasm and paraesthesia have also been reported. Hyperuricaemia may be induced and precipitate gout in some patients.

Temporary increase in plasma cholesterol and triglyceride concentrations may occur. Latent diabetes may become manifest and the insulin requirements of diabetic patients may increase.

Bone marrow depression is a rare complication and treatment should be withdrawn. The haemopoeitic status should therefore be regularly monitored.

Calcium depletion may occur and nephrocalcinosis has been reported in premature infants.

Tinnitus and deafness have occurred, usually with large parenteral doses and rapid administration and in renal impairment.

4.9 Overdose

In cases of overdosage there is a danger of dehydration and electrolyte depletion due to excessive diuresis. Treatment should be aimed at fluid replacement and correction of electrolyte imbalance. Gastric lavage may be useful if ingestion is recent.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Furosemide is one of the high ceiling diuretics, a term used to denote a group of diuretics that have a distinctive action on renal tubular function. The peak diuresis is far greater than that observed with other agents.

The main site of action is the thick ascending loop of Henle where they inhibit electrolyte re-absorption. It increases renal blood flow without increasing the filtration rate. Such a change in renal haemodynamics reduces fluid and electrolyte re-absorption in the proximal tubule and may augment the initial diuretic response.

Furosemide is an inhibitor of carbonic anhydrase but this activity is too weak to contribute to a proximal diuresis except when massive doses are employed. Furosemide enhances the excretion of both calcium and magnesium to an extent approximately proportional to the increase in sodium excretion. Unlike the thiazides, high ceiling diuretics do not increase calcium re-absorption in the distal tubule. The calciuric action of these agents is the basis for their use in symptomatic hypercalcaemia.

5.2 Pharmacokinetic Properties

Furosemide is incompletely but fairly rapidly absorbed from the gastrointestinal tract. Bioavailability is about 65%. It has a biphasic half-life in plasma with a terminal elimination phase up to about 2 hours but this is prolonged in neonates, and in patients with hepatic and renal insufficiency.

It is extensively bound to plasma proteins but is rapidly secreted by the organic acid transport system of the proximal tubule. In this manner it gains access to the tubular fluid and eventually to its site of action more distally.

It is mainly excreted in the urine largely unchanged, but also in the form of glucuronide and free amine metabolites. Variable amounts are also excreted in the bile. Furosemide crosses the placental barrier and is excreted in milk. Non renal elimination is considerably increased in renal failure. The clearance of furosemide is not increased by haemodialysis.

5.3 Preclinical Safety Data

Not relevant

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose monohydrate

Magnesium stearate (E470b)

Sodium starch glycollate

Maize starch.

Starch paste 15%

6.2 Incompatibilities

Not Applicable

6.3 Shelf Life

Tablet container: 5 Years

Blister: 2 Years

6.4 Special Precautions For Storage

Tablet containers: Do not store above 25°C. Store in the original container. Keep the container tightly closed.

Blister packs: Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

Tablet container and cap (polypropylene container with low density polyethylene cap)

Pack sizes: 28, 56, 100, 250, 500 and 1000 tablets.

Blister (250 (?m white opaque PVC and 20 (?m hard temper aluminium foil).

Pack sizes: 28 and 56 tablets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Aurobindo Pharma Limited


Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom

8. Marketing Authorisation Number(S)

PL 20532/0039

9. Date Of First Authorisation/Renewal Of The Authorisation


10. Date Of Revision Of The Text


Furosemide 20mg Tablets

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