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1. Furosemide Tablets 20mg
2. Furosemide Tablets 20mg

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Furosemide Tablets 20mg

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains Furosemide 20mg BP

3.    PHARMACEUTICAL FORM

Tablet

4.    CLINICAL PARTICULARS

4.1.    Therapeutic indications

Furosemide is a potent diuretic with rapid action.

Furosemide tablets are indicated for:

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

-    The treatment of peripheral oedema due to mild to moderate hypertension (alone, or in combination with other anti-hypertensive agents in the treatment of more severe cases), or due to mechanical obstruction.

4.2. Posology and method of administration

For oral administration only.

Adults:

The usual initial adult dose is 40mg daily, reduced to 20mg daily or 40mg on alternative days. In some patients daily doses of 80mg or higher (given in divided doses) may be required.

Elderly:

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

Children:

The usual dose is 1 to 3mg/kg body weight daily, up to a maximum total dose of 40mg/day.

4.3. Contraindications

Furosemide is contraindicated 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.

Pre-existing metabolic alkalosis (e.g. in decompensated cirrhosis of the liver) may be aggravated by Furosemide treatment.

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.

Use with caution in patients with a history of gout.

Discontinue Furosemide if bone marrow suppression occurs.

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. 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.

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.

In cases of abuse of laxatives, the risk of an increased potassium loss should be bourne in mind.

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 the cardiac toxicity of certain drugs such as antihistamines and antiarrhythmics. It may also antagonise the action of antiarrhythmics such as lignocaine, mexiletine and tocainide.

4.6. Pregnancy and lactation

Furosemide has been given after the first trimester of pregnancy for oedema, hypertension and toxyaemia of pregnancy without causing foetal or newborn adverse effects. However, it should 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

Fluid and electrolyte imbalance is the most common side effect. Uncommonly, nausea, diarrhoea, blurred vision, dizziness, headache may occur. 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

Treatment of overdose should be directed to correcting dehydration and electrolyte depletion resulting from excessive diuresis. Gastric lavage may be useful if ingestion is recent.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Furosemide is a potent diuretic with rapid action. Its primary site of action is in the ascending loop of henle where it inhibits electrolyte re-absorption, thus enhancing the excretion of water and sodium, potassium and chloride ions.

5.2. Pharmacokinetic properties

Furosemide is rapidly absorbed from the gastrointestinal tract. Bioavailability has been reported to be about 60-70%. It has a biphasic half-life in plasma with terminal elimination phase up to about two hours but this is prolonged in neonates, and in patients with hepatic and renal insufficiency. About 99% is bound to plasma proteins. It is excreted mainly in the urine, largely unchanged. Furosemide crosses the placental barrier and is excreted in milk. The clearance of Furosemide is not increased by haemodialysis.

5.3. Preclinical safety data

There is no preclinical safety data of relevance to the prescriber which are additional to those already included in other section of the SPC.

6. PHARMACEUTICAL PARTICULARS 6.1. List of excipients

The tablet contains Lactose Monohydrate Ph Eur, Pre-Gelatinised Starch BP, .Cellulose Microcrystalline Ph Eur, Colloidal Anhydrous Silica Ph Eur, Sodium Starch Glycollate Ph Eur, Magnesium Stearate Ph Eur and Purified Talc Ph Eur.

6.2. Incompatibilities

None known

6.3. Shelf life

36 months

6.4.    Special precautions for storage

Store below 25^oC and protect from light..

6.5.    Nature and contents of container

Polypropylene containers with polyethylene caps with optional polyethylene ullage filler or PVC/Aluminium foil blisters in packs sizes of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250, 500 and 1000

6.6.    Instructions for use/handling

No special requirements.