Furosemide Tablets 20mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide Tablets 20 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Furosemide 20 mg 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
Posology
Adults
The usual initial adult dose is 40 mg daily, reduced to 20 mg daily or 40 mg on alternative days. In some patients daily doses of 80 mg 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.
Paediatric population
The usual dose is 1 to 3 mg/kg body weight daily, up to a maximum total dose of 40 mg/day.
Method of administration
For oral administration only.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or sulphonamides.
Furosemide is contraindicated in the presence of anuria, electrolyte deficiency, precoma associated with hepatic cirrhosis, digitalis intoxication and porphyria.
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.
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.
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 nonsteroidal 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 borne 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 Fertility, pregnancy and lactation
Pregnancy
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.
Breast-feeding
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.
Nervous system disorders:
Not known: dizziness, fainting and loss of consciousness (caused by symptomatic hypotension)
Ear and labyrinth disorders:
Uncommon: deafness (sometimes irreversible)
Skin and subcutaneous tissue disorders:
Not known: acute generalised exanthematous pustulosis (AGEP)
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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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 25oC 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 Special precautions for disposal and other handling
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Generics [UK] Ltd t/a Mylan Station Close Potters Bar Herts EN6 1TL
8 MARKETING AUTHORISATION NUMBER(S)
PL 04569/0113
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date Granted: 13/02/86 Last Renewal: 14/04/94
10 DATE OF REVISION OF THE TEXT
07/01/2016