Furosemide Tablets B.P. 40mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide 40 mg Tablets BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Furosemide 40.00 mg
3. PHARMACEUTICAL FORM
Compressed tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Furosemide is a potent diuretic with a rapid action. Indications for Furosemide include:
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 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
Dosage:
Adults: The usual initial adult dose is 40 mg daily, reduced to 20 mg daily or 40 mg on alternate days. In some patients daily doses of 80 mg or higher (given in divided doses) may be required.
In patients with chronic renal insufficiency, an initial daily dose of 250 mg is employed. If a satisfactory diuresis is not produced then the dose may be increased in steps of 250 mg 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 usual dose is 1 to 3 mg/kg body weight daily, up to a maximum total dose of 40 mg/day.
Elderly: The usual adult dose, but caution is advised as Furosemide is excreted more slowly in the elderly.
Method of Administration - Oral.
4.3 Contraindications
Furosemide is contraindicated in
• hypersensitivity to furosemide, any of its excipients and/or sulfonamides
• anuria
• electrolyte disturbances (severe hyponatraemia: severe hypokalaemia), dehydration and/or hypotension (see section 4.4)
• pre-coma/coma associated with hepatic cirrhosis
• renal failure resulting from poisoning by nephrotoxic and/or hepatotoxic agents
• digitalis intoxication (see also section 4.5)
• porphyria
4.4 Special warnings and precautions for use
Hypotension and/or hypovolaemia (see also section 4.3)
These should be corrected before furosemide is started. Regular monitoring of fluid and electrolyte balance is recommended.
Caution required:
Caution needed in the following circumstances:
• impaired hepatic function (see section 4.3 and below - monitoring required)
• impaired renal function (see section 4.3 and below - monitoring required)
• diabetes mellitus (latent diabetes may become overt: insulin requirements in established diabetes may increase)
• adrenal disease
• elderly patients
• difficulty with micturition including prostatic hypertrophy
• gout
• bone marrow suppression (furosemide should be discontinued).
Clinical monitoring requirements (see also section 4.8):
Regular monitoring for:
• blood dyscrasias. If these occur, stop furosemide immediately
• liver damage
• idiosyncratic reactions
Laboratory monitoring requirements:
• frequent BUN in first few months of treatment, periodically thereafter.
Other alterations in lab values
• Serum creatinine and urea levels tend to rise during treatment
• Serum cholesterol and triglycerides may rise but usually return to normal within 6 months of starting furosemide
4.5 Interaction with other medicinal products and other forms of interaction
Antihypertensives - enhanced hypotensive effect possible with all types. Concurrent use with ACE-inhibitors can result in marked falls in blood pressure. Furosemide should be stopped or the dose reduced before starting an ACE-inhibitor
Antipsychotics - furosemide-induced hypokalaemia increases the risk of cardiac toxicity. Avoid concurrent use with pimozide. Increased risk of ventricular arrhythmias with amisulpride. Enhanced hypotensive effect with phenothiazines.
Anti-arrhythmics (including amiodarone, disopyramide, flecainide and sotalol) - risk of cardiac toxicity (because of furosemide-induced hypokalaemia). The effects of lidocaine, tocainide or mexiletine may be antagonised by furosemide.
Cardiac glycosides - hypokalaemia and electrolyte disturbances (including magnesium) increases the risk of cardiac toxicity
Vasodilators - enhanced hypotensive effect with moxisylyte (thymoxamine) or hydralazine
Renin inhibitors - aliskiren reduces plasma concentrations of furosemide Nitrates - enhanced hypotensive effect
Lithium - Furosemide reduces lithium excretion with increased plasma lithium concentrations (risk of toxicity). Avoid concomitant administration unless plasma levels are monitored.
Chelating agents - sucralfate may decrease the gastro-intestinal absorption of furosemide - the 2 drugs should be taken at least 2 hours apart
NSAIDs - increased risk of nephrotoxicity. Indometacin and ketorolac may antagonise the effects of furosemide
Salicylates - effects may be potentiated by furosemide
Antibiotics - increased risk of ototoxicity with aminoglycosides, polymixins or vancomycin. Increased risk of nephrotoxicity with aminoglycosides or cefaloridine. Furosemide can decrease vancomycin serum levels after cardiac surgery
Antidepressants - enhanced hypotensive effect with MAOIs. Increased risk of postural hypotension with TCAs (tricyclic antidepressants)
Antidiabetics - hypoglycaemic effects antagonised by furosemide
Antiepileptics - increased risk of hyponatraemia with carbamazepine. Diuretic effect reduced by phenytoin.
Antihistamines - hypokalaemia with increased risk of cardiac toxicity
Antifungals - increased risk of hypokalaemia with amphotericin
Anxiolytics and hypnotics - enhanced hypotensive effect. Chloral or triclofos may displace thyroid hormone from binding site.
CNS stimulants (drugs used for ADHD) - Atomexitine - there is an increased risk of QT interval prolongation. Concomitant use with diuretics that cause electrolyte imbalance.
Corticosteroids - diuretic effect antagonised (sodium retention) and increased risk of hypokalaemia
Cytotoxics - increased risk of nephrotoxicity and ototoxicity with platinum compounds
Other diuretics - profound diuresis possible when furosemide given with metolazone. Increased risk of hypokalaemia with thiazides.
Dopaminergics - enhanced hypotensive effect with levodopa.
Immunomodulators - enhanced hypotensive effect with aldesleukin
Muscle relaxants - enhanced hypotensive effect with baclofen or tizanidine
Oestrogens - diuretic effect antagonised
Prostaglandins - enhanced hypotensive effect with alprostadil
Sympathomimetics - increased risk of hypokalaemia with high doses of beta2 sympathomimetics
Theophylline - enhanced hypotensive effect
Probenecid - reduced renal clearance of furosemide and decreased diuretic effect.
Anaesthetic agents - general anaesthetic agents may enhance the hypotensive effects of furosemide.
Alcohol - enhanced hypotensive effect
Laxative abuse - increases the risk of potassium loss
Furosemide has been given after the first trimester of pregnancy for oedema, hypertension and toxaemia of pregnancy without causing foetal or newborn adverse effects. However, it should only be given during pregnancy if strictly indicated and for short-term treatment, as it may inhibit lactation and also 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. This may cause dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, oliguria, cardiac arrhythmias.
Side effects of a minor nature such as nausea, malaise or gastric upset may occur but are not usually severe enough to necessitate withdrawal of treatment. Uncommonly, diarrhoea, blurred vision, dizziness, headache, pancreatitis, photosensitivity, vasculitis, fever and interstitial nephritis have occurred very rarely.
The incidence of allergic reactions such as skin rashes; various forms of dermatitis, including urticaria, rare cases of exfoliative dermatitis and pruritus; is very low. However, 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 haemapoietic 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.
Pre-existing metabolic alkalosis (in decompensated cirrhosis of the liver) may be aggravated by furosemide treatment.
4.9
Overdose
Features
Overdose can cause massive diuresis resulting in dehydration, volume depletion and electrolyte disturbances with consequent hypotension and cardiac toxicity. High doses have the potential to cause transient deafness and may precipitate gout (disturbed uric acid secretion).
Management
• Benefits of gastric decontamination are uncertain. In patients presenting within 1 hour of ingestion, consider activated charcoal (50g for adults: 1g/kg for children)
• Observe for a minimum of 4 hours - monitor pulse and blood pressure.
• Treat hypotension and dehydration with appropriate IV fluids
• Monitor urinary output and serum electrolytes (including chloride and bicarbonate). Correct electrolyte imbalances. Monitor 12 lead ECG in patients with significant electrolyte disturbances
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Furosemide is a loop diuretic which reduces the resorption of electrolytes by the proximal and distal renal tubules and by the loop of Henle. Excretion of sodium, potassium and chloride ions is increased and as a consequence water excretion is enhanced. It has no effect on carnonic anhydrase in the renal tubular cells and urinary pH during the phase of diuresis may be temporarily lowered; it does not appreciably alter the acid base balance. Serum uric acid concentrations may be increased after administration of Furosemide.
Furosemide is rapidly absorbed when given by mouth and provokes an intense diuresis lasting for 4 to 6 hours: this initial diuresis is greater than with equivalent dosage of the thiazide derivatives, although the total volume of fluid excreted over a period of 24 hours may not be greatly different. Furosemide is used for the treatment of the same conditions as chlorothiazide. It may be effective when tolerance to thiazide diuretics has developed; its action is not enhanced by the thiazides.
5.2. Pharmacokinetic Properties
Furosemide is incompletely but fairly rapidly absorbed from the gastrointestinal tract. It has a biphasic half-life in plasma with a terminal elimination phase that has been estimated to range up to about 1 and a half hours. It is up to 99% bound to plasma proteins and is mainly excreted in the urine, largely unchanged, but also in the form of the glucoronide and free amine metabolites. Variable amounts are also excreted in the bile, non-renal elimination being considerably increased in renal failure. Furosemide crosses the placental barrier and is excreted in milk.
Not relevant.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Each tablet contains:
Lactose Maize starch Povidone
Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf-Life
36 months in tubs and glass bottles 24 months in blisters
6.4. Special Precautions for Storage
Tubs & Glass Bottles:- Protect from light, store in cool, dry place.
Blisters:- Do not store above 25°C. Store in the original container. Keep container in the outer carton.
6.5. Nature and Contents of Container
Plastic securitainer and plastic lid.
Pack sizes: 250, 500 and 1000 tablets.
Amber glass bottles with BK Steran wadded screw cap. Pack sizes: 250, 500 and 1000 tablets.
Blister pack strips, constructed from 250 micron PVC film lidded with aluminium foil containing 10 or 14 tablets per strip.
Pack sizes: 28, 30 or 100 tablets.
6.6. Instructions for Use/Handling
Not applicable.
7. MARKETING AUTHORISATION HOLDER
M & A Pharmachem Limited,
Allenby Laboratories,
Wigan Road,
Westhoughton,
Bolton,
BL5 2AL
8. MARKETING AUTHORISATION NUMBER(S)
PL 04077/0005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
04/12/2002
10 DATE OF REVISION OF THE TEXT
03/01/2012