Furosemide Tablets B.P. 40mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide Tablets BP 40mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Furosemide BP 40mg
3 PHARMACEUTICAL FORM
Uncoated tablets for oral administration
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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
Route of Administration:
Oral
Dosage
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. 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 1500mg in 24 hours. In exceptional cases up to 2000mg in 24 hours may be given.
Children:
The usual dose is 1 to 3mg/kg body weight daily, up to a maximum total dose of 40mg/day.
Elderly:
The usual adult dose but caution is advised as Furosemide is excreted more slowly in the elderly.
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.
Use with caution in patients with impaired hepatic or renal function, diabetes mellitus or adrenal disease.
Use with care in the 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 morrow suppression occurs.
Interaction with other medicinal products and other forms of interaction
4.5
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 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
Furosemide has been given after the first trimester of pregnancy or 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 machinery.
4.8 Undesirable effects
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. 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. It primary site of action is in the ascending loop of henle where it inhibits electrolyte reabsorption, thus enhancing the excretion of water and sodium, potassium and chloride ions.
5.2 Pharmacokinetic properties
Furosemide is rapidly absorbed from the GI Tract. Bioavailability has been reported to be about 60 - 70%. 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. 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 pre-clinical data of relevance to a prescriber which is additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose Potato Starch Magnesium Stearate
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store in a cool dry place, below 20°C. Protect from light.
6.5 Nature and contents of container
The product is available in packs of 500 and 1000 tablets in Securitainers. The container is made up of High Density Polypropylene body and Low Density Polyethylene cap. Packs of 20 and 50 tablets are available in Pharmapac plastic bottles with Clic-Loc caps.
The product is also available in blister packs of 28, 56, 84 or 980 tablets. Blister Pack Specification:
- PVC (white, rigid, opaque): 250 microns
- Aluminium foil (hard tempered): 20 microns
- Primer (nitrocellulose): 1.5 - 2.5 gsm
- Heat seal lacquer: 6.5 - 8.5 gsm
6.6 Special precautions for disposal
No special handling instructions are necessary.
7 MARKETING AUTHORISATION HOLDER
Strides Pharma Limited
Themistokli Dervi 3 Julia House CY-1066 Nicosia Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 41061/0007
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16/09/2005
10
DATE OF REVISION OF THE TEXT
06/10/2012