Furosemide Tablets 40mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide Tablets 40 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Furosemide 40 mg
3. PHARMACEUTICAL FORM
Tablet Flat white / creamy white bevelled tablets, marked MP22 on one side and scored on the other
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Furosemide is indicated for the treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome. Furosemide may be used in the treatment of mild or moderate hypertension either alone or in combination with other antihypertensive drugs; in oedema resulting from damage to vessel walls or as a result of mechanical obstruction; in ascites.
4.2. Posology and method of administration
Adults:
Dosage will vary from 1-3 tablets daily or on alternate days. The usual initial dose is 1 tablet (40 mg) daily which should be adjusted to achieve the effective dose. In mild oedema 1 tablet on alternate days or on three consecutive days of the week is recommended. In patients with resistant oedema daily doses of 2 or 3 tablets may be required.
Children:
The dosage range is from 1 to 3 mg/kg of bodyweight daily with a maximum dosage of 40mg per day.
Elderly:
Dosage should be titrated until the required response is achieved because in the elderly
Furosemide is generally eliminated more slowly.
Method of administration: Oral
4.3. Contraindications
Furosemide is contraindicated in renal failure with anuria, electrolyte deficiency and precomatose states associated with liver cirrhosis. Also in hypersensitivity to sulphonamides.
4.4. Special warnings and precautions for use
Warnings:
There is an increased risk of developing acute retention in patients with prostatic hypertrophy.
It may be necessary to adjust the dosage of cardiac or anti-hypertensive agents which are taken concurrently. It will be necessary to correct hypotension or hypovolaemia before commencing treatment.
Concomitant administration of Furosemide may increase the toxic effects of nephrotoxic antibiotics.
The insulin requirements of diabetic patients may increase. Latent diabetics may become manifest.
May cause hypokalaemia and hyponatraemia. May aggravate gout. Furosemide Tablets 40mg contain lactose and are unsuitable for patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabsorbtion.
Precautions:
Observe caution in patients with a history of electrolyte deficiency, liver failure, prostatic enlargement and porphyria.
4.5. Interactions with other medicinal products and other forms of interaction
Certain non-steroidal anti-inflammatory agents (e.g. indometacin and keterolac) antagonise the action of furosemide and may cause renal failure in cases of pre-existing hypovolaemia.
Carbeneoxolone, corticosteroids and oestrogens also may antagonise the diuretic action of furosemide.
Furosemide may antagonise the effects of other drugs, for example antidiabetics, pressor amines and some anti-arrhythmics.
Furosemide also occasionally may potentiate the effects of drugs such as salicylates and curare-type muscle relaxants.
Furosemide enhances the hypotensive effect of many cardiovascular system medicines (including ACE inhibitors, andrenergic neurone blockers, a- and P-blockers, angiotensin II receptor antagonists, antihypertensives, calcium channel blockers and nitrates), general anaesthetics, MAOI’ s, hypnotics and anxiolytics, phenothiazine, baclofen, tizanidine, aldeleukin, levodopa and alcohol.
Profound diuresis is possible if metolazone is given with furosemide.
Concurrent use of acetazolamide, amphoterecin, carbeneoxolone, glucorticoids, p2-sympathomimetics (in large amounts), reboxetine, theophylline and thiazide diuretics may increase the risk of potassium loss.
Carbamazepine and aminoglutethimide may increase the risk of sodium loss.
Serum lithium levels may be increased during concomitant treatment necessitating adjustment of the lithium dosage.
Furosemide may potentiate the ototoxicity of amino glycosides, other ototoxic antibiotics and cisplatin.
Due to diuretic induced hypokalaemia,
• Increased cardiac toxicity may result if cardiac glycosides or certain antiarrhythmic medicines (e.g. disopyramide, flecanide, quinidine) are administered.
• There is an increased risk of ventricular arrhythmias if amisulpride, sertindole, soltalol and terfenadine are administered. Avoid concomitant use with pimozide and thioridazine.
There is an increased risk of postural hypotension when diuretics are given with tricyclic antidepressants.
4.6. Pregnancy and lactation
Furosemide should only be used in pregnancy if strictly indicated (but not for hypertension) and then only for short-term treatment.
Furosemide should be used with caution in nursing mothers as the drug may inhibit lactation and passes into breast milk in very small quantities.
4.7. Effects on ability to drive and use machines
The ability to drive and to use machines may be affected due to reduced mental alertness.
4.8. Undesirable effects
Calcium depletion, hyponatraemia, hypokalaemia, hypomagnesaemia, hypochloraemic alkalosis and hypotension may occur. Aggravation of metabolic acidosis may occur with high dosages.
Side effects such as nausea, malaise and gastric upset occasionally occur but do not require cessation of treatment.
As with other sulponamide-based diuretics, hyperuricaemia may occur and, in rare cases, clinical gout may be precipitated. In commencing with other diuretics a transient rise in creatinine and urea levels have been reported. Hyperglycaemia may occur. The insulin requirements of diabetic patients may increase. Latent diabetes may become manifest.
There may be a temporary increase in plasma cholestrol and triglyceride concentrations
Although the incidence of allergic reactions (e.g. skin rashes and photosensitivity) is infrequent, treatment should be withdrawn when these occur.
As a rare complication, bone marrow depression has been reported and may necessitate withdrawal of treatment.
Tinnitus and deafness may occur but usually with large parenteral doses, rapid administration or in renal impairment.
4.9. Overdose
Because of the danger of dehydration and electrolyte depletion resulting from excessive diuresis, treatment should be aimed at fluid replacement and correction of the electrolyte imbalance.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Furosemide is insoluble in water and chloroform. It is soluble in 1 in 75 of
alcohol, 1 in 850 of
ether and 1 in 15 of acetone.
Its effects are reached within one hour of an oral dose and lasts from 4 to 6 hours.
5.2. Pharmacokinetic properties
Furosemide is rapidly absorbed from the gastro-intestinal tract. It has a biphasic half-life in the plasma with a terminal elimination phase range up to 1/ hours. It is 99% bound to plasma proteins and is mainly excreted in the urine unchanged, but also in the form of glucuronide and free amine metabolites. Variable amounts are also excreted in the bowel. Furosemide crosses the placental barrier and is excreted in milk.
5.3. Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Lactose Maize starch Potato starch Silica
Colloidal anhydrous Magnesium stearate
6.2. Incompatibilities
Not Applicable.
6.3. Shelf life
48 months for containers, 24 months for blister packs.
6.4.
Special precautions for storage
Blisters packs: Do not store above 25°C. Store in the original package. Containers: Do not store above 25°C. Keep the container tightly closed.
6.5. Nature and contents of container
High density polystyrene with polythene lids and/or polyproylene containers with polypropylene or polythene lids and polyurethane or polythene inserts. Pack sizes: 28, 30, 56, 60, 84, 100, 500 and 1000.
PVC/Aluminium blister-packs.
Pack sizes: 28, 30, 56, 60, 84, 100, 500 and 1000.
6.6. Instruction for use, handling and disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Metwest Pharmaceuticals Limited
15 Runnelfield
Harrow on the Hill
Middlesex
HAl 3NY
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 17521/0022
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 15/02/2006
10 DATE OF REVISION OF THE TEXT
15/02/2006