Furosemide 10 Mg/Ml Solution For Injection/Infusion
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide 10mg/ml Solution for Injection/Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml contains 10mg of Furosemide
Each 2ml ampoule contains 20mg of Furosemide Each 5ml ampoule contains 50mg of Furosemide
3 PHARMACEUTICAL FORM
Solution for Injection/Infusion
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Furosemide injection is recommended for use when prompt diuresis is required. The parenteral formulation is appropriate for use in emergencies or when oral therapy is precluded for the following indications:
Left ventricular failure Hypertension
Peripheral oedema due to mechanical obstruction or venous insufficiency Cardiac, pulmonary, hepatic or renal oedema Oliguria due to renal insufficiency
4.2. Posology and Method of Administration
Intramuscular injection or slow intravenous injection. Furosemide injection must be given slowly. (Rate should not exceed 4 mg/ml minute) Its diuretic effect is proportional to dose.
Adults
The diuretic effect of Furosemide is proportional to the dosage, initially 2050mg by intramuscular or SLOW intravenous injection. If larger doses are required they should be given by slow intravenous infusion and titrated according to response. For infusion, Furosemide injection may be diluted in sodium chloride injection or Ringer’s solution.
In oliguria: Initially 250mg over one hour may be given by slow intravenous infusion. If satisfactory response is not achieved within the subsequent hour, then a further 500mg may be given over two hours. If satisfactory response is still not obtained over the next hour, a further 1g over four hours may be administered. If response is still not achieved, dialysis is probably required. An effective dose up to 1g may be repeated every 24 hours.
Children
0.5 - 1.5 mg/kg body weight daily by intramuscular or SLOW intravenous injection, to a maximum total daily dose of 20mg.
Elderly
In the elderly, Furosemide is generally eliminated more slowly. Dosage should therefore be titrated until the required response is obtained.
4.3. Contraindications
Electrolyte deficiency, hepatic failure associated with pre-comatose states. Renal failure with anuria, digitalis intoxication, porphyria and hypersensitivity to furosemide or sulphonamides.
4.4. Special Warnings and Precautions for Use
In elderly male patients with prostate hypertrophy acute urinary retention may occur.
Where indicated, steps should be taken to correct 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 caution in patients with a history of gout.
Regular blood tests should be carried out and if bone marrow depression occurs therapy should be stopped.
This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially ‘sodium free’.
4.5. Interactions with other medicinal products and other forms of Interaction
Administration of parenteral Furosemide (Furosemide) with Chloral and Triclofos may displace thyroid hormone from binding sites.
Increased risk of hypokalaemia when loop diuretics given with Acetazolamide, Amphotericin, Corticosteroids, Thiazide related Diuretics, high doses of Beta 2 Sympathomimetics and Theophylline. Possible increased risk of hypokalaemia when loop diuretics given with Reboxetine
Hypokalaemia caused by loop diuretics increases cardiac toxicity with Amiodarone, Cardiac Glycosides, Disopyramide, Flecainide and Quinidine.
Hypokalaemia caused by loop diuretics antagonises action of Lidocaine (Lignocaine) and Mexiletine.
Hypokalaemia caused by diuretics increases risk of ventricular arrhythmias with Amisulpride, Sotalol, Pimozide (avoid concomitant use) and Sertindole.
Hypokalaemia or other electrolyte imbalance with diuretics increases risk of ventricular arrhythmias with Terfenadine
Enhanced hypotensive effect when diuretics given with ACE inhibitors, Adrenergic Neurone Blockers, Alcohol, Aldesleukin, Alpha-blockers, Alprostadil, General Anaesthetics, Angiotensin-II Receptor Antagonists, Anxiolytics and Hypnotics, Baclofen, Beta-blockers, Calcium-channel Blockers, Clonidine, Diazoxide, Hydralazine, Levodopa, MAOI,
Methyldopa, Minoxidil, Moxisylyte (thymoxamine), Moxonidine, Nitrates Nitroprusside, Phenothiazines and Tizanidine.
Increased risk of postural hypotension when diuretics given with tricyclics Antidepressants Loop diuretics antagonise hypoglycaemic effect of Antidiabetics.
Effects of diuretics antagonised by Indometacin and Ketorolac
Increased risk of otoxicity when loop diuretics given with Aminoglycosides, Polymyxins and Vancomycin
Profound diuresis possible when Furosemide given with Metolazone
Loop diuretics reduce excretion of lithium (increased plasma concentration and risk of
toxicity) although loop diuretics are safer than Thiazides.
Increased risk of hyponatraemia when diuretics given with Aminoglutethimide, Carbamazepine.
The manufacturer of Lymecycline advises avoidance of diuretics.
Diuretics increase risk of nephrotoxicity of NSAIDs, also antagonism of diuretic effect.
Increased risk of nephrotoxicity and ototoxicity when diuretics given with platinum compounds
Diuretic effect of diuretics antagonised by Corticosteroids and Oestrogens.
Bumetanide belongs to Diuretics but has no specific interaction information.
4.6. Pregnancy and Lactation
Furosemide is not used to treat hypertension in pregnancy as Furosemide crosses the placenta. Furthermore, the drug may diminish the utero-placental blood flow. Therefore, the administration of Furosemide during pregnancy should be avoided if there is no strict indication for the use of the drug.
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.
Undesirable Effects
4.8.
The most common adverse effects are fluid and electrolyte imbalance including hyponatraemia, hypokalaemia, hypomagnesaemia and hypochloraemic alkalosis. Signs of electrolyte imbalance include headache, hypotension, dry mouth, thirst, weakness, lethargy, muscle cramps, drowsiness, restlessness, oliguria, and cardiac arrhythmias.
Less common side effects include nausea, gastro-intestinal disturbances, hyperuricaemia and gout, hyperglycaemia (less common than with thiazides) and a temporary increase in plasma cholesterol and triglyceride concentrations.
Other side effects that occur rarely are rashes, photosensitivity, pancreatitis (with larger parenteral doses), blurred vision, dizziness, headache, vasculitis and interstitial nephritis. Bone marrow depression is a rare complication and treatment should be withdrawn. The haemopoietic 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
Symptoms expected: Diuresis, hypovolaemia, electrolyte imbalance.
Treatment: Symptomatic, rehydration and correction of electrolyte imbalance.
Treatment includes administration of sodium chloride and water, if necessary, by intravenous infusion.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
Furosemide acts primarily in inhibiting the resorption of chloride and thus sodium in the ascending Loop of Henle providing prompt diuresis and associated loss of sodium, potassium and chloride.
5.2 Pharmacokinetic Properties
With intravenous dosing of furosemide, onset of action occurs in 15 minutes, peak activity in 30-60 minutes and duration of effect for 1-2 hours. Furosemide 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 in haemodialysis.
5.3
Preclinical Safety Data
No additional data of relevance to the prescriber.
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Sodium hydroxide Sodium chloride Water for Injections
6.2 Incompatibilities
Furosemide injection is incompatible with solutions of low pH. Dextrose solutions are therefore unsuitable for infusions. Furosemide injection should not be mixed with other drugs or preparations to be administered.
6.3 Shelf-Life
24 months.
6.4. Special Precautions for Storage
Do not store above 25°C. Keep in outer carton
6.5 Nature and Contents of Container
2ml and 5ml colourless ampoules of Type I glass.
Packed into cartons of 10 ampoules.
6.6 Instructions for Use, Handling and Disposal
Not applicable.
7. MARKETING AUTHORISATION HOLDER
Macarthys Laboratories Limited
T/A Martindale Pharmaceuticals Bampton Road,
Harold Hill,
Romford RM3 8UG
8. MARKETING AUTHORISATION NUMBER(S)
PL 01883/0045
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
First approved: 29 April 1986 Last renewal: 23 April 1999
10 DATE OF REVISION OF THE TEXT
23/01/2012