Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Sanofi-aventis Ireland Ltd., T/A SANOFI, Citywest Business Campus, Dublin 24
Patients with hypovolaemia or dehydration, anuria or renal failure with anuria not responding to furosemide, renal failure as a result of poisoning by nephrotoxic or hepatotoxic agents or renal failure associated with hepatic coma, severe hypokalaemia, severe hyponatraemia, pre-comatose and comatose states associated with hepatic encephalopathy and breast feeding women.
Hypersensitivity to furosemide or any of the excipients of Lasix Injection. Patients allergic to sulphonamides may show cross-sensitivity to furosemide.
Too vigorous diuresis may cause orthostatic hypotension or acute hypotensive episodes.
Where indicated, steps should be taken to correct hypotension or hypovolaemia before commencing therapy.
Regular monitoring of serum sodium, potassium and creatinine is generally recommended during furosemide therapy; particularly close monitoring is required in patients at high risk of developing electrolyte imbalances or in case of significant additional fluid loss.
Hypovolaemia or dehydration as well as any significant electrolyte and acid-base disturbances must be corrected. This may require temporary discontinuation of furosemide.
Urinary output must be secured. In patients with a partial obstruction of urinary outflow increased production of urine may provoke or aggravate complaints. These patients require careful monitoring. Patients with partial obstruction of urinary outflow, for example patients with prostatic hypertrophy or impairment of micturition have an increased risk of developing acute retention and require careful monitoring.
Particularly careful monitoring is necessary in:
The use of diuretics is considered to be unsafe in acute porphyria therefore caution should be exercised.
In risperidone placebo controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone when compared to patients treated with risperidone alone or furosemide alone. Cautions should be exercised and the risks and benefits of this combination or co-treatment should be considered prior to the decision to use. Dehydration should be avoided.
The possibility exists of exacerbation or activation of systemic lupus erythematosus hence caution should be taken when administering frusemide to patients with a history of SLE.
This medicinal product contains 6.14mg sodium per 20mg/2ml dosage. To be taken into consideration by patients on a controlled sodium diet.
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.
The concomitant administration of this preparation with cardiac glycosides or hypotensive agents may necessitate adjustment of the dosage of those drugs.
The harmful effects of nephrotoxic drugs on the kidney may be increased.
Impairment of renal function may develop in patients receiving treatment with furosemide and high doses of certain cephalosporins.
Oral furosemide and sucralfate must not be taken within 2 hours of each other because sucralfate decreases the absorption of furosemide from the intestine and so reduces its effect.
Corticosteroids, corticotrophin and amphotericin B, also cause potassium loss and severe potassium depletion may occur when administered concurrently with furosemide. Carbenoxolone, liquorice in large amounts, B2 sympathomimetics, prolonged use of laxatives, reboxetine and amphotericin may increase the risk of developing hypokalaemia.
Corticosteroids administered concurrently may cause sodium retention.
If antihypertensive agents, diuretics or other drugs, with blood-pressure-lowering potential are given concomitantly with furosemide, a more pronounced fall in blood pressure must be anticipated. Concomitant administration of carbamazepine or aminoglutethimide may increase the risk of hyponatraemia.
Furosemide decreases the excretion of lithium salts and may cause increased serum lithium levels, resulting in increased lithium toxicity, including increased risk of cardiotoxic and neurotoxic effects of lithium. Therefore, it is recommended that lithium levels are carefully monitored in patients receiving this combination.
Concomitant use of ciclosporine A and furosemide is associated with increased risk of gouty arthritis secondary to furosemide induced hyperuricaemia and cyclosporine impairment of renal urate excretion.
Patients who are at high risk of radiocontrast nephropathy treated with furosemide experienced a higher incidence of deterioration in renal function after receiving radiocontrast compared to high-risk patients who received only intravenous hydration prior to receiving radiocontrast.
Patients who are receiving diuretics may suffer severe hypotension and deterioration in renal function, including cases of renal failure, especially when an angiotensin converting enzyme inhibitor (ACE inhibitor) or angiotensin II receptor antagonist is given for the first time or for the first time in an increased dose. Consideration must be given to interrupting the administration of furosemide temporarily or at least reducing the dose of furosemide for three days before starting treatment with, or increasing the dose of, an ACE inhibitor or angiotensin II receptor antagonist.
Concomitant administration of non-steroidal anti-inflammatory drugs including acetylsalicyclic acid and Indomethacin may reduce the effect of furosemide. In patients with dehydration or hypovolaemia, non-steroidal anti-inflammatory drugs may cause acute renal failure. Salicylate toxicity may be increased by furosemide.
In isolated cases intravenous administration of furosemide within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure and tachycardia. Use of furosemide concomitantly with chloral hydrate is, therefore, not recommended.
Furosemide may potentiate the ototoxicity of aminoglycosides and other ototoxic drugs. Since this may lead to irreversible damage, these drugs must only be used with furosemide if there are compelling medical reasons.
There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly. In addition, nephrotoxicity of cisplatin may be enhanced if furosemide is not given in low doses (e.g. 40 mg in patients with normal renal function) and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.
Some electrolyte disturbances (e.g. hypokalaemia, hypomagnesaemia) may increase the toxicity of certain other drugs (e.g. digitalis preparations and drugs inducing QT interval prolongation syndrome).
Attenuation of the effect of furosemide may occur following concurrent administration of phenytoin.
Severe diuresis may occur if metolazone is administered concomitantly.
Probenecid, methotrexate and other drugs which, like furosemide, undergo significant renal tubular secretion may reduce the effect of furosemide. Conversely, furosemide may decrease renal elimination of these drugs. In case of high-dose treatment (in particular, of both furosemide and the other drugs), this may lead to increased serum levels and an increased risk of adverse effects due to furosemide or the concomitant medication.
The effects of antidiabetic drugs and blood pressure increasing sympathomimetics (e.g. epinephrine, norepinephrine) may be reduced. The effects of curare-type muscle relaxants or of theophylline may be increased.
Risperidone: Caution should be exercised and the risks and benefits of the combination or co-treatment with furosemide should be considered prior to the decision to use (see section 4.4).
Levothyroxine: High doses of furosemide may inhibit binding of thyroid hormones to carrier proteins and thereby lead to an initial transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels. Thyroid hormone levels should be monitored.
Furosemide crosses the placental barrier. It must not be given during pregnancy unless there are compelling medical reasons. Treatment during pregnancy requires monitoring of foetal growth.
Furosemide passes into breast milk and may inhibit lactation. Women must not breast-feed if they are treated with furosemide.
Reduced mental alertness may impair ability to drive or operate dangerous machinery.
The frequencies are derived from literature data referring to studies where furosemide is used in a total of 1387 patients, at any dose and in any indication. When the frequency category for the same ADR was different, the highest frequency category was selected.
The following CIOMS frequency rating is used, when applicable: Very common ≥10%; Common ≥1 and <10%; Uncommon ≥0.1 and <1%; Rare ≥0.01 and <0.1%; Very rare <0.01%; Not known (cannot be estimated from available data).
Very Common: electrolyte disturbances (including symptomatic) dehydration and hypovolaemia, especially in elderly patients. Blood creatinine increased, blood triglyceride increased.
Common: hyponatremia, hypochloremia, hypokalaemia, blood cholesterol increased. Blood uric acid increased and attacks of gout, urine volume increased
Uncommon: glucose tolerance impaired.
Not known: hypocalcemia, hypomagnesemia, blood urea increased , metabolic alkalosis, Pseudo-Bartter syndrome.
Very Common: Hypotension including orthostatic hypotension.
Rare: vasculitis.
Not known: thrombosis.
Common: urine volume increased.
Rare: tubulointerstitial nephritis.
Not known:
Uncommon: nausea.
Rare: vomiting, diarrhoea.
Very Rare: pancreatitis acute.
Very Rare: cholestasis, transaminases increased.
Uncommon: hearing disorders. Cases of deafness, sometimes irreversible have been reported after oral or IV administration of furosemide.
Very Rare: tinnitus.
Uncommon: deafness (sometimes irreversible).
Uncommon: pruritus, urticaria, rashes, dermatitis bullous, erythema multiforme, pemphigoid, dermatitis exfoliative, purpura, photosensitivity reaction.
Not known: Stevens-Johnson syndrome, toxic epidermal necrolysis, AGEP (acute generalized exanthematous pustulosis) and DRESS (Drug Rash with Eosinophilia and Systemic Symptoms).
Not Known: acute generalised exanthematous pustulosis (AGEP), lichenoid reactions.
Rare: severe anaphylactic or anaphylactoid reactions.
Not known: exacerbation or activation of systemic lupus erythematosus.
Rare: paraesthesiae.
Common: hepatic encephalopathy in patients with hepatocellular insufficiency (see section 4.3).
Not Known: Dizziness, fainting or loss of consciousness (caused by symptomatic hypotension or by other causes), headache
Common: haemoconcentration.
Uncommon: thrombocytopenia.
Rare: leucopoenia, eosinophilia.
Very rare: agranulocytosis, aplastic anaemia, haemolytic anaemia.
Not known: increased risk of persistence of patent ductus arteriosus when furosemide is administered to premature infants during the first weeks of life.
Not known: following intramuscular injection, local reactions such as pain.
Rare: fever.
Not known: cases of rhabdomyolysis have been reported, often in the context of severe hypokalaemia (see section 4.3).
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Not applicable.
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