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FUROSEMIDE is a brand name for Furosemide (also known as Frusemide). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: When a prompt diuresis is required. Use in emergencies or when oral therapy is precluded. Indications include: - Oedema and/or ascites caused by cardiac or hepatic diseases - Oedema caused by renal diseases (in case of nephrotic syndrome, treatment of the underlying disease is essential) - Pulmonary oedema (e.g. in…
Verbatim from this product's MHRA label. Tap a section to expand.
Route of administration: intravenous or (in exceptional cases) intramuscular General: The parenteral administration of furosemide is indicated in cases where oral administration is not feasible or not efficient (for example in case of reduced intestinal absorption) or when a quick effect is required.
To achieve optimum efficacy and suppress counter-regulation, a continuous furosemide infusion is generally to be preferred to repeated bolus injections. Consideration should be given to current clinical guidelines where available. Where continuous furosemide infusion is not feasible for follow-up treatment after one or several acute bolus doses, a follow-up regimen with low doses given at short intervals (approx.
4 hours) is to be preferred to a regimen with higher bolus doses at longer intervals. Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response.
Intravenous furosemide must be injected or infused slowly; a rate of 4 mg per minute must not be exceeded and should never be given in association with other medicinal products in the same syringe. Generally, Furosemide should be administered intravenously.
Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenous administration is feasible. It must be noted that intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary oedema.
Adults:
In the absence of conditions requiring a reduced dose (see below) the initial dose recommended for adults and adolescents over 15 years, is of 20 mg to 40 mg furosemide by intravenous (or in exceptional cases intramuscular) administration; the maximum dose varying according to individual response.
If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. In adults, the recommended maximum daily dose of furosemide administration is 1500 mg. P. or Ringer's Solution for Injection.
In either case, the rate of infusion should not exceed 4mg/minute. The parenteral administration of furosemide is indicated in cases where oral administration is not feasible or not efficient (for example in case of reduced intestinal absorption) or when a quick effect is required.
The evaluation of adverse reactions is based on the following definition of frequency: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000); not known (cannot be estimated from the available data).
Blood and lymphatic system disorders Common: haemoconcentration Uncommon: thrombocytopenia; thrombocytopenia may become manifest, especially with an increase of haemorrhage tendency. Rare: eosinophilia, leukopenia Very rare: haemolytic anaemia, aplastic anaemia, agranulocytosis.
Immune system disorders Rare: severe anaphylactic and anaphylactoid reactions Not known: exacerbation or activation of systemic lupus erythematosus. Metabolism and nutrition disorders 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.
3).
Rare: paraesthesia Not known:
Dizziness, fainting and loss of consciousness (caused by symptomatic hypotension), headache Ear and labyrinth disorders Uncommon: hearing disorders. 4). Very rare: tinnitus Gastrointestinal disorders Uncommon: nausea Rare: vomiting, diarrhea Very Rare: pancreatitis acute Hepato-biliary disorders Very rare: cholestasis, increases in hepatic transaminases.
Vascular disorders Very Common:
Hypotension including orthostatic hypotension. Rare: vasculitis. Not known: thrombosis Skin and subcutaneous tissue disorders Uncommon: pruritus, dermatitis bullous , rashes, urticaria, purpura, erythema multiforme, pemphigoid, exfoliative dermatitis, photosensitivity reaction Not known: Stevens-Johnson syndrome, toxic epidermal necrolysis, AGEP (acute generalized exanthematous pustulosis) and DRESS (Drug Rash with Eosinophilia and Systemic Symptoms), lichenoid reactions.
g. prostatic hypertrophy, hydronephrosis, ureterostenosis). 5) - Acute porphyria (the use of diuretics is considered to be unsafe in acute porphyria and caution should be exercised) - In cases of ascites with oedema, weight loss induced by enhanced diuresis should not exceed 1 kg / day - Too vigorous diuresis may cause orthostatic hypotension or acute hypotensive episodes.
- NSAIDs may antagonise the diuretic effect of furosemide and other diuretics. Use of NSAIDs with diuretics may increase the risk of nephrotoxicity. - Where indicated, steps should be taken to correct hypotension or hypovolaemia before commencing therapy.
g. hypokalaemia, hyponatraemia). 5 - Administration of high dosages - Administration in progressive and severe renal disease - Administration with sorbitol. Concomitant administration of both substances may lead to increased dehydratation (sorbitol might cause additional fluid loss by inducing diarrhoea) - Administration in Lupus Erythematosus - Medication that prolong the QT interval 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.
Premature infants (possible development of nephrocalcinosis /nephrolithiasis; renal function must be monitored and renal ultrasonography performed). In premature infants with respiratory distress syndrome, diuretic treatment with furosemide during the first weeks of life can increase the risk of persistent ductus arteriosus Botalli.
Caution should be observed in patients liable to electrolyte deficiency. 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.
Hypersensitivity to the active substance or to any of the excipients. g. 6)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In cases where parenteral administration is used, the switch to oral administration is recommended, as soon as possible.
Children and adolescents (up to 18 years of age):
The experience in children and adolescents are limited. The intravenous administration of furosemide to children and adolescents below 15 years is only recommended in exceptional cases. 5 to 1 mg/kg body weight daily up to a maximum total daily dose of 20 mg.
There should be a switch to oral therapy as soon as possible. 5 mg furosemide per minute is not exceeded.
Elderly:
The recommended initial dose is 20 mg/day, increasing gradually until the required response is achieved.
Special dosage recommendations:
For adults, the dose is based on the following conditions: - Oedema associated to chronic and acute congestive heart failure The recommended initial dose is 20 to 40 mg daily. This dose can be adapted to the patient´s response, as necessary.
The dose should be given in two or three individual doses per day for chronic congestive heart failure and as a bolus for acute congestive heart failure. - Oedema associated with renal disease The recommended initial dose is 20 to 40 mg daily.
This dose can be adapted to the response as necessary. The total daily dose can be administered as a single dose or as several doses throughout the day. If this does not lead to an optimal fluid excretion increase, furosemide must be administered in continuous intravenous infusion, with an initial rate of 50 mg to 100 mg per hour.
Before beginning the administration of furosemide, hypovolaemia, hypotension and acid-base and electrolytic imbalances must be corrected. In dialyzed patients, the usual maintenance dose ranges from 250 mg to 1,500 mg daily. In patients with nephrotic syndrome the dosage must be determined with caution, because of the risk of a higher incidence of adverse events.
- Oedema associated with hepatic disease When intravenous treatment is absolutely needed, the initial dose should range from 20 mg to 40 mg. This dose can be adapted to the response as necessary. The total daily dose can be administered as a single dose or in several doses.
Furosemide can be used in combination with aldosterone antagonists in cases in which these agents in monotherapy are not sufficient. In order to avoid complications such as orthostatic intolerance or acid-base and electrolytic imbalances or hepatic encephalopathy, the dose must be carefully adjusted to achieve a gradual fluid loss.
5 kg. In cases of ascites with oedema, weight loss induced by enhanced diuresis should not exceed 1 kg / day. - Pulmonary oedema (in acute heart failure) The initial dose to be administered is 40 mg furosemide by intravenous application.
If required by the condition of the patient, another injection of 20 to 40 mg furosemide is given after 30 – 60 minutes. Furosemide should be used in addition to other therapeutic measures. - Hypertensive crisis (in addition to other therapeutic measures) The recommended initial dose in hypertensive crisis is 20 mg to 40 mg administrated in bolus by intravenous injection.
This dose can be adapted to the response as […]
4). m. injection local reactions such as pain may appear. Reporting of suspected adverse reactions 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.
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g. due to vomiting or diarrhoea). Hypovolaemia or dehydration as well as any significant electrolyte and acid-base disturbances must be corrected. This may require temporary discontinuation of furosemide. In patients who are at high risk for radiocontrast nephropathy, furosemide is not recommended to be used for diuresis as part of the preventative measures against radiocontrast-induced nephropathy.
1%; mean age 80 years, range 67-90 years). Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings. No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed.
Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with other potent diuretics should be considered prior to the decision to use. There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone.
3 Contraindications).
Photosensitivity:
Cases of photosensitivity reactions have been reported. If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a re-administration is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
e. essentially "sodium free”. Furosemide 10 mg/ml Solution for Injection (25 ml vial) This medicinal product contains approximately 93 mg of sodium per vial. To be taken into consideration by patients on a controlled sodium diet.