Loading…
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: Diuretic. Oedema of cardiac, hepatic or renal origin, pulmonary oedema, toxaemia of pregnancy, and mild or moderate hypertension, toxaemia of pregnancy 4.8 Undesirable effects Adverse reactions reported for furosemide are given below according to organ systems. The frequencies of the adverse reactions are classified…
Verbatim from this product's MHRA label. Tap a section to expand.
Furosemide Injection may be used when oral application of furosemide is precluded or in cases of emergency.
Adults:
Intravenous Furosemide must be injected or infused slowly, a rate of 4 mg per minute must not be exceeded. 5 mg per minute is not exceeded. Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenous administration are feasible.
It must be noted that intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary oedema. To achieve optimum efficacy and suppress counter-regulation, a continuous furosemide infusion is generally to be preferred to repeated bolus injections.
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 (approximately four hours) is to be preferred to a regimen with higher bolus doses at longer intervals.
Doses of 20 to 50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they be given by slow intravenous infusion.
The recommended maximum daily dose of furosemide administration is 1,500 mg. 5mg per kilogram body weight daily up to a maximum total daily dose of 20mg.
Elderly:
In the elderly furosemide is generally eliminated more slowly. Dosage should be adjusted according to the observed clinical response. Method of administration: by intravenous infusion or intramuscular injection. g. hypovolaemia, dehydration, haemoconcentration, cardiac arrhythmias due to excessive diuresis.
Symptoms of these disturbances include severe hypotension (progressing to shock), acute renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion.
Treatment:
Treatment should therefore be aimed at fluid replacement and correction of the electrolyte imbalance. Together with the prevention and treatment of serious complications resulting from such disturbances and of other effects on the body, this corrective action may necessitate general and specific intensive medical monitoring and therapeutic measures.
Adverse reactions reported for furosemide are given below according to organ systems. The frequencies of the adverse reactions are classified as follows: very common (≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000, including isolated reports); not known (cannot be estimated from the available data): System Organ Adverse Drug Reactions- Frequency Category Class Uncommon (≥ 1/1000 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 Thrombocytopenia Eosinophilia Leucopenia Aplastic anaemia Haemolytic anaemia Agranulocytosis Bone marrow depression (necessitates withdrawal of treatment).
The haemopoietic status should be regularly monitored. g. g. with shock) Fever Malaise Pregnancy In premature infants with respiratory distress syndrome, administration of Furosemide in the initial weeks after birth entails an increased risk of a persistent patent ductus Additional information 1 Electrolytes and water balance may be disturbed as a result of diuresis after prolonged therapy.
Furosemide leads to increased excretion of sodium and chloride and consequently water. In addition excretion of other electrolytes (in particular potassium, calcium and magnesium) is increased. g. where higher furosemide doses are administered to patients with normal renal function, acute severe electrolyte losses.
2 Severe fluid depletion may lead to haemoconcentration with a tendency for thromboses to develop. 3 During long term therapy they will usually return to normal within six months. 4In patients with diabetes mellitus this may lead to a deterioration of metabolic control; latent diabetes mellitus may become manifest.
Insulin requirements of diabetic patients may increase. Paediatric population Nephrocalcinosis / Nephrolithiasis has been reported in premature infants. If furosemide is administered to premature infants during the first weeks of life, it may increase the risk of persistence of patent ductus arteriosus.
3) • Hypotension. • Hypovolaemia. • Severe electrolyte disturbances – particularly hypokalaemia, hyponatraemia and acid-base disturbances. Furosemide is not recommended • In patients at high risk for radiocontrast nephropathy - it should not be used for diuresis as part of the preventative measures against radiocontrast- induced nephropathy.
• In patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
Particular caution and/or dose reduction required:
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.
2) • Difficulty with micturition including prostatic hypertrophy (increased risk of urinary retention: consider lower dose). g. nephritic syndrome (effect of furosemide may be impaired and its ototoxicity potentiated - cautious dose titration required).
• Acute hypercalcaemia (dehydration results from vomiting and diuresis – correct before giving furosemide). Treatment of hypercalcaemia with a high dose of furosemide results in fluid and electrolyte depletion - meticulous fluid replacement and correction of electrolyte required.
• Patients who are at risk from a pronounced fall in blood pressure • Premature infants (possible development nephrocalcinosis/nephrolithiasis; renal function must be monitored and renal ultrasonography performed). 5 for other interactions) • concurrent NSAIDs should be avoided – if not possible diuretic effect of furosemide may be attenuated • ACE-inhibitors & Angiotensin II receptor antagonists – severe hypotension may occur – dose of furosemide should be reduced/stopped (3 days) before starting or increasing the dose of these Laboratory monitoring requirements: • Serum sodium Particularly in the older people or in patients liable to electrolyte deficiency • Serum potassium The possibility of hypokalaemia should be taken into account, in particular in patients with cirrhosis of the liver, those receiving concomitant treatment with corticosteroids, those with an unbalanced diet and those who abuse laxatives.
4). 6)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Furosemide in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
No specific antidote to furosemide is known. g. activated charcoal). 1 Pharmacodynamic properties Pharmacotherapeutic group: diuretics, ATC code: C03CA01 The evidence from many experimental studies suggests that furosemide acts along the entire nephron with the exception of the distal exchange site.
The main effect is on the ascending limb of the loop of Henle with a complex effect on renal circulation. Blood-flow is diverted from the juxta-medullary region to the outer cortex. The principle renal action of furosemide is to inhibit active chloride transport in the thick ascending limb.
Re-absorption of sodium chloride from the nephron is reduced and a hypotonic or isotonic urine produced. It has been established that prostaglandin (PG) biosynthesis and the renin-angiotensin system are affected by furosemide administration and that furosemide alters the renal permeability of the glomerulus to serum proteins.
2 Pharmacokinetic properties Furosemide is a weak carboxylic acid which exists mainly in the dissociated form in the gastrointestinal tract. Furosemide is rapidly but incompletely absorbed (60-70%) on oral administration and its effect is largely over within 4 hours.
0. Regardless of route of administration 69-97% of activity from a radio- labelled dose is excreted in the first 4 hours after the drug is given. Furosemide is bound to plasma albumin and little biotransformation takes place. Furosemide is mainly eliminated via the kidneys (80- 90%); a small fraction of the dose undergoes biliary elimination and 10- 15% of the activity can be recovered from the faeces.
In renal/ hepatic impairment Where liver disease is present, biliary elimination is reduced up to 50%. Renal impairment has little effect on the elimination rate of Furosemide Injection, but less than 20% residual renal function increases the elimination time.
The elderly The elimination of furosemide is delayed in the elderly where a certain degree of renal impairment is present. New born A sustained diuretic effect is seen in the newborn, possibly due to immature tubular function. 3 Preclinical safety data Not applicable.
1 List of excipients Sodium chloride, sodium hydroxide and water for injections. 2 Incompatibilities Not known. 3 Shelf life 36 months. 4 Special precautions for storage Store in a cool dry place. Protect from light. 5 Nature and contents of container Sterile amber glass ampoules.
2ml in packs of 10 and 25. 5ml in packs of 5. 6 Special precautions for disposal Furosemide Injection should not be mixed with any other preparation. Opened ampoules should be used immediately, and any material remaining should be discarded.
7 MARKETING AUTHORISATION HOLDER Ennogen Pharma Limited Unit G4, Riverside Industrial Estate, Riverside Way, Dartford DA1 5BS 8 MARKETING AUTHORISATION NUMBER(S) PL 40147/0040 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 11/08/2012 10 DATE OF REVISION OF THE TEXT 20/12/2023
Other special populations Elderly patients The diuretic action of furosemide may lead to or contribute to hypovolaemia and dehydration, especially in elderly patients. 3). g. in decompensated cirrhosis of the liver) may be aggravated by furosemide treatment.
g. in nephritic syndrome) and/or when intravenous furosemide has been given too rapidly. Increased production of urine may provoke or aggravate complaints in patients with an obstruction of urinary outflow. Thus, acute retention of urine with possible secondary complications may occur, for example, in patients with bladder-emptying disorders, prostatic hyperplasia or narrowing of the urethra.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
1 Hypersensitivity to amiloride, sulphonamides or sulphonamide derivatives Hypovolaemia and dehydration […]
Regular monitoring of the potassium, and if necessary treatment with a potassium supplement, is recommended in all cases, but is essential at higher doses and in patients with impaired renal function. 5). A potassium-rich diet is recommended during long-term use.
8 for details of electrolyte and metabolic abnormalities) • Renal function Frequent BUN in first few months of treatment, periodically thereafter. Long term/high-dose BUN should regularly be measured. Marked diuresis can cause reversible impairment of kidney function in patients with renal dysfunction.
Adequate fluid intake is necessary in such patients. Serum creatinine and urea levels tend to rise during treatment • Glucose Adverse effect on carbohydrate metabolism - exacerbation of existing carbohydrate intolerance or diabetes mellitus.
Regular monitoring of blood glucose levels is desirable. • Other electrolytes Patients with hepatic failure/alcoholic cirrhosis are particularly at risk of hypomagnesia (as well as hypokalaemia). During long-term therapy (especially at high doses) magnesium, calcium, chloride, bicarbonate and uric acid should be regularly measured.
8): Regular monitoring for • blood dyscrasias. 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 […]