Furosemide Injection

Furosemide INJECTION
Each ampoule of 2 ml contains 20mg furosemide (10mg/ml).

 
Uses

Emergency treatment of cardiac, pulmonary, hepatic and renal oedema and hypertensive crisis.

 
Dosage

Administer slowly by intravenous or intramuscular route. Intramuscular administration must be restricted to cases where neither oral nor intravenous administration are feasible.

In an emergency, or when oral therapy cannot be given:
Adult: 20 – 50 mg per injection, if necessary further doses may be given increasing by 20 mg increments, and given not more often than every 2 hours. Doses above 50 mg are recommended to be given by slow intravenous infusion (maximum rate of intravenous administration: 4 mg/min; 2.5 mg/min in severe renal impairment).

Child: 0.5-1.5mg/kg per day, up to a maximum of 20 mg daily
In the elderly, dosage should be adjusted to reflect decreased excretion of furosemide.

 
Pregnancy and breast feeding

Furosemide should only be used during pregnancy if strictly indicated and for short term treatment.

Furosemide may inhibit lactation and is excreted in breast milk. Breast feeding during furosemide treatment is not recommended.

 

Contra-indications and warnings

Contr-indicated in hypersensitivity to furosemide or any of the excipients. Patients allergic to sulphonamides may show cross-sensitivity to furosemide. Contra-indicated in hypovolaemia, dehydration, anuria, renal failure with anuria not responding to furosemide, severe hypokalaemia or hyponatraemia, comatose or pre-comatose states associated with hepatic encephalopathy, renal failure due to poisoning by nephrotoxic or hepatotoxic drugs, renal failure associated with hepatic coma.

Furosemide is considered unsafe in porphyria. Furosemide can aggravate diabetes mellitus and gout.

Caution is required in patients with liver failure, pancreatitis or a history of pancreatitis, (history of) systemic lupus erythematosus, severe asthma, hypotension, patients who are at risk from a pronounced fail in blood pressure, patients with hepatorenal syndrome, patients with hypoproteinaemia, premature infants and neonates.

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.

Possibility of hypocalcaemic tetany in hypoparathyroid patients.

Furosemide may enhance the toxicity of other nephrotoxic (including cephalosporin antibacterials, NSAIDs, cisplatin) or ototoxic drugs (including aminoglycoside antibacterials, cisplatin).

Hypokalaemia, that can result from furosemide treatment, increases the risk of cardiotoxicity of digoxin, quinidine, amiodarone and other anti-arrhythmics. Concurrent administration may require adjustment of dosage.

Furosemide may precipitate out of solution in fluids of low pH (e.g. dextrose Solutions). Do not mix with any other drugs in the injection bottle.

Enhanced hypotensive effect with alcohol, barbiturates, opioids, general anaesthetics.
Furosemide enhances the hypotensive action of other antihypertensive drugs, including beta- blockers, calcium-channel blockers, ACE inhibitors, alpha blockers, angiotensin II receptor antagonists and hydralazine.

Furosemide may effect the response to neuromuscular blocking agents (increased or decreased effect).

Probenecid, methotrexate and other drugs which, like furosemide, undergo significant renal tubular secretion may reduce the effect of furosemide.

 
Remarks

Potassium suppletion or combination with potassium-sparing diuretics may be necessary during long-term treatment to correct potassium levels.

 
Side effects

Furosemide injection is generally well tolerated. The most common side-effect is fluid and electrolyte imbalance including hyponatraemia, hypokalaemia, and hypochioraemic alkalosis, particularly after large doses or prolonged treatment. Signs include thirst, weakness, cardiac arrhythmias, gastrointestinal disturbances, hypotension, headache and muscle cramp.

Gout may be precipitated. Bone marrow depression is rare, but necessitates withdrawal of treatment. Rapid high-dose injection or infusion of furosemide may cause tinnitus and even permanent deafness.

Hypovolaemia and dehydration may occur, especially in elderly patients.
Other adverse effects include blurred vision, yellow vision, pancreatitis, cholestatic jaundice, dizziness, orthostatic hypotension, hypersensitivity reactions (including skin rashes, photosensitivity, vasculitis, fever, urticaria and interstitial nephritis; withdraw treatment). Severe anaphylaxis or anaphylactoid reactions (e.g with shock) may also occur rarely and necessitate immediate withdrawal of furosemide treatment.

Following intramuscular injection, local reactions such as pain may occur.

 
Overdosage

Symptoms: As side effects, due to dehydration and electrolyte depletion.

Treatment: Fluid replacement and correction of electrolyte imbalance.

 
Storage

Store below 30°C, protect from light.

 

Manufactured by

D. P. Pally, Dundigal Post, Hyderabad-500043, India.

 

Distributed by

IDA Foundation, P. O. Box 37098,

1030 AB Amsterdam, The Netherlands.

www.idafoundation.org

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