Furovenir

/ BioAvenir

Duration of the treatment will depend on usage and is determined by the doctor for each individual. For adults, the maximum recommended dose is 1,500 mg daily, although it may reach 2,000 mg in exceptional cases. For children, the maximum recommended daily dose of FuroVenir for parenteral administration is 1 mg of furosemide per each kilogram of body weight, up to a maximum of 20 mg. Treatment is to be switched to the oral route as soon as possible. FuroVenir 250mg solution for IV infusion should be injected or infused slowly by intravenous route, at a rate not exceeding 4 mg per minute. In patients with severe kidney problems (serum creatinine >5 mg/dl), it is recommended that the rate of infusion does not exceed 2.5 mg per minute. It should not be administered in the form of intravenous bolus. It should be infused using only infusion pumps that control volume or speed in order to avoid a possible risk of accidental overdose. FuroVenir 250 mg solution for IV infusion should not be Mixed in the same syringe or infused together with other medicines. The suitable diluent is isotonic saline solution. No acid solutions should be used. The pH of the solution to be infused should be neutral or lightly alkaline. It is recommended that the ready-to-use solution be administered as soon as possible. FuroVenir should never be infused together with other medication in the same intravenous fluid.
Use in children: Parenteral administration is contraindicated for infants and children under the age of 15; this may be carried out only in cases involving a threat to life.

Oliguria in acute or chronic renal failure. For use only in patients with extremely reduced glomerular filtration.

Hypersensitivity to active substance or to any of the excipients.
Hypersensitivity to amiloride, sulphonamides or sulphonamide derivatives.
Hypovolaemia and dehydration (with or without accompanying hypotension).
Severe hypokalaemia: severe hyponatraemia.
Comatose or pre-comatose states associated with hepatic cirrhosis.
Anuria or renal failure with anuria not responding to furosemide, renal failure as a result of poisoning by nephrotoxic or hepatotoxic agents, renal failure associated with hepatic coma.
Impaired renal function with a creatinine clearance below 30ml/min per 1.73 m2 body surface area.
Addison’s disease.
Digitalis intoxication.
Porphyria.
Breast-feeding women.

Hypotension.
Hypovolaemia.
Severe electrolyte disturbances – particularly hypokalemia, hyponatremia 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.
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.
Elderly people (lower initial dose as particularly susceptible to side-effects).
Difficulty with micturition including prostatic hypertrophy (increased risk of urinary retention: consider lower dose). Closely monitor patients with partial occlusion of the urinary tract.
Diabetes mellitus (latent diabetes may become overt: insulin requirements in established diabetes may increase. stop furosemide before a glucose tolerance test).
Pregnancy.
Gout (furosemide may raise uric acid levels/precipitate gout).
Patients with hepatorenal syndrome.
Impaired hepatic function.
Impaired renal function.
Adrenal disease.
Hypoproteinemia e.g. nephritic syndrome (effect of furosemide may be impaired and its ototoxicity potentiated – cautious dose titration required).
Acute hypercalcemia (dehydration results from vomiting and diuresis – correct before giving furosemide). Treatment of hypercalcemia 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).
Avoidance with other medicines:
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 bereduced/stopped (3 days) before starting or increasing the dose of these.
See prescribing information for full details.

As with all medicines, FuroVenir 250 mg solution for IV infusion may have adverse effects.Like other diuretics, the prolonged administration of this medicament may increase the elimination of sodium (hyponatremia), chlorine (hypochloremic alkalosis) and of water as a result of this. It may also heighten the loss of potassium (hypopotassemia), calcium, and magnesium. Such alterations present themselves with intense thirst, headaches, confusion, muscle cramps, painful muscular contractions especially in the limbs (tetany), muscle weakness, alterations in the cardiac rhythm, and gastrointestinal symptoms.In older patients in particular, FuroVenir 250 mg solution for IV infusion may result or contribute to the occurrence of a reduction in total blood volume, dehydration, and coagulation alterations (thrombosis). FuroVenir may cause or aggravate discomfort in patients with difficulties to urinate; also, acute urinary retention may occur and cause possible secondary complications. On rare occasions, cases of kidney problems that might result from an allergy-type renal reaction (interstitial nephritis) have been reported.
For full details see prescribing information.

General: The dosage of concurrently administered cardiac glycosides, diuretics, anti-hypertensive agents, or other drugs with blood-pressure-lowering potential may require adjustment as a more pronounced fall in blood pressure must be anticipated if given concomitantly with furosemide.
The toxic effects of nephrotoxic drugs may be increased by concomitant administration of potent diuretics such as furosemide.
Some electrolyte disturbances (e.g., hypokalemia, hypomagnesaemia) may increase the toxicity of certain other drugs (e.g., digitalis preparations and drugs inducing QT interval prolongation syndrome).
Antihypertensives: enhanced hypotensive effect possible with all types. Concurrent use with ACE inhibitors or Angiotensin II receptor antagonists can result in marked falls in blood pressure, furosemide should be stopped, or the dose reduced before starting an ACE-inhibitor or Angiotensin II receptor antagonists.
Antipsychotics: furosemide-induced hypokalemia increases the risk of cardiac toxicity. Avoid concurrent use with pimozide. Increased risk of ventricular arrhythmias with amisulpride or sertindole. Enhanced hypotensive effect with phenothiazines.
When administering risperidone, caution should be exercised and the risks and benefits of the combination or co-treatment with furosemide or with other potent diuretics should be considered prior to the decision to use.
Anti-arrhythmic (including amiodarone, disopyramide, flecainide and sotalol) – risk of cardiac toxicity (because of furosemide-induced hypokalemia). The effects of lidocaine, tocainide or mexiletine may be antagonized by furosemide.
Cardiac glycosides: hypokalemia and electrolyte disturbances (including hypomagnesemia) increase the risk of cardiac toxicity.
Drugs that prolong Q-T interval: increased risk of toxicity with furosemide-induced electrolyte disturbances.
Vasodilators: enhanced hypotensive effect with moxisylyte (thymoxamine) or hydralazine.
Other diuretics: profound diuresis possible when furosemide given with metolazone. Increased risk of hypokalemia with thiazides.
Renin inhibitors: aliskiren reduces plasma concentrations of furosemide.
Nitrates: enhanced hypotensive effect.
Lithium: In common with other diuretics, serum lithium levels may be increased when lithium is given concomitantly with furosemide, 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 and where necessary the lithium dosage is adjusted in patients receiving this combination.
Chelating agents: sucralfate may decrease the gastro-intestinal absorption of furosemide – the 2 drugs should be taken at least 2 hours apart.
NSAIDs: increased risk of nephrotoxicity. Indomethacin and ketorolac may antagonise the effects of furosemide (avoid, if possible). NSAIDs may attenuate the action of furosemide and may cause acute renal failure in cases of pre-existing hypovolaemia or dehydration.
Salicylates – effects may be potentiated by furosemide. Salicylic toxicity may be increased by furosemide.
Antibiotics: increased risk of ototoxicity with aminoglycosides, polymyxins or vancomycin – only use concurrently if compelling reasons. Increased risk of nephrotoxicity with aminoglycosides or cefaloridine. Furosemide can decrease vancomycin serum levels after cardiac surgery. Increased risk of hyponatremia with trimethoprim. Impairment of renal function may develop in patients receiving concurrent treatment with furosemide and high doses of certain cephalosporins.
Antidepressants: enhanced hypotensive effect with MAOIs. Increased risk of postural hypotension with TCAs (tricyclic antidepressants). Increased risk of hypokalemia with reboxetine
Antidiabetics: hypoglycemic effects antagonised by furosemide.
Antiepileptics: increased risk of hyponatremia with carbamazepine. Diuretic effect reduced by phenytoin.
Antihistamines: hypokalemia with increased risk of cardiac toxicity
Antifungals: increased risk of hypokalemia and nephrotoxicity with amphotericin
Anxiolytics and hypnotics: enhanced hypotensive effect. Chloral or triclorfos may displace thyroid hormone from binding site.
CNS stimulants (drugs used for ADHD): hypokalemia increases the risk of ventricular arrhythmias.
Corticosteroids: diuretic effect antagonized (sodium retention) and increased risk of hypokalemia.
Glychyrrizin: contained in liquorice) may and increase the risk of developing hypokalemia.
Cytotoxics: increased risk of nephrotoxicity and ototoxicity with platinum compounds/cisplatin. 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.
Anti-metabolites: effects of furosemide may be reduced by methotrexate and furosemide may reduce renal clearance of methotrexate.
Dopaminergics: enhanced hypotensive effect with levodopa.
Immunomodulators: enhanced hypotensive effect with aldesleukin. Increased risk of hyperkalaemia with cyclosporine and tacrolimus. Increased risk of gouty arthritis with cyclosporine.
Muscle relaxants: enhanced hypotensive effect with baclofen or tizanidine. Increased effect of curare-like muscle relaxants.
Oestrogens: diuretic effect antagonised.
Progestogens (drosperidone): increased risk of hyperkalemia.
Prostaglandins: enhanced hypotensive effect with alprostadil.
Sympathomimetics: increased risk of hypokalemia with high doses of beta 2 sympathomimetics.
Theophylline: enhanced hypotensive effect.
Probenecid: effects of furosemide may be reduced by probenecid and furosemide may reduce renal clearance of probenecid.
Anesthetic agents: general anesthetic agents may enhance the hypotensive effects of furosemide. The effects of curare may be enhanced by furosemide.
Alcohol: enhanced hypotensive effect.
Laxative abuse: increases the risk of potassium loss.
Others: Concomitant administration of aminoglutethimide may increase the risk of hyponatremia.

Animal teratology studies indicate that furosemide may cause foetal abnormalities. Therefore, furosemide should only be used in women of child-bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the foetus. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.

Symptoms:
Overdose can cause massive diuresis resulting in dehydration, volume depletion and electrolyte disturbances with consequent hypotension and cardiac toxicity. High doses have the potential to cause transient deafness and may precipitate gout (disturbed uric acid secretion).
Management:
Benefits of gastric decontamination are uncertain. In patients presenting within 1 hour of ingestion, consider activated charcoal (50g for adults: 1g/kg for children).
Observe for a minimum of 4 hours – monitor pulse and blood pressure. Treat hypotension and dehydration with appropriate IV fluids.
Monitor urinary output and serum electrolytes (including chloride and bicarbonate). Correct electrolyte imbalances. Monitor 12 lead ECG in patients with significant electrolyte disturbances.