Furosemide Injection T P

Furosemide.

Each 2 mL contains Furosemide 20 mg.

Oedema due to cardiac and hepatic disease (ascites). Oedema due to renal disease (in the nephrotic syndrome, therapy of underlying diseases has precedence). Acute cardiac insufficiency, especially in pulmonary oedema (administration in conjunction with other therapeutic measures). Reduced urinary output due to gestoses (after restoring the fluid volume to normal). Supportive measures in brain oedema. Oedema due to bums. Hypertensive crisis (in addition to other antihypertensive measures). To support forced diuresis in poisoning.

Unless otherwise prescribed by the physician, the initial dose for adults and adolescents of ≥15 years is 20-40 mg Furosemide Injection IV or IM. If after a single dose of 20-40 mg Furosemide Injection, the diuretic effect is not satisfactory, the dose may be stepwise increased at 2-hourly intervals by 20 mg each time, until satisfactory diuresis is obtained. The individual dose thus established should then be given once or twice daily.
Acute Pulmonary Oedema: An initial dose of 40 mg Furosemide Injection is administered IV. If the patient's condition requires it, a further dose of 20-40 mg Furosemide Injection is injected after 20 minutes.
Forced Diuresis: 20-40 mg Furosemide Injection is given in addition to infusion of electrolyte solution. Further treatment depends on the elimination of urine and must include substitution of the fluid and electrolyte losses. In poisoning with acid or basic substances, the elimination rate can be further increased by alkalisation or acidification, respectively, of the urine.
Infants and Children <15 years: Parenteral administration (if necessary, continuous drip infusion) is indicated only in life-threatening conditions. For IV or IM injection, the dosage schedule is 1 mg furosemide/kg body weight up to a daily maximum of 20 mg Furosemide Injection. Therapy should be changed to oral administration as soon as possible.
Administration: IV or IM administration of Furosemide Injection 20 mg is indicated in all causes where intestinal adsorption is impaired or rapid fluid elimination is necessary. IV Furosemide Injection 20 mg should be injected slowly. The rate of injection of 4 mg/minute should not be exceeded. During long-term treatment, serum creatinine and urea and also plasma electrolytes, in particular potassium, calcium, chloride and bicarbonate, should be regularly checked.
Furosemide, being an anthranilic acid derivative, dissolves in alkaline media with salt formation. The solution for parenteral application contains the sodium salt of the carboxylic acid without a solubilizer. The solution has a pH of about 9 but no buffer capacity, which means that the drug may precipitate at pH values <7. If the ready-to-use solution has a pH from weakly alkaline to neutral, the mixtures may be used for up to 24 hours. Furosemide Injection 20 mg must not be mixed with other drugs in the same injection syringe. The duration of treatment is at the physician's discretion.
Special Note: Although administration of Furosemide Injection only rarely leads to hypokalaemia, a potassium-rich diet (lean meat, potatoes, bananas, tomatoes, cauliflower, spinach, dried fruits, etc.) is always advisable. Occasionally, treatment with potassium-containing or potassium-sparing preparations may be indicated.

Anuria, hepatic coma, hypokalaemia, hyponatraemia, hypovolaemia with or without hypotension. Hypersensitivity to furosemide or sulfonamides.

In individual causes, the ability to cope with road traffic or to operate machinery may be impaired, especially at the commencement of treatment or when changing over from other drugs or when alcohol is consumed during furosemide therapy.

Furosemide should be administered during pregnancy only if strictly indicated, and then only for short periods of time. In breastfeeding women where the use of furosemide is considered essential, it should be borne in mind that furosemide passes into the breast milk and inhibit lactation. In such causes, the patient should stop nursing.

As with other diuretics, electrolyte and water balance may be disturbed as a result of diuresis after prolonged therapy. At the commencement of treatment, excessive diuresis may give rise, especially in elderly patients, to circulatory disturbances, e.g. a feeling of pressure in the head, dizziness, dryness of the mouth or visual impairment, as symptoms of hypovolaemia.
In extreme causes, hypovolaemia may lead to dehydration, circulatory collapse and thrombophilia. However, with individualized dosage, acute haemodynamic reactions are generally not to be expected, although diuresis sets in rapidly.
All saluretics may cause potassium depletion, especially in cases of low-potassium diet, vomiting or chronic diarrhoea. In addition, diseases e.g. cirrhosis of the liver may cause a predisposition to potassium deficiency states.
Appropriate surveillance and replacement therapy are necessary in such cases. If salt intake is restricted too much, sodium deficiency may produce a fall in blood pressure, calf muscle cramps, anorexia, weakness, dizziness, drowsiness, vomiting and confusional states.
The serum calcium level may be reduced under furosemide therapy; in very rare cases, tetany has been observed. In premature infants, calcium salts may be deposited in the renal tissue (nephrocalcinosis).
Gastrointestinal disorders (e.g. nausea, vomiting, diarrhoea) or allergic reactions (e.g. rashes, vasculitis, fever, interstitial nephritis) and changes of the blood picture (leukopenia, agranulocytosis, anaemia, thrombocytopenia) may occasionally be observed.
Anaphylactic shock, though rare, is an acute life-threatening reaction (see Emergency Measures to be Taken in the Event of Anaphylactic Shock as follows).
Symptoms of obstructed micturition (e.g. in hydronephrosis, prostatic hypertrophy, ureterostenosis) may become manifest or aggravated under the action of diuretics.
In common with other diuretics, treatment with Furosemide Injection may induce a transient rise in serum creatinine and urea.
It should be remembered that an increase in uric acid concentration in the blood may precipitate attacks of gout in predisposed patients.
Serum cholesterol and triglyceride levels may rise under furosemide treatment, but will usually return to normal, under long-term treatment within 6 months. In rare cases, manifest diabetes mellitus may be aggravated by furosemide treatment and latent diabetes may become manifest.
Isolated cases of acute pancreatitis have been reported in which the treatment with saluretics over several weeks was considered a causal factor, including also a few cases following therapy with furosemide.
Disorders of hearing after furosemide are rare and in most cases reversible. This possibility should be borne in mind, especially if furosemide is injected too rapidly and in particular in patients with renal insufficiency (see Administration under Dosage & Administration).
Preexisting metabolic alkalosis may be aggravated by furosemide treatment (e.g. in decompensated cirrhosis of the liver).
Emergency Measures to be Taken in the Event of Anaphylactic Shock: The following emergency measures are generally recommended: At the first signs (sweating, nausea, cyanosis), interrupt the injection immediately but leave the venous cannula in place or perform venous cannulation. In addition to the usual emergency measures, ensure that the patient remains lying with the legs raised and airways patent.
Emergency Drug Therapy: Immediate epinephrine (adrenaline) IV: Dilute 1 mL of commercially available epinephrine solution 1:1000 to 10 mL. In the first instance, slowly inject 1 mL of this dilution (equivalent to 0.1 mg epinephrine) while monitoring pulse and blood pressure (watch for disturbances of cardiac rhythm). Repeat as required. Then give glucocorticoids IV, e.g. 250-1000 mg methylprednisolone. Repeat as required. Subsequently, volume substitution IV, e.g. plasma expanders, human albumin, balanced electrolyte solution should be employed.
Other Therapeutic Measures: Artificial respiration, oxygen inhalation, calcium, antihistaminics.

When a cardiac glycoside is administered concurrently, it should be remembered that potassium deficiency increases the sensitivity of the myocardium to digitalis. In case of concomitant glucocorticoid medication or abuse of laxatives, the risk of increased potassium loss should be borne in mind.
Furosemide may potentiate the nephrotoxic effects of certain antibiotics (e.g. aminoglycosides). Therefore, furosemide should be used with caution in patients with antibiotic-induced renal impairment. It should be borne in mind that the ototoxicity of aminoglycoside antibiotics (e.g. kanamycin, gentamicin, tobramycin) may be potentiated when furosemide is used concurrently. The hearing defects that result may be irreversible. Therefore, this drug combination should be restricted to vital indications. As the concomitant administration of cisplatin carries the risk of inducing hearing defects, the 2 drugs should not be used simultaneously.
Furosemide sometimes diminishes the potency of the other drugs (e.g. the effect of antidiabetics and pressor amines) or potentiates their effect (e.g. in the case of salicylates, theophylline, lithium and curarimimetic muscle relaxants). The action of other hypotensive drugs may be potentiated by furosemide. Especially in combination with ACE inhibitors, a marked fall in blood pressure may be seen.
Nonsteroidal anti-inflammatory agents (e.g. indomethacin) may antagonise the action of furosemide and may cause renal failure in case of preexisting hypovolemia.

How to use the One-Point-Cut Ampoule: Hold ampoule with blue dot pointing upwards. Shake or tap ampoule to empty the tip. With blue dot upwards, snap-off tip of ampoule by forcing it downwards.

Store below 30°C, protected from light.

Diuretics

C03CA01 - furosemide ; Belongs to the class of high-ceiling sulfonamide diuretics.

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