Uretic Injection 20 mg/2 ml, each ml contains : Furosemide 10 mg.
Uretic contains Furosemide as active ingredient available in injection 20 mg/2 ml.
- Oedema due to cardiac, hepatic and renal disease.
- Adjunctive therapy in acute pulmonary oedema and cerebral oedema where intense and rapid onset of diuresis is desired.
DOSAGE AND ADMINISTRATIONS :
In general, the dose used must be the lowest which is sufficient to achieve the desired effect.
Adults and Adolescents ≥ 15 years : Unless otherwise prescribed, the initial dose is 20 – 40 mg (1 – 2 ampoules) intravenously or in exceptional cases, intramuscularly (see Administration).
If after a single dose of 20 – 40 mg (1 – 2 ampoules), the diuretic effect is not satisfactory, the dose may be increased stepwise by 20 mg (1 ampoule) at 2-hourly intervals until a satisfactory effect is obtained. The individual dose thus established should then be given once or twice daily.
Acute Pulmonary Oedema : An initial dose of 40 mg (2 ampoules) is administered intravenously. If a satisfactory response does not occur within 1 hour, the dose may be increased to 80 mg injected slowly intravenously.
Cerebral Oedema : The following procedure is recommended pending further experience : Intravenous injection of 20 – 40 mg, 3 times daily.
Forced Diuresis : 20 – 40 mg (1 – 2 ampoules) 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 alkalization or acidification, respectively, of the urine.
Infants and Children < 15 years : In principle, Furosemide should be administered orally. Parenteral administration (if necessary, continuous drip infusion) is indicated only in life-threatening conditions. The dosage schedule is Furosemide 1 mg/kg body weight up to a maximum of 20 mg (1 ampoule) daily.
Intravenous administration of Furosemide is indicated in all cases where oral administration is either not feasible or is ineffective (e.g., in impaired intestinal absorption) or where a rapid effect is necessary. Intravenous injection of Furosemide should be given slowly, not exceeding an injection rate of 4 mg/min.
Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenously administration are feasible. Intramuscular injection is not suitable for the treatment of acute conditions e.g., pulmonary oedema.
A change from parenteral to oral administration should be carried out as soon as possible.
Furosemide injection solution has a pH of about 9; it has no buffering capacity. For this reason, the active ingredient may precipitate at pH values < 7. Therefore, if Furosemide is diluted, care must be taken to ensure that the pH of the solution is within the slightly alkaline to neutral range. Normal saline is suitable as diluent. Diluted solutions should be used as soon as possible.
Furosemide must not be mixed with other drugs in the same syringe.
The duration of treatment is determined by the doctor and will depend on the nature and severity of illness.
Medical treatment may be required in the event of an overdose. Therefore, inform the doctor if overdosage is suspected.
The clinical picture of an acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss e.g., hypovolaemia, dehydration, haemoconcentration, cardiac arrhythmias (including AV block and ventricular fibrillation). Symptoms of these disturbances include severe hypotension (progressing to shock), acute renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion.
No specific antidote to Furosemide is known. If ingestion has only just taken place, attempts may be made to limit further systemic absorption of the active ingredient by measures eg., gastric lavage or those designed to reduce absorption (e.g., activated charcoal).
Clinically relevant disturbances in electrolyte and fluid balance must be corrected. 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.
Special Notes : Although administration of Furosemide only rarely leads to hypokalaemia, a potassium-rich diet (lean meat, potatoes, bananas, tomatoes, cauliflower, spinach, dried fruit, etc) is always advisable. Occasionally, treatment with potassium-containing or potassium-sparing preparations may be indicated.
Emergency Measures to be Taken in the Event of Anaphylactic Shock : Generally, the following emergency procedure is 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 down, with the legs raised and airways patent.
Emergency Drug Therapy : Immediately administer Epinephrine (Adrenaline) intravenously : In the first instance, slowly inject 1 ml of a solution containing Epinephrine 0.1 mg/ml while monitoring pulse and blood pressure (watch for disturbances in cardiac rhythm). Repeat as required.
Then volume substitution intravenous e.g., plasma expanders, human albumin and balanced electrolyte solution.
Subsequently, Glucocorticoids intravenous e.g., 250 – 1000 mg Methylprednisolone. Repeat as required.
The dosage recommendations refer to adults of normal weight. In children, the reduction of dose should be in relation to body weight.
Other therapeutic measures e.g., artificial respiration, oxygen inhalation and antihistaminics.
- Patients with renal failure accompanied by lack of urine formation (anuria).
- Hepatic coma and pre-coma.
- Electrolyte deficiencies e.g., severely reduced blood levels of potassium (hypokalaemia) or of sodium (hyponatraemia).
- Decreased volume of blood in the body (hypovolaemia) with or without reduced blood pressure (hypotension) or dehydration.
- Hypersensitivity to Furosemide or any of the excipients of this product.
- Patients allergic to Sulphonamides (e.g., Sulphonamide antibiotics or Sulphonylureas) may show cross-sensitivity to Furosemide.
- Use in pregnancy & lactation : Furosemide must not be given during pregnancy unless there are compelling medical reasons because Furosemide crosses the placental barrier. If Furosemide is given during pregnancy, fetal growth must be monitored. Furosemide must not be used during breastfeeding because Furosemide passes into breast milk and inhibits lactation.
WARNINGS AND PRECAUTIONS :
- Patients whose outflow is obstructed (e.g., those with prostatic hypertrophy, ureterostenosis or hydronephrosis), careful monitoring is required, especially at the beginning of treatment.
- Particularly careful surveillance is necessary in : Hypotension; patients at particular risk from a pronounced fall in blood pressure; latent or manifest diabetes mellitus; gout; renal failure in association with severe liver disease (hepatorenal syndrome); reduced protein content in the blood; premature infants.
- Serum sodium, potassium and creatinine should be monitored regularly. Patients at high risk of developing electrolyte imbalances, and those with significant additional fluid loss due to e.g., vomiting, diarrhoea, or intense sweating must be closely monitored. Hypovolaemia or dehydration, as well as any significant disturbances in electrolyte content and acid-base balance, must be corrected. A temporary discontinuation of treatment with Furosemide may become necessary. Where indicated, steps should be taken to correct hypotension or hypovolaemia before commencing therapy.
Uretic Injection 20 mg/2 ml Box, 10 ampoules @ 2 ml Reg. No. DKL0202332543A1
STORE BELOW 30oC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia