FUROSEMIDE INJ USP is a brand name for Furosemide (also known as Frusemide), supplied as a liquid. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
Do not add furosemide into the tubing of a running infusion solution. Changes in blood pressure should be carefully monitored when furosemide is used with other antihypertensive drugs, especially during initial therapy. The dosage of other agents must be reduced by at least 50% as soon as furosemide is added to the regimen to prevent an excessive drop in blood pressure.
As blood pressure falls under the potentiating effects of furosemide, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.
Adults Edema:
Usual initial dose is 20 to 40 mg injected IM or IV as a single dose. IV injections should be given slowly over a period of 1 to 2 minutes. Ordinarily, a prompt diuresis ensues. If the diuretic response with a single dose of 20 to 40 mg is not satisfactory it may be increased by increments of 20 mg not sooner than 2 hours after the previous dose until the desired diuretic effect has been obtained.
Maximum daily dose: 100 mg. Once the effective single dose has been determined, it should then be given once or twice daily. Parenteral furosemide therapy should be replaced by oral therapy as soon as this is practical. 5 hours later, as indicated by the patient's condition.
Children Institute therapy in the hospital, in carefully selected patients, under close observation with frequent monitoring of serum electrolytes. Do not add furosemide into the tubing of a running infusion solution. 0 mg/kg body weight.
The total daily dose (given in divided doses of 6 to 12 hours apart) should not exceed 2 mg/kg orally or 1 mg/kg parenterally. In the newborn and in premature babies, the daily dose should not exceed 1 mg/kg. Adopt an intermittent dosage schedule as soon as possible using the minimum effective dose at the longest possible intervals.
Particular caution with potassium concentrations is always desirable when furosemide is used in infants and children. Absorption, Metabolism and Excretion Following intravenous administration of Furosemide Injection USP, the diuresis occurs within 30 minutes and the duration of action is about 2 hours.
Urinary excretion is accomplished both by glomerular filtration and proximal tubular secretion; together this accounts for roughly 2/3 of the dose, the remainder being excreted in the feces. A small fraction is metabolised by cleavage of the side chain.
Furosemide Injection UPS Page 11 of 16 The following Table summarizes the elimination kinetics of furosemide. Subjects Route of Administration Dose (mg) Rate of Administration Biliary Excretion Max. V. V. V. 1000 4 mg/min -- 29 mcg/ml -- Furosemide Injection UPS Page 12 of 16 PHARMACEUTICAL INFORMATION Drug Substance Proper Name: Furosemide Chemical Name: 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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8 g/mol Description: White to yellowish white crystalline powder soluble in acetone, dimethylformamide, dilute alkalis, and ethanol, slightly soluble in water, with a melting range of 202 to 205C (with decomposition). Furosemide Injection UPS Page 13 of 16 COMPOSITION Each mL of Furosemide Injection USP contains: furosemide 10 mg, sodium hydroxide to adjust pH and water for injection.
STABILITY AND STORAGE RECOMMENDATIONS Store between 15C and 30C. AVAILABILITY Furosemide Injection USP is available in single use 2 mL amber ampoules, boxes of 10 and in single use 4 mL amber vials, boxes of 10. TOXICOLOGY Acute In mice the LD50 after IV or IM injection are respectively 528 and >250 mg/kg of body weight.
6 mg/kg respectively. Most animals exhibited reduced motor activity, muscular weakness, ataxia and bradypnea. Furosemide has been reported to be more toxic in newborn than adult rats. Chronic Toxicity Rats A one year study was performed on 100 Wistar rats at dosages of 0, 50, 100, 200 and 400 mg/kg/day, five days a week.
The drug was administered by gastric intubation in the form of an aqueous suspension. Discharge from the eye, lethargy, anorexia, dyspnea and weight loss have been observed in animals receiving 200 mg/kg and 400 mg/kg doses. One death in the 100 mg/kg, two in the 200 mg/kg and ten in the 400 mg/kg groups occurred.
There was a significant dose-related increase in the relative weight of the kidneys. Cardiac and hepatic lesions, related to furosemide, have been observed. Histological examination of the myocardium revealed severe local fibrosis, similar to the fibrosis induced by potassium deficiency.
The most consistent pathological changes seen in the kidney were degenerative changes in the tubular epithelium manifested by swollen cells with increased density of the cytoplasm. Furosemide Injection UPS Page 14 of 16 Occasionally, focal necrosis of the epithelium and decreased cell size were evident, and accumulation of some calcified material.
These changes were considered consistent with the nephropathy of potassium deficiency. Dogs In a six-month study, twenty beagle dogs have been treated with oral daily doses of 0, 10, 30, 100 and 350 mg/kg. The highest dose was reduced to 250 mg/kg after the death of two of the four dogs in that group.
Levels of blood sugar and urea nitrogen were elevated in the animals treated with the highest doses. These normalized after treatment was stopped. Urinalysis remainded normal throughout the investigation except for urinary volume, creatinine and electrolyte levels.
These changes are in keeping with the action of a diuretic drug. There was no significant or consistent effect on organ weight. The most consistent pathological findings were renal lesions consisting of calcifications and […]