Product Elements:
Furosemide furosemide furosemide furosemide sodium chloride sodium hydroxide hydrochloric acid water furosemide furosemide furosemide furosemide sodium chloride sodium hydroxide hydrochloric acid water furosemide furosemide furosemide furosemide sodium chloride sodium hydroxide hydrochloric acid water
Boxed Warning:
Warning furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patientâs needs. (see dosage and administration .)
Indications and Usage:
Indications and usage parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. edema: furosemide injection is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. furosemide injection is particularly useful when an agent with greater diuretic potential is desired. furosemide injection is indicated as adjunctive therapy in acute pulmonary edema. the intravenous administration of furosemide injection is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. if gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide injection is indicated by the intravenous or intramuscular route. parenteral use should be replaced with oral furosemide as soon as practical.
Warnings:
Warnings in patients with hepatic cirrhosis and ascites, furosemide therapy is best initiated in the hospital. in hepatic coma and in states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma; therefore, strict observation is necessary during the period of diuresis. supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis. if increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued. cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminogl
Read more...ycoside antibiotics, ethacrynic acid, or other ototoxic drugs. if the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used). (see precautions, drug interactions . ) pediatric use: in premature neonates with respiratory distress syndrome, diuretic treatment with furosemide in the first few weeks of life may increase the risk of persistent patent ductus arteriosus (pda), possibly through a prostaglandin-e-mediated process. literature reports indicate that premature infants with post conceptual age (gestational plus postnatal) less than 31 weeks receiving doses exceeding 1 mg/kg/24 hours may develop plasma levels which could be associated with potential toxic effects including ototoxicity. hearing loss in neonates has been associated with the use of furosemide injection (see warnings , above).
Dosage and Administration:
Dosage and administration adults parenteral therapy with furosemide injection should be used only in patients unable to take oral medication or in emergency situations and should be replaced with oral therapy as soon as practical. edema the usual initial dose of furosemide is 20 to 40 mg given as a single-dose, injected intramuscularly or intravenously. the intravenous dose should be given slowly (1 to 2 minutes). ordinarily a prompt diuresis ensues. if needed, another dose may be administered in the same manner 2 hours later or the dose may be increased. the dose may be raised by 20 mg and given not sooner than 2 hours after the previous dose until the desired diuretic effect has been obtained. this individually determined single-dose should then be given once or twice daily. therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response. close medical supervision is necessary. when
Read more... furosemide injection is given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable. (see precautions: laboratory tests . ) if the physician elects to use high dose parenteral therapy, add the furosemide injection to either sodium chloride injection usp, lactated ringer's injection usp, or dextrose (5%) injection usp after ph has been adjusted to above 5.5, and administer as a controlled intravenous infusion at a rate not greater than 4 mg/min. furosemide injection is a buffered alkaline solution with a ph of about 9 and drug may precipitate at ph values below 7. care must be taken to ensure that the ph of the prepared infusion solution is in the weakly alkaline to neutral range. acid solutions, including other parenteral medications (e.g., labetalol, ciprofloxacin, amrinone, milrinone) must not be administered concurrently in the same infusion because they may cause precipitation of the furosemide. in addition, furosemide injection should not be added to a running intravenous line containing any of these acidic products. acute pulmonary edema the usual initial dose of furosemide is 40 mg injected slowly intravenously (over 1 to 2 minutes). if a satisfactory response does not occur within 1 hour, the dose may be increased to 80 mg injected slowly intravenously (over 1 to 2 minutes). if necessary, additional therapy (e.g., digitalis, oxygen) may be administered concomitantly. geriatric patients in general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range. (see precautions: geriatric use . ) pediatric patients parenteral therapy should be used only in patients unable to take oral medication or in emergency situations and should be replaced with oral therapy as soon as practical. the usual initial dose of furosemide injection (intravenously or intramuscularly) in pediatric patients is 1 mg/kg body weight and should be given slowly under close medical supervision. if the diuretic response to the initial dose is not satisfactory, dosage may be increased by 1 mg/kg not sooner than 2 hours after the previous dose, until the desired diuretic effect has been obtained. doses greater than 6 mg/kg body weight are not recommended. literature reports suggest that the maximum dose for premature infants should not exceed 1 mg/kg/day. (see warnings, pediatric use. ) furosemide injection should be inspected visually for particulate matter and discoloration before administration.
Contraindications:
Contraindications furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.
Adverse Reactions:
Adverse reactions adverse reactions are categorized below by organ system and listed by decreasing severity. gastrointestinal system reactions 1. hepatic encephalopathy in patients with hepatocellular insufficiency 2. pancreatitis 3. jaundice (intrahepatic cholestatic jaundice) 4. increased liver enzymes 5. anorexia 6. oral and gastric irritation 7. cramping 8. diarrhea 9. constipation 10. nausea 11. vomiting systemic hypersensitivity reactions 1. severe anaphylactic or anaphylactoid reactions (e.g. with shock) 2. systemic vasculitis 3. interstitial nephritis 4. necrotizing angiitis central nervous system reactions 1. tinnitus and hearing loss 2. paresthesias 3. vertigo 4. dizziness 5. headache 6. blurred vision 7. xanthopsia hematologic reactions 1. aplastic anemia 2. thrombocytopenia 3. agranulocytosis 4. hemolytic anemia 5. leukopenia 6. anemia 7. eosinophilia dermatologic-hypersensitivity reactions 1. exfoliative dermatitis 2. bullous pemphigoid 3. erythema multiforme 4. purpura 5.
Read more... photosensitivity 6. urticaria 7. rash 8. pruritus 9. stevens-johnson syndrome 10. toxic epidermal necrolysis cardiovascular reactions 1. orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics 2. increase in cholesterol and triglyceride serum levels. other reactions 1. hyperglycemia 2. glycosuria 3. hyperuricemia 4. muscle spasms 5. weakness 6. restlessness 7. urinary bladder spasm 8. thrombophlebitis 9. transient injection site pain following intramuscular injection 10. fever whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.
Overdosage:
Overdosage the principal signs and symptoms of overdose with furosemide are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its diuretic action. the acute toxicity of furosemide has been determined in mice, rats and dogs. in all three, the oral ld50 exceeded 1,000 mg/kg body weight, while the intravenous ld50 ranged from 300 to 680 mg/kg. the acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats. the concentration of furosemide in biological fluids associated with toxicity or death is not known. treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses. serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy). hemodialysis does not accelerate furosemide elimination.
Description:
Description furosemide is a diuretic which is an anthranilic acid derivative. chemically, it is 4-chloro- n- furfuryl-5-sulfamoylanthranilic acid. furosemide injection usp, 10 mg/ml is a sterile, non-pyrogenic, clear colorless solution in vials for intravenous and intramuscular injection. furosemide, usp is a white to slightly yellow, crystalline powder. it is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. the structural formula is as follows: each ml contains: furosemide, usp 10 mg, water for injection q.s., sodium chloride for isotonicity, sodium hydroxide and, if necessary, hydrochloric acid to adjust ph between 8.0 and 9.3. furosemide chemical structure
Clinical Pharmacology:
Clinical pharmacology investigations into the mode of action of furosemide have utilized micropuncture studies in rats, stop flow experiments in dogs and various clearance studies in both humans and experimental animals. it has been demonstrated that furosemide inhibits primarily the reabsorption of sodium and chloride not only in the proximal and distal tubules but also in the loop of henle. the high degree of efficacy is largely due to this unique site of action. the action on the distal tubule is independent of any inhibitory effect on carbonic anhydrase and aldosterone. recent evidence suggests that furosemide glucuronide is the only or at least the major biotransformation product of furosemide in man. furosemide is extensively bound to plasma proteins, mainly to albumin. plasma concentrations ranging from 1 to 400 mcg/ml are 91 to 99% bound in healthy individuals. the unbound fraction averages 2.3 to 4.1% at therapeutic concentrations. the onset of diuresis following intravenous a
Read more...dministration is within 5 minutes and somewhat later after intramuscular administration. the peak effect occurs within the first half hour. the duration of diuretic effect is approximately 2 hours. in fasted normal men, the mean bioavailability of furosemide from furosemide tablets and furosemide oral solution is 64% and 60%, respectively, of that from an intravenous injection of the drug. although furosemide is more rapidly absorbed from the oral solution (50 minutes) than from the tablet (87 minutes), peak plasma levels and area under the plasma concentration-time curves do not differ significantly. peak plasma concentrations increase with increasing dose but times-to-peak do not differ among doses. the terminal half-life of furosemide is approximately 2 hours. significantly more furosemide is excreted in urine following the intravenous injection than after the tablet or oral solution. there are no significant differences between the two oral formulations in the amount of unchanged drug excreted in urine. geriatric population furosemide binding to albumin may be reduced in elderly patients. furosemide is predominantly excreted unchanged in the urine. the renal clearance of furosemide after intravenous administration in older healthy male subjects (60 to 70 years of age) is statistically significantly smaller than in younger healthy male subjects (20 to 35 years of age). the initial diuretic effect of furosemide in older subjects is decreased relative to younger subjects. (see precautions: geriatric use .)
How Supplied:
How supplied furosemide injection, usp is a sterile, non-pyrogenic, clear colorless solution and is available as follows: 20 mg per 2 ml (10 mg/ml) 2 ml single-dose amber colored vials in a carton of 25 ndc 55150-322-25 40 mg per 4 ml (10 mg/ml) 4 ml single-dose amber colored vials in a carton of 25 ndc 55150-323-25 100 mg per 10 ml (10 mg/ml) 10 ml single-dose amber colored vials in a carton of 25 ndc 55150-324-25 do not use if solution is discolored. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from light. the vial stopper is not made with natural rubber latex. distributed by: auromedics pharma llc 279 princeton-hightstown rd. e. windsor, nj 08520 manufactured by: eugia pharma specialities limited hyderabad - 500032 india revised: december 2021
Package Label Principal Display Panel:
Package label-principal display panel - 20 mg per 2 ml (10 mg/ml) - container label rx only ndc 55150-322-01 furosemide injection, usp 20 mg per 2 ml (10 mg/ml) for i.v. or i.m. use preservative free 2 ml single dose vial package label-principal display panel - 20 mg per 2 ml (10 mg/ml) â container label
Package label-principal display panel - 20 mg per 2 ml (10 mg/ml) â container-carton (25 vials) rx only ndc 55150-322-25 furosemide injection, usp 20 mg per 2 ml (10 mg/ml) for intravenous or intramuscular use preservative free 25 x 2 ml single dose vials auromedics package label-principal display panel - 20 mg per 2 ml (10 mg/ml) â container-carton (25 vials)
Package label-principal display panel - 40 mg per 4 ml (10 mg/ml) â container label rx only ndc 55150-323-01 furosemide injection, usp 40 mg per 4 ml (10 mg/ml) for intravenous or intramuscular use preservative free 4 ml single dose vial package label-principal display panel - 40 mg per 4 ml (10 mg/ml) â container label
Package label-principal display panel - 40 mg per 4 ml (10 mg/ml) â container-carton (25 vials) rx only ndc 55150-323-25 furosemide injection, usp 40 mg per 4 ml (10 mg/ml) for intravenous or intramuscular use preservative free 25 x 4 ml single dose vials auromedics package label-principal display panel - 40 mg per 4 ml (10 mg/ml) â container-carton (25 vials)
Package label-principal display panel - 100 mg per 10 ml (10 mg/ml) â container label rx only ndc 55150-324-01 furosemide injection, usp 100 mg per 10 ml (10 mg/ml) for intravenous or intramuscular use preservative free 10 ml single dose vial package label-principal display panel - 100 mg per 10 ml (10 mg/ml) â container label
Package label-principal display panel - 100 mg per 10 ml (10 mg/ml) â container-carton (25 vials) rx only ndc 55150-324-25 furosemide injection, usp 100 mg per 10 ml (10 mg/ml) for intravenous or intramuscular use preservative free 25 x 10 ml single dose vials auromedics package label-principal display panel - 100 mg per 10 ml (10 mg/ml) â container-carton (25 vials)