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16 HOW SUPPLIED/STORAGE AND HANDLING Furosemide Injection is a sterile, colorless solution for injection, available as a single-dose vial that contains 10 mg/mL of furosemide, and is supplied as follows: Unit of Sale Presentations Strength NDC 0143-9155-25 Box of 25 amber glass single-dose vials 20 mg/2 mL (10 mg/mL) NDC 0143-9156-10 Box of 10 amber glass single-dose vials 40 mg/4 mL (10 mg/mL) NDC 0143-9157-10 Box of 10 amber glass single-dose vials 100 mg/10 mL (10 mg/mL) NDC 0143-9158-01 Box of 1 clear glass single-dose vial with hanger 500 mg/50 mL (10 mg/mL) NDC 0143-9159-01 Box of 1 clear glass single-dose vial with hanger 1,000 mg/100 mL (10 mg/mL) Discard unused portion. Do not use if solution is discolored or contains particulate. 2 mL, 4 mL and 10 mL amber glass single-dose vials: Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature]. Protect from light. 50 mL and 100 mL clear glass single-dose vials: Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature]. Protect from light. Retain in carton until contents are used.; PRINCIPAL DISPLAY PANEL NDC 0143- 9155 -01 Rx Only Furosemide Injection, USP 20 mg per 2 mL (10 mg/mL) For Intravenous or Intramuscular Use 2 mL Single-Dose Vial Discard unused portion NDC 0143- 9155 -25 Rx Only Furosemide Injection, USP 20 mg per 2 mL (10 mg/mL) For Intravenous or Intramuscular Use 25 X 2 mL Single-Dose Vials Discard unused portion Furosemide 2 mL Vial Furosemide 2 mL Carton Label; PRINCIPAL DISPLAY PANEL NDC 0143- 9156 -01 Rx Only Furosemide Injection, USP 40 mg per 4 mL (10 mg/mL) For Intravenous or Intramuscular Use 4 mL Single-Dose Vial Discard unused portion NDC 0143- 9156 -10 Rx Only Furosemide Injection, USP 40 mg per 4 mL (10 mg/mL) For Intravenous or Intramuscular Use 10 X 4 mL Single-Dose Vials Discard unused portion Furosemide 4 mL Vial Furosemide 4 mL Carton Label; PRINCIPAL DISPLAY PANEL NDC 0143- 9157 -01 Rx Only Furosemide Injection, USP 100 mg per 10 mL (10 mg/mL) For Intravenous or Intramuscular Use 10 mL Single-Dose Vial Discard unused portion NDC 0143- 9157 -10 Rx Only Furosemide Injection, USP 100 mg per 10 mL (10 mg/mL) For Intravenous or Intramuscular Use 10 X 10 mL Single-Dose Vials Discard unused portion Furosemide 10 mL Vial Furosemide 10 mL Carton Label; PRINCIPAL DISPLAY PANEL NDC 0143- 9158 -01 Rx Only Furosemide Injection, USP 500 mg per 50 mL (10 mg/mL) For Intravenous or Intramuscular Use 50 mL Single-Dose Vial Discard unused portion NDC 0143- 9158 -01 Rx Only Furosemide Injection, USP 500 mg per 50 mL (10 mg/mL) For Intravenous or Intramuscular Use 1 x 50 mL Single-Dose Vial Discard unused portion Furosemide 50 mL Vial Furosemide 50 mL Carton; PRINCIPAL DISPLAY PANEL NDC 0143- 9159 -01 Rx Only Furosemide Injection, USP 1,000 mg per 100 mL (10 mg/mL) For Intravenous or Intramuscular Use 100 mL Single-Dose Vial Discard unused portion NDC 0143- 9159 -01 Rx Only Furosemide Injection, USP 1,000 mg per 100 mL (10 mg/mL) For Intravenous or Intramuscular Use 1 x 100 mL Single-Dose Vial Discard unused portion Furosemide 100 mL Vial Furosemide 100 mL Carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING Furosemide Injection is a sterile, colorless solution for injection, available as a single-dose vial that contains 10 mg/mL of furosemide, and is supplied as follows: Unit of Sale Presentations Strength NDC 0143-9155-25 Box of 25 amber glass single-dose vials 20 mg/2 mL (10 mg/mL) NDC 0143-9156-10 Box of 10 amber glass single-dose vials 40 mg/4 mL (10 mg/mL) NDC 0143-9157-10 Box of 10 amber glass single-dose vials 100 mg/10 mL (10 mg/mL) NDC 0143-9158-01 Box of 1 clear glass single-dose vial with hanger 500 mg/50 mL (10 mg/mL) NDC 0143-9159-01 Box of 1 clear glass single-dose vial with hanger 1,000 mg/100 mL (10 mg/mL) Discard unused portion. Do not use if solution is discolored or contains particulate. 2 mL, 4 mL and 10 mL amber glass single-dose vials: Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature]. Protect from light. 50 mL and 100 mL clear glass single-dose vials: Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature]. Protect from light. Retain in carton until contents are used.
- PRINCIPAL DISPLAY PANEL NDC 0143- 9155 -01 Rx Only Furosemide Injection, USP 20 mg per 2 mL (10 mg/mL) For Intravenous or Intramuscular Use 2 mL Single-Dose Vial Discard unused portion NDC 0143- 9155 -25 Rx Only Furosemide Injection, USP 20 mg per 2 mL (10 mg/mL) For Intravenous or Intramuscular Use 25 X 2 mL Single-Dose Vials Discard unused portion Furosemide 2 mL Vial Furosemide 2 mL Carton Label
- PRINCIPAL DISPLAY PANEL NDC 0143- 9156 -01 Rx Only Furosemide Injection, USP 40 mg per 4 mL (10 mg/mL) For Intravenous or Intramuscular Use 4 mL Single-Dose Vial Discard unused portion NDC 0143- 9156 -10 Rx Only Furosemide Injection, USP 40 mg per 4 mL (10 mg/mL) For Intravenous or Intramuscular Use 10 X 4 mL Single-Dose Vials Discard unused portion Furosemide 4 mL Vial Furosemide 4 mL Carton Label
- PRINCIPAL DISPLAY PANEL NDC 0143- 9157 -01 Rx Only Furosemide Injection, USP 100 mg per 10 mL (10 mg/mL) For Intravenous or Intramuscular Use 10 mL Single-Dose Vial Discard unused portion NDC 0143- 9157 -10 Rx Only Furosemide Injection, USP 100 mg per 10 mL (10 mg/mL) For Intravenous or Intramuscular Use 10 X 10 mL Single-Dose Vials Discard unused portion Furosemide 10 mL Vial Furosemide 10 mL Carton Label
- PRINCIPAL DISPLAY PANEL NDC 0143- 9158 -01 Rx Only Furosemide Injection, USP 500 mg per 50 mL (10 mg/mL) For Intravenous or Intramuscular Use 50 mL Single-Dose Vial Discard unused portion NDC 0143- 9158 -01 Rx Only Furosemide Injection, USP 500 mg per 50 mL (10 mg/mL) For Intravenous or Intramuscular Use 1 x 50 mL Single-Dose Vial Discard unused portion Furosemide 50 mL Vial Furosemide 50 mL Carton
- PRINCIPAL DISPLAY PANEL NDC 0143- 9159 -01 Rx Only Furosemide Injection, USP 1,000 mg per 100 mL (10 mg/mL) For Intravenous or Intramuscular Use 100 mL Single-Dose Vial Discard unused portion NDC 0143- 9159 -01 Rx Only Furosemide Injection, USP 1,000 mg per 100 mL (10 mg/mL) For Intravenous or Intramuscular Use 1 x 100 mL Single-Dose Vial Discard unused portion Furosemide 100 mL Vial Furosemide 100 mL Carton
Overview
Furosemide Injection, USP contains furosemide as the active pharmaceutical ingredient. Furosemide is a loop diuretic which is an anthranilic acid derivative. Furosemide chemical name is 4-chloro- N -furfuryl-5-sulfamoylanthranilic acid. Furosemide 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: Molecular formula: C 12 H 11 CIN 2 O 5 S Molecular weight: 330.74 Furosemide Injection, USP 10 mg/mL is a sterile, non-pyrogenic solution, available in single-dose vials for intravenous and intramuscular injection. Each mL contains: Furosemide 10 mg, Sodium Chloride 7.5 mg for isotonicity, Sodium Hydroxide 1.35 mg, Sodium Hydroxide and Hydrochloric Acid, if necessary, to adjust pH between 8.0 and 9.3, Water for Injection q.s. Structural Formula
Indications & Usage
Furosemide injection is a loop diuretic indicated for: The treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease ( 1.1 ) Acute pulmonary edema as adjunctive therapy ( 1.2 ) 1.1 Edema Furosemide injection is indicated in adults and pediatric patients for the treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 1.2 Acute Pulmonary Edema Furosemide injection is indicated as adjunctive therapy in acute pulmonary edema.
Dosage & Administration
Edema : Initial dose is 20 mg to 40 mg once given intramuscularly or intravenously. The intravenous dose should be administered slowly over 1 minute to 2 minutes ( 2.2 ) If needed, a second dose may be administered 2 hours after the first dose ( 2.2 ) May be administered as a continuous intravenous infusion at a rate not greater then 4 mg/min ( 2.2 ) Acute Pulmonary Edema : Initial dose is 40 mg injected slowly intravenously over 1 minute to 2 minutes ( 2.2 ) If needed, a second dose is 80 mg injected intravenously slowly over 1 minute to 2 minutes may be given after 1 hour ( 2.2 ) Pediatric Dosage : The initial dose in pediatric patients is 1 mg/kg body weight once given slowly intramuscularly or intravenously. If needed, 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 ( 2.3 ) 2.1 General Considerations Inspect Furosemide injection visually for particulate matter and discoloration before administration. Discard unused portion. 2.2 Recommended Dosage for Adults Edema Individualize therapy according to patient response. The usual initial dose of furosemide is 20 mg to 40 mg given as a single-dose, injected intramuscularly or intravenously. Give the intravenous dose slowly (over 1 minute to 2 minutes). If needed, administer another dose in the same manner 2 hours later or increase the dose. The dose may be raised by 20 mg and administered not sooner than 2 hours after the previous dose until the desired diuretic effect has been obtained. Administer this individually determined single-dose once or twice daily. Furosemide may also be administered via continuous intravenous infusion at a rate not greater than 4 mg/min. Acute Pulmonary Edema The usual initial dose of furosemide is 40 mg injected slowly intravenously (over 1 minute to 2 minutes). If a satisfactory response does not occur within 1 hour, increase the dose to 80 mg injected slowly intravenously (over 1 minute to 2 minutes). 2.3 Recommended Dosage for Pediatric Patients The usual initial dose of Furosemide injection (intravenously or intramuscularly) in pediatric patients is 1 mg/kg body weight administered slowly (over 1 minute to 2 minutes). 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. The maximum dose for premature infants should not exceed 1 mg/kg/day [see Use in Specific Populations ( 8.4 )] .
Warnings & Precautions
Fluid, Electrolyte, and Metabolic Abnormalities : Monitor serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid ( 5.1 ) Worsening Renal Function : Monitor for dehydration and azotemia. ( 5.2 ) Ototoxicity: Avoid rapid injection and higher than recommended doses. ( 5.3 , 7.1 ) Acute Urinary Retention : Monitor patients with symptoms of urinary retention. ( 5.4 ) 5.1 Fluid, Electrolyte, and Metabolic Abnormalities Furosemide may cause fluid, electrolyte, and metabolic abnormalities such as hypovolemia, hypokalemia, azotemia, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypocalcemia, hyperglycemia, or hyperuricemia, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy. In patients with hepatic cirrhosis and ascites, sudden alterations of fluid and electrolyte balance may precipitate hepatic encephalopathy and coma. Treatment in such patients is best initiated in the hospital with small doses and careful monitoring of the patient's clinical status and electrolyte balance. 5.2 Worsening Renal Function Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued [see Clinical Pharmacology ( 12.3 )] . Furosemide use in the first year of life, especially in patients born pre-term, may precipitate nephrocalcinosis/nephrolithiasis. Therefore renal function must be monitored and renal ultrasonography performed in this age group [see Use in Specific Populations ( 8.4 )] . 5.3 Ototoxicity 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 aminoglycoside 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 Drug Interactions ( 7.1 )] . Hearing loss in neonates, including premature neonates has been associated with the use of Furosemide injection [see Use in Specific Populations ( 8.4 )]. 5.4 Acute Urinary Retention In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. Thus, these patients require careful monitoring, especially during the initial stages of treatment.
Contraindications
Furosemide injection is contraindicated in patients with anuria. Furosemide injection is contraindicated in patients with a history of hypersensitivity to furosemide. Anuria ( 4 ) Hypersensitivity to furosemide ( 4 )
Adverse Reactions
The following adverse reactions are described elsewhere in the labeling: Fluid, Electrolyte, and Metabolic Abnormalities [see Warnings and Precautions ( 5.1 )] Ototoxicity [see Warnings and Precautions ( 5.3 )] The following adverse reactions associated with the use of furosemide were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions: pancreatitis, jaundice (intrahepatic cholestatic jaundice), increased liver enzymes, anorexia, oral and gastric irritation, cramping, diarrhea, constipation, nausea, vomiting. Systemic Hypersensitivity Reactions: severe anaphylactic or anaphylactoid reactions (e.g., with shock), systemic vasculitis, interstitial nephritis, necrotizing angiitis. Central Nervous System Reactions: tinnitus and hearing loss, paresthesias, vertigo, dizziness, headache, blurred vision, xanthopsia. Hematologic Reactions: aplastic anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, leukopenia, anemia, eosinophilia. Dermatologic-Hypersensitivity Reactions: toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, drug rash with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, exfoliative dermatitis, bullous pemphigoid, purpura, photosensitivity, rash. Cardiovascular Reactions: orthostatic hypotension, increase in cholesterol and triglyceride serum levels. Other Reactions: glycosuria, muscle spasm, weakness, restlessness, urinary bladder spasm, thrombophlebitis, transient injection site pain following intramuscular injection, fever. Most common adverse reactions are related to fluid and electrolyte imbalance ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug Interactions
Aminoglycoside antibiotics : Increased potential ototoxicity of the antibiotics. Avoid combination ( 7.1 ) Ethacrynic acid : Risk of ototoxicity. Avoid combination ( 7.1 ) Salicylates : Risk of salicylate toxicity ( 7.1 ) Cisplatin and nephrotoxic drugs : Risk of ototoxicity and nephrotoxicity ( 7.1 ) Lithium : Risk of lithium toxicity ( 7.1 ) Renin-angiotensin inhibitors : Increased risk of hypotension and renal failure.( 7.1 ) Adrenergic blocking drugs : Risk of potentiation ( 7.1 ) Drugs undergoing renal tubular secretion : Risk of toxicity potentiation ( 7.1 ) 7.1 Effects of Furosemide on Other Drugs Drug/Substance Class or Name Drug Interaction Effect Recommendations Aminoglycoside antibiotics Furosemide may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function [see Warnings and Precautions ( 5.3 )]. Avoid combination except in life-threatening situations. Ethacrynic acid Possibility of ototoxicity [see Warnings and Precautions ( 5.3 )]. Avoid concomitant use with ethacrynic acid. Salicylates May experience salicylate toxicity at lower doses because of competitive renal excretory sites. Monitor for symptoms of salicylate toxicity. Cisplatin There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly [see Warnings and Precautions ( 5.3 )]. Cisplatin and nephrotoxic drugs Nephrotoxicity Administer furosemide at lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment. Monitor renal function. Paralytic agents Furosemide has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine. Monitor for skeletal muscle effect. Lithium Furosemide reduces lithium’s renal clearance and add a high-risk of lithium toxicity. Avoid concomitant use with lithium. Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers May lead to severe hypotension and deterioration in renal function, including renal failure. Monitor for changes in blood pressure and renal function and interrupt or reduce the dosage of furosemide, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers if needed. Antihypertensive drugs Furosemide may add to or potentiate the therapeutic effect of other antihypertensive drugs. Monitor for changes in blood pressure and adjust the dose of other antihypertensive drugs if needed. Adrenergic blocking drugs or peripheral adrenergic blocking drugs Potentiation occurs. Monitor for changes in blood pressure and adjust the dose of adrenergic blocking drugs if needed. Norepinephrine Furosemide may decrease arterial responsiveness (vasoconstricting effect) to norepinephrine. Monitor blood pressure (or mean arterial pressure). Chloral hydrate In isolated cases, intravenous administration of furosemide within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Concomitant use with chloral hydrate is not recommended. Methotrexate and other drugs undergoing renal tubular secretion Furosemide may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of furosemide may result in elevated serum levels of these drugs and may potentiate their toxicity. Monitor serum levels of drugs undergoing renal tubular secretion and adjust the dose if needed. Cephalosporin Furosemide can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment. Monitor for changes in renal function. Cyclosporine Increased risk of gouty arthritis secondary to furosemide-induced hyperuricemia and cyclosporine impairment of renal urate excretion. Monitor serum urate levels. Thyroid hormones High-doses (> 80 mg) of furosemide may inhibit the binding of thyroid hormones to carrier proteins and result in transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels. Monitor the total thyroid hormone levels. 7.2 Effects of Other Drugs on Furosemide Drug/Substance Class or Name Drug Interaction Effect Recommendations Phenytoin Interferes directly with renal action of furosemide. Monitor diuretic effects of furosemide and adjust the dose of furosemide if needed. Methotrexate and other drugs undergoing renal tubular secretion May reduce the effect of furosemide. High-dose treatment of methotrexate and these other drugs may result in elevated serum levels of furosemide and may potentiate the toxicity of furosemide. Monitor for enhanced toxicity of furosemide. Indomethacin Coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of furosemide in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and furosemide should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved.
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