Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING FUROSCIX injection is a sterile, clear to slightly yellow, non-pyrogenic liquid supplied in a single-dose prefilled cartridge for subcutaneous infusion co-packaged with the On-body Infusor. Each single-use On-body Infusor with prefilled cartridge is designed to deliver 80 mg of FUROSCIX in 10 mL solution over 5-hours. Carton containing one 80 mg/10 mL (8 mg/mL) prefilled cartridge co-packaged with one On-body Infusor NDC 71767-100-01 Store between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze. Protect FUROSCIX from light. Do not remove the cartridge from carton until it is ready for use. Do not use if the solution is discolored or cloudy. Protect the On-body Infusor from water.; Cartridge Carton NDC 71767-100 FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) 10 mL Single Dose Cartridge FOR SUBCUTANEOUS USE ONLY Rx Only Drug Product Cartridge Carton; Cartridge NDC 71767-100 FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) 10 mL Single Dose Cartridge FOR SUBCUTANEOUS USE ONLY Rx Only Drug Product Cartridge; Device Tyvek Lid On-Body Infusor for FUROSCIX® (furosemide injection) 80 mg/10 mL (8 mg/mL) For subcutaneous use Device Tyvek Lid; Device (Direct Pad Printing) On-Body Infusor for FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) For subcutaneous use Device Pad; Combination Product Primary Carton NDC 71767-100-01 1 X 10 mL Single Dose Prefilled Cartridge 1 X Single Use On-Body Infusor FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) FOR SUBCUTANEOUS USE ONLY Single Dose Rx Only Combination Product Primary Carton; Combination Product Physician Sample Primary Carton NDC 71767-100-01 PHYSICIAN SAMPLE ONLY NOT FOR SALE 1 X 10 mL Single Dose Prefilled Cartridge 1 X Single Use On-Body Infusor FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) FOR SUBCUTANEOUS USE ONLY Single Dose Rx Only Physician Sample
- 16 HOW SUPPLIED/STORAGE AND HANDLING FUROSCIX injection is a sterile, clear to slightly yellow, non-pyrogenic liquid supplied in a single-dose prefilled cartridge for subcutaneous infusion co-packaged with the On-body Infusor. Each single-use On-body Infusor with prefilled cartridge is designed to deliver 80 mg of FUROSCIX in 10 mL solution over 5-hours. Carton containing one 80 mg/10 mL (8 mg/mL) prefilled cartridge co-packaged with one On-body Infusor NDC 71767-100-01 Store between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze. Protect FUROSCIX from light. Do not remove the cartridge from carton until it is ready for use. Do not use if the solution is discolored or cloudy. Protect the On-body Infusor from water.
- Cartridge Carton NDC 71767-100 FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) 10 mL Single Dose Cartridge FOR SUBCUTANEOUS USE ONLY Rx Only Drug Product Cartridge Carton
- Cartridge NDC 71767-100 FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) 10 mL Single Dose Cartridge FOR SUBCUTANEOUS USE ONLY Rx Only Drug Product Cartridge
- Device Tyvek Lid On-Body Infusor for FUROSCIX® (furosemide injection) 80 mg/10 mL (8 mg/mL) For subcutaneous use Device Tyvek Lid
- Device (Direct Pad Printing) On-Body Infusor for FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) For subcutaneous use Device Pad
- Combination Product Primary Carton NDC 71767-100-01 1 X 10 mL Single Dose Prefilled Cartridge 1 X Single Use On-Body Infusor FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) FOR SUBCUTANEOUS USE ONLY Single Dose Rx Only Combination Product Primary Carton
- Combination Product Physician Sample Primary Carton NDC 71767-100-01 PHYSICIAN SAMPLE ONLY NOT FOR SALE 1 X 10 mL Single Dose Prefilled Cartridge 1 X Single Use On-Body Infusor FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) FOR SUBCUTANEOUS USE ONLY Single Dose Rx Only Physician Sample
Overview
FUROSCIX (furosemide injection 80 mg/10 mL) is a loop diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is a white to slightly yellow crystalline powder. It is 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 ClN 2 O 5 S Molecular Weight: 330.75 g/mol FUROSCIX is a single-dose prefilled cartridge co-packaged with a single-use, On-body Infusor. The single-dose prefilled cartridge contains 80 mg per 10 mL sterile, clear to slightly yellow, and non-pyrogenic furosemide solution. The pH of FUROSCIX, 7.4, differs from that of Furosemide Injection, USP. Each 1 mL of FUROSCIX contains the following inactive ingredients: hydrochloric acid for pH adjustment if needed, sodium chloride (5.84 mg), sodium hydroxide for pH adjustment if needed, tris HCl (7.88 mg), and water for injection (q.s.). FUROSCIX is administered via a wearable, single-use, electromechanical (battery powered, micro-processor controlled), On-body delivery system that is pre-programmed to deliver 80 mg of FUROSCIX over 5-hours using a bi-phasic delivery profile. Structure
Indications & Usage
FUROSCIX is indicated for the treatment of edema in pediatric patients weighing 43 kg and above and in adult patients adult patients with chronic heart failure or chronic kidney disease (CKD), including the nephrotic syndrome. FUROSCIX is a loop diuretic indicated for the treatment of edema in pediatric patients weighing 43 kg and above and in adult patients with chronic heart failure or chronic kidney disease, including the nephrotic syndrome. ( 1 )
Dosage & Administration
The single-use, On-body Infusor is pre-programmed to deliver 30mg of furosemide over the first hour then 12.5 mg per hour for the subsequent 4 hours. ( 2.1 ) FUROSCIX is not for chronic use and should be replaced with oral diuretics as soon as practical. ( 2.1 ) See Full Prescribing Information for important administration instructions. ( 2.2 ) 2.1 Recommended Dosage The single-use, On-body Infusor with prefilled cartridge is pre-programmed to deliver 30 mg of furosemide over the first hour followed by 12.5 mg per hour for the subsequent 4 hours [see Use in Specific Populations ( 8.6 ) and see Clinical Pharmacology ( 12 )]. FUROSCIX is not for chronic use and should be replaced with oral diuretics as soon as practical. 2.2 Important Administration Instructions FUROSCIX is intended for use in a setting where the patient can limit their activity for the duration of administration. [see Warnings and Precautions ( 5.5 )] FUROSCIX is not compatible with use in an MRI setting. Inspect FUROSCIX prefilled cartridge prior to administration. FUROSCIX is a clear to slightly yellow solution. Do not use FUROSCIX if solution is discolored or cloudy [see Description ( 11 )] . Refer to the Instructions for Use for additional information. Load the prefilled cartridge of furosemide into the On-body Infusor and close the cartridge holder. Peel away the adhesive liner on the On-body Infusor and apply onto a clean, dry area of the abdomen between the top of the beltline and the bottom of the ribcage that is not tender, bruised, red or indurated. The distance from the top of the beltline to the bottom of the ribcage should be at least 2 ½ inches. Start the injection by firmly pressing and releasing the blue start button. Do not remove until the injection is complete (signaled by the solid green status light, beeping sound, and the white plunger rod filling the cartridge window). Rotate the site of each subcutaneous administration. In pediatric patients weighing at least 43 kg, FUROSCIX must be administered by a healthcare provider or adult caregiver. Adult patients or caregivers should receive proper instruction in preparing and administering FUROSCIX before using the FUROSCIX On-body Infusor. 2.1 Recommended Dosage The single-use, On-body Infusor with prefilled cartridge is pre-programmed to deliver 30 mg of furosemide over the first hour followed by 12.5 mg per hour for the subsequent 4 hours [see Use in Specific Populations ( 8.6 ) and see Clinical Pharmacology ( 12 )]. FUROSCIX is not for chronic use and should be replaced with oral diuretics as soon as practical. 2.2 Important Administration Instructions FUROSCIX is intended for use in a setting where the patient can limit their activity for the duration of administration. [see Warnings and Precautions ( 5.5 )] FUROSCIX is not compatible with use in an MRI setting. Inspect FUROSCIX prefilled cartridge prior to administration. FUROSCIX is a clear to slightly yellow solution. Do not use FUROSCIX if solution is discolored or cloudy [see Description ( 11 )] . Refer to the Instructions for Use for additional information. Load the prefilled cartridge of furosemide into the On-body Infusor and close the cartridge holder. Peel away the adhesive liner on the On-body Infusor and apply onto a clean, dry area of the abdomen between the top of the beltline and the bottom of the ribcage that is not tender, bruised, red or indurated. The distance from the top of the beltline to the bottom of the ribcage should be at least 2 ½ inches. Start the injection by firmly pressing and releasing the blue start button. Do not remove until the injection is complete (signaled by the solid green status light, beeping sound, and the white plunger rod filling the cartridge window). Rotate the site of each subcutaneous administration. In pediatric patients weighing at least 43 kg, FUROSCIX must be administered by a healthcare provider or adult caregiver. Adult patients or caregivers should receive proper instruction in preparing and administering FUROSCIX before using the FUROSCIX On-body Infusor.
Warnings & Precautions
Fluid, Electrolyte, and Metabolic Abnormalities : Monitor serum electrolytes, CO 2 , BUN, creatinine, glucose, and uric acid. ( 5.1 ) Worsening Renal Function : Monitor for dehydration and azotemia. ( 5.2 ) Ototoxicity : Avoid higher than recommended doses. ( 5.3 , 7.1 ) Acute Urinary Retention : Monitor patients with symptoms of urinary retention. ( 5.4 ) Incomplete Dosing : Fluid contact and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure the patient or caregiver can detect and respond to alarms. ( 5.5 ) 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, CO 2 , BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy [see Use in Specific Populations ( 8.6 )] . 5.2 Worsening Renal Function Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide [see Clinical Pharmacology ( 12.3 )]. 5.3 Ototoxicity Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. 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 )]. 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. These patients require careful monitoring, especially during the initial stages of treatment. 5.5 Incomplete Dosing The On-body Infusor should not be allowed to get wet from water or any other fluids (blood or drug product). Fluid contact with the circuit board can lead to device errors and premature termination of infusion. The On-body Infusor is intended for use in a setting where the patient can limit their activity for the duration of administration. Certain patient movements may cause interruption of device adherence to skin and premature termination of infusion. The On-body Infusor for FUROSCIX should only be administered in settings where alarms can be detected and responded to in order to ensure a complete dose is administered [see Dosage and Administration ( 2.2 )] . 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, CO 2 , BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy [see Use in Specific Populations ( 8.6 )] . 5.2 Worsening Renal Function Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide [see Clinical Pharmacology ( 12.3 )]. 5.3 Ototoxicity Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. 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 )]. 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. These patients require careful monitoring, especially during the initial stages of treatment. 5.5 Incomplete Dosing The On-body Infusor should not be allowed to get wet from water or any other fluids (blood or drug product). Fluid contact with the circuit board can lead to device errors and premature termination of infusion. The On-body Infusor is intended for use in a setting where the patient can limit their activity for the duration of administration. Certain patient movements may cause interruption of device adherence to skin and premature termination of infusion. The On-body Infusor for FUROSCIX should only be administered in settings where alarms can be detected and responded to in order to ensure a complete dose is administered [see Dosage and Administration ( 2.2 )] .
Contraindications
FUROSCIX is contraindicated in: Patients with anuria Patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation, or medical adhesives. Anuria ( 4 ) Hypersensitivity to furosemide, components of FUROSCIX formulation, or medical adhesives. ( 4 )
Adverse Reactions
The following important adverse reactions are discussed 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 trials or post-marketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably, or to 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. Administration Site and Skin Reactions : erythema, bruising, edema, infusion site pain. Other Reactions : glycosuria, muscle spasm, weakness, restlessness, urinary bladder spasm, thrombophlebitis, transient injection site pain following intramuscular injection, fever. The most common adverse reactions during treatment with the Furoscix Infusor were administration site and skin reactions: erythema, bruising, edema and infusion site pain. (6) To report SUSPECTED ADVERSE REACTIONS, contact scPharmaceuticals, Inc. at 1-855-727-4276 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 ) See 17 for PATIENT COUNSELING INFORMATION . 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 Effect of Other Drugs on Furosemide Drug/Substance Class or Name Drug Interaction Effect Recommendations Phenytoin 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. 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 Effect of Other Drugs on Furosemide Drug/Substance Class or Name Drug Interaction Effect Recommendations Phenytoin 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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