Furosemide Injection 80 Mg/ 10 Ml
FDA Drug Information • Also known as: Furoscix
- Brand Names
- Furoscix
- Drug Class
- Loop Diuretic [EPC]
- Route
- SUBCUTANEOUS
- Dosage Form
- INJECTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION 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
What Is Furosemide Injection 80 Mg/ 10 Ml Used For?
1 INDICATIONS AND 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 and Administration
2 DOSAGE AND 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...
Side Effects (Adverse Reactions)
6 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
7 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...
Contraindications
4 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 )
Overdosage
10 OVERDOSAGE The principal signs and symptoms of overdose with FUROSCIX are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its diuretic action. 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.
How Supplied
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.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.