Furosemide Injection 80 Mg/ 10 Ml
Generic Name: furosemide injection 80 mg/ 10 ml
Brand Names:
Furoscix
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.
Overview
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.
Uses
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
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.
Side Effects
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.
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 .
Warnings
5 WARNINGS AND 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. 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 )
Storage
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.
Frequently Asked Questions
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 )
What are the side effects of Furosemide Injection 80 Mg/ 10 Ml?▼
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.
What are the important warnings for Furosemide Injection 80 Mg/ 10 Ml?▼
5 WARNINGS AND 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. 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.