藥劑部參考美國 Johns Hopkins 大學研究團隊所建立的 NxP (Nephrotoxic Potential) 專家共識分級清單，本品具「顯著以上腎毒性風險」，被認定具中度至高度腎損傷潛勢，特別是同時合併其他腎毒性藥物、脫水、高齡或既有腎功能異常的患者族群，應更加注意。

【藥品性質提示】 根據 2019 AGS Beers Criteria，本藥品為【潛在不適當用藥 (PIM)】，用於老年人時須謹慎使用(監測血鈉值)。

高血壓 (diuretics) 利尿劑 (loop diuretics)
Edema: Management of edema associated with heart failure, cirrhosis of the liver (ie, ascites), or renal disease (including nephrotic syndrome); acute pulmonary edema

Inhibits reabsorption of sodium and chloride in the ascending loop of Henle and proximal and distal renal tubules, interfering with the chloride-binding cotransport system, thus causing increased excretion of water, sodium, chloride, magnesium, and calcium

Onset of action: Diuresis: IV: 5 minutes. Oral, sublingual (SL): 30 to 60 minutes. Symptomatic improvement with acute pulmonary edema: Within 15 to 20 minutes; occurs prior to diuretic effect. Peak effect: Oral, SL: 1 to 2 hours. IV: Neonates and Infants (mean GA 30.7 weeks [range: 26 to 35 weeks], mean PNA 29 days [range: 10 to 57 days]): 1 to 3 hours (Ross 1978). Adults: 0.5 hours. SUBQ: 4 hours. Duration: Oral, SL: 6 to 8 hours. IV: Neonates and Infants (mean GA 30.7 weeks [range: 26 to 35 weeks], mean PNA 29 days [range: 10 to 57 days]): 6 hours (Ross 1978). Adults: ~2 hours. Protein binding: 91% to 99%; primarily to albumin. Metabolism: Minimally hepatic. Bioavailability: Oral tablet: 47% to 64%; Oral solution: 50%; SUBQ: 99.6%; SL administration of oral tablet: ~60%; results of a small comparative study (n=11) showed bioavailability of SL administration of tablet was ~12% higher than oral administration of tablet (Haegeli 2007). Half-life elimination: Preterm neonates: GA <28 weeks (PNA <14 days): IV: 15.3 ± 2.3 hours (Okazaki 2022). GA 26 to 36 weeks (PNA <21 days): IV: 19.9 ± 3 hours (range: 8.7 to 46 hours) (Peterson 1980). Adults: Oral, IV: Normal kidney function: 0.5 to 2 hours; End-stage kidney disease: 9 hours; SUBQ: 3.2 ± 0.9 hours. Excretion: Urine (Oral: 50%, IV: 80%) within 24 hours; feces (as unchanged drug); nonrenal clearance prolonged in kidney impairment.

1. Anuria
2. History of hypersensitivity to furosemide

Use with caution due to the potential reduction in placental blood flow.

The manufacturer recommends that caution be used if administered to a breastfeeding woman.

Cardiovascular: Necrotizing angiitis, orthostatic hypotension, thrombophlebitisDermatologic: Acute generalized exanthematous pustulosis, bulla (hemorrhagic), bullous pemphigoid, erythema multiforme, exfoliative dermatitis, lichenoid eruption, pruritus, skin photosensitivity, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticariaEndocrine & metabolic: Glycosuria, hyperglycemia, hyperuricemia, hypocalcemia, hypochloremic alkalosis, hypokalemia, hypomagnesemia, hypovolemia, increased serum cholesterol, increased serum triglyceridesGastrointestinal: Abdominal cramps, anorexia, constipation, diarrhea, gastric irritation, nausea, oral irritation, pancreatitis, vomitingGenitourinary: Bladder spasmHematologic & oncologic: Agranulocytosis, anemia, aplastic anemia, hemolytic anemia, leukopenia, purpuric disease, thrombocytopeniaHepatic: Hepatic encephalopathy, increased liver enzymes, intrahepatic cholestatic jaundiceHypersensitivity: Anaphylactic shock, anaphylaxis, angioedema, nonimmune anaphylaxisImmunologic: Drug reaction with eosinophilia and systemic symptomsNervous system: Dizziness, headache, paresthesia, restlessness, vertigoNeuromuscular & skeletal: Asthenia, muscle spasmOphthalmic: Blurred vision, xanthopsiaOtic: Deafness (Ref), tinnitusRenal: Acute kidney injury, calcium nephrolithiasis (pediatric patients), interstitial nephritis (allergic), nephrolithiasis (pediatric patients)Miscellaneous: Fever

Edema:
1. Naive to loop diuretics: Initial 20-40 mg once then titrate as needed to an effective dose
2. Refractory edema or acute decompensation in patients taking oral loop diuretics: Initial 1 to 2.5 times the total daily oral maintenance dose once (eg, a patient taking oral furosemide 40 mg twice daily at home [80 mg/day] can be given 80 mg to 200 mg IV as an initial bolus); then titrate as needed to an effective dose

Oral: Infants, Children, and Adolescents:Intermittent dosing (acute): Oral: Initial: 2 mg/kg as a single dose; if ineffective, may increase in 6 to 8 hours in increments of 1 to 2 mg/kg/dose; maximum dose: 6 mg/kg/dose.Maintenance dosing (chronic): Limited data available: Oral: Initial: 0.5 to 2 mg/kg/dose every 6 to 24 hours; usual initial adult dose: 20 to 40 mg/dose; if initial dose ineffective, may increase dose in increments of 1 to 2 mg/kg/dose; maximum daily dose: 6 mg/kg/day, not to exceed maximum adult daily dose: 600 mg/day; adjust dose to minimal effective dose for maintenance (Ref). Note: Smaller doses on a mg/kg basis may be needed in larger children, especially in those who are diuretic naive.Intermittent IV, IM: Infants, Children, and Adolescents: Limited data available: Initial: 0.5 to 2 mg/kg/dose every 6 to 12 hours; usual initial adult dose: 20 to 40 mg/dose; if initial dose ineffective after 2 hours, may increase dose by 1 mg/kg/dose; maximum dose: 6 mg/kg/dose, not to exceed maximum adult dose: 200 mg/dose; adjust to minimal effective dose for maintenance (Ref). Note: Smaller doses on a mg/kg basis may be needed in larger children, especially in those who are diuretic naive. Dosing in adolescents based on experience in adult and pediatric patients.Continuous IV infusion:Infants and Children: Limited data available: Initial: IV bolus dose of 1 to 2 mg/kg (reported range, 0.1 to 2 mg/kg) followed by continuous IV infusion of 0.05 to 0.4 mg/kg/hour; titrate dosage to clinical effect; doses up to 1 mg/kg/hour have been described (Ref).Adolescents: Very limited data available; dosing in adolescents based on reported experience in adult and pediatric patients (Ref): IV bolus dose of 0.1 to 2 mg/kg; usual adult bolus dose: 40 mg over 1 to 2 minutes, followed by continuous IV infusion of 0.1 to 0.4 mg/kg/hour; usual adult dosing range: 10 to 40 mg/hour.

1. eGFR >30 mL/minute/1.73 m2: No dosage adjustment necessary
2. eGFR ≤30 mL/minute/1.73 m2: Higher doses may be required to achieve desired diuretic response due to decreased secretion into the tubular fluid. However, single doses >160 to 200 mg IV (or oral equivalent) are unlikely to result in additional diuretic effect

N/A

Store below 30°C, protected from light, and avoid freezing. 【文字內容由仿單翻譯而來】