FUROSEMIDE- furosemide injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)

Διαθέσιμο από:

Fresenius Kabi USA, LLC

INN (Διεθνής Όνομα):

FUROSEMIDE

Σύνθεση:

FUROSEMIDE 10 mg in 1 mL

Οδός χορήγησης:

INTRAMUSCULAR

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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. Furosemide Injection is indicated as adjunctive therapy in acute pulmonary edema. - Furosemide Injection is contraindicated in patients with anuria. - Furosemide Injection is contraindicated in patients with a history of hypersensitivity to furosemide. Risk Summary Available data from published observational studies, case reports, and postmarketing reports, from decades of use, have not demonstrated a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with furosemide use during pregnancy. Untreated congestive heart failure and cirrhosis of the liver can lead to adverse outcomes for the mother and the fetus (see Clinical Considerations) . In animal reproduction studies, furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits when administered orally during organogenesis at 4 times a human i.v. dose of 80 mg based on body surface area (BSA) and oral bioavailability corrections, presumably secondary to volume depletion (see Data) . The estimated background risk for major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with congestive heart failure are at increased risk for pre-term birth. Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. Clinical classification of heart disease may worsen with pregnancy and lead to maternal death and/or stillbirth. Closely monitor pregnant patients for destabilization of their heart failure. Pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, pre-term delivery, fetal growth restriction and maternal death. Outcomes are worse with coexisting esophageal varices. Pregnant women with cirrhosis of the liver should be carefully monitored and managed accordingly. Data Animal Data The effects of furosemide on embryonic and fetal development and on pregnant dams were studied in mice, rats and rabbits. Furosemide caused unexplained maternal deaths and abortions in the rabbit at the lowest dose of 25 mg/kg (approximately 4 times a human i.v. dose of 80 mg based on BSA and oral bioavailability corrections). In another study, a dose of 50 mg/kg (approximately 7 times a human i.v. dose of 80 mg based on BSA and oral bioavailability corrections) also caused maternal deaths and abortions when administered to rabbits between Days 12 and 17 of gestation. In a third study, none of the pregnant rabbits survived an oral dose of 100 mg/kg. Data from the above studies indicate fetal lethality that can precede maternal deaths. The results of the mouse study and one of the three rabbit studies also showed an increased incidence and severity of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters) in fetuses of treated dams as compared with the incidence of fetuses from the control group. Risk Summary The presence of furosemide has been reported in human milk. There are no data on the effects on the breastfed infant or the effects on milk production. Doses of furosemide associated with clinically significant diuresis may impair milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for furosemide and any potential adverse effects on the breastfed infant from furosemide or from the underlying maternal condition. Published reports indicate that premature infants with post conceptual age (gestational plus postnatal) less than 31 weeks receiving doses exceeding 1 mg/kg/24 hours may develop plasma levels which could be associated with potential toxic effects including ototoxicity [see Warnings and Precautions (5.3)] . Furosemide in the first year of life, especially in patients born pre-term, may precipitate nephrocalcinosis/nephrolithiasis [see Warnings and Precautions (5.2)] . Controlled clinical studies of furosemide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function [see Clinical Pharmacology (12.3)] .

Περίληψη προϊόντος:

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. Furosemide Injection, USP 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: Preservative Free. Discard unused portion. Do not use if solution is discolored or contains particulate.

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

FUROSEMIDE - FUROSEMIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FUROSEMIDE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FUROSEMIDE INJECTION.
FUROSEMIDE INJECTION (FUROSEMIDE), FOR INTRAVENOUS OR INTRAMUSCULAR
USE INITIAL U.S.
APPROVAL: 1982
INDICATIONS AND 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)
DOSAGE AND 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)
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 in 1
minute to 2 minutes (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)
DOSAGE FORMS AND STRENGTHS
Injection: Furosemide Injection, USP is supplied as a sterile,
colorless solution as
20 mg/2 mL (10 mg/mL) in a single-dose vial (3)
40 mg/4 mL (10 mg/mL) in a single-dose vial (3)
100 mg/10 mL (10 mg/mL) in a single-dose vial (3)
CONTRAINDICATIONS
Anuria (4)
Hypersensitivity to furosemide (4)
WARNINGS AND PRECAUTIONS
Fluid, Electrolyte, and Metabolic Abnormalities: Monitor serum
electrolytes, CO , 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 dos