MANNITOL injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A)

Tilgjengelig fra:

HF Acquisition Co LLC, DBA HealthFirst

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Mannitol Injection is indicated for the following purposes in adults and pediatric patients. Therapeutic Use Reduction of intracranial pressure and brain mass. Reduction of high intraocular pressure. Diagnostic Use Measurement of glomerular filtration rate. Mannitol Injection is contraindicated in patients with: Well established anuria due to severe renal disease. Severe pulmonary congestion or frank pulmonary edema. Active intracranial bleeding except during craniotomy. Severe dehydration. Progressive heart failure or pulmonary congestion after institution of mannitol therapy. Do not administer to patients with a known hypersensitivity to mannitol. 8.1 Pregnancy Risk Summary There are no well-controlled studies in pregnant women that establish developmental toxicity related to the use of mannitol injection. Mannitol crosses the placenta and may cause fluid shifts that could potentially result in adverse effects in the fetus (see Data). The available data do not establish the presence or absence of developmental toxicity related to the use of mannitol. There are limited animal data in the published literature. The effects of mannitol on embryo-fetal development have not been evaluated; however, fluid shifts occurred in animal studies in response to maternal infusion of mannitol. Mannitol injection should be given to a pregnant woman only if clearly needed. The estimated background risk of major birth defects and miscarriage for the indicated population 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 clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Human Data Published literature reports the presence of mannitol in amniotic fluid when mannitol is administered to pregnant women during the third trimester of pregnancy. 8.2 Lactation Risk Summary Lactation studies have not been conducted with mannitol. It is not known whether this drug is excreted in human milk. Mannitol injection should be administered to lactating women only if clearly indicated. Studies assessing the effects of mannitol injection in breastfed children have not been performed. Studies to assess the effect of mannitol on milk production or excretion have not been performed. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mannitol and any potential adverse effects on the breastfed child from mannitol or from the underlying maternal condition. 8.5 Geriatric Use Mannitol is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in elderly patients with impaired renal function. Evaluate the renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances prior to administration of mannitol [see Warnings and Precautions (5)]. 8.6 Renal Impairment Patients with pre-existing renal disease, patients with conditions that put them at high risk for renal failure, or those receiving potentially nephrotoxic drugs or other diuretics, are at increased risk of renal failure with administration of mannitol. Evaluate the renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances prior to administration of mannitol [see Warnings and Precautions (5)].

Produkt oppsummering:

Mannitol Injection, USP is supplied in single-dose containers as follows: 25% MANNITOL INJECTION, USP is supplied in the following dosage forms. NDC 51662-1468-1 25% MANNITOL INJECTION, USP 12.5g/50mL (250mg/mL) 50mL VIAL NDC 51662-1468-2 25% MANNITOL INJECTION, USP 12.5g/50mL (250mg/mL) 50mL VIAL, 1 VIAL PER POUCH NDC 51662-1468-3 25% MANNITOL INJECTION, USP 12.5g/50mL (250mg/mL) 50mL VIAL, 1 VIAL PER POUCH, 25 POUCHES PER CASE HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 NOTE: Crystals may form in mannitol solutions especially if the solutions are chilled. To dissolve the crystals, warm the bottle in hot water at 80°C and periodically shake vigorously. 25% Mannitol Injection, USP may be autoclaved at 121°C for 20 minutes at 15 psi. Remove cover from fliptop vial and cleanse stopper with antiseptic before use. Cool to body temperature or less before administering. When infusing 25% mannitol concentrations, the administration set should include a filter. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] INSTRUCTlONS FOR USE Remove cover and cleanse stopper with antiseptic before use.

Autorisasjon status:

New Drug Application

Preparatomtale

MANNITOL- MANNITOL INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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25% MANNITOL INJECTION, USP 12.5G/50ML (250MG/ML) 50ML VIAL
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
MANNITOL INJECTION
safely and effectively. See full prescribing information for MANNITOL
INJECTION.
MANNITOL injection, for intravenous use
Initial U.S. Approval: 1964
INDICATIONS AND USAGE
Mannitol Injection is indicated for the following purposes in adults
and pediatric patients.
Therapeutic Use
Reduction of intracranial pressure and brain mass. ( 1)
Reduction of high intraocular pressure. ( 1)
Diagnostic Use
Measurement of glomerular filtration rate. ( 1)
DOSAGE AND ADMINISTRATION
Administration Instructions ( 2-2.1):
For intravenous use only.
Do not add mannitol in whole blood for transfusion.
Recommended Dosage ( 2-2.2):
The dosage, concentration and rate of administration depend on the
age, weight and
condition of the patient.
Reduction of Intracranial Pressure and Brain Mass:
Adults: 0.25 to 2 g/kg body weight as a 15% to 25% solution
administered over a period
of 30 to 60 minutes
Pediatric patients: 1 to 2 g/kg body weight or 30 to 60 g/m2 body
surface area over a
period of 30 to 60 minutes.
Small or debilitated patients: 500 mg/kg
Reduction of Intraocular Pressure:
Adults: 0.25 to 2 g/kg body weight as a 15% to 25% solution
administered over a period
of 30 to 60 minutes
Pediatric patients: 1 to 2 g/kg body weight or 30 to 60 g/m2 body
surface area over a
period of 30 to 60 minutes
Small or debilitated patients: 500 mg/kg
Measurement of Glomerular Filtration Rate (GFR):
100 mL of a 20% solution (20 g) should be diluted with 180 mL of
sodium chloride
injection (normal saline) or 200 mL of a 10% solution (20 g) should be
diluted with 80 mL
of sodium chloride injection (normal saline). The resulting 280 mL of
7.2% solution is
infused at a rate of 20 mL per minute.
DOSAGE FORMS AND STRENGTHS
Mannitol Injection, USP: 25% (25