MANNITOL injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Fresenius Kabi USA, LLC

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Mannitol Injection, USP is indicated for the following therapeutic uses: • The promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established.  • The reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass.  • The reduction of elevated intraocular pressure when it cannot be lowered by other means.  • The promotion of urinary excretion of toxic substances. Mannitol solution, 2.5% is indicated as an irrigation solution in transurethral prostatic resection or other transurethral surgical procedures. • Well established anuria due to severe renal disease.  • Severe pulmonary congestion or frank pulmonary edema.  • Active intracranial bleeding except during craniotomy.  • Severe dehydration.  • Progressive renal damage or dysfunction after institution of mannitol therapy, including increasing oliguria and azotemia.  • Progressive heart failure or pulmonary congestion after mannitol therapy

Produkt oppsummering:

Mannitol Injection, USP, 25% Use only if solution is clear and seal intact and undamaged. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Preservative Free.  Discard unused portion.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

MANNITOL- MANNITOL INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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MANNITOL INJECTION, USP
Rx only
25%
_For Intravenous Use and Urologic Irrigation_
DESCRIPTION
Mannitol is a 6-carbon sugar alcohol and has the following structure:
C H O 182.17
Mannitol occurs naturally in fruits and vegetables, and is
metabolically inert in humans.
Mannitol Injection, USP, 25%, an osmotic diuretic, is a sterile,
nonpyrogenic solution of
mannitol in Water for Injection. It is a supersaturated solution at
room temperature.
Each mL contains: Mannitol 250 mg; Water for Injection q.s. The
osmolar concentration
is 1372 mOsmol/L (calc.). It contains no antimicrobial agents. The pH
of a 5% solution
is between 4.5 and 7.0.
CLINICAL PHARMACOLOGY
Mannitol is an osmotic diuretic. After intravenous injection it is
confined to the
extracellular space, metabolized only slightly and excreted rapidly by
the kidneys.
Approximately 80% of a 100 g dose appears in the urine in three hours.
Mannitol is
freely filtered by the glomeruli with less than 10% tubular
reabsorption. It is not
secreted by tubular cells. It induces diuresis by elevating the
osmolarity of the
glomerular filtrate and thereby hinders tubular reabsorption of water.
Urinary output of
water and excretion of sodium and chloride are enhanced. Mannitol is
poorly absorbed
from the gastrointestinal tract.
Mannitol injection is free of electrolytes and is used in urology as a
nonhemolytic
irrigant. The amount of mannitol absorbed intravascularly during
transurethral prostatic
surgery is variable and depends primarily on the extent of the
surgery. Such mannitol is
excreted by the kidneys and produces osmotic diuresis.
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INDICATIONS AND USAGE
FOR INTRAVENOUS INJECTION
Mannitol Injection, USP is indicated for the following therapeutic
uses:
• The promotion of diuresis, in the prevention and/or treatment of
the oliguric phase of
acute renal failure before irreversible renal failure becomes
established.
• The reduction of intracranial pressure and treatment of cerebral
edema by