MANNITOL irrigant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

B. Braun Medical Inc.

INN (International Name):

MANNITOL

Composition:

MANNITOL 5 g in 100 mL

Administration route:

IRRIGATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

5% Mannitol is indicated for use as a urologic irrigation fluid for transurethral prostatic resection and other transurethral surgical procedures. 5% Mannitol is not for injection. It is contraindicated in patients with anuria.

Product summary:

5% Mannitol Irrigation is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Containers). The 2000 mL containers are packaged 8 per case and the 4000 mL containers are packaged 4 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).

Authorization status:

New Drug Application

Summary of Product characteristics

MANNITOL- MANNITOL IRRIGANT
B. BRAUN MEDICAL INC.
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5% MANNITOL IRRIGATION
Package Insert
PIC (PLASTIC IRRIGATION CONTAINERS)
NONELECTROLYTE IRRIGATING FLUID FOR TRANSURETHRAL
SURGICAL PROCEDURES.
FOR UROLOGIC IRRIGATION ONLY.
NOT FOR INJECTION.
DESCRIPTION
Each 100 mL contains:
Mannitol USP 5 g
Water for Injection USP qs
pH: 5.5 (4.5–7.0)
Calculated Osmolarity: 275 mOsmol/liter
The formula of the active ingredient is:
INGREDIENT
MOLECULAR FORMULA
MOLECULAR WEIGHT
Mannitol USP
182.17
5% Mannitol Irrigation is a prediluted, sterile, nonpyrogenic aqueous
solution suitable for urologic
irrigation. The solution is approximately isotonic.
Mannitol USP is chemically designated D-mannitol (C H O ). Mannitol is
a hexitol naturally occurring
in fruits and vegetables and is produced commercially by the reduction
of glucose.
The solution contains no antimicrobial or bacteriostatic agents or
added buffers.
The plastic container is a copolymer of ethylene and propylene
formulated and developed for parenteral
drugs. The copolymer contains no plasticizers and exhibits virtually
no leachability. The plastic
container is also virtually impermeable to vapor transmission and
therefore, requires no overwrap to
maintain the proper drug concentration. The safety of the plastic
container has been confirmed by
biological evaluation procedures. The material passes Class Vl testing
as specified in the U.S.
Pharmacopeia for Biological Tests — Plastic Containers. These tests
have shown that the container is
nontoxic and biologically inert.
The PIC Container is PVC-free and DEHP-free.
CLINICAL PHARMACOLOGY
In humans, mannitol is confined to the extracellular space and is only
slightly metabolized. It is rapidly
excreted in the urine. When mannitol is absorbed intravascularly, it
produces osmotic diuresis and will
be excreted by the kidneys.
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6
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Mannitol is nonelectrolytic and is, therefore, nonconductive, making
it suitable for urologic irrigation
during electrosurgical procedures.
5% Mannitol is a nonhemolytic irriga