Rx Item-Resectisol 5% Solution 8X2000Ml By B.Braun

MANNITOL- mannitol injection, solution
Hospira, Inc.


Flexible Plastic Container

Fliptop Vial

Rx only

DESCRIPTION



Mannitol intravenous (Mannitol Injection, USP) is a sterile, nonpyrogenic solution of mannitol in water for injection available in concentrations of 15%, 20% in flexible plastic containers and 25% in a fliptop vial for administration by intravenous infusion only.

The content and characteristics of the available concentrations are as follows:

Conc. (%)

g/100 mL

mOsmol/liter (calc.)

pH*

15

15

823

6.3 (4.5 to 7.0)

20

20

1098

6.3 (4.5 to 7.0)

25

25

1372

5.9 (4.5 to 7.0)

*Concentrations up to 20% may contain sodium bicarbonate for pH adjustment; the 25% concentration may contain sodium bicarbonate and/or hydrochloric acid for pH adjustment.

The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded.

Mannitol Injection, USP is a parenteral obligatory osmotic diuretic.

Mannitol, USP is chemically designated D-mannitol (C6 H14 O6 ), a white crystalline powder or free-flowing granules freely soluble in water. It has the following structural formula:

structural formula mannitol
(click image for full-size original)
Water for Injection, USP is chemically designated H2 0.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap, but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25�C/77�F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

CLINICAL PHARMACOLOGY

When administered intravenously mannitol is confined to the extracellular space, only slightly metabolized and rapidly excreted by the kidney. Approximately 80% of a 100 g dose appears in the urine in 3 hours. The drug is freely filtered by the glomeruli with less than 10% tubular reabsorption; it is not secreted by tubular cells. Mannitol induces diuresis by elevating the osmolarity of the glomerular filtrate and thereby hindering tubular reabsorption of water. Excretion of sodium and chloride is also enhanced.

INDICATIONS AND USAGE

Mannitol intravenous (Mannitol Injection, USP) is indicated for the following purposes in adults and pediatric patients.

Therapeutic Use

Promotion of diuresis in the prevention or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established.

Reduction of intracranial pressure and brain mass.

Reduction of high intraocular pressure when the pressure cannot be lowered by other means.

Promotion of urinary excretion of toxic materials.

Diagnostic Use

Measurement of glomerular filtration rate.

RX ITEM-Resectisol 5% Solution 8X2000Ml
NDC 00264-2303-50 UPC/GTIN No.3-02642-30350-2 Mfg.Part No.00264-2303-50

Resectisol 5% Solution 8X2000Ml By B.Bra
BRAND: RESECTISOL NDC: 00264-2303-50,264230350 UPC: 3-02642-30350-2,302642303502 B.Braun

MANNITOL URETHRAL IRRIG S
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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