LACTATED RINGERS AND DEXTROSE- sodium chloride, sodium lactate, potassium chloride, calcium chloride and dextrose monohydrate in

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

Baxter Healthcare Corporation

INN (International Name):

DEXTROSE MONOHYDRATE

Composition:

DEXTROSE MONOHYDRATE 5 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lactated Ringer’s and 5% Dextrose Injection, USP is indicated as a source of water, electrolytes and calories or as an alkalinizing agent. Lactated Ringer’s and 5% Dextrose Injection, USP is contraindicated in: Patients with a known hypersensitivity to sodium lactate (see WARNINGS ).

Product summary:

Lactated Ringer’s and 5% Dextrose Injection, USP in VIAFLEX plastic containers is available as follows: Code Size NDC 2B2073 500 mL NDC 0338-0125-03 2B2074 1000 mL NDC 0338-0125-04 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

Authorization status:

New Drug Application

Summary of Product characteristics

LACTATED RINGERS AND DEXTROSE- SODIUM CHLORIDE, SODIUM LACTATE,
POTASSIUM
CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATE INJECTION,
SOLUTION
BAXTER HEALTHCARE CORPORATION
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LACTATED RINGER’S AND 5% DEXTROSE INJECTION, USP
IN VIAFLEX PLASTIC CONTAINER
DESCRIPTION
Lactated Ringer’s and 5% Dextrose Injection, USP is a sterile,
nonpyrogenic solution for fluid and
electrolyte replenishment and caloric supply in a single dose
container for intravenous administration.
Each 100 mL contains 5 g Dextrose Hydrous, USP*; 600 mg Sodium
Chloride, USP (NaCl); 310 mg
Sodium Lactate (C H NaO ); 30 mg of Potassium Chloride, USP (KCl); and
20 mg Calcium Chloride,
USP (CaCl
· 2H 0). It contains no antimicrobial agents.
Approximate pH 5.0 (4.0 to 6.5).
D-GLUCOPYRANOSE MONOHYDRATE
Dextrose is derived from corn.
Lactated Ringer’s and 5% Dextrose Injection, USP administered
intravenously has value as a source of
water, electrolytes, and calories. One liter has an ionic
concentration of 130 mEq sodium, 4 mEq
potassium, 2.7 mEq calcium, 109 mEq chloride and 28 mEq lactate. The
osmolarity is 525 mOsmol/L
(calc). Normal physiologic range is approximately 280 to 310 mOsmol/L.
The caloric content is 180
kcal/L.
The VIAFLEX plastic container is fabricated from a specially
formulated polyvinyl chloride (PL 146
Plastic). The amount of water that can permeate from inside the
container into the overwrap is
insufficient to affect the solution significantly. Solutions in
contact with the plastic container can leach
out certain of its chemical components in very small amounts within
the expiration period, e.g., di-2-
ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the
safety of the plastic has been
confirmed in tests in animals according to USP biological tests for
plastic containers as well as by
tissue culture toxicity studies.
CLINICAL PHARMACOLOGY
Lactated Ringer’s and 5% Dextrose Injection, USP has value as a
source of water, electrolytes, and
calories. It is capable of inducing diuresis depending on the c