ISOLYTE P IN DEXTROSE- dextrose, sodium acetate, potassium chloride, magnesium chloride, and potassium phosphate, dibasic inject

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37, ACETATE ION - UNII:569DQM74SC), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (POTASSIUM CATION - UNII:295O53K152, PHOSPHATE ION - UNII:NK08V

Available from:

B. Braun Medical Inc.

INN (International Name):

DEXTROSE MONOHYDRATE

Composition:

DEXTROSE MONOHYDRATE 5 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

This solution is indicated for use in adults as a source of electrolytes, calories and water for hydration, and as an alkalinizing agent. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

Product summary:

Isolyte® P (Multi-Electrolyte Injection) in 5% Dextrose is supplied sterile and nonpyrogenic in EXCEL® containers. The 500 mL containers are packaged 24 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).

Authorization status:

New Drug Application

Summary of Product characteristics

ISOLYTE P IN DEXTROSE- DEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE,
MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASIC INJECTION,
SOLUTION
B. BRAUN MEDICAL INC.
----------
ISOLYTE P IN 5% DEXTROSE (MULTI-ELECTROLYTE INJECTION)
DESCRIPTION
Each 100 mL of Isolyte® P (Multi-Electrolyte Injection) in 5%
Dextrose contains:
Hydrous Dextrose USP 5 g; Sodium Acetate Trihydrate USP 0.32 g
Potassium Chloride USP 0.13 g; Magnesium Chloride Hexahydrate USP
0.031 g
Dibasic Potassium Phosphate USP 0.026 g; Water for Injection USP qs
pH adjusted with Hydrochloric Acid NF
pH: 5.0 (4.0–6.0) Calories per liter: 170
Calculated Osmolarity: 340 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 23; Chloride 29
Acetate (CH COO ) 23; Potassium 20; Magnesium 3;
Phosphate (HPO ) 3
Isolyte® P in 5% Dextrose is sterile, nonpyrogenic, and contains no
bacteriostatic or
antimicrobial agents or added buffers. This product is intended for
intravenous
administration.
The formulas of the active ingredients are:
INGREDIENTS
MOLECULAR
FORMULA
MOLECULAR
WEIGHT
Sodium Acetate Trihydrate USP
CH COONa•3H O
136.08
Potassium Chloride USP
KCl
74.55
Magnesium Chloride Hexahydrate USP MgCl
•6H O
203.30
Dibasic Potassium Phosphate USP
K HPO
174.18
Hydrous Dextrose USP
198.17
Not made with natural rubber latex, PVC or DEHP.
The plastic container is made from a multilayered film specifically
developed for
parenteral drugs. It contains no plasticizers. The solution contact
layer is a rubberized
copolymer of ethylene and propylene. Solutions in contact with the
plastic container may
leach out certain chemical components from the plastic in very small
amounts; however,
®
3
-
1
3
2
2
2
2
4
biological testing was supportive of the safety of the plastic
container materials. The
container-solution unit is a closed system and is not dependent upon
entry of external
air during administration. The container is overwrapped to provide
protection from the
physical environment and to provide an additional moisture barrier
when necessary.
Exposure to