POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE- dextrose monohydrate, sodium chloride, and potassium chloride injection, sol

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), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

Hospira, Inc.

INN (International Name):

DEXTROSE MONOHYDRATE

Composition:

DEXTROSE MONOHYDRATE 50 g in 1000 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride. Solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered. To Open Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. To Add Medication - Prepare additive port. - Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. - The additive port may be protected by covering with an additive cap. - Mix container contents thoroughly. Preparation for Admin

Product summary:

Intravenous solutions with potassium chloride (I.V. solution with KCl) are supplied in single-dose flexible plastic containers. See Tables: TABLE 1 Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Inj., USP COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na+ ) Potassium (K+ ) Chloride (Cl– ) Approximate kcal/L NDC NO. 10 mEq 1000 50 2.25 0.745 349 4.2 (3.5 to 6.5) 38.5 10 48.5 170 0409-7997-09 10 mEq 500 50 2.25 1.49 370 4.2 (3.5 to 6.5) 38.5 20 58.5 170 0409-7901-03 20 mEq 1000 50 2.25 1.49 370 4.2 (3.5 to 6.5) 38.5 20 58.5 170 0409-7901-09  30 mEq 1000 50 2.25 2.24 389 4.2 (3.5 to 6.5) 38.5 30 68.5 170 0409-7991-09 40 mEq 1000 50 2.25 2.98 409 4.2 (3.5 to 6.5) 38.5 40 78.5 170 0409-7992-09 TABLE 2 Potassium Chloride in 5% Dextrose and 0.3% Sodium Chloride Inj., USP COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na+ ) Potassium (K+ ) Chloride (Cl– ) Approximate kcal/L NDC NO. 10 mEq 500 50 3.0 1.49 395 4.2 (3.5 to 6.5) 51 20 71 170 0409-7998-03 20 mEq 1000 50 3.0 1.49 395 4.2 (3.5 to 6.5) 51 20 71 170 0409-7998-09 TABLE 3 Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Inj., USP COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na+ ) Potassium (K+ ) Chloride (Cl– ) Approximate kcal/L NDC NO. 10 mEq 1000 50 4.5 0.745 426 4.2 (3.5 to 6.5) 77 10 87 170 0409-7993-09 10 mEq 500 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 0409-7902-03 20 mEq 1000 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 0409-7902-09 30 mEq 1000 50 4.5 2.24 467 4.2 (3.5 to 6.5) 77 30 107 170 0409-7903-09 40 mEq 1000 50 4.5 2.98 487 4.2 (3.5 to 6.5) 77 40 117 170 0409-7904-09 TABLE 4 Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Inj., USP COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na+ ) Potassium (K+ ) Chloride (Cl– ) Approximate kcal/L NDC NO. 20 mEq 1000 50 9 1.49 600 4.2 (3.5 to 6.5) 154 20 174 170 0409-7107-09 40 mEq 1000 50 9 2.98 640 4.2 (3.5 to 6.5) 154 40 194 170 0409-7109-09 May contain HCl for pH adjustment. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]  Protect from freezing. Revised: April, 2009 Printed in USA                                          EN-2100 Hospira, Inc., Lake Forest, IL 60045 USA

Authorization status:

New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE- DEXTROSE
MONOHYDRATE,
SODIUM CHLORIDE, AND POTASSIUM CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
----------
INTRAVENOUS SOLUTIONS
WITH POTASSIUM CHLORIDE
R only
Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP
FLEXIBLE PLASTIC CONTAINER
DESCRIPTION
Intravenous solutions with potassium chloride (I.V. solutions with
KCl) are sterile and nonpyrogenic
solutions in water for injection. They are for administration by
intravenous infusion only.
See Tables for summary of content and characteristics of these
solutions.
The solutions contain no bacteriostat, antimicrobial agent or added
buffer and each is intended only for
use as a single-dose injection. When smaller doses are required the
unused portion should be
discarded.
These solutions are parenteral fluid, nutrient and/or electrolyte
replenishers.
Dextrose, USP is chemically designated D-glucose, monohydrate (C H O
• H O), a hexose sugar
freely soluble in water. It has the following structural formula:
Potassium Chloride, USP is chemically designated KCl, a white granular
powder freely soluble in
water.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely soluble in
water.
Water for Injection, USP is chemically designated H O.
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 the 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
Wh