POTASSIUM CHLORIDE IN DEXTROSE- dextrose monohydrate and potassium chloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

Hospira, Inc.

INN (International Name):

DEXTROSE MONOHYDRATE

Composition:

DEXTROSE MONOHYDRATE 5 g in 100 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. 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. 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. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target

Product summary:

Potassium Chloride in Dextrose Injection, USP solutions are supplied in single-dose flexible plastic containers. See Table: Table of Contents and Characteristics Grams/100 mL Per 1000 mL mEq Potassium Size (mL) NDC No. Dextrose Hydrous Potassium Chloride Potassium (K + ) Chloride (Cl¯) Caloric Value Calculated Osmolarity (mOsmol) Tonicity pH 20 mEq 1000 0409–7905–09 5 0.149 20 mEq 20 mEq 170 292 isotonic 4.3 (3.5 to 6.5) 30 mEq 1000 0409–7996–09 5 0.224 30 mEq 30 mEq 170 312 isotonic 4.3 (3.5 to 6.5) 40 mEq 1000 0409–7906–09 5 0.298 40 mEq 40 mEq 170 332 slightly hyper. 4.3 (3.5 to 6.5) 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: June, 2009 EN-2163 Printed in USA Hospira, Inc., Lake Forest, IL 60045 USA

Authorization status:

New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE IN DEXTROSE- DEXTROSE MONOHYDRATE AND POTASSIUM
CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
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POTASSIUM CHLORIDE
IN DEXTROSE INJECTION, USP
20, 30 or 40 mEq/liter Potassium Chloride in 5% Dextrose Injection
R only
DESCRIPTION
Potassium Chloride in Dextrose Injection, USP are sterile and
nonpyrogenic solutions in water for
injection. They are for administration by intravenous infusion only.
See Table 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 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.
Water for Injection, USP is chemically designated H O.
The flexible plastic container is fabricated from a specially
formulated polyvinyl chloride. 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, these solutions provide a source of
water and potassium chloride
with carbohydrate.
x
6
12
6
2
2
Solutions containing carbohydrate in the form of dextrose restore
blood gluco