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:

Fresenius Kabi USA, LLC

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. Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. Flexible Plastic Container (free flex ® bag) To Open - Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. - Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. - Do not use if the solution is cloudy or a precipitate is present. To Add Medication - Identify WHITE Additive Port with arrow pointing toward container. - Immediately before injecting additives, break off WHIT

Product summary:

Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Injection, USP is supplied in single-dose free flex ® plastic containers as follows: Avoid excessive heat. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE- DEXTROSE
MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE INJECTION,
SOLUTION
FRESENIUS KABI USA, LLC
----------
POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE
R only
POTASSIUM CHLORIDE IN 5% DEXTROSE AND 0.225% 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 table below for summary of content and characteristics of these
solutions.
Table 1
COMPOSITION (g/L)
Approx. Ionic Concentrations (mEq/L)
Potassium
Chloride in 5%
Dextrose
and 0.225%
Sodium
Chloride
Injection, USP
mEq
Potassium
Size
(mL)
Dextrose,
Hydrous
Sodium
Chloride
Potassium
Chloride
Calculated
Osmolarity
(mOsmol/L)
pH Sodium
(Na )
Potassium
(K )
Chloride
(Cl )
Approximate
Kcal/L
10 mEq
500
50
2.25
1.49
370
4.2
(3.5
to
6.5)
38.5
20
58.5
170
20 mEq 1000
50
2.25
1.49
370
4.2
(3.5
to
6.5)
38.5
20
58.5
170
May contain HCl for pH adjustment.
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:
x
+
+
-
6
12
6
2
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 non-plasticized,
film containing polypropylene and thermoplastic elastomers (FREE_flex_
bag). Water can
permeate from inside the container into the overwrap bu