NEUT- 4% sodium bicarbonate additive solution injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)

Available from:

General Injectables and Vaccines, Inc

INN (International Name):

SODIUM BICARBONATE

Composition:

SODIUM BICARBONATE 0.2 g in 5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Neut (4% sodium bicarbonate additive solution) is indicated for use asa an additive to raise the pH of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion. Not for use as a systemic alkalizer. None known.

Product summary:

Neut (4% sodium bicarbonate additive solution) is supplied in partial-fill single-dose containers. 5 mL fliptop vial (list No. 6609). Store at 20 to 25C (68 to 77F). [See USP Controlled Room Temperature.] Revised: November, 2004 ©Hospira 2004 EN-0545 HOSPIRA, INC., LAKE FOREST, IL 60045 USA Printed in USA

Authorization status:

unapproved drug other

Summary of Product characteristics

NEUT- 4% SODIUM BICARBONATE ADDITIVE SOLUTION INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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NEUT
_DESCRIPTION_
TO ADJUST ACIDIC PARENTERAL SOLUTIONS TO A MORE NEARLY NEUTRAL PH.
FLIPTOP VIAL
(0.2 G IN 5 ML)
Neut (4% sodium bicarbonate additive solution) is a sterile,
nonpyrogenic solution of sodium
bicarbonate in water for injection. It is adminsitered by the
intravenous route only after addition as a
neutralizing agent to an acidic large volume parenteral solution. Each
5 mL contains sodium bicarbonate
0.2 g (2.4 mEq each of Na+ and HCO3-); edetate disodium, anhydrous 10
mg added as a stabliizer. Total
sodium (Na+) content of each 5 mL is 56.1 mg (11.2 mg/mL).
The solutions contain no bacteriostat, antimicrobial agent or added
buffer; pH 8.0 (7.0 to 8.5).
Sodium Bicarbonate, USP is chemically designated as NaHCO3, a white
crystalline powder soluble in
water.
_CLINICAL PHARMACOLOGY_
The acid pH of most intrvenous solutions has been implicated as a
factor in the production of
postinfusion (chemical) phlebitis not caused by obvious infection.
Vein irritation, with local redness and
tenderness near the site of venipuncture or along the course of a
vein, appears to be realated to the
nature of the substances in the infusion and the speed (insufficient
dilution by the bloodstream) as well
as the duration (prolonged exposure of the intima) of infusion. Other
contributing factors include the
size of the vein used for venipuncture, shape or method of insertion
of the venipuncture needle, the use
or type of indwelling catheter, infection at the infusion site and the
age of the patient (children and
females seem to be more susceptible).
The pH of commonly used dextrose infustion solutions ranges from 3.5
to 6.5. Other commonly used
solutions also may have an acid pH. Since non-neutral parenteral
solutions with a low (