NEUT- sodium bicarbonate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)

Available from:

Hospira, 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 as 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 (sodium bicarbonate 4% additive solution), single-dose glass fliptop vial NDC 0409-6609-25: 2.4 mEq/5 mL (0.48 mEq/mL), supplied in a 5 mL partial-fill single-dose, glass fliptop vial. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

unapproved drug other

Summary of Product characteristics

NEUT- SODIUM BICARBONATE INJECTION, SOLUTION
HOSPIRA, 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™
_SODIUM BICARBONATE 4%_
2.4 MEQ/5 ML (0.48 MEQ/ML)
RX ONLY
_ADDITIVE SOLUTION_
TO ADJUST ACIDIC PARENTERAL SOLUTIONS TO A MORE NEARLY NEUTRAL PH.
FLIPTOP VIAL
(0.2 G IN 5 ML)
DESCRIPTION
Neut (4% sodium bicarbonate additive solution) is a sterile,
nonpyrogenic solution of sodium
bicarbonate in water for injection. It is administered 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 HCO ‾ ); edetate disodium, anhydrous
10 mg added as a stabilizer. 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 NaHCO , a white
crystalline powder soluble in
water.
CLINICAL PHARMACOLOGY
The acid pH of most intravenous 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 related 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 infusion solutions ranges from 3.5 to
6.5. Other commonly used
solutions also may have an acid pH. Since non-neutral