NEUT- 4% sodium bicarbonate additive solution injection, solution

Neut by

Drug Labeling and Warnings

Neut by is a Prescription medication manufactured, distributed, or labeled by General Injectables and Vaccines, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 (acid) pH are known to cause chemical irritation of tissues, it is not surprising that chemical phlebitis may occur as a complication with their infusion. Vein irritation is most likely when the duration of infusion i slong or when hemodilution is minimized by a large needle in a small vein.

The amount of sodium bicarbonate recommended as an additive to neutralize acid parenteral solutions is too small to exert a clinicallly significant increase in electrolyte content.

INDICATIONS AND USAGE

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.

CONTRAINDICATIONS

Not for use as a systemic alkalizer.

WARNINGS

None known.

PRECAUTIONS

Do not administer unless solution is clear and seal in intact. Discard unused portion.

Solutions prepared with Neut (4% sodium bicarbonate additive solution) should be administered promptly. When introducing additives, use aseptic technique, mix thoroughly and do not store.

When Neut is added to Hospira solutions, the compatibility of these solutions with other drugs may be altered. (See section on COMPATIBILITY, etc., for listing of additives tested with Neut added D5-W.)

Raising the pH of I.V. fluids with Neut will only reduce the incidence of chemical irritation caused by the infusate; it will not diminish any foreign body effects caused by the needle or catheter.

Pregnancy Category C. Animal reproduction studies have not been conducted with sodium bicarbonate. It is also not known whether sodium bicarbonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium bicarbonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium bicarbonate should be given to a pregnant woman only if clearly needed.

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

None known.

DOSAGE AND ADMINISTRATION

One vial (5 mL) of Neut added to a liter (1000 mL) of any of the following Hospira parenteral solutions will increase the pH to a more physiologic range. Specific pH may vary slightly from lot to lot.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

Addition of one vial of Neut to one-half liter (500 mL) is recommended to achieve a more physiologic pH of the following Hospira parenteral solutions:

Note: Some products, e.g., Amniosyn® solutions and those lonosol® and Normosol® formulas containing dextrose will NOT be brought to near physiologic pH by the addition of Neut. This is due to the relatively high buffer capacity of these fluids.

COMPATIBILITY & EFFECTIVNESS FO NEUT WITH ADDITIVES TO 5% DEXTROSE INJECTION (D5-W)

When medications are added to intravenous solutions, the resultant admixtures may or may not be compatible in solutions containing Neut (4%

sodium bicarbonate additive solution).

Following is a list of medications each added to one liter of 5% Dextrose Injection, USP (D5-W) classified according to their effect with Neut (4% sodium bicarbonate additive solution).

It should be noted that the admixtures were evaluated for physical compatibility, not for pharmacological compatibility. It, therefore, would be erroneous to circumvent medical judgment which must be involved in administering any solution that appears to be compatible on the basis of having no visible haze or precipitate. The inclusion of drugsin this study of their compatibility in solution does not imply their therapeutic usefulness or safety. This matter remains the judgment of the prescribing physician.

NOTE: The compatibility information contained herein in based on the studies involving Hospira dextrose only. Variationsin compativility could occur due to lot-to-lot variations or formula changes in the additivies or dextrose solutions of other manufacturers.

HOW SUPPLIED

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

SAMPLE PACKAGE LABEL

INGREDIENTS AND APPEARANCE

NEUT 
4% sodium bicarbonate additive solution injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52584-609(NDC:0409-6609)
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	0.2 g  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52584-609-02	1 in 1 BAG	07/31/2017	11/01/2020
1		5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/31/2014	11/01/2020

Labeler - General Injectables and Vaccines, Inc (108250663)