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SODIUM BICARBONATE 4% (2.4%mEq) ADDITIVE SOLUTION 5mL | SODIUM BICARBONATE 4% (2.4%mEq) [HF Acquisition Co LLC, DBA HealthFirst] | BioPortfolio

13:05 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

To adjust acidic parenteral solutions to a more nearly neutral pH.

Fliptop Vial

Rx Only

(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 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 HCO3– ); 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 NaHCO3, a white crystalline powder soluble in water.

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 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 is long 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 clinically significant increase in electrolyte content.

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.

Do not administer unless solution is clear and seal is 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 in DOSAGE & ADMINISTRATION, 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

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 should be given to a pregnant woman only if clearly needed.

None known.

None known.

None known.

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., Aminosyn® solutions and those Ionosol® 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 & EFFECTIVENESS OF 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).

* Requires 2 vials of Neut to bring admixture to approximate neutrality.

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 drugs in 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 is based on the studies involving Hospira dextrose only. Variations in compatibility could occur due to lot-to-lot variations or formula changes in the additives or dextrose solutions of other manufacturers.

Neut (4% sodium bicarbonate additive solution) is supplied in partial-fill single-dose containers 5 mL fliptop vial. Unit of Sale is a Tray containing 25 vials (NDC: 0409-6609-02).

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1233-2.0

Revised: 06/2018

Manufacturer

HF Acquisition Co LLC, DBA HealthFirst

Active Ingredients

Source

Drugs and Medications [64 Associated Drugs and Medications listed on BioPortfolio]

Not applicable [sterling knight pharmaceuticals llc]

These highlights do not include all the information needed to use OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE AND SODIUM BICARBON...

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NA

Clinical Trials [1757 Associated Clinical Trials listed on BioPortfolio]

Pilot Study of Sodium Bicarbonate in Generally Healthy People With Low Bicarbonate

The goal of this pilot study is to determine whether oral sodium bicarbonate can raise low serum bicarbonate concentration in people without chronic kidney disease (CKD). Participants will...

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This pilot phase I trial studies the safety of long-term use of sodium bicarbonate in patients with cancer. Sodium bicarbonate may neutralize tumor acidity and as a result may inhibit the ...

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Painless Local Anaesthesia With Bicarbonate Admixture

This study examines whether the injection of local anesthesia mixed with sodium bicarbonate in the ratio of 3:1 creates a less burning sensation and is as effective regarding the anestheti...

Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy

The purpose of this study is to determine whether sodium bicarbonate is effective in the prevention of sodium-induced nephropathy

PubMed Articles [1778 Associated PubMed Articles listed on BioPortfolio]

High doses of sodium bicarbonate increase lactate levels and delay exhaustion in a cycling performance test.

It is well established that ingestion of sodium bicarbonate (NaHCO) causes metabolic alkalosis. However, there is no consensus in terms of optimal NaHCO doses leading to enhanced performance. This stu...

Sodium bicarbonate regulates nitric oxide production in mouse macrophage cell lines stimulated with lipopolysaccharide and interferon γ.

Macrophages are known to play pivotal roles in host-defense through inflammation via both innate and acquired immune systems, and so on. In an earlier paper, we showed the influence of the type of cul...

Sodium bicarbonate catheter lock solution reduces hemodialysis catheter loss due to catheter-related thrombosis and blood stream infection: an open-label clinical trial.

There is no ideal lock solution that prevents hemodialysis (HD) catheter loss due to catheter-related thrombosis (CRT) and catheter-related bloodstream infection (CRBSI). Catheter loss is associated w...

Sodium bicarbonate nanoparticles modulate the tumor pH and enhance the cellular uptake of doxorubicin.

Acidic pH in the tumor microenvironment is associated with cancer metabolism and creates a physiological barrier that prevents from drugs to penetrate cells. Specifically, ionizable weak-base drugs, s...

Acute Kidney Injury, AKI - Update 2018.

Acute Kidney Injury (AKI) remains a frequent and serious complication in hospitalized individuals worldwide. The current article will focus on three AKI-related aspects: prevention of contrast-Induced...

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