Advertisement

Topics

SODIUM BICARBONATE INJ., 8.4% USP NEUTRALIZING ADDITIVE SOLUTION Rx only Volume 2.7 mL per cartridge 2.7 mEq (1mEq/mL) Volume 1.7 mL per cartridge 1.7 mEq (1mEq/mL) | Sodium Bicarbonate [Onpharma, Inc.] | BioPortfolio

12:49 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.

Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution is a sterile, nonpyrogenic, solution of sodium bicarbonate (NaHCO3) in Water for Injection. It is added to an appropriate local anesthetic as a neutralizing agent immediately prior to administration.

The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for single-use. pH is adjusted with carbon dioxide. Per the USP monograph for Sodium Bicarbonate Inj., pH is between 7.0 and 8.5. Osmolar concentration is 2 mOsmol/mL (calc.).

Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3-.

Sodium Bicarbonate, USP is chemically designated as NaHC03, a white crystalline powder soluble in water. Sodium bicarbonate in water dissociates to provide sodium (Na+) and bicarbonate (HCO3-) ions.

Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Bicarbonate (HCO3-) is a normal constituent of body fluids and the normal plasma level ranges from 24 to 31 mEq/liter. Bicarbonate anion is considered “labile” since at a proper concentration of hydrogen ion (H+) it may be converted to carbonic acid (H2CO3) and thence to its volatile form, carbon dioxide (CO2) excreted by the lung. Normally a ratio of 1:20 (carbonic acid; bicarbonate) is present in the extracellular fluid. In a healthy adult with normal kidney function, practically all the glomerular filtered bicarbonate ion is reabsorbed; less than 1% is excreted in the urine.

Non-neutral parenteral solutions with a low (acidic) pH are known to cause chemical irritation of tissues.

Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution is indicated to hasten onset of analgesia and reduce injection pain, by adjusting commercial preparations of Lidocaine w/ Epinephrine anesthetic solution to a more physiologic pH.

The practitioner should choose a volume of Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution to be mixed with Lidocaine w/ Epinephrine in a ratio of 1:10 (local anesthetic solution to sodium bicarbonate solution). The below table provides a mixing guide showing for convenience the volumes of 8.4% Sodium Bicarbonate Neutralizing Additive Solution to be added to the commercial preparations of Lidocaine with Epinephrine in order to achieve a mixed ratio of 10:1.

                                                                                                                                                10:1 Anesthetic-to-Bicarbonate Solution Ratio Mixing Guide for 10:1

 Volume (mL), Lidocaine w/ Epinephrine (container type)  Volume (mL), 8.4% Sodium Bicarbonate Solution
 1.8 mL (cartridge)  0.18 mL
 20 mL (Vial)  2.0 mL
 30 mL (Vial)  3.0 mL
 50 mL (Vial)  5.0 m

Not for use as a systemic alkalizer.

None known.

Administer local anesthetic solution immediately after combining with Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution. When combining local anesthetic solution with Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution, use aseptic technique, mix thoroughly, and do not store. Do not use unless Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution is clear, colorless, and free of particulates or cloudiness, and the container or seal is intact. Do not use if the inner or outer packaging are damaged. Discard unused portion.

Do not use local anesthetic combined with Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution unless the combined solution is clear, colorless, and free of particulates or cloudiness.

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

Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution and Lidocaine w/ Epinephrine are compatible. See Compatibility section under Sodium Bicarbonate in The Handbook on Injectable Drugs by Lawrence A. Trissel, 14th ed. 2007 (American Society of Health-System Pharmacists, Bethesda, MD).

Animal reproduction studies have not been conducted in which Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution was evaluated. Animal reproduction studies have not been conducted in which Lidocaine w/ Epinephrine that has been pH adjusted by the addition of Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution was evaluated.

It is not known whether Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution can cause fetal harm when administered to a pregnant woman or whether it can affect reproduction capacity. It is not known whether Lidocaine w/ Epinephrine that has been pH adjusted by the addition of Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution can cause fetal harm when administered to a pregnant woman or whether it can affect reproduction capacity.

None known.

Adding a volume of Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution to Lidocaine w/ Epinephrine solution such that the pH of the Lidocaine w/ Epinephrine is raised above physiologic pH may cause anesthetic to precipitate out of solution, reducing the clinical effectiveness of the anesthetic. See, e.g., Mulroy MF, Regional Anesthesia, An Illustrated Procedural Guide, 3rd Ed. 2002 (Lippincott Williams and Wilkins, Philadelphia, PA). In addition, solutions that contain precipitate should not be injected. Adding a volume of Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution to Lidocaine w/ Epinephrine solution such that the pH of the Lidocaine w/ Epinephrine is raised well above (7.8) physiologic pH may cause tissue irritation when the solution is injected. See Whitcomb M, et al, A Prospective Randomized, Double Blind Study of the Anesthetic Efficacy of Sodium Bicarbonate Buffered 2% Lidocaine with 1:100,000 Epinephrine in Inferior Alveolar Nerve Blocks, Anesth Prog, vol 57, p 59 (2010).

Sodium Bicarbonate Inj., 8.4% USP is supplied in 2.7 mL or 1.7 mL single-dose cartridges, packaged in a four-cartridge package.

Store at 20°-25°C (68°-77°F). (See USP).

Barash PG, Cullen BF, Stoelting RK, Clinical Anesthesia (4th Ed. 2001 Lippincott Williams and Wilken). Bhatt H, Powell KJ, Jean DA, First Aid for the Anesthesiology Boards, An Insider's Guide (2011, McGraw-Hill Medical). Cepeda MS, Tzortzopoulou A, Thackrey M, Hudcova J, Arora Gandhi P, Schumann R., Adjusting the pH of lidocaine for reducing pain on injection. Cochrane Database of Systematic Reviews 2010, Issue 12. Art. No.: CD006581. Chu LF, Clinical Anesthesiology Board Review(2005, McGraw-Hill Medical). Malamed SF,Handbook of Local Anesthesiology(5th Ed. 2004, Elsevier Mosby). Miller RD, Miller's Anesthesia (6th Ed. 2004). Stoelting RK, Miller RD,Basics of Anesthesia(5th Ed. 2007, Churchill Livingstone Elsevier).

Christoph RA, Buchanan L, Begalla K, Schwartz S, Pain reduction in local anesthetic administration through pH buffering, Annals of Emergency Medicine, vol 17, no 2, p 117 (1988).

Martin AJ, pH-adjustment and discomfort caused by the intradermal injection of lignocaine, Anaesthesia, vol 45, p 975 (1990).

Masters JE, Randomised control trial of pH buffered lignocaine with adrenaline in outpatient operations, British Journal of Plastic Surgery, vol 51, p 385 (1998).

McKay W, Morris R, Mushlin P, Sodium bicarbonate attenuates pain on skin infiltration with or without epinephrine, Anesthesia and Analgesia, vol 66, p 572 (1987).

Narvaez J, Wessels I, Bacon G, Chin VR, Baqai WK, Zimmerman GJ, Prospective randomized evaluation of short-term complications when using buffered or unbuffered lidocaine 1% with epinephrine for blepharoplasty surgery, Ophthalmic Plastic and Reconstructive Surgery, vol 26, no1, p 33 (2010).

Talu H, Elibol O, Yanyali A, Karabas L, Alp B, Caglar Y, Effect of warming and buffering lidocaine on pain during facial anesthesia, Annals of Ophthalmology, vol 33, no 1, p 43 (2001).

Manufactured for Onpharma Inc., Los Gatos, CA 95030

Customer Care Center: (877) 336-6738 NDC 50509-100-01NDC 50509-100-03Copyright © 2011 Onpharma Inc.  All Rights Reserved        (11/2011) LS013-D

Manufacturer

Onpharma, Inc.

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...

Sodium bicarbonate 4% (2.4%meq) [hf acquisition co llc, dba healthfirst]

SODIUM BICARBONATE 4% (2.4%mEq) ADDITIVE SOLUTION 5mL

Neut [general injectables and vaccines, inc]

Neut

Polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate [novel laboratories, inc.]

PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution with Flavor pack

Sodium bicarbonate [fresensius kabi usa, llc]

NA

Clinical Trials [1772 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...

Extended Use of Sodium Bicarbonate in Patients With Cancer

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 ...

A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms

This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothp...

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 [1776 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 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...

IN VITRO EVALUATION OF THE EFFECT OF AIR POLISHING WITH DIFFERENT ABRASIVE POWDERS ON THE ROUGHNESS OF IMPLANT ABUTMENT SURFACE.

The aim of this in vitro study was to evaluate the effect of air-polishing on implant abutment surface using different abrasives powder: sodium bicarbonate and amino acid glycine. Fifteen grade III ma...

The effects of sodium bicarbonate ingestion on cycling performance and acid base balance recovery in acute normobaric hypoxia.

This study investigated the effects of two separate doses of sodium bicarbonate (NaHCO) on 4 km time trial (TT) cycling performance and post-exercise acid base balance recovery in hypoxia. Fourteen cl...

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Anesthesia
Anesthesia is the loss of feeling or sensation in all or part of the body. It may result from damage to nerves or can be induced by an anesthetist (a medical professional) using anesthetics such as thiopental or propofol or sevoflurane during a surgical ...

Blood
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...


Drugs and Medication Quicklinks


Searches Linking to this Drug Record