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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

05:21 EDT 27th August 2014 | BioPortfolio
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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 2mOsmol/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: (a) hasten onset of analgesia; and (b) reduce injection pain, by adjusting commercial preparations of Lidocaine w/ Epinephrine anesthetic solution to a more physiologic pH.

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.

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).

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        (02/2011) LS013-B

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Onpharma, Inc.

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Clinical Trials [1482 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 [1731 Associated PubMed Articles listed on BioPortfolio]

Impact of Sodium Bicarbonate-Buffered Lidocaine on Patient Pain During Image-Guided Breast Biopsy.

This randomized, double-blind controlled study evaluated the effectiveness of sodium bicarbonate-buffered lidocaine on reducing pain during imaging-guided breast biopsies.

Randomized control trial of benzydamine HCl versus sodium bicarbonate for prophylaxis of concurrent chemoradiation-induced oral mucositis.

The purpose of the study is to compare the efficacy of benzydamine HCl with sodium bicarbonate in the prevention of concurrent chemoradiation-induced oral mucositis in head and neck cancer patients.

Two Randomized Clinical Studies to Confirm Differential Plaque Removal by Sodium Bicarbonate Dentifrices in a Single Timed Brushing Model.

This study evaluated and compared plaque removal efficacy of commercially available dentifrices containing sodium bicarbonate (NaHCO3) to those without NaHCO3 in a single timed brushing clinical study...

Effect of sodium bicarbonate on prolonged running performance: A randomized, double-blind, cross-over study.

The ability to sustain intense exercise seems to be partially limited by the body's capability to counteract decreases in both intra- and extracellular pH. While the influence of an enhanced buffering...

Randomized, Controlled Trial of TRC101 to Increase Serum Bicarbonate in Patients with CKD.

Metabolic acidosis is common in patients with CKD and has significant adverse effects on kidney, muscle, and bone. We tested the efficacy and safety of TRC101, a novel, sodium-free, nonabsorbed hydroc...

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