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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 [1610 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 [1751 Associated PubMed Articles listed on BioPortfolio]

Potential of using sodium bicarbonate as external carbon source to cultivate microalga in non-sterile condition.

In this study, a saline-alkaline tolerant microalgal strain was isolated and identified as Chlorella sp. LPF. This strain was able to grow at pH values up to 10 and at salinities up to 5%, and tolerat...

Sodium bicarbonate cotransporter NBCe2 gene variants increase sodium and bicarbonate transport in human renal proximal tubule cells.

Salt sensitivity of blood pressure affects >30% of the hypertensive and >15% of the normotensive population. Variants of the electrogenic sodium bicarbonate cotransporter NBCe2 gene, SLC4A5, are assoc...

Six-Month Evaluation of a Sodium Bicarbonate-Containing Toothpaste for Reduction of Established Gingivitis: A Randomized USA-Based Clinical Trial.

Short-term use of sodium bicarbonate (NaHCO3)-containing toothpaste reduces plaque and improves clinical measures of gingivitis. To examine this over a longer period, we compared efficacy and tolerabi...

The effect of chronic progressive-dose sodium bicarbonate ingestion on CrossFit-like performance: A double-blind, randomized cross-over trial.

Sodium bicarbonate (SB) has been proposed as an ergogenic aid, as it improves high-intensity and resistance exercise performance. However, no studies have yet investigated SB application in CrossFit. ...

Acute attenuation of fatigue after sodium bicarbonate supplementation does not manifest into greater training adaptations after 10-weeks of resistance training exercise.

In two concurrent studies, we aimed to a) confirm the acute effect of 0.3 g·kg-1 body weight (BW) sodium bicarbonate (NaHCO3) supplementation on central and peripheral mechanisms associated with expl...

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