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Onpharma sodium bicarbonate, 11-22 final

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 SODIUM BICARBONATE INJ., 8.4% USP
Parenteral drug products should be inspected visually for particulate matter, cloudiness NEUTRALIZING ADDITIVE SOLUTION
and discoloration prior to administration, whenever solution and container permit. Drug Interactions
Volume 2.7 mL per cartridge 2.7 mEq (1mEq/mL)
Volume 1.7 mL per cartridge 1.7 mEq (1mEq/mL)

Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution and Lidocaine w/ Epinephrine are compatible. See Compatibility section under Sodium Bicarbonate in DESCRIPTION:
The Handbook on Injectable Drugs by Lawrence A. Trissel, 14th ed. 2007 (American Society of Health-System Pharmacists, Bethesda, MD). Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution is a sterile, Pregnancy Category C
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 Animal reproduction studies have not been conducted in which Sodium Bicarbonate administration. Inj., 8.4% USP Neutralizing Additive Solution was evaluated. Animal reproduction The solution contains no bacteriostat, antimicrobial agent or added buffer and is 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 intended only for single-use. pH is adjusted with carbon dioxide. Per the USP Solution was evaluated. monograph for Sodium Bicarbonate Inj., pH is between 7.0 and 8.5. Osmolar concentration is 2mOsmol/mL (calc.). It is not known whether Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO 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 Sodium Bicarbonate, USP is chemically designated as NaHC03, a white crystalline that has been pH adjusted by the addition of Sodium Bicarbonate Inj., 8.4% USP powder soluble in water. Sodium bicarbonate in water dissociates to provide sodium Neutralizing Additive Solution can cause fetal harm when administered to a pregnant woman or whether it can affect reproduction capacity. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in ADVERSE REACTIONS:
the therapy of fluid and electrolyte disturbances. Bicarbonate (HCO3-) is a normal None known. 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 OVERDOSAGE:
ion (H+) it may be converted to carbonic acid (H2CO3) and thence to its volatile form, Adding a volume of Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive
carbon dioxide (CO2) excreted by the lung. Normally a ratio of 1:20 (carbonic acid; Solution to Lidocaine w/ Epinephrine solution such that the pH of the Lidocaine w/ bicarbonate) is present in the extracellular fluid. In a healthy adult with normal kidney Epinephrine is raised above physiologic pH may cause anesthetic to precipitate out of function, practically all the glomerular filtered bicarbonate ion is reabsorbed; less than solution, reducing the clinical effectiveness of the anesthetic. See, e.g., Mulroy MF, Regional Anesthesia, An Illustrated Procedural Guide, 3rd Ed. 2002 (Lippincott Non-neutral parenteral solutions with a low (acidic) pH are known to cause chemical Williams & Wilkins, Philadelphia, PA). In addition, solutions that contain precipitate irritation of tissues. INDICATIONS AND USAGE:
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/ Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution is indicated to Epinephrine is raised well above (7.8) physiologic pH may cause tissue irritation when hasten onset of analgesia and reduce injection pain, by adjusting commercial the solution is injected. See Whitcomb M, et al, A Prospective Randomized, Double preparations of Lidocaine w/ Epinephrine solution to a more physiologic pH. 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 The practitioner should choose a volume of Sodium Bicarbonate Inj., 8.4% USP 59 (2010).
Neutralizing Additive Solution to be mixed with Lidocaine w/ Epinephrine in a ratio of HOW SUPPLIED:
10:1 (local anesthetic solution to sodium bicarbonate solution). Sodium Bicarbonate Inj., 8.4% USP is supplied in 2.7 mL or 1.7 mL single-dose The below table provides a mixing guide showing for convenience the volumes of cartridges, packaged in a four-cartridge package. 8.4% Sodium Bicarbonate Neutralizing Additive Solution to be added to common Store at 20°-25°C (68°-77°F). (See USP). commercial preparations of Lidocaine w/ Epinephrine in order to achieve a mixed ratio of 10:1. REFERENCES, INDICATIONS AND USAGE:
Barash PG, Cullen BF, Stoelting RK, Clinical Anesthesia (4th Ed. 2001, Lippincott Williams & Wilken).
10:1 Anesthetic-to-Bicarbonate Solution Ratio
Bhatt H, Powell KJ, Jean DA, First Aid for the Anesthesiology Boards, An Insider's Guide (2011,
Mixing Guide for 10:1  
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.
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).
REFERENCES, DOSAGE:
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 117-120 (1988).
CONTRAINDICATIONS:
Martin AJ, pH-adjustment and discomfort caused by the intradermal injection of lignocaine, Anaesthesia,
WARNINGS:
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
PRECAUTIONS:
epinephrine, Anesthesia and Analgesia, vol 66, p 572 (1987).
Administer local anesthetic solution immediately after combining with Sodium Narvaez J, Wessels I, Bacon G, Chin VR, Baqai WK, Zimmerman GJ, Prospective randomized evaluation
Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution.
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).
When combining local anesthetic solution with Sodium Bicarbonate Inj., 8.4% USP Talu H, Elibol O, Yanyali A, Karabas L, Alp B, Caglar Y, Effect of warming and buffering lidocaine on
Neutralizing Additive Solution, use aseptic technique, mix thoroughly, and do not pain during facial anesthesia, Annals of Ophthalmology, vol 33, no 1, p 43 (2001).
store.
Do not use unless Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution Manufactured For Onpharma Inc., Los Gatos, CA 95030 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. Copyright 2011 Onpharma Inc. All Rights Reserved

Source: http://www.onpharma.com/pdf/Onpharma_Sodium%20Bicarbonate_Additive_Solution_Package_Insert.pdf

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