SODIUM BICARBONATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)

Available from:

Onpharma, Inc.

INN (International Name):

SODIUM BICARBONATE

Composition:

SODIUM BICARBONATE 84 mg in 1 mL

Administration route:

PARENTERAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Not for use as a systemic alkalizer. 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 El

Product summary:

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.

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM BICARBONATE- SODIUM BICARBONATE SOLUTION
ONPHARMA, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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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)
DESCRIPTION:
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 kno