DESCRIPTION
id: 65dc1d7c-3877-434b-85f4-4770b646c340
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Sodium Bicarbonate 4.2% Neutralizing Additive Solution is a sterile, nonpyrogenic solution of sodium bicarbonate in Water for Injection. It is administered by the intravenous route only after addition as a neutralizing agent to an acidic large volume parenteral solution.
Each mL contains: Sodium bicarbonate 42 mg (0.5 mEq each of Na+ and HCO3
–
). Total sodium (Na
+
) content of each 5 mL is 57.5 mg (11.5 mg/mL). pH adjusted with carbon dioxide and as a result, pressure may be present.
The solution contains no bacteriostat, antimicrobial agent or added buffer. pH 7.0–8.5 and the osmolar concentration is 1 mOsmol/mL.
Sodium Bicarbonate, USP is chemically designated as NaHCO3, a white crystalline powder soluble in water.
CLINICAL PHARMACOLOGY
id: 971f976a-55ae-454b-ac45-0496a4e52bf2
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
The acid pH of most intravenous solutions has been implicated as a factor in the production of postinfusion (chemical) phlebitis not caused by obvious infection. Vein irritation, with local redness and tenderness near the site of venipuncture or along the course of a vein, appears to be related to the nature of the substances in the infusion and the speed (insufficient dilution by the bloodstream) as well as the duration (prolonged exposure of the intima) of infusion. Other contributing factors include the size of the vein used for venipuncture, shape or method of insertion of the venipuncture needle, the use or type of indwelling catheter, infection at the infusion site and the age of the patient (children and females seem to be more susceptible).
The pH of commonly used dextrose infusion solution ranges from 3.5 to 6.5. Other commonly used solutions also may have an acid pH. Since parenteral solutions with a low (acid) pH are known to cause chemical irritation of tissues, it is not surprising that chemical phlebitis may occur as a complication with their infusion. Vein irritation is most likely when the duration of infusion is long or when hemo-dilution is minimized by a large needle in a small vein. The amount of sodium bicarbonate recommended as an additive to neutralize acid parenteral solutions is too small to exert a clinically significant increase in electrolyte content.
INDICATIONS AND USAGE
id: ecb121d6-b190-4675-93fb-b0fcfbe3bb61
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Sodium Bicarbonate 4.2% Neutralizing Additive Solution is indicated for use as a neutralizing solution to raise the pH of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion.
CONTRAINDICATIONS
id: 03a60434-1770-44b8-9bad-b7aefdb837d7
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Not for use as a systematic alkalizer.
DOSAGE AND ADMINISTRATION
id: cc6a517b-e7a1-4de1-8e16-28a542fef63e
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
One vial (5 mL) of Sodium Bicarbonate 4.2% Neutralizing Additive Solution added to a liter (1,000 mL) of any of the following parenteral solutions will increase the pH to a more physiologic range. Specific pH may vary slightly from lot to lot.
5% Alcohol and D5-W
5% Dextrose and Ringer’s
5% Dextrose and 0.45% Sodium Chloride Injection, USP
2.5% Dextrose and 0.45% Sodium Chloride Injection, USP
5% and 0.225% Sodium Chloride Injection, USP
5% Dextrose and 0.9% Sodium Chloride Injection, USP
2.5% Dextrose Injection, USP
5% Dextrose Injection, USP
10% Dextrose Injection, USP
20% Dextrose Injection, USP
10% Invert Sugar
Lactated Ringer’s
Ringer’s Injection
0.9% Sodium Chloride Injection, USP
0.45% Sodium Chloride Injection, USP
Sodium Lactate 1/6 Molar
NOTE:
Some products such as amino acid solutions and multiple electrolyte solutions
containing dextrose will NOT be brought to near physiologic pH by the addition of
Sodium Bicarbonate 4.2% Neutralizing Additive Solution. This is due to the relatively
high buffer capacity of these fluids.
COMPATIBILITY AND EFFECTIVENESS OF SODIUM BICARBONATE 4.2% NEUTRALIZING ADDITIVE SOLUTION WITH ADDITIVES TO
5% DEXTROSE INJECTION (D5-W)
When medications are added to intravenous solutions, the resultant admixture may or may not be compatible in solutions containing Sodium Bicarbonate 4.2% Neutralizing Additive Solution. (See Compatibility section under Sodium Bicarbonate in
Handbook on Injectable Drugs
by Lawrence A. Trissel.)
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
HOW SUPPLIED
id: 0dc24cdd-6569-4902-9894-d4fccd8cce58
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Sodium Bicarbonate 4.2% Neutralizing Additive Solution supplied as:
Product
No.
|
NDC
No.
|
Strength
|
|
|
2605
|
63323-026-05
|
4.2%
(42 mg/mL)
|
5 mL fill in a 6 mL single dose vial, in packages of 25.
|
Preservative Free.
Discard Unused Portion.
No stabilizers. Sterile, Nonpyrogenic.
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Use only if solution is clear and seal intact.
