SODIUM BICARBONATE (Page 2 of 2)

DOSAGE AND ADMINISTRATION

Sodium Bicarbonate Injection, USP is administered by the intravenous route.

In cardiac arrest , a rapid intravenous dose of 44.6 to 100 mEq may be given initially and continued at a rate of 44.6 to 50 mEq every 5 to 10 minutes if necessary (as indicated by arterial pH and blood gas monitoring) to reverse the acidosis. Caution should be observed in emergencies where very rapid infusion of large quantities of bicarbonate is indicated. Bicarbonate solutions are hypertonic and may produce an undesirable rise in plasma sodium concentration in the process of correcting the metabolic acidosis. In cardiac arrest, however, the risks from acidosis exceed those of hypernatremia.

In less urgent forms of metabolic acidosis, Sodium Bicarbonate Injection, USP may be added to other intravenous fluids. The amount of bicarbonate to be given to older children and adults over a four-to-eight-hour period is approximately 2 to 5 mEq/kg of body weight – depending upon the severity of the acidosis as judged by the lowering of total CO2 content, blood pH and clinical condition of the patient. In metabolic acidosis associated with shock, therapy should be monitored by measuring blood gases, plasma osmolarity, arterial blood lactate, hemodynamics and cardiac rhythm. Bicarbonate therapy should always be planned in a stepwise fashion since the degree of response from a given dose is not precisely predictable. Initially an infusion of 2-5 mEq/kg body weight over a period of 4 to 8 hours will produce a measurable improvement in the abnormal acid-base status of the blood. The next step of therapy is dependent upon the clinical response of the patient. If severe symptoms have abated, then the frequency of administration and the size of the dose may be reduced.

In general, it is unwise to attempt full correction of a low total CO2 content during the first 24 hours of therapy, since this may be accompanied by an unrecognized alkalosis because of a delay in the readjustment of ventilation to normal. Owing to this lag, the achievement of total CO2 content of about 20 mEq/liter at the end of the first day of therapy will usually be associated with a normal blood pH. Further modification of the acidosis to completely normal values usually occurs in the presence of normal kidney function when and if the cause of the acidosis can be controlled. Values for total CO2 which are brought to normal or above normal within the first day of therapy are very likely to be associated with grossly alkaline values for blood pH, with ensuing undesired side effects.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .

HOW SUPPLIED

Sodium Bicarbonate Injection, USP is supplied in the following dosage forms.

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Store at 20 to 25°C (68 to 77°F).

[See USP Controlled Room Temperature.] Protect from freezing.

Product repackaged by: Henry Schein, Inc., Bastian, VA 24314
From Original Manufacturer/Distributor’s NDC and Unit of SaleTo Henry Schein Repackaged Product NDC and Unit of SaleTotal Strength/Total Volume (Concentration) per unit
NDC 0409-5555-02
25 in 1 TRAY
NDC 0404-9951-05
1 5 mL Glass Vial in a bag
(Vial bears NDC 0409-5555-12)
4.2%
2.5 mEq/5 mL
(0.5 mEq/mL)

Revised: 01/2018

LAB-0809-1.0

EN-4395

Hospira, Inc., Lake Forest, IL 60045 USA

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SODIUM BICARBONATE
sodium bicarbonate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-9951(NDC:0409-5555)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 42 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0404-9951-05 1 VIAL, SINGLE-USE in 1 BAG contains a VIAL, SINGLE-USE
1 5 mL in 1 VIAL, SINGLE-USE This package is contained within the BAG (0404-9951-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202981 01/12/2022
Labeler — Henry Schein, Inc. (012430880)

Revised: 11/2022 Henry Schein, Inc.

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