Sodium Bicarbonate (Page 2 of 3)

ADVERSE REACTIONS

Overly aggressive therapy with Sodium Bicarbonate Injection, USP can result in metabolic alkalosis (associated with muscular twitchings, irritability, and tetany) and hypernatremia.

Inadvertent extravasation of intravenously administered hypertonic solutions of sodium bicarbonate have been reported to cause chemical cellulitis because of their alkalinity, with tissue necrosis, ulceration or sloughing at the site of infiltration. Prompt elevation of the part, warmth and local injection of lidocaine or hyaluronidase are recommended to reduce the likelihood of tissue sloughing from extravasated I.V. solutions.

OVERDOSAGE

Should alkalosis result, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indicated in severe alkalosis. (See WARNINGS and PRECAUTIONS.)

DOSAGE AND ADMINISTRATION

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

In cardiac arrest, a rapid intravenous dose of one to two 50 mL syringes (44.6 to 100 mEq) may be given initially and continued at a rate of 50 mL (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 CO ₂ 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 to 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 CO ₂ 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 CO ₂ 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 CO ₂ 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.

NDC No. (Unit of Sale) (NDC No. (Each))	Dosage Form	Conc. %	mg/mL (NaHCO 3 )	mEq/mL (Na +)	mEq/mL (HCO 3 –)	mEq/ Container size (mL)	mOsm / mL	pH
0409-4916-14 (0409-4916-24)	Lifeshield ® Abboject ® Syringe	7.5	75	0.9	0.9	44.6/50	1.40	8.0 (7.0 – 8.5)
0409-6637-14 (0409-6637-24)	Lifeshield ® Abboject ® Syringe	8.4	84	1	1	50/50	1.56	8.0 (7.0 – 8.5)

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Hospira, Inc., Lake Forest, IL 60045 USA

ABBOJECT ^® is a trademark of the Abbott group of companies.
LIFESHIELD ^® is the trademark of ICU Medical, Inc. and is used under license.

LAB-1019-3.0

01/2018

PRINCIPAL DISPLAY PANEL — VIAL LABEL

8.4% Sodium Bicarbonate

50 mL Single-dose

8.4% Sodium Bicarbonate
Injection, USP
50 mEq/50 mL (1 mEq/mL)

Rx only

For intravenous use. Usual dosage: See insert. Sterile, nonpyrogenic.
Discard unused portion.
1.56 mOsmol/mL.
pH 8.0 (7.0 to 8.5).