Sodium bicarbonate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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Overview
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
- Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis – e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself.
- Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial – e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.
Dosage
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 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 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 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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Indications and Dosing
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium bicarbonate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Sodium bicarbonate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sodium bicarbonate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium bicarbonate in pediatric patients.
Contraindications
- Sodium Bicarbonate Injection, USP is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction, and in patients receiving diuretics known to produce a hypochloremic alkalosis.
Warnings
- Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.
- In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
- The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
- Extravascular infiltration should be avoided.
Adverse Reactions
Clinical Trials Experience
- 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.
Postmarketing Experience
There is limited information regarding Sodium bicarbonate Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Sodium bicarbonate Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Sodium bicarbonate in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sodium bicarbonate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Sodium bicarbonate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Sodium bicarbonate in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Sodium bicarbonate in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Sodium bicarbonate in geriatric settings.
Gender
There is no FDA guidance on the use of Sodium bicarbonate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Sodium bicarbonate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Sodium bicarbonate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Sodium bicarbonate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Sodium bicarbonate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Sodium bicarbonate in patients who are immunocompromised.
Others
Administration and Monitoring
Administration
IV
Monitoring
There is limited information regarding Sodium bicarbonate Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Sodium bicarbonate and IV administrations.
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.
Pharmacology
There is limited information regarding Sodium bicarbonate Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Sodium bicarbonate Mechanism of Action in the drug label.
Structure
There is limited information regarding Sodium bicarbonate Structure in the drug label.
Pharmacodynamics
There is limited information regarding Sodium bicarbonate Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Sodium bicarbonate Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Sodium bicarbonate Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Sodium bicarbonate Clinical Studies in the drug label.
How Supplied
Sodium Bicarbonate Injection, USP is supplied in the following dosage forms.
Storage
- Store at room temperature 15o - 30o C (59o - 86o F)
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Sodium bicarbonate Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Sodium bicarbonate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Sodium bicarbonate Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Sodium bicarbonate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Drug Shortage
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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