Sodium Bicarbonate
Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-1400Sodium Bicarbonate is a human prescription drug labeled by 'Hf Acquisition Co Llc, Dba Healthfirst'. National Drug Code (NDC) number for Sodium Bicarbonate is 51662-1400. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Sodium Bicarbonate drug includes Sodium Bicarbonate - 42 mg/mL . The currest status of Sodium Bicarbonate drug is Active.
Drug Information:
| Drug NDC: | 51662-1400 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sodium Bicarbonate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sodium Bicarbonate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hf Acquisition Co Llc, Dba Healthfirst |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SODIUM BICARBONATE - 42 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 19 Oct, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | HF Acquisition Co LLC, DBA HealthFirst
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1868469
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UPC: | 0363323083052
|
| UPC stands for Universal Product Code. |
| UNII: | 8MDF5V39QO
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51662-1400-1 | 5 mL in 1 VIAL, SINGLE-DOSE (51662-1400-1) | 19 Oct, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Sodium bicarbonate sodium bicarbonate sodium bicarbonate bicarbonate ion water carbon dioxide
Indications and Usage:
Indications & usage 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 blood pigments. 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 â e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. but sin
Read more...ce 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 â e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.
Warnings:
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, see adverse reactions .
Dosage and Administration:
Dosage & administration sodium bicarbonate injection, usp is administered by the intravenous route. in cardiac arrest, a rapid intravenous dose of 200 to 300 meq of bicarbonate, given as a 4.2% or 8.4% solution is suggested for adults. cautions 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 infants (up to two years of age), intravenous administration at a dose not to exceed 8 meq/kg/day is recommended. slow administration rates and a solution of 4.2% are recommended in neonates, to guard against the possibility of producing hypernatremia, decreasing cerebrospinal fluid pressure and inducing intracranial hemorrhage. in less urgent forms of metabolic acidosis, sodium bicarbonate injection
Read more..., 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 â depending upon the severity of the acidosis as judged by the lowering of total co2 content, blood ph and clinical condition of the patient. 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 acidbase 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 . do not use unless solution is clear and the container or seal is intact. discard unused portion.
Contraindications:
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.
Adverse Reactions:
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 prevent sloughing of extravasated iv infusions.
Overdosage:
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 .
Description:
Description sodium bicarbonate injection, usp is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (nahco3), usp, in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. ph of the solution is 7.0 to 8.5. solutions are offered in concentrations of 4.2% and 8.4%. see table in how supplied/storage and handling section for contents and characteristics. the solutions contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection. when smaller doses are required, the unused portion should be discarded with the entire unit. sodium bicarbonate, 84 mg is equal to one milliequivalent each of na+ and hco3-. sodium bicarbonate, usp is chemically designated nahco3, a white crystalline powder soluble in water. water for injection, usp is chemically designated h2o.
Clinical Pharmacology:
Clinical pharmacology intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood ph and reverses the clinical manifestations of acidosis. 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. plasma concentration is regulated by the kidney through acidification of the urine when there is a deficit or by alkalinization of the urine when there is an excess. bicarbonate anion is considered âlabileâ since at a proper concentration of hydrogen ion (h+) it may be converted to carbonic acid (h2c03) and thence to its volatile form, carbon dioxide (co2) excreted by the lung. normally a ratio of 1:20 (carbonic acid: bicarbonat
Read more...e) 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% excreted in the urine.
How Supplied:
How supplied/storage and handling sodium bicarbonate injection, usp is supplied in the following dosage forms. ndc 51662-1400-1 sodium bicarbonate injection, usp, 4.2% 2.5meq (0.5meq per ml) 5ml vial hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufacture supplied dosage forms sodium bicarbonate injection, usp is supplied in the following dosage forms: store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. for product inquiry: 1-800-551-7176 or www.fresenius-kabi.us 451554 issued: june 2017 how supplied - storage and handling logo
Package Label Principal Display Panel:
Principal display panel - vial labeling vial 1 vial 2 vial 3
Principal display panel - serialized labeling serialized labeling