Bacitracin
Xellia Pharmaceuticals Usa Llc
Human Prescription Drug
NDC 70594-026Bacitracin is a human prescription drug labeled by 'Xellia Pharmaceuticals Usa Llc'. National Drug Code (NDC) number for Bacitracin is 70594-026. This drug is available in dosage form of Injection, Powder, For Solution. The names of the active, medicinal ingredients in Bacitracin drug includes Bacitracin - 50000 [USP'U]/1 . The currest status of Bacitracin drug is Active.
Drug Information:
| Drug NDC: | 70594-026 |
| 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: | Bacitracin |
| 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: | Bacitracin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Xellia Pharmaceuticals Usa Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Powder, For 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: | BACITRACIN - 50000 [USP'U]/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
|
| 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: | ANDA |
| 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: | 01 Oct, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Mar, 2023 |
| 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. |
| Application Number: | ANDA203177 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 22 Dec, 2025 |
| 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: | Xellia Pharmaceuticals USA LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 562411
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000008479
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 58H6RWO52I
|
| 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. |
| Pharmacologic Class PE: | Decreased Cell Wall Synthesis & Repair [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Decreased Cell Wall Synthesis & Repair [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 70594-026-01 | 1 VIAL, GLASS in 1 CARTON (70594-026-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS | 01 Oct, 2018 | 31 Mar, 2023 | No |
| 70594-026-02 | 10 VIAL, GLASS in 1 CARTON (70594-026-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS | 01 Oct, 2018 | 31 Mar, 2023 | 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:
Bacitracin bacitracin bacitracin bacitracin
Boxed Warning:
Warning nephrotoxicity bacitracin in parenteral (intramuscular) therapy may cause renal failure due to tubular and glomerular necrosis. its use should be restricted to infants with staphylococcal pneumonia and empyema when due to organisms shown to be susceptible to bacitracin. it should be used only where adequate laboratory facilities are available and when constant supervision of the patient is possible. renal function should be carefully determined prior to and daily during therapy. the recommended daily dose should not be exceeded and fluid intake and urinary output maintained at proper levels to avoid kidney toxicity. if renal toxicity occurs the drug should be discontinued. the concurrent use of other nephrotoxic drugs, particularly streptomycin, kanamycin, polymyxin b, polymyxin e (colistin), and neomycin should be avoided.
Indications and Usage:
Indications and usage in accordance with the statements in the "warning box" the use of intramuscular bacitracin is limited to the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug. to reduce the development of drug-resistant bacteria and maintain the effectiveness of bacitracin and other antibacterial drugs, bacitracin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Dosage and Administration:
Dosage and administration to be administered intramuscularly only infant dose for infants under 2500 grams-900 units/kg/24 hours in 2 or 3 divided doses. for infants over 2500 grams-1,000 units/kg/24 hours, in 2 or 3 divided doses. intramuscular injections of the solution should be given in the upper outer quadrant of the buttocks, alternating right and left and avoiding multiple injections in the same region because of the transient pain following injection. preparation of solutions should be dissolved in sodium chloride injection containing 2 percent procaine hydrochloride. the concentration of the antibiotic in the solution should not be less than 5,000 units per ml nor more than 10,000 units per ml. diluents containing parabens should not be used to reconstitute bacitracin; cloudy solutions and precipitate formation have occurred. reconstitution of the 50,000 unit vial with 9.8 ml of diluent will result in a concentration of 5,000 units per ml. solutions are stable for one week whe
Read more...n stored in a refrigerator 2° to 8°c (36° to 46°f).
Contraindications:
Contraindications this drug is contraindicated in those individuals with a history of previous hypersensitivity or toxic reaction to it.
Adverse Reactions:
Adverse reactions nephrotoxic reactions. albuminuria, cylindruria, azotemia. rising blood levels without any increase in dosage. other reactions. nausea and vomiting. pain at site of injection. skin rashes. to report suspected adverse reactions, contact xellia pharmaceuticals usa, llc at safety@xellia.com or 1-833-295-6953, or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Description:
Description sterile bacitracin, usp is an antibiotic for intramuscular administration. bacitracin is derived from cultures of bacillus subtilis (tracey). it is a white to pale buff, hygroscopic powder, odorless or having a slight odor. it is freely soluble in water; insoluble in acetone, chloroform, and ether. while soluble in alcohol, methanol, and glacial acetic acid, there is some insoluble residue. it is precipitated from its solutions and inactivated by many of the heavy metals. the structural formula is: bacitracin a the molecular formula is: c 66 h 103 n 17 o 16 s. bacitracin is comprised of a polypeptide complex and bacitracin a is the major component in this complex. the molecular weight of bacitracin a is 1422.71. chemical structure
Clinical Pharmacology:
Clinical pharmacology bacitracin exerts pronounced antibacterial action in vitro against a variety of gram-positive and a few gram-negative organisms. however, among systemic diseases, only staphylococcal infections qualify for consideration of bacitracin therapy. bacitracin is assayed against a standard and its activity is expressed in units, 1 mg having a potency of not less than 50 units. absorption of bacitracin following intramuscular injection is rapid and complete. a dose of 200 or 300 units/kg every 6 hours gives serum levels of 0.2 to 2 mcg/ml in individuals with normal renal function. the drug is excreted slowly by glomerular filtration. it is widely distributed in all body organs and is demonstrable in ascitic and pleural fluids after intramuscular injection. susceptibility testing for specific information regarding susceptibility test criteria and associated test methods and quality control standards recognized by fda for this drug, please see: www.fda.gov/stic.
How Supplied:
How supplied sterile bacitracin, usp is available in a vial (1's) containing 50,000 units (ndc 70594-026-01) and as pack of ten (10's) each containing 50,000 units (ndc 70594-026-02). store the unreconstituted product in a refrigerator 2° to 8°c (36° to 46°f).
Information for Patients:
Information for patients patients should be counseled that antibacterial drugs including bacitracin should only be used to treat bacterial infections. they do not treat viral infections (e.g., the common cold). when bacitracin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by bacitracin or other antibacterial drugs in the future.
Package Label Principal Display Panel:
Principal display panel - 1 vial carton ndc 70594-026-01 rx only for intramuscular use bacitracin for injection, usp 50,000 units per vial xellia pharmaceuticals 1 vial principal display panel - 1 vial carton
Principal display panel - 10 vial carton ndc - 70594-026-02 rx only bacitracin for injection, usp 50,000 units per vial xellia pharmaceuticals for intramuscular use 10 vials principal display panel - 10 vial carton