Tobramycin
Proficient Rx Lp
Human Prescription Drug
NDC 63187-024Tobramycin is a human prescription drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Tobramycin is 63187-024. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Tobramycin drug includes Tobramycin - 3 mg/mL . The currest status of Tobramycin drug is Active.
Drug Information:
| Drug NDC: | 63187-024 |
| 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: | Tobramycin |
| 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: | Tobramycin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Proficient Rx Lp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | 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: | TOBRAMYCIN - 3 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| 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: | 29 Nov, 1993 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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. |
| Application Number: | ANDA064052 |
| 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: | 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: | Proficient Rx LP
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 313415
|
| 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: | 0363187024055
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175477
M0000946
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | VZ8RRZ51VK
|
| 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 EPC: | Aminoglycoside Antibacterial [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Aminoglycosides [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Aminoglycoside Antibacterial [EPC]
Aminoglycosides [CS]
|
| 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 |
|---|
| 63187-024-05 | 1 BOTTLE, DROPPER in 1 CARTON (63187-024-05) / 5 mL in 1 BOTTLE, DROPPER | 01 Nov, 2018 | 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:
Tobramycin tobramycin tobramycin tobramycin benzalkonium chloride boric acid water sodium chloride sodium hydroxide sodium sulfate sulfuric acid tyloxapol
Indications and Usage:
Indications and usage: tobramycin ophthalmic solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution. clinical studies have shown tobramycin to be safe and effective for use in children.
Warnings:
Warnings: not for injection into the eye. sensitivity to topically applied aminoglycosides may occur in some patients. if a sensitivity reaction to tobramycin ophthalmic solution occurs, discontinue use.
General Precautions:
General: as with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. if superinfection occurs, appropriate therapy should be initiated.
Dosage and Administration:
Dosage and administration: in mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. in severe infections, instill two drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation. do not use if imprinted neckband is not intact. for ophthalmic use only
Contraindications:
Contraindications: tobramycin ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.
Adverse Reactions:
Adverse reactions: the most frequent adverse reactions to tobramycin ophthalmic solution is localized ocular toxicity and hypersensitivity, including lid itching and swelling, and conjunctival erythema. these reactions occur in less than three of 100 patients treated with tobramycin. similar reactions may occur with the topical use of other aminoglycoside antibiotics. other adverse reactions have not been reported from tobramycin therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.
Overdosage:
Overdosage: clinically apparent signs and symptoms of an overdose of tobramycin ophthalmic solution (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.
Description:
Description: tobramycin ophthalmic solution is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external infections. each ml contains: active: tobramycin 3 mg (0.3%). inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol and purified water. sodium hydroxide and/or sulfuric acid may be added to adjust ph (7.0 - 8.0). preservative added: benzalkonium chloride 0.1 mg (0.01%). the structural formula of tobramycin is molecular formula: c 18 h 37 n 5 o 9 molecular weight: 467.52 chemical name: o-[3-amino-3-deoxyâα-d-gluco-pyranosyl-(1 â 4)]-o-[2,6-diamino-2,3,6-trideoxy-α-d-ribohexo-pyranosyl- (1 â 6)]-2-deoxystreptamine. tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. tobramycin (structural formula)
Clinical Pharmacology:
Clinical pharmacology: in vitro data: in vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: staphylococci, including s. aureus and s. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. streptococci, including some of the group a-betahemolytic species, some nonhemolytic species, and some streptococcus pneumoniae. pseudomonas aeruginosa, escherichia coli, klebsiella pneumoniae, enterobacter aerogenes, proteus mirabilis, morganella morganii, most proteus vulgaris strains, haemophilus influenzae and h. aegyptius, moraxella lacunata, and acinetobacter calcoaceticus and some neisseria species. bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin. a significant bacterial population resistant to tobramycin has not yet emerged; however, bacterial resistance may develop upon prolonged use.
How Supplied:
How supplied: tobramycin ophthalmic solution usp, 0.3% is supplied in a plastic bottle with a controlled drop tip in the following size: 5 ml bottle â ndc 63187-024-05 storage: store at 2°-25°c (36°-77°f). avoid excessive heat. keep out of reach of children. revised august 2007 bausch & lomb incorporated tampa, fl 33637 ©bausch & lomb incorporated 9116801 (folded) 9116901 (flat) repackaged by: proficient rx lp thousand oaks, ca 91320
Information for Patients:
Information for patients: do not touch dropper tip to any surface, as this may contaminate the contents.
Package Label Principal Display Panel:
Principal display panel 63187-024-05