NDC 62332-518 Tobramycin Ophthalmic Solution

Tobramycin Ophthalmic Solution

NDC Product Code 62332-518

NDC 62332-518-05

Package Description: 1 BOTTLE in 1 CARTON > 5 mL in 1 BOTTLE

NDC Product Information

Tobramycin Ophthalmic Solution with NDC 62332-518 is a a human prescription drug product labeled by Alembic Pharmaceuticals Inc.. The generic name of Tobramycin Ophthalmic Solution is tobramycin ophthalmic solution. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Alembic Pharmaceuticals Inc.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Tobramycin Ophthalmic Solution Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TOBRAMYCIN 3 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BORIC ACID (UNII: R57ZHV85D4)
  • TYLOXAPOL (UNII: Y27PUL9H56)
  • SODIUM SULFATE (UNII: 0YPR65R21J)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SULFURIC ACID (UNII: O40UQP6WCF)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Aminoglycoside Antibacterial - [EPC] (Established Pharmacologic Class)
  • Aminoglycosides - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Alembic Pharmaceuticals Inc.
Labeler Code: 62332
FDA Application Number: ANDA211847 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 04-19-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Tobramycin Ophthalmic

Tobramycin Ophthalmic is pronounced as (toe bra mye' sin)

Why is tobramycin ophthalmic medication prescribed?
Ophthalmic tobramycin is used to treat eye infections. Tobramycin is in a class of medications called antibiotics. It works by killing bacteria that cause infections....
[Read More]

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Tobramycin Ophthalmic Solution Product Label Images

Tobramycin Ophthalmic Solution Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Tobramycin ophthalmic solution USP, 0.3 % is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of Tobramycin ophthalmic solution USP contains: Active: tobramycin 0.3 % (3 mg). Preservative: benzalkonium chloride 0.01 % (0.1 mg). Inactives: boric acid, sodium sulfate decahydrate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection. Tobramycin ophthalmic solution USP, 0.3 % has a pH range between 7.0 and 8.0 and an osmolality of 260 to 320 mOsm/kg.Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.The chemical structure of tobramycin is: Molecular Weight = 467.51 Molecular Formula: C18H37N5O9 Chemical name: 0-13-amino-3-dexoy-α-D-gluco-pyranosyl-(1→4)}-0-[2,6-diamino-2,3,6-trideoxyl-α-D-ribohexo-pyranosol-(1→6) ]-2-deoxystreptamine.

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 -beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabillis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzea and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.

Indications And Usage

Tobramycin ophthalmic solution USP, 0.3 % 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 USP. Clinical studies have shown tobramycin to be safe and effective for use in children.

Contraindications

Tobramycin ophthalmic solution USP, 0.3 % is contraindicated in patients with known hypersensitivity to any of its components.

Warnings

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to tobramycin ophthalmic solution USP, 0.3 % occurs, discontinue use.

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. Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

Information For Patients

Do not touch dropper tip to any surface, as this may contaminate the solution.

Pregnancy Category B

Reproduction studies in three types of animals at doses up to thirty-three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Because of the potential for adverse reactions in nursing infants from tobramycin ophthalmic solution USP, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of two months has not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions

The most frequent adverse reactions to tobramycin ophthalmic solution USP are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with tobramycin ophthalmic solution USP. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from tobramycin ophthalmic solution USP, 0.3 % therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

Overdosage

Clinically apparent signs and symptoms of an overdose of tobramycin ophthalmic solution USP, 0.3 % (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients

Dosage & 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.

How Supplied

Tobramycin ophthalmic solution USP, 0.3 % is supplied in opaque white low density polyethylene bottle which is closed with natural low density polyethylene nozzle and then with tan colored high density polyethylene cap  containing tobramycin 0.3% (3 mg/mL).5 mL in a 5 mL bottle (NDC 62332-518-05).Storage:  Store at 2 to 25°C (36 to 77°F). Manufactured for:Alembic Pharmaceutical, Inc. 750 Route 202, Bridgewater, NJ 08807 USA Made in India Manufactured by: Gland Pharma Limited Survey No. 143 – 148, 150 & 151, Near Gandimaisamma Cross Roads, D.P. Pally, Dundigal Post, Dundigal - Gandimaisamma Mandal, Medchal - Malkajgiri District, Hyderabad-500 043, Telangana, India (IND)Revised: 06/ 2018.

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