NDC 0065-0652 Tobradex St

Tobramycin / Dexamethasone

NDC Product Code 0065-0652

NDC CODE: 0065-0652

Proprietary Name: Tobradex St What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Tobramycin / Dexamethasone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat people with a certain inherited condition (cystic fibrosis) who have a persistent lung infection with a certain bacteria (Pseudomonas aeruginosa). People with cystic fibrosis produce thick, sticky mucus that can plug up the tubes, ducts and passageways in the lungs. This can result in serious breathing problems and infections in the lungs. Tobramycin belongs to a class of drugs known as aminoglycoside antibiotics. Tobramycin inhalation solution works by stopping the growth of a certain bacteria (Pseudomonas aeruginosa) that commonly infects the lungs of people with cystic fibrosis. This effect decreases lung infections and damage, and helps to improve breathing.
  • Dexamethasone is used to treat conditions such as arthritis, blood/hormone/immune system disorders, allergic reactions, certain skin and eye conditions, breathing problems, certain bowel disorders, and certain cancers. It is also used as a test for an adrenal gland disorder (Cushing's syndrome). This medication is a corticosteroid hormone (glucocorticoid). It decreases your body's natural defensive response and reduces symptoms such as swelling and allergic-type reactions.

NDC Code Structure

NDC 0065-0652-01

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 1 mL in 1 BOTTLE, DROPPER

NDC 0065-0652-05

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

NDC Product Information

Tobradex St with NDC 0065-0652 is a a human prescription drug product labeled by Alcon Laboratories, Inc.. The generic name of Tobradex St is tobramycin / dexamethasone. The product's dosage form is suspension/ drops and is administered via ophthalmic form.

Labeler Name: Alcon Laboratories, Inc.

Dosage Form: Suspension/ Drops - A suspension which is usually administered in a dropwise 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.

Tobradex St 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
  • DEXAMETHASONE .5 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)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • TYLOXAPOL (UNII: Y27PUL9H56)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM SULFATE (UNII: 0YPR65R21J)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • 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.
  • 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]
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

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

Labeler Name: Alcon Laboratories, Inc.
Labeler Code: 0065
FDA Application Number: NDA050818 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: NDA - A product marketed under an approved 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: 09-07-2010 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

Dexamethasone Ophthalmic

Dexamethasone Ophthalmic is pronounced as (dex a meth' a sone)

Why is dexamethasone ophthalmic medication prescribed?
Dexamethasone reduces the irritation, redness, burning, and swelling of eye caused by chemicals, heat, radiation, infection, allergy, or foreign bodies in the eye. It is ...
[Read More]
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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Tobradex St 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

1 Indications And Usage

TOBRADEX® ST ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant isolates. Streptococci, including some Group A and other beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris isolates, Haemophilus influenzae, H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

Instill one drop into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one drop every two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

2.2 Prescription Guideline

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in WARNINGS AND PRECAUTIONS (5).

3 Dosage Forms And Strengths

TOBRADEX ST ophthalmic suspension contains 3 mg/mL tobramycin and 0.5 mg/mL dexamethasone.

4.1 Nonbacterial Etiology

TOBRADEX ST, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. (4.1)

4.2 Hypersensitivity

Hypersensitivity to a component of the medication.

5.1 Iop Increase

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored.

5.2 Aminoglycoside Sensitivity

Sensitivity to topically applied aminoglycosides may occur.

5.3 Cataracts

Use of corticosteroids may result in posterior subcapsular cataract formation.

5.4 Delayed Healing

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

5.5 Bacterial Infections

Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

5.6 Viral Infections

Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

5.7 Fungal Infections

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.

5.8 Use With Systemic Aminoglycosides

If product is used in combination with systemic aminoglycoside antibiotics the patient should be monitored for total serum concentration.

6 Adverse Reactions

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available.The most frequent adverse reactions to topical ocular tobramycin (TOBREX®) are hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritus, eyelid edema, and conjunctival hyperemia. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics.The reactions due to the steroid component are: increased intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve disorder; subcapsular cataract; and impaired healing.Secondary Infection.The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.Non-ocular adverse events occurring at an incidence of 0.5% to 1% included headache and increased blood pressure.

8.1 Pregnancy

Pregnanacy Category C. Corticosteroids have been shown to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits. Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy. Reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day (equivalent to human doses of 16 and 32 mg/kg/day, respectively) and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well controlled studies in pregnant women. TOBRADEX® ST ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.2 Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when TOBRADEX® ST is administered to a nursing woman.

8.3 Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

8.4 Geriatric Use

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

11 Description

TOBRADEX® ST (tobramycin / dexamethasone ophthalmic suspension) 0.3%/0.05% is a sterile, isotonic, white, aqueous antibiotic and steroid suspension with a pH of approximately 5.7 and an osmolality of approximately 290 mOsm/kg.The chemical name of tobramycin is O-3-amino-3-deoxy-α-D-glucopyranosyl-(14)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(16)]-2-deoxy- L-streptamine. It has a molecular formula of C18H37N5O9 and a molecular weight of 467.52. The chemical structure is:The chemical name of dexamethasone is 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. It has a molecular formula of C22H29FO5 and a molecular weight of 392.47. The chemical structure is:Each mL of TOBRADEX® ST contains: Actives: tobramycin 3 mg and dexamethasone 0.5 mg. Preservative: benzalkonium chloride 0.1 mg. Inactives: xanthan gum, tyloxapol, edetate disodium, sodium chloride, propylene glycol, sodium sulfate, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water.

12.1 Mechanism Of Action

Dexamethasone is a potent corticoid. Corticoids suppress the inflammatory response to a variety of agents and they can delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant.Tobramycin is an antibacterial drug. It inhibits the growth of bacteria by inhibiting protein synthesis. Tobramycin is included in this combination product to provide action against susceptible bacteria.

12.3 Pharmacokinetics

In a multi-center, double-masked, parallel-group, randomized, single-dose pharmacokinetic study in male and female cataract surgery patients, mean dexamethasone concentrations following administration of TOBRADEX ST were similar to dexamethasone concentrations following administration of TOBRADEX (tobramycin /dexamethasone ophthalmic suspension) 0.3%/0.1%. Aqueous humor concentrations reached a mean peak of 33.7 ng/mL 2 hours following single-dose administration of TOBRADEX ST.No data are available on the extent of systemic absorption of dexamethasone or tobramycin from TOBRADEX ST ophthalmic suspension. Following multiple-dose (QID for 2 days) bilateral ocular administration of TOBRADEX (Tobramycin 0.3%/Dexamethasone 0.1% ophthalmic suspension) in healthy male and female volunteers, peak plasma concentrations of dexamethasone were less than 1 ng/mL and occurred within 2 hours post-dose across all subjects.

12.4 Microbiology

The antibiotic component (tobramycin) in the combination is included to provide action against susceptible bacteria. In vitro studies have demonstrated that tobramycin is active against susceptible isolates of the following bacteria: Staphylococcus aureus (includes penicillin-resistant isolates), Staphylococcus epidermidis (includes penicillin-resistant isolates), Streptococci, including some Group A other beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Acinetobacter calcoaceticus, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Haemophilus aegypticus, Klebsiella pneumoniae, Moraxella lacunata, Morganella morganii, Neisseria perflava, Neisseria sicca, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa.In vitro bacterial studies demonstrate that in some cases bacteria resistant to gentamicin are susceptible to tobramycin.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

No studies have been conducted to evaluate the carcinogenic or mutagenic potential. No impairment of fertility was noted in studies of subcutaneous tobramycin in rats at doses of 50 and 100 mg/kg/day (equivalent to human doses of 8 and 16 mg/kg/day, at least 2 orders of magnitude greater than the topical ocular dose).

16 How Supplied/Storage And Handling

TOBRADEX® ST is supplied as a 2.5 mL, 5 mL, or 10 mL suspension in a 4 mL, 8 mL or 10 mL natural polyethylene DROP-TAINER® bottle with a natural polyethylene dispenser tip and a pink polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the bottle.NDC 0065-0652-25: 2.5 mLNDC 0065-0652-05: 5 mLNDC 0065-0652-10: 10 mLStorageStore at 2° to 25°C (36° to 77°F).Protect from light.

17.1 Storage And Handling

Patients should be instructed to store the bottle upright and away from light. Shake well before using.

17.2 Avoid Contamination

Patients should be instructed not to touch dropper tip to any surface, as this may contaminate the contents.

17.3 Contact Lens Wear

Contact lenses should not be worn during the use of this product.

Other

Alcon Laboratories, Inc.Fort Worth, Texas 76134 USAPrinted in USAU.S. Patent No. 7,795,316©2008, 2011 Alcon, Inc.        9006383-0111

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