Tobradex ST .5 mg/mL
tobramycin / dexamethasone · SUSPENSION/ DROPS · Eyevance Pharmaceuticals, LLC
Tobradex ST is a suspension/ drops containing tobramycin / dexamethasone at .5 mg/mL, taken ophthalmic. Manufactured by Eyevance Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Tobradex ST
- Generic Name
- tobramycin / dexamethasone
- NDC Code (Product)
71776-035- Manufacturer
- Eyevance Pharmaceuticals, LLC
- Strength
- .5 mg/mL
- Dosage Form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA050818
- Drug Class
- Corticosteroid [EPC]; Aminoglycoside Antibacterial [EPC]
- Marketing Start
- 05/19/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. epidermidi s (coagulase-positive and coagulase-negative), including penicillin-resistant isolates. Streptococci , i…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Instill one drop into the conjunctival sac(s) every 4 to 6 hours. ( 2.1 ) During the initial 24 to 48 hours, dosage may be increased to one drop every 2 hours. ( 2.1 ) Frequency should be decreased gradually as warranted by improvement in clinical signs, but care should be taken not to discontinue therapy prematurely. ( 2.1 ) 2.1 Initiation and Continuation of Treatment Evaluate intraocular pressure (IOP) prior to the initial prescription and renewal of the medication order [see Warnings and Precautions (5.1) ] . Perform ophthalmic examination with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining, prior to the initial prescription and renewal of the medication order. Re-evaluate the patient if signs and symptoms fail to improve after 2 days [see Warnings and Precautions (5.4 , 5.5) ] . Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation. 2.2 Recommended Dosage Instill one drop into the conjunctival sac(s) every 4 to 6 hours. During the initial 24 to 48 hours, the dosage may be increased to one drop every 2 hours. Frequency sh…
Contraindications
4 CONTRAINDICATIONS 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 ) Hypersensitivity to any component of the medication ( 4.2 ) 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. 4.2 Hypersensitivity Hypersensitivity to a component of the medication.
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions to topical ocular tobramycin are hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritus, eyelid edema, and conjunctival hyperemia. The reactions due to the steroid component are increases in IOP with possible development of glaucoma. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 1-833-4HARROW(427769) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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 …
Frequently Asked Questions
What is Tobradex ST used for?
Tobradex ST contains tobramycin / dexamethasone. It is a suspension/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Tobradex ST a controlled substance?
Tobradex ST is not classified as a controlled substance by the DEA.
What is the generic name for Tobradex ST?
The generic name for Tobradex ST is tobramycin / dexamethasone. There are no other listed brand versions of tobramycin / dexamethasone.
What is the NDC code for Tobradex ST .5 mg/mL?
The NDC (National Drug Code) for Tobradex ST .5 mg/mL is 71776-035, listed by Eyevance Pharmaceuticals, LLC.
Other Tobradex ST Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)