TOBRAMYCIN AND DEXAMETHASONE 1 mg/mL
tobramycin and dexamethasone · SUSPENSION/ DROPS · Bryant Ranch Prepack
Tobramycin and dexamethasone is an eye drop suspension that combines an antibiotic and a steroid to treat bacterial eye infections and reduce inflammation. It is applied directly to the eye as prescribed by your doctor.
Key Facts
- Brand Name
- TOBRAMYCIN AND DEXAMETHASONE
- Generic Name
- tobramycin and dexamethasone
- NDC Code (Product)
63629-9572- Manufacturer
- Bryant Ranch Prepack
- Strength
- 1 mg/mL
- Dosage Form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA212715
- Marketing Start
- 03/17/2022
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE: Tobramycin and dexamethasone 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 strains. Str…
Dosage & Administration
DOSAGE AND ADMINISTRATION: One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely. Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
Warnings
WARNINGS: FOR EYE USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions, such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If a sensitivity reaction does occur, discontinue use. Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Intraocular pressure (IOP) should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions and parasitic infections of the eye, steroids may mask infection or enhance existing infection. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.
Contraindications
CONTRAINDICATIONS: Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.
Adverse Reactions
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 (tobramycin ophthalmic solution 0.3%) are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than 4% of patients. The reactions due to the steroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound 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. Po…
Frequently Asked Questions
What is TOBRAMYCIN AND DEXAMETHASONE used for?
Tobramycin and dexamethasone is an eye drop suspension that combines an antibiotic and a steroid to treat bacterial eye infections and reduce inflammation. It is applied directly to the eye as prescribed by your doctor.
Is TOBRAMYCIN AND DEXAMETHASONE a controlled substance?
TOBRAMYCIN AND DEXAMETHASONE is not classified as a controlled substance by the DEA.
What is the generic name for TOBRAMYCIN AND DEXAMETHASONE?
The generic name for TOBRAMYCIN AND DEXAMETHASONE is tobramycin and dexamethasone. There are 7 other brand versions of tobramycin and dexamethasone.
What is the NDC code for TOBRAMYCIN AND DEXAMETHASONE 1 mg/mL?
The NDC (National Drug Code) for TOBRAMYCIN AND DEXAMETHASONE 1 mg/mL is 63629-9572, listed by Bryant Ranch Prepack.