Tobradex St Information
Tobradex st (Tobramycin/dexamethasone) Indications And Usage
Tobradex st (Tobramycin/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: , including and (coagulase-positive and coagulase-negative), including penicillin-resistant isolates. Streptococci, including some Group A and other beta-hemolytic species, some nonhemolytic species, and some most and some .
Tobradex st (Tobramycin/dexamethasone) Dosage Forms And Strengths
Tobradex st (Tobramycin/dexamethasone) ophthalmic suspension contains 3 mg/mL tobramycin and 0.5 mg/mL dexamethasone.
Tobradex st (Tobramycin/dexamethasone) 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.
Tobradex st (Tobramycin/dexamethasone) Description
Tobradex st (Tobramycin/dexamethasone) (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 -3-amino-3-deoxy-α-D-glucopyranosyl-(14)--[2,6-diamino-2,3,6-trideoxy-α-D--hexopyranosyl-(16)]-2-deoxy- L-streptamine. It has a molecular formula of CHNO 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 CHFOand a molecular weight of 392.47. The chemical structure is:
Each mL of Tobradex st (Tobramycin/dexamethasone) contains: tobramycin 3 mg and dexamethasone 0.5 mg. benzalkonium chloride 0.1 mg. xanthan gum, tyloxapol, edetate disodium, sodium chloride, propylene glycol, sodium sulfate, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water.
Tobradex st (Tobramycin/dexamethasone) Clinical Pharmacology
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.
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 (Tobramycin/dexamethasone) 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 (Tobramycin/dexamethasone) .
No data are available on the extent of systemic absorption of dexamethasone or tobramycin from Tobradex st (Tobramycin/dexamethasone) 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.
The antibiotic component (tobramycin) in the combination is included to provide action against susceptible bacteria. studies have demonstrated that tobramycin is active against susceptible isolates of the following bacteria: (includes penicillin-resistant isolates), (includes penicillin-resistant isolates), Streptococci, including some Group A other beta-hemolytic species, some nonhemolytic species, and some
In vitro
Tobradex st (Tobramycin/dexamethasone) How Supplied/storage And Handling
Tobradex st (Tobramycin/dexamethasone) 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 mL
NDC 0065-0652-05: 5 mL
NDC 0065-0652-10: 10 mL
Store at 2° to 25°C (36° to 77°F).
Protect from light.
Tobradex st (Tobramycin/dexamethasone)
Tobradex st (Tobramycin/dexamethasone) Principal Display Panel
NDC 0065-0652-05
(tobramycin/dexamethasone
ophthalmic suspension)
0.3%/0.5%
5 mL
