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Manufacturer
VALEANT
SKU
24208029510

tobramycin-dexameth ophth susp

Generic
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Uses

Ophthalmic Bacterial Infections

Tobramycin is used topically in the treatment of superficial infections of the eye caused by susceptible bacteria.

Although most cases of mild bacterial conjunctivitis improve without anti-infective therapy, topical application of anti-infectives may shorten the infectious process. In addition, topical application of anti-infectives may reduce recurrence rate and morbidity associated with bacterial conjunctivitis.

Tobramycin also is used topically in conjunction with topical corticosteroids in some cases of bacterial ocular infections. Concomitant therapy with a corticosteroid may be used for steroid-responsive ocular inflammatory conditions for which a corticosteroid is indicated and where a superficial ocular bacterial infection or risk of ocular bacterial infection exists. However, the benefit of concomitant therapy must be weighed against reduced resistance to bacterial, fungal, or viral infections and suppression of signs and symptoms of infection or hypersensitivity.(See Cautions: Precautions and Contraindications.)

For systemic uses of tobramycin sulfate, see Uses in the Aminoglycosides General Statement 8:12.02.

Dosage and Administration

Administration

Tobramycin is applied topically to the eye in the form of an ophthalmic ointment or solution. Tobramycin in fixed combination with dexamethasone is applied to the eye as an ophthalmic ointment or suspension. Tobramycin in fixed combination with loteprednol etabonate is applied to the eye as an ophthalmic suspension.

The suspension should be shaken vigorously prior to use.

A 5- to 7-day course of anti-infective therapy usually is adequate for the treatment of mild bacterial conjunctivitis.

Tobramycin ophthalmic solution is not for injection and should not be injected subconjunctivally or directly into the anterior chamber of the eye.

Dosage

Ophthalmic Bacterial Infections

For mild to moderate infections, a ribbon of the ointment (approximately 1.25 cm in length) should be applied to the infected eye 2 or 3 times daily. Alternatively, 1 or 2 drops of the ophthalmic solution should be instilled onto the infected eye every 4 hours.

For severe infections, the ointment should be applied every 3-4 hours or 2 drops of the solution should be instilled onto the infected eye(s) every hour. When improvement occurs, frequency of application should be decreased.

When the fixed-combination preparation containing tobramycin and dexamethasone (e.g., TobraDex) is used for the management of steroid-responsive ocular conditions where a superficial ocular bacterial infection or risk of ocular bacterial infection exists, a ribbon of the ointment (approximately 1.25 cm in length) should be applied to the affected eye(s) up to 3 or 4 times daily. Alternatively, 1 or 2 drops of the suspension should be instilled into the affected eye(s) every 4-6 hours. During the initial 24-48 hours, dosing may be increased to 1 or 2 drops of the suspension every 2 hours. When improvement occurs, frequency of application of the suspension can be decreased. Therapy should not be discontinued prematurely.

When the fixed-combination suspension containing tobramycin and loteprednol etabonate (Zylet) is used for the management of steroid-responsive ocular conditions where a superficial ocular bacterial infection or risk of ocular bacterial infection exists, 1 or 2 drops of the suspension should be instilled into the affected eye(s) every 4-6 hours. During the initial 24-48 hours, dosing may be increased to every 1-2 hours. When improvement occurs, frequency of application can be decreased. Therapy should not be discontinued prematurely.

Cautions

Adverse Effects

Tobramycin appears to have a low order of toxicity when applied topically to the eye; however, sensitization to the drug may occasionally result from topical application. In addition, commercially available tobramycin ophthalmic solution contains other ingredients such as benzalkonium chloride which may rarely cause allergic contact dermatitis. If a sensitivity reaction occurs during topical tobramycin therapy, the drug should be discontinued.

The most frequent adverse reactions to tobramycin ophthalmic ointment and solution are localized ocular toxicity and hypersensitivity including itching and edema of the eyelid and conjunctival erythema. These reactions occur in 3% or less of patients receiving ophthalmic tobramycin. Punctate keratitis and increased lacrimation have also been reported following excessive topical application of tobramycin ophthalmic ointment or solution.

Precautions and Contraindications

Serious adverse reactions including ototoxicity and nephrotoxicity have occurred in patients receiving systemic tobramycin sulfate therapy. Although these effects have not been reported to date following topical use of tobramycin, the possibility of cumulative toxicity should be considered. If tobramycin is administered topically in conjunction with systemic aminoglycoside therapy, serum aminoglycoside concentrations should be monitored.

Topical corticosteroids, when used in combination with tobramycin, may mask the clinical signs of bacterial, fungal, or viral infections, or may suppress hypersensitivity reactions to the antibiotic or other ingredients in the formulations. The possibility of corticosteroid-induced adverse ocular effects, including increased intraocular pressure, glaucoma, delayed wound healing, and cataract formation, also must be considered. When tobramycin is used in fixed combination with a corticosteroid, other cautions, precautions, and contraindications associated with EENT corticosteroids also must be considered in addition to those associated with the anti-infective.

Topical use of tobramycin may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs during tobramycin therapy, the drug should be discontinued and appropriate therapy instituted.

Tobramycin ophthalmic ointment and solution are contraindicated in patients who are hypersensitive to the drug or any ingredients in the formulations. Cross-allergenicity among the aminoglycosides has been demonstrated, and the possibility that patients who become sensitized to topical tobramycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.

Pediatric Precautions

Safety and efficacy of tobramycin ophthalmic solution in infants younger than 2 months of age have not been established. Safety and efficacy of tobramycin and dexamethasone ophthalmic preparations have not been established in children younger than 2 years of age. Safety and efficacy of loteprednol etabonate and tobramycin ophthalmic suspension have not been established in children younger than 18 years of age.

Geriatric Precautions

No overall differences in safety or efficacy of tobramycin ophthalmic solution have been observed between geriatric and younger patients.

Mutagenicity and Carcinogenicity

Studies have not been performed to date to evaluate the mutagenic or carcinogenic potential of tobramycin.

Pregnancy, Fertility, and Lactation

Pregnancy

Reproduction studies in animals using systemic tobramycin dosages up to 33 times the usual human systemic dosage have not revealed evidence of impaired fertility or harm to the fetus. There are no controlled studies to date using topical or systemic tobramycin in pregnant women, and ophthalmic tobramycin should be used during pregnancy only when clearly needed.

Lactation

Topically applied tobramycin is probably not distributed into milk; however, because systemic tobramycin is distributed into milk and because of the potential for serious adverse reactions from the drug in nursing infants, ophthalmic tobramycin should not be used in nursing women. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pharmacokinetics

Studies in rabbits suggest that tobramycin is absorbed into the aqueous humor following topical instillation onto the eye of a solution of the drug containing 3 mg/mL; it is not known whether tobramycin is absorbed into the vitreous humor following topical instillation. Absorption of tobramycin is greatest when the cornea is abraded. The manufacturer states that topically administered tobramycin ophthalmic solution is cleared from the surface of the eye in approximately 15-30 minutes.

Information on absorption of tobramycin following topical application to the eye of an ophthalmic ointment containing the drug is not currently available.

In one study in rabbits with normal corneas, peak concentrations of tobramycin were attained in the cornea and aqueous humor 1-2 hours after topical instillation of a solution of the drug containing 3 mg/mL. Within 1-2 hours, peak cornea concentrations of tobramycin in these rabbits averaged 4.5 mcg/g of cornea and peak aqueous humor concentrations averaged 0.28 mcg/mL.

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