Optidex T

Optidex T® (suspensión oftálmica de tobramicina y dexametasona) está indicado para afecciones oculares inflamatorias sensibles a los esteroides para las cuales está indicado un corticosteroide y donde existe infección ocular bacteriana superficial o riesgo de infección ocular bacteriana.

Los esteroides oculares están indicados en condiciones inflamatorias de la conjuntiva palpebral y bulbar, la córnea y el segmento anterior del globo donde se acepta el riesgo inherente de uso de esteroides en ciertas conjuntivícidas infecciosas para obtener una disminución en el edema y la inflamación. También están indicados en uveítis anterior crónica y lesión corneal por quemaduras químicas, radiológicas o térmicas, o penetración de cuerpos extraños.

El uso de un medicamento combinado con un componente antiinfeccioso está indicado cuando el riesgo de infección ocular superficial es alto o cuando existe la expectativa de que un número potencialmente peligroso de bacterias estará presente en el ojo.

El fármaco antiinfeccioso particular en este producto es activo contra los siguientes patógenos oculares bacterianos comunes:

Staphylococci, incluidos S. aureus y S. epidermidis (coagulasa positiva y coagulasa negativa), incluidas las cepas resistentes a la penicilina.

Estreptococos, incluidas algunas de las especies hemolíticas del grupo A, algunas especies no hemolíticas y algunas Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, más Proteus vulgaris cepas, Haemophilus influenzae y H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus y algunos Neisseria especie.

Una o dos gotas inculcadas en los sacos conjuntivales cada cuatro o seis horas. Durante las 24 a 48 horas iniciales, la dosis puede aumentarse a una o dos gotas cada dos (2) horas. La frecuencia debe reducirse gradualmente según lo justifique la mejora en los signos clínicos. Se debe tener cuidado de no interrumpir la terapia prematuramente.

No se deben recetar inicialmente más de 20 ml y la receta no se debe rellenar sin una evaluación adicional como se describe en las PRECAUCIONES anteriores.

Queratitis epitelial del herpes simple (queratitis dendrítica), vaccinia, varicela y muchas otras enfermedades virales de la córnea y la conjuntiva. Infección micobacteriana del ojo. Enfermedades fúngicas de estructuras oculares. Hipersensibilidad a un componente del medicamento.

WARNINGS

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. 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 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 those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

PRECAUTIONS

General

The possibility of fungal infections of the cornea should be considered after long-term steroid dosing. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. When multiple prescriptions are required, or whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

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.

Pregnancy Category C

Corticosteroids have been found 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 parenterally and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well controlled studies in pregnant women. Optidex T® (tobramycin and dexamethasone ophthalmic suspension) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 Optidex T® (tobramycin and dexamethasone ophthalmic suspension) is administered to a nursing woman.

Pediatric Use

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

Geriatric Use

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

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® (tobramycin ophthalmic solution)] are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration. The reactions due to the steroid component are: elevation of intraocular pressure (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.

Clinically apparent signs and symptoms of an overdosage of Optidex T® (tobramycin and dexamethasone ophthalmic suspension) punctate keratitis, erythema, increased lacrimation, edema and lid itching may be similar to adverse reaction effects seen in some patients.