TOBRADEX Ophthalmic ointment (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Novartis Pharmaceuticals Corporation

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1. Description

TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. The chemical structures for tobramycin and dexamethasone ...

2. Clinical Pharmacology

Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the bodys defense mechanism against infection, a concomitant antimicrobial ...

3. Indications and Usage

TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular ...

4. 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 ...

5. Warnings

FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local ...

6.1. 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, ...

6.2. Information for Patients

Do not touch tube tip to any surface, as this may contaminate the contents. Contact lenses should not be worn during the use of this product. Do not use the product if the imprinted carton seals have ...

6.6. 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. ...

6.7. Pregnancy

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. ...

6.9. 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 ...

6.10. Pediatric Use

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

6.11. Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

7. 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 ...

10. Dosage and Administration

Apply a small amount (approximately ½ inch ribbon) into the conjunctival sac(s) up to three or four times daily. How to apply TOBRADEX (tobramycin and dexamethasone ophthalmic ointment): Tilt ...

11. How Supplied

3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap (NDC 0078-0876-01). Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New ...

12. Storage and Handling

Store at 2°C to 25°C (36°F to 77°F). After opening, TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) can be used until the expiration date on the tube.