TobraDex Adverse Reactions

tobramycin + dexamethasone




Firma Chun Cheong
Full Prescribing Info
Adverse Reactions
Summary of the safety profile: No serious ophthalmic adverse events related to TOBRADEX were reported in clinical studies. The most frequently reported treatment-related adverse reactions were eye pain, intraocular pressure increased, eye irritation, and eye pruritus occurring in less than 1% of patients.
Tabulated summary of adverse reactions: The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions have been observed during clinical trials and post-marketing experience with TOBRADEX. (See Table 1.)

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Description of selected adverse reactions: Topical ophthalmic corticosteroid use may result in increased intraocular pressure with damage to the optic nerve, reduced visual acuity and visual field defect, and posterior subcapsular cataract formation (see Precautions).
Due to the steroid component, in diseases causing thinning of the cornea or sclera there is a higher risk for perforation especially after longer treatment (see Precautions).
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 ocular infection following suppression of host responses also occurs. (See Precautions.)
When administered systemically, tobramycin may induce renal, vestibular and auditory nerve toxicity, especially in patients receiving high doses or prolonged treatment. Doses recommended for ocular administration are significantly lower than those used systemically, and these systemic effects are extremely unlikely with TOBRADEX (see Precautions).
Sensitivity to topically administered aminoglycosides may occur in some patients (see Precautions).
Undesirable effects have occurred with steroid/antibiotic combination drugs which can usually be attributed to either the steroid component or the antibiotic component. The following adverse effects have been reported following use of topical ophthalmic dexamethasone or tobramycin. (See Table 2.)

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Reporting of suspected adverse reactions: Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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