Tobrex Adverse Reactions





Firma Chun Cheong
Full Prescribing Info
Adverse Reactions
Summary of the safety profile: In clinical trials, the most frequently reported adverse reactions were ocular hyperaemia and ocular discomfort, occurring in approximately 1.4% and 1.2% of patients.
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 were obtained from clinical trials and postmarketing spontaneous reports. The following adverse reactions were observed following ophthalmic use of TOBREX: See table.

Click on icon to see table/diagram/image

Description of selected adverse events: Sensitivity to topically administered aminoglycosides may occur in some patients (see Precautions).
If topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration (see Precautions).
Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic tobramycin therapy (see Precautions).
TOBREX may be used in children 1 year of age and older at the same dose as in adults. Currently available data is described in Pharmacology: Pharmacodynamics under Actions. The safety and efficacy in children younger than 1 year of age have not been established, and no data are available (see Dosage & Administration).
Pediatric population: The frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Reporting of suspected adverse reactions: Reporting 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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