Travatan Adverse Reactions





Firma Chun Cheong
Full Prescribing Info
Adverse Reactions
Summary of the safety profile: In clinical trials with TRAVATAN eye drops, the most common adverse reactions were ocular hypearemia and iris hyperpigmentation, occurring in approximately 20% and 6% of patients respectively.
Tabulated list 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 (frequency cannot be estimated from the available data). Within each frequency group, adverse reactions are presented in decreasing order of seriousness. The adverse reactions were obtained from clinical studies and post-marketing data with TRAVATAN eye drops. (See Table 2.)

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Paediatric Population: In a 3 month phase 3 study and a 7 days pharmacokinetic study, involving 102 paediatric patients exposed to TRAVATAN eye drops, the types and characteristics of adverse reactions reported were similar to what has been observed in adult patients. The short-term safety profiles in the different paediatric subsets were also similar (see Pharmacology: Pharmacodynamics under Actions). The most frequent adverse reactions reported in the paediatric population were ocular hyperaemia (16.9%) and growth of eyelashes (6.5%). In a similar 3 month study in adult patients, these events occurred at an incidence of 11.4% and 0.0%, respectively.
Additional adverse drug reactions reported in paediatric patients in the 3 month paediatric study (n=77) compared to a similar trial in adults (n=185) included erythema of eyelid, keratitis, lacrimation increased, and photophobia all reported as single events with an incidence of 1.3% versus 0.0% seen 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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