ODEFSEY FILM-COATED TABLET 200MG/25MG/25MG

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

TABLET, FILM COATED

**Dosage and Administration** **Adults and Pediatric Patients 12 to less than 18 years of age and weighing ≥35 kg** The recommended dose of ODEFSEY® is one tablet taken orally once daily with food (see _Pharmacological Properties – Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). If the patient misses a dose of ODEFSEY® within 12 hours of the time it is usually taken, the patient should take ODEFSEY® with food as soon as possible and resume the normal dosing schedule. If a patient misses a dose of ODEFSEY® by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. If the patient vomits within 4 hours of taking ODEFSEY®, another tablet should be taken with food. If a patient vomits more than 4 hours after taking ODEFSEY®, they do not need to take another dose of ODEFSEY® until the next regularly scheduled dose. **Special populations** _**Pediatrics (less than 12 years of age)**_ The safety and efficacy of ODEFSEY® have not been established in pediatric patients less than 12 years of age or weighing < 35 kg. _**Elderly (65 years of age and older)**_ No data are available on which to make a dose recommendation for patients over the age of 65 years. _**Renal impairment**_ No dose adjustment of ODEFSEY® is required in adult patients with estimated creatinine clearance greater than or equal to 30 mL/minute. ODEFSEY® should not be initiated in patients with estimated creatinine clearance below 30 mL/minute as there are insufficient data available regarding the use of ODEFSEY® in this population. No data are available to make dose recommendations in pediatric patients with renal impairment. _**Hepatic impairment**_ No dose adjustment of ODEFSEY® is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. ODEFSEY® has not been studied in patients with severe hepatic impairment (Child-Pugh Class C). Hence, ODEFSEY® is not recommended for use in patients with severe hepatic impairment. (see _Pharmacological Properties – Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).