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Response to therapy should be monitored by determination of serum lipid values. If an adequate response has not been achieved after several months (e.g. 3 months), complementary or different therapeutic measures should be considered.
Posology: Adults: The recommended dose is one tablet containing 145mg fenofibrate taken once daily. Patients currently taking one 200 mg capsule (or one 160 mg tablet) can be changed to one 145mg fenofibrate tablet without further dose adjustment.
Special Populations: Geriatric Populations: In elderly patients, without renal impairment, the usual adult dose is recommended.
Dosage reduction is required in patients with renal impairment. In moderate chronic kidney disease (creatinine clearance 30 to 60mL/min), and if a low dose is available, start with one capsule of 100mg standard once daily.
If no low dose is available, then fenofibrate is not recommended.
In patients with severe chronic kidney disease (creatinine clearance < 30ml/min), fenofibrate is contraindicated.
Hepatic impairment: Fenofibrate 145mg tablet is not recommended for use in patients with hepatic impairment due to the lack of data.
Pediatric population: The safety and efficacy of fenofibrate in children and adolescents younger than 18 years has not been established. No data are available. Therefore the use of fenofibrate is not recommended in paediatric subjects under 18 years.
Method of administration: LIPANTHYL PENTA 145, film-coated tablet may be given at any time of the day, with or without food (see Pharmacology: Pharmacokinetics under Actions). Tablet should be swallowed whole with a glass of water.
