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ATORVASTATIN CALCIUM + FENOFIBRATE

FENOSTAT 20MG / 160MG FILM-COATED TABLET

Indication*

Mixed Dyslipidemia: Fenostat is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, apoB, and TG levels and to increase HDLC in adult patients with mixed dyslipidemia. Hypercholesterolemia: Fenostat is indicated as an adjunct to diet to0 reduce elevated total-C, LDL-C apoB and increase HDL-C in adult patients with primary hypercholesterolemia. Lipid altering agents should be used in addition to diet restricted in saturated fat and cholesterol only when the response to diet and other non-pharmacological measures has been inadequate. After the LDL-C goal has been achieved, if the TG level is still >200mg/dL, non-HDL-C (TC minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 20mg/dL higher than LDL-C goals for each risk category.

Directions for Use*

Patients should be placed on an appropriate lipid-lowering diet before receiving the fixed dose combination of Atorvastatin and Fenofibrate, and should continue this diet during treatment. The fixed dose combination of Atorvastatin and Fenofibrate should be given with meals, thereby optimizing the bioavailability of the medication. Adults and the Elderly: Start with Atorvastatin 10mg plus Fenofibrate 160mg (or Atorvastatin 10mg plus Fenofibrate 200mg) once daily. The dosage can titrated upwards depending on the patients response and tolerability to treatment to a maximum of Atorvastatin 40mg plus Fenofibrate 160mg (or Atorvastatin 40mg plus Fenofibrate 200mg) Or as prescribed by the physician. Patients with Renal and Hepatic Impairment: The fixed dose combination of Atorvastatin plus Fenofibrate is contraindicated in patients with severe renal and hepatis impairment. Children and Adolescents: No data is available on the use of the fixed dose combination of Atorvastatin and Fenofibrate in patients under the age of 18 years. Therefore, the use of the fixed dose combination of Atorvastatin and Fenofibrate in this age group is not recommended.

Administration*

Should be taken with food.

*written indications, directions, and administration are updated as of June 10, 2025 and may not be accurate with the actual product purchased. Please read the details in the packaging.

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