TRILIPIX

Country: Indonesia

Language: Indonesian

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Available from:

ABBOTT INDONESIA - Indonesia

Dosage:

135 MG

Pharmaceutical form:

KAPSUL LEPAS TUNDA

Units in package:

DUS, 3 BLISTER @ 10 KAPSUL LEPAS TUNDA

Manufactured by:

MYLAN LABORATORIES SAS, MAILLARD - France

Authorization date:

2019-08-16

Summary of Product characteristics

TRILIPIX
®
CHOLINE FENOFIBRATE 135 MG DELAYED RELEASE CAPSULE
1. NAME OF THE MEDICINAL PRODUCT
Trilipix
®
45 mg delayed release capsule
Trilipix
®
135 mg delayed release capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delayed release capsule contains choline fenofibrate equivalent
to 45 or 135 mg of fenofibric
acid.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard, delayed release capsule, with 45 mg and 135 mg choline
fenofibrate, respectively.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Trilipix
®
is indicated for mixed dyslipidemia in addition to lifestyle
modification and statin, in patients
with high cardiovascular risk dyslipidemia (Frederickson type IIb):
Triglyceride ≥ 150 mg/dL (≥1.69
mmol/L), High Density Lipoprotein-C < 40 mg/dL (< 1.02 mmol/L) in
males or < 50 mg/dL (< 1.28
mmol/L) in females, and Low Density Lipoprotein-C ≥130 mg/dL (≥
3.37 mmol/L); obesity (BMI > 25
kg/m
2
), diabetes mellitus, coronary heart disease) when triglyceride is not
adequately controlled.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Patients should be placed on an appropriate lipid-lowering diet before
receiving Trilipix
®
as co-
administered with a statin, and should continue this diet during
treatment. Trilipix
®
delayed release
capsule can be taken without regard to meals.
Serum lipids should be monitored periodically.
The maximum dose is 135 mg once daily.
Adults
Co-administration therapy with statins for the treatment of mixed
dyslipidemia:
Trilipix
®
135 mg may be co-administered with an HMG-CoA reductase inhibitor
(statin) in patients with
mixed dyslipidemia. For convenience, the daily dose of Trilipix
®
may be taken at the same time as a
statin, according to the dosing recommendations for each medication.
Co-administration with the
maximum dose of a statin has not been evaluated in clinical studies
and should be avoided unless the
benefits are expected to outweigh the risks.
Elderly
Dose selection for the elderly should be made on the basis of renal
function.