Product Information
Registration Status: ActiveTROLIP 300 CAPSULE 300mg is approved to be sold in Singapore with effective from 1999-01-14. It is marketed by APOTHECA MARKETING PTE LTD, with the registration number of SIN10668P.
This product contains Fenofibrate 300mg in the form of CAPSULE. It is approved for ORAL use.
This product is manufactured by PT DEXA MEDICA in INDONESIA REP OF.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Fenofibrate is a prodrug of fenofibric acid, an antilipemic agent which reduces both cholesterol and triglycerides in the blood.
Indication
For use as adjunctive therapy to diet to reduce elevated LDL-C, Total-C,Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb)
Mechanism of Action
Fenofibrate exerts its therapeutic effects through activation of peroxisome proliferator activated receptor a (PPARa). This increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III. The resulting fall in triglycerides produces an alteration in the size and composition of LDL from small, dense particles, to large buoyant particles. These larger particles have a greater affinity for cholesterol receptors and are catabolized rapidly.
Pharmacokinetics
- Absorption
- Fenofibrate is well absorbed from the gastrointestinal tract. After absorption, fenofibrate is mainly excreted in the urine in the form of metabolites, primarily fenofibric acid and fenofibric acid glucuronide
- Distribution
- In healthy adults, the volume of distribution is 30 L. The volume of distribution is 95 L in individuals with moderate renal impairment and creatinine clearance of 50 to 90 mL/min [FDA Label].
- Metabolism
- Elimination
Clearance
* 1.2 L/h [Eldery]
Toxicity
LD50=1600 mg/kg (Oral, in mice); Investigated as a teratogen and reproductive hazard.
Active Ingredient/Synonyms
2-(4-(4-Chlorobenzoyl)phenoxy)-2-methylpropanoic acid 1-methylethyl ester | Fenofibrato | Fenofibratum | Finofibrate | FNF | Isopropyl (4'-(p-chlorobenzoyl)-2-phenoxy-2-methyl)propionate | Isopropyl 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropionate | Procetofen | Fenofibrate |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.