TRICHEK

COMPOSITION:

Trichek-160

Each film coated tablet contains: Fenofibrate USP 160 mg

Trichek-200

Each hard gelatin capsule contains: Fenofibrate USP 200 mg

CLINICAL PHARMACOLOGY:

Mechanism of Action:  

Fenofibrate is a fibric acid derivative that activates PPARα, enhancing triglyceride breakdown and increasing lipoprotein lipase activity. It reduces apoprotein CIII production while boosting apoproteins AI and AII synthesis, lowering VLDL and LDL levels, and raising HDL levels. Additionally, it promotes LDL clearance and decreases small dense LDL, which are linked to coronary heart disease risk.

Pharmacokinetics 

Absorption: Fenofibrate is well absorbed from the gastrointestinal tract, with peak plasma levels occurring within 6-8 hours; absorption is increased by 35% in non-fasting conditions.

Distribution: Steady-state plasma levels are achieved within 5 days, with fenofibric acid 99% bound to plasma proteins in normal and hyperlipidemic subjects.

Metabolism: Fenofibrate is rapidly hydrolyzed to fenofibric acid, the active metabolite, and is primarily conjugated with glucuronic acid before excretion in urine.

Excretion: Fenofibrate and its metabolites, mainly fenofibric acid, are excreted in urine, with fenofibric acid having a half-life of approximately 20 hours.

INDICATIONS AND USAGE: 

Primary Hypercholesterolemia and Mixed Dyslipidemia Fenofibrate is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Hypertriglyceridemia Fenofibrate is indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia.

DOSAGE AND ADMINISTRATION: 

Primary Hypercholesterolemia or Mixed Dyslipidemia; For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of Fenofibrate is 160mg or 200mg per day.  

Hypertriglyceridemia: For adult patients with hypertriglyceridemia, the initial dose is 67mg to 200mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 200mg per day.

WARNING & PRECAUTIONS:

Warning: 

Fenofibrate may cause increased serum transaminases and cholelithiasis, requiring regular liver function monitoring and discontinuation if enzyme levels exceed three times the normal limit or if gallstones are found. Caution is advised when using fenofibrate with oral anticoagulants, as it can prolong prothrombin time/INR, necessitating dosage adjustments and frequent monitoring to prevent bleeding.

Precautions: 

Before starting fenofibrate, confirm lipid abnormalities with tests, address contributing factors, discontinue if no response after two months of maximum-dose treatment, and monitor for pancreatitis, hypersensitivity, hematologic changes, myopathy, rhabdomyolysis, and reversible increases in serum creatinine.

ADVERSE REACTIONS: 

Common: Abdominal pain, nausea, vomiting, diarrhea, flatulence, and increased transaminases.

Uncommon: Headache, pulmonary embolism, deep vein thrombosis, pancreatitis, cholelithiasis, cutaneous hypersensitivity (e.g., rashes, pruritus, urticaria), and muscle disorders (e.g., myalgia, myositis, muscle spasms, and weakness).

Rare: Decreased hemoglobin and white blood cell count.

DRUG INTERACTIONS: 

Use fenofibrate cautiously with anticoagulants, statins, cyclosporine, or colchicine due to interaction risks, take it 1 hour before or 4–6 hours after bile acid sequestrants, and note its potential to improve glucose tolerance with antidiabetic medications.

USE IN SPECIAL POPULATIONS:

Pregnancy: Pregnancy Category C Safety in pregnant women has not been established. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Fenofibrate should not be used in nursing mothers. Because of the potential for tumorigenicity seen in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug. 

Pediatric Use: Pediatric Use: Safety and efficacy in pediatric patients have not been established

Geriatric Use: Fenofibric acid exposure is not influenced by age. However, elderly patients have a higher incidence of renal impairment, such that dose selection for the elderly should be made on the basis of renal function 

Renal Impairment: Treatment with Fenofibrate should be initiated at a dose of 67mg/day in patients with impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. 

CONTRAINDICATIONS: 

Fenofibrate is contraindicated in patients with hypersensitivity to the drug, severe renal or hepatic dysfunction, pre-existing gallbladder disease, and pancreatitis not caused by severe hypertriglyceridemia. It is also not recommended for nursing mothers or patients with unexplained persistent liver function abnormalities.

OVER DOSAGE: 

There is no specific treatment for fenofibrate overdose; general supportive care, including monitoring vital signs and clinical status, is recommended. If needed, unabsorbed drug can be removed via emesis or gastric lavage, but hemodialysis is not effective due to the drug's high plasma protein binding.

STORAGE:

Store between 15°C - 30°C protected from light and moisture.

PRESENTATION: 

Trichek-200: Carton containing 10 blister strips of 10 capsules.

Trichek-160: Carton containing 10 blister strips of 10 tablets.