Fenox
Generic Name
Fenofibrate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
fenox 120 mg tablet | ৳ 7.00 | ৳ 70.00 |
Description
Overview of the medicine
Fenofibrate is a lipid-modifying agent used to reduce elevated cholesterol and triglyceride levels in the blood, primarily in hypercholesterolemia and mixed dyslipidemia.
Uses & Indications
Dosage
Adults
The usual dose is 145 mg or 160 mg once daily, taken with a meal.
Elderly
For elderly patients, a reduced dosage may be considered based on renal function.
Renal_impairment
Dose reduction is necessary for patients with mild to moderate renal impairment. Fenofibrate is contraindicated in severe renal impairment (eGFR < 30 mL/min/1.73m²).
How to Take
Fenox tablets should be swallowed whole with water. It is recommended to take the medicine with a meal to enhance absorption.
Mechanism of Action
Fenofibrate is a prodrug that is rapidly hydrolyzed to its active metabolite, fenofibric acid. Fenofibric acid activates peroxisome proliferator-activated receptor alpha (PPARα), which regulates lipid metabolism. This activation leads to increased lipolysis and elimination of triglyceride-rich particles from plasma, and a reduction in VLDL and LDL cholesterol. It also increases HDL cholesterol levels.
Pharmacokinetics
Onset
Lipid-lowering effects typically begin within days and reach maximum in 2-4 weeks.
Excretion
Primarily excreted in the urine as fenofibric acid and its glucuronide conjugate (about 70% in 72 hours), and to a lesser extent in feces (about 25%).
Half life
The plasma elimination half-life of fenofibric acid is approximately 20-23 hours.
Absorption
Fenofibrate is well absorbed from the gastrointestinal tract, especially when taken with food. Peak plasma concentrations are reached in 6-8 hours after oral administration.
Metabolism
Fenofibrate is rapidly hydrolyzed by esterases to its active metabolite, fenofibric acid. Fenofibric acid is then glucuronidated.
Side Effects
Contraindications
- Severe renal impairment (eGFR < 30 mL/min/1.73m²)
- Active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities
- Pre-existing gallbladder disease
- Known hypersensitivity to fenofibrate or to any of the excipients
- History of photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen
Drug Interactions
Ciclosporin
May impair renal function and require dosage adjustment.
Oral anticoagulants (e.g., Warfarin)
Potentiation of anticoagulant effect, requiring close monitoring of INR.
Statins (HMG-CoA reductase inhibitors)
Increased risk of myopathy and rhabdomyolysis.
Bile acid resins (e.g., Cholestyramine)
May reduce absorption of fenofibrate. Administer fenofibrate 1 hour before or 4-6 hours after the resin.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for fenofibrate overdose. In case of overdose, supportive treatment and symptomatic measures should be implemented. Gastric lavage or activated charcoal may be considered if taken recently.
Pregnancy & Lactation
Pregnancy Category C. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not recommended during breastfeeding as it is unknown if fenofibric acid is excreted in human milk.
Side Effects
Contraindications
- Severe renal impairment (eGFR < 30 mL/min/1.73m²)
- Active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities
- Pre-existing gallbladder disease
- Known hypersensitivity to fenofibrate or to any of the excipients
- History of photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen
Drug Interactions
Ciclosporin
May impair renal function and require dosage adjustment.
Oral anticoagulants (e.g., Warfarin)
Potentiation of anticoagulant effect, requiring close monitoring of INR.
Statins (HMG-CoA reductase inhibitors)
Increased risk of myopathy and rhabdomyolysis.
Bile acid resins (e.g., Cholestyramine)
May reduce absorption of fenofibrate. Administer fenofibrate 1 hour before or 4-6 hours after the resin.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for fenofibrate overdose. In case of overdose, supportive treatment and symptomatic measures should be implemented. Gastric lavage or activated charcoal may be considered if taken recently.
Pregnancy & Lactation
Pregnancy Category C. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not recommended during breastfeeding as it is unknown if fenofibric acid is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture.
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Off-patent
Clinical Trials
Extensive clinical trials have demonstrated fenofibrate's efficacy in reducing LDL-C, total cholesterol, and triglycerides, and increasing HDL-C in patients with dyslipidemia.
Lab Monitoring
- Lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides)
- Liver function tests (ALT, AST)
- Renal function tests (creatinine, eGFR)
- Creatine kinase (CK) if muscle symptoms occur
Doctor Notes
- Monitor liver function tests (LFTs) periodically, especially during the first year of treatment.
- Caution when co-administering with statins due to increased risk of muscle toxicity; consider lower doses or alternative treatments.
- Assess renal function before initiating treatment and periodically thereafter.
Patient Guidelines
- Take Fenox exactly as prescribed by your doctor.
- Take the tablet whole with a meal to improve absorption.
- Do not stop taking Fenox without consulting your doctor, even if you feel well.
- Report any unexplained muscle pain, tenderness, or weakness immediately to your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Fenofibrate may cause dizziness in some patients. If you experience dizziness, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a balanced diet low in saturated fat and cholesterol.
- Incorporate regular physical exercise into your routine.
- Manage your weight to a healthy level.
- Avoid excessive alcohol consumption.
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