Fibroz
Generic Name
Fenofibrate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| fibroz 100 mg capsule | ৳ 235.00 | ৳ 2,350.00 |
Description
Overview of the medicine
Fibroz 100 mg Capsule contains Fenofibrate, a lipid-modifying agent used to reduce elevated cholesterol and triglyceride levels in the blood, thereby lowering the risk of cardiovascular diseases. It is used in conjunction with diet and exercise to treat primary hypercholesterolemia, mixed dyslipidemia, and severe hypertriglyceridemia.
Uses & Indications
Dosage
Adults
The recommended dose is 100 mg once daily with a main meal. Initial therapy should be accompanied by dietary measures.
Elderly
No dose adjustment is typically required in elderly patients with normal renal function. However, careful monitoring of renal function is recommended.
Renal_impairment
In patients with mild to moderate renal impairment (eGFR 30-59 mL/min/1.73 m²), the dose should be reduced. Fenofibrate is contraindicated in severe renal impairment (eGFR < 30 mL/min/1.73 m²).
How to Take
Fibroz 100 mg Capsule should be taken orally once daily, preferably with a main meal to ensure optimal absorption. Swallow the capsule whole with water; do not chew or crush it.
Mechanism of Action
Fenofibrate works by activating peroxisome proliferator-activated receptor alpha (PPARα), which leads to increased synthesis of lipoprotein lipase and reduced production of apolipoprotein CIII. This results in enhanced catabolism of very low-density lipoprotein (VLDL) and increased high-density lipoprotein (HDL) cholesterol levels, ultimately lowering plasma triglycerides and LDL-C.
Pharmacokinetics
Onset
Lipid-lowering effects typically begin within days, with maximal effects observed after several weeks of continuous therapy.
Excretion
Mainly excreted in the urine as fenofibric acid and its glucuronide conjugate (about 70% within 6 days). A smaller amount is excreted in feces.
Half life
The elimination half-life of fenofibric acid is approximately 20 hours.
Absorption
Well-absorbed from the gastrointestinal tract, especially when taken with food, reaching peak plasma concentrations within 6-8 hours. The active metabolite, fenofibric acid, is almost 100% absorbed.
Metabolism
Fenofibrate is rapidly hydrolyzed by esterases to its active metabolite, fenofibric acid. Fenofibric acid is then primarily conjugated with glucuronic acid and undergoes minimal oxidative metabolism.
Side Effects
Contraindications
- •Known hypersensitivity to fenofibrate or fenofibric acid, or to any component of the capsule.
- •Severe renal impairment (eGFR < 30 mL/min/1.73 m²).
- •Active liver disease, including primary biliary cirrhosis, or unexplained persistent liver function abnormalities.
- •Pre-existing gallbladder disease.
- •Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.
Drug Interactions
Cyclosporine
Concomitant use may lead to reversible renal dysfunction. Monitoring of renal function is recommended.
Oral Contraceptives
May alter lipid profiles, potentially affecting the efficacy of fenofibrate, though significant interactions are rare.
Oral Anticoagulants (e.g., Warfarin)
Fenofibrate can potentiate the effects of vitamin K antagonists, increasing the risk of bleeding. Close monitoring of INR (International Normalized Ratio) and dose adjustment of the anticoagulant are necessary.
Statins (HMG-CoA Reductase Inhibitors)
Concomitant use with statins may increase the risk of myopathy, rhabdomyolysis, and acute renal failure. Careful monitoring of muscle symptoms and creatine kinase levels is advised.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children. Do not freeze.
Overdose
There is no specific antidote for Fenofibrate overdose. In case of an overdose, symptomatic and supportive treatment should be initiated. This may include gastric lavage and general supportive measures as clinically indicated. Hemodialysis is not effective in removing fenofibric acid.
Pregnancy & Lactation
Pregnancy Category C. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. It is not known whether fenofibrate is excreted in human milk; caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture when stored under recommended conditions.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by major regulatory authorities (e.g., FDA, EMA, DGDA)
Patent Status
Patent expired; generic versions available worldwide
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