Novelip
Generic Name
Fenofibrate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| novelip 180 mg tablet | ৳ 30.00 | ৳ 150.00 |
Description
Overview of the medicine
Novelip 180 mg tablet contains Fenofibrate, a lipid-lowering medication used to reduce high cholesterol and triglyceride levels in the blood, especially in conditions like hypertriglyceridemia and mixed dyslipidemia.
Uses & Indications
Dosage
Adults
The usual dose is one Novelip 180 mg tablet orally once daily, taken with a meal. Initial dosage may vary based on lipid levels.
Elderly
Similar to adult dosage; however, renal function should be monitored, and dose adjustment may be necessary if renal impairment is present.
Renal_impairment
Contraindicated in severe renal impairment (creatinine clearance < 30 mL/min). In moderate renal impairment (creatinine clearance 30-59 mL/min), a reduced dose of 100 mg once daily or 145 mg every other day is recommended.
How to Take
Novelip 180 mg tablet should be taken orally, once daily, with a major meal. The tablet should be swallowed whole with water; do not crush, chew, or break it.
Mechanism of Action
Fenofibrate is a fibric acid derivative that activates peroxisome proliferator-activated receptor alpha (PPARα). This activation leads to increased lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing apolipoprotein C-III. It also increases the synthesis of apolipoprotein A-I and A-II, leading to an increase in HDL cholesterol.
Pharmacokinetics
Onset
Lipid-lowering effects are generally observed within a few weeks of consistent therapy.
Excretion
Mainly excreted in urine (about 70%) as fenofibric acid and its glucuronide conjugate, and about 25% in feces.
Half life
Approximately 20 hours for fenofibric acid (the active metabolite).
Absorption
Well absorbed from the gastrointestinal tract, especially when taken with food. Bioavailability is enhanced with food.
Metabolism
Rapidly hydrolyzed by esterases to its active metabolite, fenofibric acid, which is then primarily metabolized in the liver via glucuronidation.
Side Effects
Contraindications
- Severe renal impairment (creatinine clearance < 30 mL/min)
- Active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities
- Pre-existing gallbladder disease
- Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen
- Hypersensitivity to fenofibrate or to any of the excipients
Drug Interactions
Cyclosporine
Concurrent use may impair renal function. Monitor renal function closely.
Statins (e.g., Atorvastatin)
Increased risk of myopathy and rhabdomyolysis when co-administered. Use with caution and monitor for muscle symptoms.
Oral Anticoagulants (e.g., Warfarin)
May potentiate the anticoagulant effect, increasing the risk of bleeding. Close monitoring of INR and anticoagulant dose adjustment is required.
Bile Acid Sequestrants (e.g., Cholestyramine)
May decrease fenofibrate absorption. Administer fenofibrate at least 1 hour before or 4-6 hours after bile acid sequestrants.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for fenofibrate overdose. Treatment should be symptomatic and supportive, including gastric lavage (if indicated) and close monitoring of vital signs and clinical status. Fenofibric acid is not eliminated by hemodialysis.
Pregnancy & Lactation
Limited data are available on fenofibrate use in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether fenofibrate is excreted in human milk, so caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory authorities
Patent Status
Expired (Generic available)
Clinical Trials
Fenofibrate has undergone extensive clinical trials demonstrating its efficacy in reducing triglyceride levels, LDL cholesterol, and increasing HDL cholesterol, thereby contributing to cardiovascular risk reduction in dyslipidemic patients.
Lab Monitoring
- Lipid profile (total cholesterol, LDL, HDL, triglycerides) at baseline and periodically (e.g., every 3-6 months).
- Liver function tests (ALT, AST, alkaline phosphatase) at baseline, every 3 months for the first year, and periodically thereafter.
- Renal function tests (serum creatinine, eGFR) at baseline and periodically, especially in elderly or patients with pre-existing renal impairment.
Doctor Notes
- Emphasize the importance of lifestyle modifications (diet, exercise) as a cornerstone of lipid management.
- Advise patients about potential muscle-related side effects, especially when co-administered with statins, and instruct them to report symptoms promptly.
- Ensure regular monitoring of liver function tests and renal function, particularly at the initiation of therapy and during dose adjustments.
Patient Guidelines
- Continue dietary restrictions (low-fat, low-cholesterol diet) and lifestyle modifications (regular exercise, weight management) as advised by your doctor.
- Do not stop taking Novelip 180 mg suddenly without consulting your doctor, even if you feel well.
- Report any unusual muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine, to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Novelip 180 mg is not known to affect the ability to drive or operate machinery. However, if you experience dizziness or visual disturbances, you should avoid driving or performing tasks requiring alertness.
Lifestyle Advice
- Maintain a healthy, balanced diet rich in fruits, vegetables, and whole grains, and low in saturated and trans fats.
- Engage in regular physical activity, aiming for at least 30 minutes of moderate-intensity exercise most days of the week.
- Avoid excessive alcohol consumption and smoking, as these can negatively impact lipid levels and overall cardiovascular health.
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