Fenofibrate
Generic Name: Fenofibrate
Brand Name: Antara, Lipofen, Tricor, Triglide
Indications
Fenofibrate is indicated for the treatment of high cholesterol (hypercholesterolemia) and high triglyceride levels (hypertriglyceridemia). It is used in combination with a diet low in cholesterol and saturated fat.
Dosage and Administration
Fenofibrate is available for oral administration in different strengths in different labels.
Normal Dosage:
Patients should be placed on an appropriate lipid-lowering diet before receiving Antara, and should continue this diet during treatment with Antara. Antara capsules may be taken without regard to meals.
For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of Antara is 130 mg per day.
For adult patients with hypertriglyceridemia, the initial dose is 43 to 130 mg 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 130 mg per day.
Treatment with Antara should be initiated at a dose of 43 mg/day in patients having impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. In the elderly, the initial dose should likewise be limited to 43 mg/day.
Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Antara if lipid levels fall significantly below the targeted range.
Drug Description
Antara (fenofibrate) Capsules, is a lipid regulating agent available as capsules for oral administration. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:
The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79°-82°C. Fenofibrate is a white solid which is stable under ordinary conditions.
Side Effects
The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
- Disturbances of the gut such as diarrhoea, flatulence, nausea, vomiting or abdominal pain.
- Headache.
- Fatigue.
- Balance problems involving the inner ear (vertigo).
- Skin reactions such as rash and itch.
- Abnormal reaction of the skin to light, usually a rash, redness or blistering (photosensitivity).
- Inflammation of the pancreas (pancreatitis).
- Abnormal blood clot in a blood vessel, eg in the leg (deep vein thrombosis) or lungs (pulmonary embolism).
- Hair loss (alopecia).
- Sexual problems.
- Alteration in results of liver function tests.
- Gallstones.
- Muscle pain, inflammation, cramps or weakness.
- Muscle breakdown (rhabdomyolysis).
- Inflammation of the liver (hepatitis).
Precautions
- Follow any diet or exercise plan outlined by your doctor. Diet and exercise are important factors in controlling cholesterol.
- Avoid alcohol or use it only in moderation. Alcohol can raise triglyceride levels, and it can be damaging to the liver if you are taking this medicine.
- Before taking fenofibrate, tell your doctor if you have:
- liver disease
- biliary cirrhosis
- kidney disease
- gallbladder disease
- hypothyroidism (an underactive thyroid gland)
- diabetes
- You may not be able to take this medication, or you may be required to take a special dosage or monitoring during treatment if you have any of the conditions listed above.
- This drug belongs in the class of the FDA pregnancy category C and this means that taking this drug may affect the foetus. Do not take this medicine without consulting your doctor.
- Fenofibrate should not be used by nursing mothers.
Drug Interactions
The following drugs can interact with fenofibrate. Tell your doctor if you are using any of these medicines:
- a blood thinner such as warfarin (Coumadin);
- cyclosporine (Neoral, Sandimmune, Gengraf); or
- other cholesterol-lowering medicines such as lovastatin (Mevacor), simvastatin (Zocor), pravastatin (Pravachol), fluvastatin (Lescol), atorvastatin (Lipitor), or cerivastatin (Baycol).
- If you are using any of these drugs, you may not be able to take fenofibrate, or you may need dosage adjustments or special tests during treatment.
