Brand Name: Lipired
Manufacturer:Â Square Pharmaceuticals Ltd.
INDICATION
Fenofibrate (fenofibrate capsules), micronised, is indicated as adjunctive
therapy to diet for treatment of hyperlipidemias of Type IIa, IIb, III, IV and V
who do not respond adequately to a determined dietary effort or other
appropriate measures to control them.
DOSAGE AND ADMINISTRATION
The dose is one 200 mg capsule per day. Dosage should be individualized
according to patient response, and should be increased sequentially if
necessary following repeat serum triglyceride estimations at 4 to 8 week
intervals.
Patients should be placed on an appropriate triglyceride-lowering diet
before receiving fenofibrate, and should continue this diet during treatment
with fenofibrate. Fenofibrate should be given with meals, thereby optimizing
the bioavailability of the medication.
CONTRAINDICATION
1. Hepatic or severe renal dysfunction, including primary biliary cirrhosis,
and patients with unexplained persistent liver function abnormality.
2. Preexisting gallbladder disease.
3. Hypersensitivity to fenofibrate.
SPECIAL POPULATION
Geriatrics : This indicates that a similar dosage regimen can be used in the
elderly, without increasing accumulation of the drug or metabolites.
Pediatrics : No data are available. Fenofibrate is not indicated for use in the
pediatric population.
Gender : No pharmacokinetic difference between male and female has
been observed for fenofibrate.
Renal insufficiency : The dosage of fenofibrate should be minimized in
patients who have severe renal impairment, while no modification of dosage
is required in patients having moderate renal impairment.
Hepatic insufficiency : No pharmacokinetic study has been conducted in
patients having hepatic insufficiency.
SIDE EFFECT
Digestive: hepatitis, cholelithiasis, cholecystitis, hepatomegaly
Musculoskeletal: myalgia, myasthenia, rhabdomyolysis
Skin and appendages: photosensitivity, eczema
Cardiovascular: peripheral edema, angina, palpitations, tachycardia, and
migraine
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