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Uses and Important Safety Information You
Should Know About FenaCor
Uses
FenaCor® (fenofibrate tablets) is
a prescription medicine used along with diet to lower
triglycerides, total cholesterol, and LDL (bad) cholesterol, and
increase HDL (good) cholesterol.
FenaCor is also used along with diet to lower
high triglycerides. Excess body weight, drinking alcohol,
diseases such as diabetes and certain thyroid problems, and
various drugs can increase triglyceride levels and should be
evaluated by your doctor before you take FenaCor.
FenaCor should be used with a diet low in
saturated fat and cholesterol when non-drug measures alone have
not been successful.
Important Safety Information
FenaCor should not be taken by people with
liver, gallbladder, or severe kidney disease, or those allergic
to any product ingredient.
FenaCor is associated with increases in liver
enzymes as measured by blood tests. Your healthcare provider may
do blood tests before and during treatment with FenaCor to check
for liver problems.
Some people who take FenaCor have developed
gallstones. Contact your healthcare provider if you experience
abdominal pain, nausea, or vomiting while taking FenaCor. These
may be signs of inflammation of the gallbladder or pancreas.
Unexplained muscle pain, tenderness, or
weakness, particularly when occurring with tiredness and fever,
may be a sign of a serious but rare muscle problem and should be
reported to your healthcare provider right away.
Tell your healthcare provider about all the
medicines you take, including any other cholesterol medications,
to determine if the combination of these medicines is right for
you.
FenaCor has not been shown to prevent heart
disease or heart attack.
FenaCor may cause allergic-type reactions and
possible changes in blood chemistry.
The most common side effects with FenaCor
include stomach pain, back pain, headache, increases in liver
enzymes measured by blood tests, and respiratory symptoms.
This is the most important information to know
about FenaCor. For more information, talk with your healthcare
provider.
Indications and Important Safety Information
About FenaCor
FenaCor Type IIa/IIb
Indications
FenaCor is indicated as
adjunctive therapy to diet in adult patients with primary
hypercholesterolemia or mixed dyslipidemia (Fredrickson types
IIa and IIb) to: increase high-density lipoprotein cholesterol (HDL-C),
reduce triglycerides (TG), reduce low-density lipoprotein
cholesterol (LDL-C), reduce total cholesterol (Total-C), reduce
apolipoprotein B (Apo B).
Lipid-altering agents should be used in
addition to a diet restricted in saturated fat and cholesterol
when response to diet and nonpharmacological interventions alone
has been inadequate.
FenaCor Type IV/V
Indications
FenaCor is indicated as
adjunctive therapy to diet for treatment of adult patients with
hypertriglyceridemia (Fredrickson types IV and V hyperlipidemia).
Improving glycemic control in diabetic patients with fasting
chylomicronemia usually obviates the need for drug therapy.
The effect of FenaCor on pancreatitis risk
reduction in patients with markedly elevated serum TG has not
been adequately studied.
Drug therapy is not indicated for patients
with type I hyperlipoproteinemia.
The use of FenaCor should be considered only
when reasonable attempts have been made to obtain satisfactory
results with nondrug methods such as diet, exercise, and
reduction of alcohol intake. If the decision is made to use
FenaCor, the patient should be instructed that this does not
reduce the importance of adhering to diet. Diseases or drugs
which contribute to hyperlipidemia should be evaluated and
appropriate interventions begun.
Important Safety Information
FenaCor is
contraindicated in patients with: hypersensitivity to
fenofibrate; hepatic or severe renal dysfunction including
primary biliary cirrhosis; unexplained persistent liver function
abnormality; and preexisting gallbladder disease.
Fenofibrate has been
associated with increases in serum transaminases. Regular liver
function monitoring should be performed, and therapy
discontinued if enzyme levels persist >3 times the normal limit.
Fenofibrate may lead to
cholelithiasis. If cholelithiasis is confirmed, FenaCor should
be discontinued.
FenaCor may increase
the effects of coumarin-type anticoagulants. Dosage adjustment
based on frequent prothrombin time/INR determinations is
advisable.
The combined use of FenaCor and HMG-CoA
reductase inhibitors should be avoided unless the benefit of
further alterations in lipid levels is likely to outweigh the
increased risk. This combination has been associated with
rhabdomyolysis, markedly elevated creatine kinase levels and
myoglobinuria, leading to acute renal failure.
FenaCor may
occasionally be associated with myositis, myopathy, or
rhabdomyolysis. Muscle pain, tenderness, or weakness should have
prompt medical evaluation. Discontinue FenaCor if markedly
elevated CPK levels occur or myopathy/myositis is suspected or
diagnosed.
The effect of FenaCor on coronary heart
disease morbidity and mortality and noncardiovascular mortality
has not been established.
Other precautions include increases in serum
creatinine that tend to be reversible, pancreatitis,
hypersensitivity reactions, venothromboembolic events, and
hematologic changes.
Adverse events most frequently observed in
clinical trials: abnormal liver function tests; respiratory
disorder; abdominal pain; back pain; and headache.
Presentation
Fenacor-160
Strips of 10 Tablets Fenacor-200 Strips of 10 Tablets
Note :This product information is intended only
for residents of the India. Taj Pharmaceuticals Limited,
medicines help to treat and prevent a range of conditions—from the
most common to the most challenging—for people around the world.
Information for Health Care Professionals
*** Please consult local Prescribing
Information for any product before use. This website is an
international information resource for healthcare professionals
with an interest in disease management. This website is not
intended to replace the advice of a qualified healthcare
professional. Above brand is a trademark of the Taj group of
companies (Taj Pharmaceuticals Limited).
Adjunctive Therapy to Diet in Adult Patients with Primary
Hypercholesterolemia
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