Warnings
Liver: About 1% of patients who took ZOCOR in clinical trials
developed elevated levels of some liver enzymes. Patients
who had these increases usually had no symptoms. Elevated
liver enzymes usually returned to normal levels when therapy
with ZOCOR was stopped. Your doctor should perform routine
blood tests to check these enzymes before you start treatment
with ZOCOR and periodically thereafter (for example, semiannually)
for your first year of treatment or until one year after
your last elevation in dose. If your enzyme levels increase,
your doctor should order more frequent tests. If your liver
enzyme levels remain unusually high, your doctor should
discontinue your medication. Tell your doctor about any
liver disease you may have had in the past and about how
much alcohol you consume. ZOCOR should be used with caution
in patients who consume large amounts of alcohol.
Because
there are risks in combining therapy with ZOCOR with lipid-lowering
doses of nicotinic acid (niacin) or with drugs that suppress
the immune system, your doctor should carefully weigh the
potential benefits and risks. He or she should also carefully
monitor patients for any muscle pain, tenderness, or weakness,
particularly during the initial months of therapy and if
the dose of either drug is increased. Your doctor may also
monitor the level of certain muscle enzymes in your body,
but there is no assurance that such monitoring will prevent
the occurrence of severe muscle disease.
Precautions
Before starting treatment with ZOCOR, try to lower your
cholesterol by other methods such as diet, exercise, and
weight loss. Ask your doctor about how best to do this.
Any other medical problems that can cause high cholesterol
should also be treated.
Drug
Interactions
Because
of possible serious drug interactions, it is important to
tell your doctor what other drugs you are taking, including
those obtained without a prescription. ZOCOR can interact
with Posicor, Lopid, niacin, erythromycin, clarithromycin,
nefazodone, certain antifungal drugs, and drugs that suppress
the immune system (called immunosuppressive drugs, such
as Sandimmune). Some
patients taking lipid-lowering agents similar to ZOCOR and
coumarin anticoagulants (a type of blood thinner) have experienced
bleeding and/or increased blood clotting time. Patients
taking these medicines should have their blood tested before
starting therapy with ZOCOR and should continue to be monitored.
Endocrine
(Hormone) Function: ZOCOR and other drugs in this class
may affect the production of certain hormones. Caution should
be exercised if a drug used to lower cholesterol levels
is administered to patients also receiving other drugs (e.g.,
ketoconazole, spironolactone, cimetidine) that may decrease
the levels or activity of hormones. If you are taking any
such drugs, tell your doctor.
Side Effects
Most patients tolerate treatment with ZOCOR well; however,
like all prescription drugs, ZOCOR can cause side effects,
and some of them can be serious. Side effects that do occur
are usually mild and short-lived. Only your doctor can weigh
the risks versus the benefits of any prescription drug.
In clinical studies with ZOCOR, less than 1.5% of patients
dropped out of the studies because of side effects. In a
large, long-term study, patients taking ZOCOR experienced
similar side effects to those patients taking placebo (sugar
pills). Some of the side effects that have been reported
with ZOCOR or related drugs are listed below. This list
is not complete. Be sure to ask your doctor about side effects
before taking ZOCOR and to discuss any side effects that
occur. Digestive System: Constipation, diarrhea,
upset stomach, gas, heartburn, stomach pain/cramps, anorexia,
loss of appetite, nausea, inflammation of the pancreas,
hepatitis, jaundice, fatty changes in the liver, and, rarely,
severe liver damage and failure, cirrhosis, and liver cancer.
Muscle, Skeletal: Muscle cramps, aches,
pain, and weakness; joint pain; muscle breakdown.
Nervous System: Dizziness, headache, insomnia,
tingling, memory loss, damage to nerves causing weakness
and/or loss of sensation and/or abnormal sensations, anxiety,
depression, tremor, loss of balance, psychic disturbances.
Skin: Rash, itching, hair loss, dryness,
nodules, discoloration.
Eye/Senses: Blurred vision, altered taste
sensation, progression of cataracts, eye muscle weakness.
Hypersensitivity (Allergic) Reactions: On
rare occasions, a wide variety of symptoms have been reported
to occur either alone or together in groups (referred to
as a syndrome) that appeared to be based on allergic-type
reactions, which may rarely be fatal. These have included
one or more of the following: a severe generalized reaction
that may include shortness of breath, wheezing, digestive
symptoms, and low blood pressure and even shock; an allergic
reaction with swelling of the face, lips, tongue and/or
throat with difficulty swallowing or breathing; symptoms
mimicking lupus (a disorder in which a person's immune system
may attack parts of his or her own body); severe muscle
and blood vessel inflammation; bruises; various disorders
of blood cells (that could result in anemia, infection,
or blood clotting problems) or abnormal blood tests; inflamed
or painful joints; hives; fatigue and weakness; sensitivity
to sunlight; fever, chills; flushing; difficulty breathing;
and severe skin disorders that vary from rash to a serious
burn-like shedding of skin all over the body, including
mucous membranes such as the lining of the mouth.
Other:
Loss of sexual desire, breast enlargement, impotence.
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