simvastatin, Zocor - Alway check liver

GENERIC NAME: simvastatin
BRAND NAME: Zocor
DRUG CLASS AND MECHANISM: Simvastatin is a cholesterol-lowering drug.
It belongs to a classof drugs called HMG-CoA reductase inhibitors,
commonly called " statins ." Other statins include lovastatin
(Mevacor), atorvastatin (Lipitor), fluvastatin (Lescol), and
rosuvastatin (Crestor). Statins reduce cholesterol by inhibiting an
enzyme in the liver (HMG-CoA reductase) that is necessary for the
production of cholesterol. In the blood, statins lower total and low
density lipoprotein (LDL) or "bad" cholesterol as well as
triglycerides . LDL cholesterol is believed to be an important cause
of coronary artery disease. Lowering LDL cholesterol levels slows and
may even reverse coronary artery disease. Statins also increase
highdensity lipoprotein (HDL) or "good" cholesterol. Raising HDL
cholesterol levels, like lowering LDL cholesterol may slow coronary
artery disease. The FDA approved simvastatin in Decembe, 1991.
PRESCRIPTION: Yes
GENERIC AVAILABLE: Yes
PREPARATIONS:
Tablets: 5, 10, 20, 40, and 80 mg.
Orally disintegrating tablets: 10, 20, 40, and 80 mg.
STORAGE:
Tablets should be stored between 5-30 C (41-86 F).
Orally disintegrating tablets shouldbe stored between 20-25 C (68-77 F).
PRESCRIBED FOR: Simvastatin is used for reducing total cholesterol,LDL
cholesterol, and triglycerides, and for increasing HDL cholesterol.In
patients with coronary heart disease , diabetes , peripheral vascular
disease , or history of stroke or other cerebrovascular disease,
simvastatin is prescribed for reducing the risk of mortality by
reducing death from coronary heart disease, reducing nonfatal
myocardial infarction ( heart attack ) and stroke, and reducing the
need for coronary and noncoronary revascularization procedures.
DOSING: The recommended dose range of simvastatin is 10 mg to 40 mg,
and it is administered once daily in the evening with or without food.
Therapy usually is initiated with 10 or 20 mg daily, but individuals
who have a high risk of heart disease can be started on 40mg daily.
Simvastatin 80 mg is restricted to patients who have been taking
simvastatin 80 mg chronically (for example, for 12 months or more)
without evidence of muscle toxicitybecause the 80 mg dose is
associated with increased risk of muscle toxicity, including
rhabdomyolysis . Patients who are currently tolerating the 80 mg dose
of simvastatin who need to start an interacting drug that should not
be taken with simvastatin or is associated with a dose cap for
simvastatin should be switched to an alternative statin orstatin-based
regimen with less potential for the drug-drug interaction.
Patients that require more than the40 mg dose should be switched to an
alternative drug.
DRUG INTERACTIONS : Decreased elimination of simvastatin could
increase the levels of simvastatin in the body and increase the risk
ofmuscle toxicity from simvastatin. Examples of drugs that decrease
elimination of simvastatin include erythromycin (E-Mycin),
ketoconazole (Nizoral), itraconazole (Sporanox), clarithromycin
(Biaxin), telithromycin (Ketek), cyclosporine (Sandimmune), nefazodone
(Serzone), boceprevir (Victrelis),
telaprevir (incivek), voriconazole (Vfend), posaconazole (Noxafil),
and HIV protease inhibitors such as indinavir (Crixivan) and ritonavir
(Norvir). They should not be combined with simvastatin.
It is important to clarify that ALT and AST levels do not reflect the
function of the liver, even though they commonly are referred to as
liver function tests or LFTs. They only are used to detect
inflammation due to injury or damage to the liver from any source.
Even in conditions when AST and ALT are very elevated, theliver may
function properly.
*The blood tests that truly reflect the liver function are the following:
Coagulation panel (prothrombin time or PT, and international
normalized ratio or INR): These tests measure blood's ability for
normal clotting and prevention of bleeding and bruising . This is the
function of certain proteins called clotting factors that are produced
in the normally functioning liver.
Albumin level (hypoalbuminemia): Albumin is a very common protein
found in the blood with a variety of functions. It also is produced
only in the liver, and if its levels are lower than normal it can be
suggestive of chronic liver disease.Of note, other conditions may also
cause low albumin levels.
Bilirubin: This byproduct of the routine destruction of red blood
cells occurring in the liver is released as bile in the feces.
Elevation of the bilirubin can suggest liver dysfunction.
Platelet count: Low platelet count ( thrombocytopenia ) has many
causes, one of which can be advanced liver disease.
SIDE EFFECTS: The most common side effects of simvastatin are headache
, nausea , vomiting , diarrhea , abdominal pain , muscle pain , and
abnormal liver tests . Hypersensitivity reactions have also been
reported.
The most serious potential side effects are liver damage and muscle
inflammation or breakdown. Simvastatin shares side effects, such as
liver and muscle damage associated with all statins. Seriousliver
damage caused by statins is rare. More often, statins cause
abnormalities of liver tests. Abnormal tests usually return to normal
even if a statin is continued, but if the *abnormal test value is
greater than three times the upper limit of normal, the statin usually
is stopped. Liver tests should be measured before simvastatin is
started and if there is a medical concern about liver damage
thereafter.
Inflammation of the muscles caused by statins can lead to a serious
breakdown of muscle cells called rhabdomyolysis. Rhabdomyolysis causes
the releaseof muscle protein (myoglobin) into the blood. Myoglobin can
cause kidney failure and even death. When used alone, statins cause
rhabdomyolysis in less than one percent of patients. To prevent
thedevelopment of rhabdomyolysis, patients taking simvastatin should
contact their health care professional immediately if they develop
unexplained muscle pain, weakness , or muscle tenderness.
Statins have been associated with increases in HbA1c and fasting serum
glucose levels as are seen in diabetes .
There are also post-marketing reports of memory loss , forgetfulness,
amnesia, confusion ,and memory impairment. Symptoms may start one day
to years after starting treatment and resolve within a median of three
weeks after stopping the statin.
Reference: FDA Prescribing Information

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