Therapeutic Index

Each Tablet contains:
Simvastatin tablet....................... 20mg
 
COMPOSITION :
Vascor Tablets 20mg

INDICATIONS :
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.

In patients with coronary heart disease (CHD) or at high risk of CHD, Vascor can be started simultaneously with diet.

USES :
Vascor is an enzyme blocker (HMG-CoA reductase inhibitor), also known as a "statin". It is used along with a proper diet to help lower cholesterol and fats (triglycerides) in the blood. In general, this drug is prescribed after non-drug treatment options have not been fully successful at lowering cholesterol (e.g., diet change, increase in exercise, weight loss if overweight). Reducing cholesterol and triglycerides help prevent strokes and heart attacks.

Vascor is used in adults and children (10 years of age and older). Young girls must have had their menstrual periods for at least one year before starting this medication.

SIDE EFFECTS :
Stomach upset may occur. If this effect persists or worsens, notify your doctor or pharmacist promptly. This drug may infrequently cause muscle damage (which can rarely lead to a very serious, possibly fatal, condition called rhabdomyolysis). Seek immediate medical attention if you develop: muscle pain/tenderness/weakness (especially with fever or unusual tiredness). Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: yellowing eyes and skin, dark urine, severe fatigue, stomach/abdominal pain, persistent nausea, change in the amount of urine.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS :
Before taking Vascor , tell your doctor or pharmacist if you are allergic to it; or to other "statins"; or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease, history of liver disease, kidney disease, underactive thyroid (hypothyroidism), diabetes (poorly controlled), alcohol use.

The rare development of severe muscle damage (see Side Effects) can infrequently lead to serious kidney problems. This medication is usually temporarily stopped if you have any condition which can increase your risk of developing kidney problems. Before stopping your medication, notify your doctor immediately if you have any of the following conditions: major surgery, trauma, serious illness (e.g., sepsis, severe metabolic/endocrine/electrolyte disorders), very low blood pressure, uncontrolled seizures. Limit alcoholic beverages. Daily use of alcohol may increase your chance for serious side effects. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially muscle damage.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is recommended that young girls and women of child-bearing age use effective birth control measures to prevent pregnancy while taking this drug since simvastatin may cause fetal harm. It is not known if this drug passes into breast milk. Because of the potential risk of undesirable effects on a nursing infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


PACKAGING INFORMATION :
Vascor Tablets.................. 20mg



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