Atorvastatin

GENERIC NAME: atorvastatin

DRUG CLASS AND MECHANISM
Atorvastatin is an oral drug that lowers the level of cholesterol in the blood. It belongs to a class of drugs referred to as statins, which includes lovastatin (Mevacor), simvastatin, (Zocor), fluvastatin (Lescol), and pravastatin (Pravachol). All statins, including atorvastatin, prevent the production of cholesterol in the liver by blocking HMG-CoA reductase, an enzyme that makes cholesterol. Statins reduce total cholesterol as well as LDL cholesterol in blood. LDL cholesterol is believed to be the "bad" cholesterol that is primarily responsible for the development of coronary artery disease. Reducing LDL cholesterol levels retards progression and may even reverse coronary artery disease. Atorvastatin also reduces the concentration of triglycerides in the blood and raises the concentrations of HDL ("good") cholesterol. High blood concentrations of triglycerides also have been associated with coronary artery disease. The FDA approved atorvastatin in December 1996.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No

PREPARATIONS: Tablets of 10, 20, 40, and 80 mg

PRESCRIBED FOR
Atorvastatin is used for the treatment of elevated total cholesterol, LDL, triglycerides and to elevate HDL cholesterol. The effectiveness of atorvastatin in lowering cholesterol is dose-related, meaning that higher doses reduce cholesterol more.

Atorvastatin prevents angina, stroke, heart attack, hospitalization for congestive heart failure, and revascularization procedures in individuals with coronary heart disease.

Atorvastatin reduces the risk of myocardial infarction, stroke, angina and revascularization procedures in adults with multiple risk factors for coronary artery disease.

Atorvastatin also prevents heart attacks and strokes in patients with type 2 diabetes with multiple risk factors for coronary artery disease.

DOSING
Atorvastatin is prescribed once daily. The usual starting dose is 10-20 mg per day, and the maximum dose is 80 mg per day. Individuals who need more than a 45% reduction in LDL cholesterol may be started at 40 mg daily. Atorvastatin may be taken with or without food and at any time of day.

DRUG INTERACTIONS
Decreased elimination of atorvastatin could increase levels of atorvastatin in the body and increase the risk of muscle toxicity from atorvastatin. Therefore, atorvastatin should not be combined with drugs that decrease its elimination. Examples of such drugs include erythromycin (E-Mycin), ketoconazole (Nizoral), itraconazole (Sporanox), clarithromycin (Biaxin), telithromycin (Ketek), cyclosporine (Sandimmune), nefazodone (Serzone), and HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir).

USES
Atorvastatin 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. Atorvastatin is used in adults and children (10 years of age and older). Young girls must have had their first menstrual period before starting this medication.

HOW TO USE
Take this medication by mouth usually once daily with or without food, or as directed by your doctor. This drug is best taken in the evening. Dosage is based on your medical condition, response to therapy, and use of certain interacting medicines. Many of the drugs listed in the Drug Interactions section may increase the chances of muscle injury when used with atorvastatin. Consult your doctor or pharmacist for more details. Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit juice can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details. If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take atorvastatin at least 2 hours after these medications. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. It may take up to 4 weeks before the full benefit of this drug takes effect. It is important to continue taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick.

SIDE EFFECTS
Headache, diarrhea, stomach/abdominal pain, or joint pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. 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, severe stomach/abdominal pain, persistent nausea, change in the amount of urine. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS
Before taking atorvastatin, 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 atorvastatin may cause fetal harm. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

OVERDOSE
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

MISSED DOSE
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE
Store at room temperature between 68 and 77 degrees F (20 to 25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

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.