Lipitor (Atorvastatin)

We often cannot see or feel the problems that high cholesterol causes until a lot of time has passed. That's why it is important to take these pills just as prescribed. You/your child and your doctor will be watching your/your child's cholesterol levels to get them down to a safe range. Here are some important tips.

• Follow the plan that you/your child and your doctor make for diet, exercise and weight control.
• Take LIPITOR as a single dose. It does not matter if LIPITOR is taken with food or without food, but it should not be taken with grapefruit juice. Your doctor will usually tell you/your child to take it in the evenings.
• Do not change the dose unless directed by a doctor.
• If you/your child get sick, have an operation, or need medical treatment, inform your doctor or pharmacist that you/your child are taking LIPITOR.
• If you/your child have to take any other medicine—prescription or non-prescription—while taking LIPITOR, talk to your doctor or pharmacist first.
• If you/your child have to see a different doctor for any reason, be sure to inform him/her that you/your child are/is taking LIPITOR.
• LIPITOR was prescribed for you/your child only. Don't give these pills to anyone else.

Usual dose:

Adults: The recommended starting dose of LIPITOR is 10 or 20 mg once daily, depending on your required LDL-C reduction. Patients who need a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of LIPITOR is 10 to 80 mg once daily. The maximum dose is 80 mg/day.

The recommended dose of LIPITOR is 10 to 80 mg/day for people who have already suffered a heart attack.

Children (10-17 years old):

The recommended starting dose of LIPITOR is 10 mg/day; the maximum recommended dose is 20 mg/day.

Overdose:

In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed dose:

If you/your child miss taking a pill, take it as soon as possible. But if it is almost time for the next dose, skip the missed dose and just take the next dose. Don't take a double dose.

Most people do not have any problems with side effects when taking this medicine. However, all medicines can cause unwanted side effects. Check with your doctor or pharmacist promptly if any of the following persist or become troublesome:

• constipation/diarrhea/gas
• depression (in children)
• headache
• skin rash
• stomach pain or upset
• vomiting or throwing up

Very rarely, a few people may suffer from jaundice (which may be manifested by yellowing of the skin and eyes), from a liver condition called hepatitis (inflammation of the liver).

Possible side effects reported with some statins:

• breathing problems including persistent cough and/or shortness of breath or fever
• cases of erectile dysfunction (difficulty to achieve or maintain an erection)
• sleep disturbances (difficulty sleeping or staying asleep), including insomnia and nightmares
• mood related disorders including depression
• poor memory, confusion and memory loss

LIPITOR can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

This is not a complete list of side effects. If you/your child notice anything unusual or any unexpected effects while taking LIPITOR, contact your doctor or pharmacist.

Serious Warnings and Precautions

Tell your doctor if you/your child have any muscle pain, tenderness, soreness or weakness during treatment with LIPITOR.

Before using this medicine:

Before taking LIPITOR, tell your doctor or pharmacist if you/your child:

• are/is pregnant, intend to become pregnant. Cholesterol compounds are essential elements for the development of a fetus. Cholesterol-lowering drugs can harm the fetus. Females of child-bearing age should discuss with their doctor the potential hazards to the fetus and the importance of birth control methods. LIPITOR should not be used by pregnant women. If you/your child become pregnant, discontinue use immediately and discuss with your doctor.
• are/is breast-feeding or intend to breast-feed. This medicine may be present in breast milk.
• have thyroid problems
• have had a stroke or a mini stroke (TIA)
• regularly drink three or more alcoholic drinks daily
• are taking any other cholesterol lowering medication such as fibrates (gemfibrozil, fenofibrate), niacin or ezetimibe
• have a family history of muscular disorders
• had any past problems with the muscles (pain, tenderness), after using an HMG-CoA reductase inhibitor (“statin”) such as atorvastatin (LIPITOR), fluvastatin (LESCOL), lovastatin (MEVACOR), pravastatin (PRAVACHOL), rosuvastatin (CRESTOR) or simvastatin (ZOCOR) or have developed an allergy or intolerance to them
• have kidney or liver problems
• have diabetes (as the dosage of LIPITOR may need to be adjusted)
• have undergone surgery or other tissue injury
• do excessive physical exercise
• are taking fusidic acid

Slightly increased blood sugar can occur when you take LIPITOR. Discuss with the doctor your risk of developing diabetes.

LIPITOR may cause muscle pain, aching or weakness that does not go away even after stopping the drug.

LIPITOR was studied in boys and girls (girls who already started their period) 10-17 years at a dose of 10 and 20 mg. LIPITOR has not been studied in pre-pubertal patients or patients younger than 10 years of age. Adolescent girls should discuss with their doctor the potential hazards to the fetus and the importance of birth control while on LIPITOR therapy.

As with most medicines, interaction with other drugs is possible. Tell your doctor or pharmacist if you are taking any other medications, including prescription, non-prescription and natural health products. In particular, these drugs may interact with LIPITOR:

• corticosteroids (cortisone-like medicines)
• cyclosporine (SANDIMMUNE)
• gemfibrozil (LOPID)
• fenofibrate (LIPIDIL MICRO) or bezafibrate (BEZALIP)
• lipid-modifying doses of niacin (nicotinic acid)
• erythromycin, clarithromycin or azole antifungal agents (ketoconazole or itraconazole)
• nefazodone (SERZONE)
• indinavir sulfate (CRIXIVAN), nelfinavir mesylate (VIRACEPT), ritonavir (NORVIR), saquinavir mesylate (INVIRASE), lopinavir/ritonavir (e.g. KALETRA), telaprevir (INCIVEK), tipranavir (APTIVUS), darunavir (PREZISTA), fosamprenavir (TELZIR), boceprevir (VICTRELIS)
• fusidic acid (e.g. FUCIDIN)
• digoxin
• diltiazem
• efavirenz, rifampin
• antacids (frequent use) and LIPITOR should be taken 2 hours apart
• colchicine
• grapefruit juice—especially if ingesting upwards of 1.2 litres of grapefruit juice at once