Pravachol (Pravastatin)

Use only as specifically directed. Do not alter the dosage unless ordered to do so by your physician. Check with your physician before discontinuing medication since this may result in an increase of your blood lipids.

Before taking PRAVACHOL, tell your doctor or pharmacist if you:

• are breast-feeding or intend to breast-feed,
• have thyroid problems,
• have a family history of muscular disorders,
• have 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,
• have undergone surgery or other tissue injury,
• do excessive physical exercise.
• suffer from alcohol abuse
• are 65 years of age or older.

Pregnancy:

Before using this medication, discuss the following with your doctor:

• Cholesterol compounds are essential elements for the development of a fetus.
• Cholesterol-lowering drugs can harm the fetus. If you are of child-bearing age, discuss with your doctor the potential hazards to the fetus and the importance of birth control methods.
• PRAVACHOL should not be used by pregnant women. If you become pregnant, discontinue use immediately and discuss with your doctor.

Slightly increased blood sugar can occur when you take an HMG-CoA reductase inhibitor (“statin”). Discuss with the doctor your risk of developing diabetes.

Side effects may include:

• abdominal pain, constipation, diarrhea, nausea, indigestion
• headache, dizziness
• skin rashes
• persistent cough
• trouble sleeping, insomnia, nightmares
• sexual problems
• depression, anxiety, nervousness

Muscle effects:

Side effects such as muscle pain, muscle disease with aching or weakness, rhabdomyolosis (a muscle wasting disease), associated tenderness, and rare cases of rhabdomylosis leading to kidney failure have been reported with other drugs of this class, known as HMG-CoA reductase inhibitors ("statins"), including PRAVACHOL.

As these muscle problems are on rare occasions serious, you should contact your physician promptly if you experience any of the side effects listed in the Table below.

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

PRAVACHOL may interact with other drugs, including those you take without a prescription. You must tell your doctor or pharmacist about all drugs, including prescription and nonprescription, herbal products and supplements, you are taking or planning to take before you take PRAVACHOL.

You should tell your doctor if you are taking other cholesterol lowering medication such as fibrates (gemfibrozil, fenofibrate), niacin, or ezetimibe. If you take these drugs and PRAVACHOL together, you may be at an increased risk of myopathy (muscle disease with aching or weakness).

If you are taking a bile acid-binding resin (such as cholestyramine, colestipol), your doctor will recommend that you take PRAVACHOL either one hour or more before or at least four hours following the resin. Taking them together causes lower amounts of PRAVACHOL in the blood, making it less effective.

If you are taking cyclosporine, your doctor may need to adjust the dose of PRAVACHOL.

If you are taking certain antibiotics (such as azithromycin or clarithromycin) to treat an infection your doctor my need to adjust the dose of PRAVACHOL.

Excessive alcohol intake should be avoided when taking PRAVACHOL. Tell your doctor if you regularly drink three or more alcoholic drinks daily.

• Do not change the dose unless directed by a doctor.
• PRAVACHOL should be taken as a single dose at bedtime, as prescribed by your physician.
• Your physician will monitor your clinical condition and your blood tests at regular intervals. It is important to have these check-ups done on schedule. Please keep your appointments accurately.
• Notify your physician about any illness which may develop during your treatment with PRAVACHOL and about any new prescription or non-prescription medication you may take. If you require medical help for other reasons, inform the attending physician that you are taking PRAVACHOL.
• Notify your physician if you are going to have major surgery or have sustained a severe injury.
• Notify your physician of any muscle pain, tenderness or weakness developing during treatment with PRAVACHOL

Usual adult dose:

The recommended starting dose is 20 mg once daily at bed time. Patients who require a large dose reduction in cholesterol may be started at 40 mg once daily. The dose of 80 mg once daily should be reserved for patients who do not achieve their treatment goal with lower doses. PRAVACHOL may be taken without regard to meals.

Overdose:

If you think you have taken too much PRAVACHOL contact your doctor, pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.