What Pravachol is used for and how to use it
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Pravachol - Consumer Medicine Information

Manufacture: Bristol-Myers Squibb
Country: Canada
Condition: High Cholesterol, High Cholesterol, Familial Heterozygous, Hyperlipoproteinemia Type IV, Elevated VLDL, Hyperlipoproteinemia Type III, Elevated beta-VLDL IDL, Hyperlipoproteinemia Type IIb, Elevated LDL VLDL, Hyperlipoproteinemia Type IIa, Elevated LDL, Hyperlipoproteinemia, Ischemic Stroke, Prophylaxis, Myocardial Infarction, Prophylaxis, Revascularization Procedures, Prophylaxis
Class: Statins
Form: Tablets
Ingredients: pravastatin sodium, croscarmellose sodium, D & C yellow no. 10 (40 mg tablets), FD & C blue no. 1 (40 mg tablets), lactose, magnesium oxide, magnesium stearate, microcrystalline cellulose, povidone, red ferric oxide (10 mg tablets) and yellow ferric oxide (20 mg tablets)

PRAVACHOL
pravastatin sodium

About This Medication

What the medication is used for

PRAVACHOL is available only with your physician's prescription. It is to be used as an adjunct to a medically recommended and carefully supervised diet for the long-term treatment of hypercholesterolemia and is not a substitute for such a diet. This has been shown to decrease the chances of experiencing a first or second heart attack, or stroke, and may help prevent heart disease if caused by cholesterol clogging the blood vessels, or slow the progression of atherosclerosis (hardening) of the arteries that nourish your heart, so-called coronary heart disease (CHD). In addition, depending on your condition, your physician may recommend an appropriate regimen of exercise, weight control and other measures.

What it Does

PRAVACHOL lowers the level of cholesterol, particularly Low Density Lipoprotein (LDL) cholesterol, in the blood. PRAVACHOL reduces cholesterol production by the liver and induces some changes of cholesterol transport and disposition in the blood and tissues.

When it should not be used

Do not use PRAVACHOL if you

  • are pregnant, since its use in the event of pregnancy may harm the unborn. Only female patients who are highly unlikely to conceive can be candidates for PRAVACHOL treatment. In the event of pregnancy during treatment, PRAVACHOL should be discontinued and the physician should be informed.
  • know that you are allergic to pravastatin or any of the non-medicinal ingredients of PRAVACHOL.
  • have liver disease.
  • are less than 18 years of age. The safety of PRAVACHOL in this age group has not been established.

What the medicinal ingredient is

Pravastatin sodium.

What the non-medicinal ingredients are

croscarmellose sodium, D & C yellow no. 10 (40 mg tablets), FD & C blue no. 1 (40 mg tablets), lactose, magnesium oxide, magnesium stearate, microcrystalline cellulose, povidone, red ferric oxide (10 mg tablets) and yellow ferric oxide (20 mg tablets).

What dosage forms it comes in

10, 20 and 40 mg tablets.

Warnings and Precautions

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)1 fluvastatin (Lescol)2, lovastatin (Mevacor)3, pravastatin (Pravachol*), rosuvastatin (Crestor)4 or simvastatin (Zocor)3, 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

1 Lipitor is a registered trademark of Pfizer Ireland Pharmaceuticals.

2 Lescol is a registered trademark of Sandoz Canada Inc.

3 Mevacor and Zocor are registered trademarks of Merck & Co., Inc.

4 Crestor is a registered trademark of IPR Pharmaceuticals Inc.

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 HMG-CoA reductase inhibitor (“statin”). Discuss with the doctor your risk of developing diabetes.

Interactions with this Medication

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 non-prescription, 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.

Proper Use of this Medication

  • 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 (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM).

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.

Side Effects and what to do about them

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

Serious Side Effects, how often they happen and what to do about them

Symptom / effectTalk with your doctor or pharmacistStop taking drug and seek immediate medical help
Only if severeIn all cases
Raremuscle pain that you cannot explain
muscle tenderness or muscle weakness, or muscle cramping
generalized weakness, especially if you do not feel well (ie. fever or fatigue)
brownish or discoloured urine
Symptoms of liver problems (upper belly pain, dark urine, itchy skin, nausea or vomiting, loss of appetite, pale stools, yellowing of skin or the whites of your eyes)
Cough and/or shortness of breath
Severe Skin reaction with fever, sore mouth or throat, blistering and/or peeling of your skin or mucous membranes
UncommonAllergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing
Memory
В problems: poor memory, forgetfulness, confusion, memory loss
CommonVision problems, blurred vision
UnknownIncreased Blood Sugar: Frequent urination, thirst and hunger
Chest pain

This is not a complete list of side effects. For any unexpected effects while taking PRAVACHOL, contact your doctor or pharmacist.

How to Store it

PRAVACHOL should be stored at room temperature (15-30°C). Protect from moisture and light.

Keep out of reach and sight of children.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at  

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals is available by contacting the sponsor, Bristol-Myers Squibb Canada, at:

1-866-463-6267