Pravastatin (Sanis Health): Uses, Side Effects and Dosage

What PRAVASTATIN is used for:

PRAVASTATIN (pravastatin sodium) is used along with a change in diet to lower the level of cholesterol in adults and:

• for the long-term treatment of hypercholesterolemia and is not a substitute for such a diet. Help treat high cholesterol over a long period of time.
• lower the risk of having a first or second heart attack or stroke. To decrease the chances of experiencing a first or second heart attack, or stroke.
• to help prevent heart disease caused by cholesterol clogging the blood vessels, or slow the hardening of the arteries that bring blood to your heart [called coronary heart disease (CHD)].

In addition, depending on your condition, your healthcare professional may recommend exercise, weight control and other measures.

How PRAVASTATIN works:

PRAVASTATIN belongs to a class of medicines known as “statins”, more specifically called HMG-CoA reductase inhibitors. Statins block an enzyme called HMG-CoA reductase from being made in your liver, which is involved in the production of cholesterol in your body. Statins are used along with changes to diet and exercise to help control the amount of cholesterol produced by the body. PRAVASTATIN lowers the level of cholesterol, particularly Low Density Lipoprotein (LDL) cholesterol, in the blood. PRAVASTATIN reduces cholesterol production by the liver and induces some changes of cholesterol transport and disposition in the blood and tissues.

PRAVASTATIN can help your body:

• decrease LDL (bad) cholesterol and triglyceride levels.
• increase HDL (good) cholesterol levels.
• decrease the Total Cholesterol/HDL-Cholesterol Ratio (TC: HDL-C Ratio). The ratio represents the balance between good and bad cholesterol.

If levels of bad cholesterol are too high, they can cause the gradual build-up of cholesterol called plaque on the walls of the blood vessels. Over time, this plaque can build up so much that it narrows the arteries. Narrow arteries can slow or block blood flow to vital organs like the heart and brain. Blocked blood flow can result in a heart attack or stroke. By reducing bad cholesterol levels, PRAVASTATIN reduces the risk of heart attack or stroke in adults who have risk factors, and reduces their risk of undergoing a serious medical procedure to treat severely blocked arteries due to plaque buildup.

The ingredients in PRAVASTATIN are:

Medicinal ingredient: Pravastatin sodium.

Non-medicinal ingredients: Croscarmellose sodium, lactose monohydrate (Spray-Dried), magnesium stearate and microcrystalline cellulose (PH 102).

Colourants are present in the tablets as follows:

• 10 mg tablet: ferric oxide red (Orange Shade #34690)
• 20 mg tablet: ferric oxide yellow
• 40 mg tablet: brilliant blue FCF aluminum lake 12% and D&C yellow #10 aluminum lake 14-18%

PRAVASTATIN comes in the following dosage forms:

Tablets: 10 mg, 20 mg and 40 mg.

Do not use PRAVASTATIN if:

• you are allergic to pravastatin or any of the non-medicinal ingredients of PRAVASTATIN.
• you are pregnant, think you might be pregnant or thinking of becoming pregnant.
• you are breast-feeding.
• You have liver disease or unexplained increases in liver enzymes.
• you are less than 16 years of age. The safety of PRAVASTATIN in this age group has not been established.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PRAVASTATIN. Talk about any health conditions or problems you may have, including if you:

• have previously taken any cholesterol-lowering medicines in the past.
• have a genetic condition where high blood cholesterol is inherited from one or two of the parents (homozygous or heterozygous familial hypercholesterolemia).
• have high blood sugar or diabetes, or are at risk for diabetes.

• have risk factors for muscle problems. This includes if you:

  • have had or have a family history of muscular disorders.
  • had any past problems with muscles (pain, tenderness) after using statins such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin or simvastatin or have developed an allergy or intolerance to them.
  • currently take fibrates (such as gemfibrozil, fenofibrate fenofibrate, other fibrates) or niacin (nicotinic acid) (used to lower fat levels in the blood).
  • have thyroid problems.

  • suffer from alcohol abuse, or drink three or more alcoholic drinks daily

  • do excessive physical exercise.
  • are above 65 years of age.
  • have or have had past problems with your liver.
  • have kidney problems.
  • have diabetes accompanied with excess fat build-up in your liver.
  • had surgery or other tissue injury.
  • have a condition that causes weakness or frailty.
  • have any conditions or take any medicines that may increase the level of PRAVASTATIN in the blood. Talk to your healthcare professional if you are unsure.
• have heart problems.
• have or have had myasthenia gravis (a disease causing general muscle weakness including the eye muscles and in some cases, muscles used for breathing) as statins may lead to occurrence of myasthenia or aggravate the condition,
• have kidney or liver problems,
• have diabetes,
• have undergone surgery or other tissue injury,

• are lactose intolerant or have one of the following rare hereditary diseases:

  • Galactose intolerance
  • Lapp lactase deficiency
  • Glucose-galactose malabsorption

Because lactose is a non-medicinal ingredient in PRAVASTATIN.

Other warnings you should know about:

PRAVASTATIN can cause serious side effects, including:

• Hyperglycemia (high blood sugar):

  • This may lead to the development of diabetes.
  • Your healthcare professional will monitor your blood sugar level regularly.
  • If you have diabetes, closely monitor your blood sugar while taking PRAVASTATIN and report any unusual results to your healthcare professional.

• Muscle disorders such as:

  • Myalgia (muscle pain)
  • Rhabdomyolysis (breakdown of damaged muscle)
  • Immune-Mediated Necrotizing Myopathy (IMNM) (a type of autoimmune disease that causes muscle cell death)

Tell your healthcare professional right away if you have any muscle pain, tenderness, soreness or weakness while taking PRAVASTATIN.

See the Serious side effects and what to do about them table for more information on these and other serious side effects.

Pregnancy:

• PRAVASTATIN should not be taken during pregnancy. It could harm an unborn baby. Your healthcare professional will discuss the potential risks with you.
• If you are a woman who could become pregnant, your healthcare professional will ask you to use a highly effective birth control method while taking PRAVASTATIN.
• If you discover that you are pregnant while taking PRAVASTATIN, stop taking the medicine and contact your healthcare professional as soon as possible.

Breast-feeding: It is not known whether PRAVASTATIN can pass into breast milk and harm a breastfed baby. As such, PRAVASTATIN is not recommended during breastfeeding. Talk to your healthcare professional about ways to feed your baby while taking PRAVASTATIN.

Check-ups and testing: Your healthcare professional may do blood tests before you start PRAVASTATIN and during your treatment. These tests will check:

• the level of CoQ10 (an antioxidant) in your blood.
• the amount of sugar (glucose) in your blood.
• that your liver or muscles are working properly.
• the amount of cholesterol and other fats in your blood.

Depending on your test results, your healthcare professional may adjust your dose, temporarily stop or discontinue your treatment with PRAVASTATIN.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with PRAVASTATIN:

• medicines used to reduce stomach acid such as cimetidine (used to treat heartburn and stomach or intestinal ulcers).
• medicines used to lower blood cholesterol. These include other statins (e.g., atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin), fibrates (e.g., gemfibrozil, fenofibrate, bezafibrate), niacin (nicotinic acid), cholestyramine or colestipol.
• digoxin, used to treat heart problems.
• medicines used to treat bacterial infections, such as erythromycin.
• macrolides, antibiotics like azithromycin or clarithromycin.
• medicines used to lower blood pressure such as propranolol.
• medicines used to treat fungal infections such as ketoconazole.
• cyclosporine, used to prevent organ transplant rejection.

How to take PRAVASTATIN:

Your healthcare professional prescribed this medicine only for you. Do not give your medicine to anyone else because it may harm them, even if their symptoms are the same as yours.

• Take PRAVASTATIN exactly as your healthcare professional tells you to keep taking it even if you feel well.
• Do not change the dose unless directed by a healthcare professional.
• PRAVASTATIN should be taken as a single dose at bedtime, as prescribed by your healthcare professional.
• Your healthcare professional 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 healthcare professional about any illness which may develop during your treatment with PRAVASTATIN and about any new prescription or non-prescription medication you may take. If you require medical help for other reasons, inform the attending healthcare professional that you are taking PRAVASTATIN.
• Notify your healthcare professional if you are going to have major surgery or have sustained a severe injury.
• Notify your healthcare professional of any muscle pain, tenderness or weakness developing during treatment with PRAVASTATIN.

Usual dose:

The dose of PRAVASTATIN prescribed to you will depend on your medical condition and your blood cholesterol level.

Adults:

• 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 is usually prescribed for patients who do not achieve their treatment goal with lower doses.
• PRAVASTATIN may be taken without regard to meals.

Overdose:

If you think you, or a person you are caring for, have taken too much PRAVASTATIN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you missed a dose of this medication, take it as soon as you remember. But if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule. Do not take two doses at the same time.

Possible side effects from using PRAVASTATIN:

These are not all the possible side effects you may have when taking PRAVASTATIN. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• memory loss or confusion
• loss of appetite
• nausea / vomiting
• abdominal pain
• diarrhea or constipation
• indigestion or heartburn
• fatigue
• headache, dizziness
• skin rashes, itchy skin, dry skin
• persistent cough
• common cold, runny nose
• influenza (flu) symptoms such as fever, chills, coughing, sore throat or stuffy nose
• shortness of breath
• trouble sleeping or falling asleep
• insomnia
• nightmares
• muscle aches and pain
• joint pain, inflammation
• numbness of hands and feet
• sexual problems
• impotence (inability to get or keep an erection)
• breast growth in males
• burning, stinging or itching when urinating
• urinating too much at night
• depression, anxiety, nervousness
• weight gain

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

PRAVASTATIN should be stored at room temperature 15°C to 30°C.

Protect from moisture and light.

Keep out of reach and sight of children.

If you want more information about PRAVASTATIN:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website https://sanis.com/products; or by calling 1-866-236-4076.