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Medications Lexicon

How does this medication work? What will it do for me?

Pravastatin belongs to the family of medications known as HMG CoA reductase inhibitors ("statins"). It is used in addition to diet and exercise to lower high cholesterol levels. Pravastatin works by blocking an enzyme that is needed to make cholesterol in the liver. Therefore, less cholesterol is made and levels of cholesterol in the blood decrease. Lowering cholesterol levels in the blood has been shown to reduce the risks associated with heart disease, such as heart attack.

Pravastatin can be used to reduce the risk of death, heart attacks, stroke, and angioplasty for people with heart disease and normal to moderately-high cholesterol. It is also used to reduce the risk of heart attacks, angioplasty and death for people with high cholesterol who do not already have heart disease.

The medication usually takes about 4 weeks to have a significant effect on cholesterol levels in your blood. After this time, your doctor will likely send you for a lab test to check for changes in your cholesterol levels.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

Before starting pravastatin, you should be on a cholesterol-lowering diet. If appropriate, a program of weight control and physical exercise should be implemented.

The recommended starting dose of pravastatin is 20 mg daily, taken with or without food in a single dose at bedtime. Your doctor will do blood tests to tell how well this dose is working for you and may gradually increase the dose to get the desired response. The maximum recommended dose for adults is 80 mg taken once daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

For best results in lowering your cholesterol, it is very important that you closely follow the diet suggested by your doctor. It is also very important that you take pravastatin exactly as prescribed by your doctor.

If you miss a dose of this medication, take it as soon as you remember and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

10 mg
Each pink-to-peach, rounded, rectangular, biconvex, compressed tablet, engraved "N" on one side and "10" on the other side, contains pravastatin 10 mg. Nonmedicinal ingredients: calcium phosphate dibasic anhydrous, croscarmellose sodium, crospovidone, ferric oxide red, lactose anhydrous, microcrystalline cellulose, povidone, and sodium stearyl fumarate.

20 mg
Each yellow, rounded, rectangular-shaped, biconvex, compressed tablet, engraved "N" on one side and "20" on the other side, contains pravastatin 20 mg. Nonmedicinal ingredients: calcium phosphate dibasic anhydrous, croscarmellose sodium, crospovidone, ferric oxide yellow, lactose anhydrous, microcrystalline cellulose, povidone, and sodium stearyl fumarate.

40 mg
Each green, rounded, rectangular, biconvex, compressed tablet, engraved "N" on one side and "40" on the other side, contains pravastatin 40 mg. Nonmedicinal ingredients: calcium phosphate dibasic anhydrous, D&C Yellow No. 10 Aluminum Lake 18%-24%, FD&C Blue No. 1 Aluminum Lake 11%-13%, croscarmellose sodium, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone, and sodium stearyl fumarate.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to pravastatin or any ingredients of this medication
  • are breast-feeding
  • are pregnant or plan to become pregnant
  • have active liver disease or unexplained increases in liver function tests

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • diarrhea
  • dizziness
  • fatigue
  • headache
  • heartburn
  • rash

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • confusion
  • memory loss
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • symptoms of liver problems (such as yellow skin or eyes, abdominal pain, dark urine, clay-coloured stools, loss of appetite, nausea and vomiting, or itching)
  • symptoms of muscle damage (unexplained muscle pain, tenderness or weakness, or brown or discoloured urine – especially if you also have a fever or a general feeling of being unwell)

Stop taking the medication and seek medical attention immediately if any of the following occur:

  • severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
  • symptoms of a serious allergic reaction (such as swelling of the face or throat, hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

January 24, 2013

Health Canada has issued new restrictions concerning the use of pravastatin. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Alcohol: People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking this medication.

Diabetes: Pravastatin may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Diet: Pravastatin is not intended to be used alone to reduce high cholesterol levels. It is important that a cholesterol-reducing diet along with appropriate exercise be attempted before taking any medication and continued while taking medication.

Grapefruit Juice: Tell your pharmacist or doctor if you regularly drink grapefruit juice, because grapefruit juice may interact with pravastatin.

Kidney problems: If you have decreased kidney function or a history of kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Pravastatin may reduce liver function and can cause liver failure. Laboratory signs of harmful effects to the liver occur in about 0.5% of adults who take pravastatin for extended periods. When the medication is stopped, the laboratory tests usually slowly return to normal.

Your doctor may want to test your liver function regularly with blood tests while you are taking this medication. This medication should not be used by people with active liver disease or by people whose liver function tests are higher than normal. If you have a history of liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Muscle effects: In rare cases, serious muscle damage been associated with the use of statin medications (i.e., cholesterol-lowering medications whose names end in "-statin," such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, or simvastatin), especially at higher doses. Before taking this medication, tell your doctor or pharmacist if you:

  • are over the age of 70
  • are taking other medications, including prescription, non-prescription and natural health products, as drug interactions are possible
  • are taking other cholesterol-lowering medication such as fibrates (gemfibrozil, fenofibrate) or niacin
  • do excessive physical exercise
  • have diabetes
  • have a family history of muscular disorders
  • have kidney or liver problems
  • have thyroid problems
  • have undergone surgery or other tissue injury
  • have had any past problems with the muscles (pain, tenderness), after using a statin
  • regularly drink three or more alcoholic drinks daily

Report any unexplained muscle pain, tenderness, weakness, cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, stop taking it immediately and contact your doctor.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking pravastatin, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: There is limited experience with the use of this medication by children. The safety and effectiveness of using this medication have not been established for children under 16 years of age.

Seniors: If you are older than 65 years of age, you will probably need to have regular liver tests while you are taking this medication.

What other drugs could interact with this medication?

There may be an interaction between pravastatin and any of the following:

  • amiodarone
  • antifungal medications (e.g., ketoconazole, itraconazole)
  • aripiprazole
  • boceprevir
  • carbamazepine
  • carvedilol
  • cholestyramine
  • cimetidine
  • colestipol
  • colchicine
  • cyclosporine
  • dexamethasone
  • digoxin
  • efavirenz
  • fibrates (e.g., bezafibrate, gemfibrozil, fenofibrate)
  • fosphenytoin
  • grapefruit juice
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • mefloquine
  • nefazodone
  • niacin (nicotinic acid)
  • niacinamide
  • paroxetine
  • pazopanib
  • phenytoin
  • pimozide
  • propranolol
  • proton pump inhibitors (PPIs; e.g., lansoprazole, omeprazole, pantoprazole)
  • protease inhibitors (e.g., darunavir, nelfinavir, saquinavir)
  • quinidine
  • quinine
  • rifabutin
  • rifampin
  • rifamycin
  • tacrolimus
  • tamoxifen
  • trabectedin
  • trazodone
  • verapamil
  • vinblastine
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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