Patient Medication Information: uses, side effects, how to take - Pravastatin Tablets
ABOUT THIS MEDICATION
What the medication is used for:
Pravastatin Tablets 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:
Pravastatin Tablets lowers the level of cholesterol, particularly Low Density Lipoprotein (LDL) cholesterol, in the blood. Pravastatin Tablets 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:
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 Pravastatin Tablets treatment. In the event of pregnancy during treatment, Pravastatin Tablets should be discontinued and the physician should be informed.
If you know that you are allergic to pravastatin sodium
or any of the non-medicinal ingredients of Pravastatin Tablets (please refer section “What the important non-medicinal ingredients are:”)
- If you have liver disease.
In adolescents and children since the safety of
Pravastatin Tablets in this age group has not been established.
What the medicinal ingredient is:
pravastatin sodium
What the important non-medicinal ingredients are:
D & C yellow no. 10 aluminum lake, FD & C blue no.1 aluminum lake, ferric oxide (red), ferric oxide (yellow), lactose anhydrous and sodium stearyl fumarate.
What dosage forms it comes in:
10 mg, 20 mg 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 Pravastatin Tablets, 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.
- 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 (Pravacho1®)4, rosuvastatin (Crestor®)5, or simvastatin (Zocor®)3, or have developed an allergy or intolerance to them,
- have kidney or liver problems,
- diabetes,
- have undergone surgery or other tissue injury,
- do excessive physical exercise.
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.
- Pravastatin Tablets should not be used by pregnant women. If you become pregnant, discontinue use immediately and discuss with your doctor.
1 Lipitor® is a registered trade-mark of Pfizer Ireland Pharmaceuticals 2 Lescol® is a registered trade-mark of Sandoz Canada Inc.
3 Mevacor® and Zocor® are registered trade-marks of Merck and Co., Inc. 4 Pravachol® is a registered trade-mark of Bristol-Myers Squibb Canada 5 Crestor® is a registered trade-mark of IPR Pharmaceuticals, Inc.
INTERACTIONS WITH THIS MEDICATION
Pravastatin Tablets 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 Pravastatin Tablets.
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 Pravastatin Tablets 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 Pravastatin Tablets either one hour or more before or at least four hours following the resin. Taking them together causes lower amounts of Pravastatin Tablets in the blood making it less effective.
If you are taking cyclosporine, your doctor may need to adjust the dose of Pravastatin Tablets.
Excessive alcohol intake should be avoided when taking Pravastatin Tablets. Tell your doctor if you regularly drink three or more alcoholic drinks daily.
Pravastatin sodium may increase creatine phosphokinase and transaminase levels. If you are being treated for chest pain, tell your doctor that you are taking Pravastatin Tablets.
PROPER USE OF THIS MEDICATION
- Do not change the dose unless directed by a doctor
Pravastatin Tablets 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 Pravastatin Tablets 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 Pravastatin Tablets.
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 Pravastatin Tablets (see SIDE EFFECTS).
Usual dose:
The recommended starting dose is 20 mg once daily at bed time. Patients who require a large dose reduction in LDL-C 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. Pravastatin Tablets may be taken without regard to meals.
Overdose:
There is no specific recommended therapy for overdose with Pravastatin Tablets.
In case of overdose, contact your doctor immediately or go to the nearest hospital emergency room.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Along with its intended action, any medication may cause unwanted effects.
Check with your physician as soon as possible if any of the following side effects occurs: aching muscles, muscle cramping, tiredness or weakness, fever and blurred vision.
Muscle effects
Side effects such as myelgia (muscle pain), myopathy (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 pravastatin.
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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Rare |
discloured urine. | 9 9 9 9 | ||
Other side effects may occasionally occur which usually do not require stopping treatment. They may come and go during treatment without any particular danger, but you should mention them to your physician, without undue delay, if they become persistent or bothersome. Such adverse experiences include abdominal pain, constipation, diarrhea, nausea, headache, dizziness and skin rashes.
This is not a complete list of side effects. For any unexpected effects while taking Pravastatin Tablets, contact your doctor or pharmacist.
HOW TO STORE IT
Pravastatin Tablets should be stored at room temperature (15-30°C). Protect from moisture and light.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
Last prepared: August 17, 2009