Details for: PRIVA-PRAVASTATIN
Company: PHARMAPAR INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02445379 | PRIVA-PRAVASTATIN | PRAVASTATIN SODIUM | 10 MG | TABLET | ORAL |
02445395 | PRIVA-PRAVASTATIN | PRAVASTATIN SODIUM | 20 MG | TABLET | ORAL |
02445409 | PRIVA-PRAVASTATIN | PRAVASTATIN SODIUM | 40 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Priva-PRAVASTATIN 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
Priva-PRAVASTATIN lowers the level of cholesterol, particularly Low Density Lipoprotein (LDL) cholesterol, in the blood. Priva-PRAVASTATIN 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 Priva-PRAVASTATIN treatment. In the event of pregnancy during treatment, Priva-PRAVASTATIN should be discontinued and the physician should be informed.
- If you know that you are allergic to pravastatin or any of the non-medicinal ingredients of Priva-PRAVASTATIN.
- If you have liver disease.
- In adolescents and children since the safety of Priva-PRAVASTATIN in this age group has not been established.
What the medicinal ingredient is
pravastatin sodium
What the non-medicinal ingredients are
Anhydrous lactose, magnesium oxide, croscarmellose
sodium, microcrystalline cellulose, povidone,
crospovidone and magnesium stearate.
Along with the above non-medicinal ingredients tablets
have colouring agents too: Ferric oxide red in 10 mg,
Ferric oxide yellow in 20 mg and FD& C blue No. 1 Al.
Lake & D& C yellow No. 10 Al. Lake in 40 mg tablet
What dosage form 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 Priva-PRAVASTATIN, 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 (Pravachol®)5, rosuvastatin (Crestor®)4 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.
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.
5 Pravachol® is a registered trademark of Bristol-Meyers Squibb Company.
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.
- Priva-PRAVASTATIN should not be used by pregnant women. If you become pregnant, discontinue use immediately and discuss with your doctor.
Interactions with this medication
Priva-PRAVASTATIN 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 Priva-PRAVASTATIN.
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 Priva-PRAVASTATIN 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 Priva-PRAVASTATIN either one hour or
more before or at least four hours following the resin.
Taking them together causes lower amounts of Priva-PRAVASTATIN
in the blood, making it less effective.
If you are taking cyclosporine, your doctor may need to
adjust the dose of Priva-PRAVASTATIN.
Excessive alcohol intake should be avoided when taking
Priva-PRAVASTATIN. 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.
- Priva-PRAVASTATIN 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 Priva-PRAVASTATIN 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 Priva-PRAVASTATIN,
- 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 Priva-PRAVASTATIN (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM).
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. Priva-PRAVASTATIN may be taken without regard to meals.
Overdose
There is no specific recommended therapy for overdose with Priva-PRAVASTATIN.
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 myalgia (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 Priva-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.
Possible side effects reported with some statins: breathing
problems including persistent cough and/or shortness of
breath or fever, mood problems including depression,
problems sleeping including insomnia and nightmares and
sexual problems.
Poor memory, confusion and memory loss have also been
reported with all statins.
Priva-PRAVASTATIN can also cause abnormal blood
test results. Your doctor will decide when to perform
blood tests and will interpret the results.
Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your docto or pharmacist in all cases | Stop taking drug and seek immediate emergency medical attention |
---|---|---|---|
Rare | |||
Muscle pain that you cannot explain | ✔ | ||
Muscle tenderness or muscle weakness | ✔ | ||
Generalized weakness, especially if you do not feel well (i.e. 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 | ✔ | ||
Unknown | |||
Increased blood sugar: frequent urination, thirst and hunger | ✔ |
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 Priva-PRAVASTATIN,
contact your doctor or pharmacist.
How to store
Priva-PRAVASTATIN should be stored at room temperature (15-30°C). Protect from moisture and light.
Reporting 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, ON 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 can be found by
contacting Pharmapar Inc.
This leaflet was prepared by:
Pharmapar Inc.
100-5950, Ch. de la Côte de Liesse
Mont-Royal, Qc, H4T 1E2
Phone# (514) 731-2003; Fax: (514) 731-2004
Date of Preparation: September 1, 2015