pravastatin (Oral route)

prav-a-STAT-in

Commonly used brand name(s):

In the U.S.

• Pravachol

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: HMG-COA Reductase Inhibitor

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Uses For pravastatin

Pravastatin is used together with proper diet to treat high cholesterol levels in the blood. Using pravastatin may help prevent medical problems caused by such substances clogging the blood vessels. pravastatin may also be used to prevent certain types of heart problems in patients with risk factors for heart problems .

Pravastatin belongs to the group of medicines called 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. It works by blocking an enzyme that is needed by the body to make cholesterol, thereby reducing the amount of cholesterol in the blood .

Pravastatin is available only with your doctor's prescription .

Importance of Diet

Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed .

Before Using pravastatin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pravastatin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pravastatin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Pravastatin is safe to use in children and adolescents (8 to 18 years of age) for treating certain types of high cholesterol. Safety and efficacy in children younger than 8 years of age have not been established .

Adolescent girls taking pravastatin should be counseled on appropriate contraceptive methods .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of pravastatin in the elderly .

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using pravastatin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bezafibrate
• Ciprofibrate
• Clofibrate
• Colchicine
• Dalfopristin
• Fenofibrate
• Gemfibrozil
• Quinupristin

Using pravastatin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amprenavir
• Cyclosporine
• Darunavir
• Efavirenz
• Eltrombopag
• Nefazodone
• Nelfinavir
• Oat Bran
• Pectin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of pravastatin. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Liver disease, history—Use with caution. These conditions may increase the amount of pravastatin in your blood .

• Kidney disease, severe—Use with caution. pravastatin may make the condition worse .

• Liver disease, active or
• Liver enzymes, persistently high levels—pravastatin should NOT be used in these conditions. Use of pravastatin may make liver problems worse .

• Convulsions (seizures), uncontrolled or
• Electrolyte disorder, severe or
• Endocrine disorder (such as diabetes mellitus), severe or
• Infection, severe or
• Low blood pressure or
• Major surgery or trauma or
• Metabolic disorder, severe—Patients with these conditions may be at risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure .

Proper Use of pravastatin

Take pravastatin only as directed by your doctor. Do not take more or less of it, and do not take more or less often than your doctor ordered .

Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly .

Remember that pravastatin will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your cholesterol levels down .

pravastatin may be taken with or without food .

Dosing

The dose of pravastatin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pravastatin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For high cholesterol:
  • For oral dosage form (tablets):
    • Adults—At first, 40 milligrams (mg) once daily. Your doctor may adjust your dose if needed.
    • Children (14 to 18 years of age)—40 mg once a day.
    • Children (8 to 13 years of age)—20 mg once a day.
    • Children (less than 8 years of age)—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of pravastatin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using pravastatin

It is very important that your doctor check your progress at regular visits to make sure that pravastatin is working properly. Blood tests will be needed to check for unwanted effects .

Your doctor will need to check your liver before you start using pravastatin .

Do not take pravastatin if you are pregnant. Check with your doctor immediately if you think that you may be pregnant. pravastatin may cause birth defects or other problems in the baby if taken during pregnancy. Do not breastfeed while you are using pravastatin.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking pravastatin .

Do not use excessive amounts of alcohol while taking pravastatin because it can worsen the adverse effects of pravastatin on the liver .

Check with your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by unusual tiredness or fever. These may be symptoms of a muscle condition called rhabdomyolysis, which can lead to serious kidney problems .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements .

pravastatin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Difficulty in moving
• muscle or bone pain
• muscle stiffness
• pain in joints
• pain, localized

• Arm, back or jaw pain
• body aches or pain
• chest pain or discomfort
• chest tightness or heaviness
• chills
• cough
• dark-colored urine
• diarrhea
• difficult or labored breathing
• ear congestion
• fast or irregular heartbeat
• fever
• general feeling of discomfort or illness
• headache
• loss of appetite
• loss of voice
• muscle cramps or spasms
• muscular tenderness, wasting or weakness
• nasal congestion
• nausea
• runny nose
• shivering
• shortness of breath
• sore throat
• sneezing
• sweating
• swollen joints
• tightness in chest
• trouble sleeping
• unusual tiredness or weakness
• vomiting
• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Stomach pain

• Acid or sour stomach
• belching
• bloated full feeling
• blurred vision or other changes in vision
• burning while urinating
• difficult or painful urination
• difficulty having a bowel movement (stool)
• discouragement
• dizziness
• double vision
• excess air or gas in stomach or intestines
• fear, nervousness
• feeling of indigestion
• feeling sad or empty
• increased urge to urinate during the night
• irritability
• loss of interest or pleasure
• pain in the chest below the breastbone
• passing gas
• passing urine more often
• rash
• seeing double
• stomach discomfort or upset
• stuffy nose
• tiredness
• trouble concentrating
• waking to urinate at night

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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