Pronunciation:

prav-a-STAT-in

Brand Names:

• Pravachol

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antihyperlipidemic

Pharmacologic—

HMG-COA Reductase Inhibitor

Uses of This Medicine:

Pravastatin is used together with a proper diet to lower cholesterol and triglycerides (fat) in the blood. This medicine may help prevent or slow down medical problems, like atherosclerosis (hardening of the arteries), that are caused by fats clogging the blood vessels. It may also be used to prevent certain types of heart and blood vessel problems in patients with risk factors for heart problems.

Pravastatin belongs to the group of medicines called HMG-CoA reductase inhibitors, or statins. It works by blocking an enzyme that is needed by the body to make cholesterol, so this reduces the amount of cholesterol in the blood.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pravastatin in children 8 years of age and older. However, safety and efficacy have not been established in children younger than 8 years of age.

Teenage girls taking pravastatin should be counseled on appropriate birth control methods to prevent pregnancy.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pravastatin in the elderly. However, elderly patients are more likely to have age-related muscle problems, which may require caution in patients receiving pravastatin.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine 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.

• Atazanavir
• Bempedoic Acid
• Bezafibrate
• Ciprofibrate
• Clofibrate
• Cobicistat
• Colchicine
• Colesevelam
• Cyclosporine
• Dalfopristin
• Daptomycin
• Darolutamide
• Darunavir
• Dasabuvir
• Elexacaftor
• Enasidenib
• Encorafenib
• Fenofibrate
• Fenofibric Acid
• Fusidic Acid
• Gemfibrozil
• Leniolisib
• Midostaurin
• Ombitasvir
• Paritaprevir
• Quinupristin
• Ritonavir
• Trofinetide

Using this medicine 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
• Boceprevir
• Clarithromycin
• Efavirenz
• Eltrombopag
• Fosamprenavir
• Glecaprevir
• Nefazodone
• Nelfinavir
• Oat Bran
• Pectin
• Pibrentasvir
• St John's Wort
• Voxilaprevir

Other interactions—

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or
• Liver disease, recent history—Use with caution. May cause side effects to become worse.

• Convulsions (seizures), not well-controlled or
• Electrolyte disorder, severe or
• Endocrine disorder, severe or
• Hypotension (low blood pressure) or
• Hypothyroidism (underactive thyroid), not well-controlled or
• Kidney disease, severe or
• Major surgery, recent or
• Major trauma, recent or
• Metabolic disorder, severe or
• Sepsis (infection in the blood)—Patients with these conditions may be at risk of developing muscle and kidney problems.

• Liver disease, active or
• Liver enzymes, persistently high levels—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet.

This medicine may be taken with or without food.

If you are also taking other medicines to lower your cholesterol (eg, cholestyramine, colestipol, Colestid®, Questran®), take these medicines at least 4 hours before or 1 hour after taking pravastatin.

Dosing—

The dose of this medicine 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 this medicine. 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 oral dosage form (tablets):
  • For high cholesterol:
    • Adults—At first, 40 milligrams (mg) once a day. 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 younger than 8 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride levels and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have a major surgery, a major injury, or you develop other serious health problems.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These may be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM).

Call your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Check with your doctor right away if you get a headache, stomach pain, vomiting, dark-colored urine, loss of appetite, weight loss, general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin. These could be symptoms of liver damage.

Do not drink large amounts of alcohol while taking pravastatin. This could cause liver damage.

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.

Side Effects of This Medicine:

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:

More common

Difficulty with moving

muscle or bone pain

muscle stiffness

pain in the joints

pain, localized

Less common

Arm, back, or jaw pain

chest pain, discomfort, or tightness

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

muscle cramps, spasms, tenderness, wasting, or weakness

nausea

runny or stuffy nose

shivering

sneezing

sore throat

sweating

swollen joints

trouble sleeping

unusual tiredness or weakness

vomiting

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:

More common

Stomach pain

Less common

Acid or sour stomach

belching

bloated or full feeling

blurred vision or other changes in vision

difficult or painful urination

difficulty having a bowel movement (stool)

dizziness

double vision

fear or nervousness

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

rash

stomach discomfort or upset

tiredness

trouble concentrating

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.