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Pravachol (pravastatin) belongs to a group of drugs called HMG CoA reductase inhibitors, or "statins."
Pravachol is used together with diet to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL), to increase levels of "good" cholesterol (high-density lipoprotein, or HDL), and to lower triglycerides (a type of fat in the blood).
Pravachol is also used to lower the risk of stroke, heart attack, and other heart complications in people with or without coronary heart disease or other risk factors.
Pravachol is used in adults and children who are at least 8 years old.
You should not take Pravachol if you are pregnant or breastfeeding, or if you have liver disease.
Stop taking Pravachol and tell your doctor right away if you become pregnant.
Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.
Pravastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark urine.
Avoid eating foods that are high in fat or cholesterol. Pravachol will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.
Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.
Pravachol is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.
You should not use Pravachol if you are allergic to pravastatin, or if you have:
liver disease; or
if you are pregnant or breastfeeding.
To make sure Pravachol is safe for you, tell your doctor if you have:
kidney disease;
abnormal liver function tests;
a thyroid disorder; or
if you drink more than 2 alcoholic beverages daily.
Pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).
This medicine can harm an unborn baby or cause birth defects. Do not use if you are pregnant. Stop taking Pravachol and tell your doctor right away if you become pregnant. Use effective birth control to prevent pregnancy while you are taking this medicine.
Pravastatin can pass into breast milk and may harm a nursing baby. Do not breastfeed while using this medicine.
Take Pravachol exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Pravachol is usually taken once a day, with or without food. Take the medicine at the same time each day.
Pravastatin doses are based on age, and are lower in children and teenagers. People taking this medicine during childhood or adolescence may need a different dose as adults.
You may need to stop using Pravachol for a short time if you have:
uncontrolled seizures;
an electrolyte imbalance (such as high or low potassium levels in your blood);
severely low blood pressure;
a severe infection or illness; or
surgery or a medical emergency.
While using Pravachol, you may need frequent blood tests.
Pravastatin is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.
Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.
Usual Adult Dose of Pravachol for Hyperlipidemia:
Initial dose: 40 mg once daily.
Maintenance dose: 40 to 80 mg once daily.
Usual Adult Dose for Myocardial Infarction -- Prophylaxis:
Initial dose: 40 mg once daily.
Maintenance dose: 40 to 80 mg once daily.
Usual Adult Dose for Revascularization Procedures -- Prophylaxis:
Initial dose: 40 mg once daily.
Maintenance dose: 40 to 80 mg once daily.
Usual Adult Dose of Pravachol for Ischemic Stroke -- Prophylaxis:
Initial dose: 40 mg once daily.
Maintenance dose: 40 to 80 mg once daily.
Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia:
8 to 13 years: 20 mg orally once daily
14 to 18 years: 40 mg orally once daily
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
If you also take cholestyramine or colestipol, avoid taking them within 1 hour after or 4 hours before you take Pravachol.
Avoid eating foods that are high in fat or cholesterol. Pravachol will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.
Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.
Grapefruit may interact with pravastatin and lead to unwanted side effects. Avoid the use of grapefruit products.
Get emergency medical help if you have signs of an allergic reaction to Pravachol: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure.
Call your doctor at once if you have:
unexplained muscle pain, tenderness, or weakness;
fever, unusual tiredness;
dark colored urine;
chest pain;
upper stomach pain, loss of appetite; or
jaundice (yellowing of the skin or eyes).
Common Pravachol side effects may include:
muscle or joint pain;
nausea, vomiting, diarrhea;
headache; or
cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If you take cholestyramine or colestipol, take your pravastatin dose 1 hours before or 4 hours after you take the other medicine.
Using certain other drugs together with Pravachol can increase your risk of serious muscle problems. It is very important to tell your doctor about all medicines you use, and those you start or stop using during your treatment, especially:
colchicine;
cyclosporine;
erythromycin;
gemfibrozil, fenofibric acid, fenofibrate; or
medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others) or nicotinic acid.
This list is not complete. Other drugs may interact with pravastatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Pravachol only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Pravachol (www.drugs.com/pravachol.html).
Note: This document contains side effect information about pravastatin. Some of the dosage forms listed on this page may not apply to the brand name Pravachol.
More frequent side effects include: increased serum alanine aminotransferase, skin rash, and increased creatine phosphokinase in blood specimen. See below for a comprehensive list of adverse effects.
Applies to pravastatin: oral tablet
Along with its needed effects, pravastatin (the active ingredient contained in Pravachol) 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 while taking pravastatin:
More common
Less common
Some side effects of pravastatin 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
Less common
Applies to pravastatin: oral tablet
The most frequently reported side effects were musculoskeletal pain, nausea/vomiting, upper respiratory tract infection, diarrhea, and headache.
Very common (10% or more): Musculoskeletal pain (up to 24.9%), musculoskeletal traumatism (10.2%)
Common (1% to 10%): Myalgia, muscle cramp, arthralgia
Uncommon (0.1% to 1%): Muscle weakness
Postmarketing reports: Myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, lupus erythematosus-like syndrome, polymyalgia rheumatica, arthritis, myositis, polymyositis, tendon disorder
Very common (10% or more): Nausea/vomiting (up to 10.5%)
Common (1% to 10%): Diarrhea, flatulence, dyspepsia/heartburn, abdominal distension, constipation
Uncommon (0.1% to 1%): Abdominal pain
Postmarketing reports: Pancreatitis
Very common (10% or more): Chest pain (up to 10%)
Common (1% to 10%): Fatigue, influenza, creatinine phosphokinase increased, edema, fever, weight gain, weight loss, viral infection
Uncommon (0.1% to 1%): Edema, weakness, hearing loss, tinnitus
Frequency not reported: Head/neck edema, vertigo
Postmarketing reports: Chills, asthenia
Common (1% to 10%): ALT increased, GGT increased, AST increased
Postmarketing reports: Hepatitis, chronic active hepatitis, cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, fatal hepatic failure, nonfatal hepatic failure, liver function test abnormalities
Common (1% to 10%): Headache, dizziness, paresthesia
Uncommon (0.1% to 1%): Numbness
Frequency not reported: Memory impairment, neuropathy/peripheral neuropathy, taste disturbance
Postmarketing reports: Intraocular movement impaired, facial paresis, peripheral nerve palsy, cognitive impairment, forgetfulness, amnesia
Very common (10% or more): Upper respiratory tract infection (up to 21.2%)
Common (1% to 10%): Pharyngitis, rhinitis, cough, pulmonary infection, sinus abnormality/sinusitis, tracheobronchitis, dyspnea
Frequency not reported: Interstitial lung disease
Common (1% to 10%): Rash, dermatitis
Uncommon (0.1% to 1%): Pruritus, urticaria, scalp/hair abnormality, alopecia
Postmarketing reports: Skin discoloration, skin nodules, dry mucous membranes, changes to hair/nails, angioedema, dermatomyositis, purpura, photosensitivity, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome
Common (1% to 10%): Angina pectoris
Uncommon (0.1% to 1%): Disturbance of rhythm, hypertension, myocardial infarction
Frequency not reported: Flushing
Postmarketing reports: Vasculitis
Common (1% to 10%): Blurred vision, diplopia
Uncommon (0.1% to 1%): Eye inflammation, lens opacity
Common (1% to 10%): Sleep disturbance, anxiety/nervousness, depression
Uncommon (0.1% to 1%): Insomnia
Frequency not reported: Libido change
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Dysuria, urinary frequency, nocturia, sexual dysfunction
Postmarketing reports: Thyroid function abnormalities, gynecomastia
Postmarketing reports: Hemolytic anemia, erythrocyte sedimentation rate increased, transient asymptomatic eosinophilia
Frequency not reported: Allergic/hypersensitivity reaction
Postmarketing reports: Anaphylaxis, positive antinuclear antibodies
Postmarketing reports: Hepatoma
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Pravachol (www.drugs.com/pravachol.html).
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