Pravastatin 20mg Tablets
It is used to lower bad cholesterol, lower triglycerides, and raise good cholesterol (HDL).It is used to slow the progress of heart disease.It is used to lower the chance of heart attack, stroke, and death in some people.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antilipemic agent
Pharmacologic Class
HMG-CoA reductase inhibitor
Pregnancy Category
Category X
FDA Approved
Oct 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Pravastatin is a medication used to lower high cholesterol and triglyceride levels in your blood. It works by reducing the amount of 'bad' cholesterol (LDL) your body makes and increasing the amount of 'good' cholesterol (HDL). Lowering cholesterol can help prevent heart attacks, strokes, and other heart problems.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue taking it even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep the container tightly closed and store it in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue taking it even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep the container tightly closed and store it in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take this medication exactly as prescribed, usually once daily in the evening.
- Continue to follow a cholesterol-lowering diet (low in saturated fat and cholesterol).
- Engage in regular physical activity as recommended by your doctor.
- Maintain a healthy weight.
- Limit alcohol intake.
- Do not stop taking this medication without consulting your doctor, even if you feel well.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg orally once daily in the evening
Dose Range:
10 - 80 mg
Condition-Specific Dosing:
primaryHypercholesterolemia:
Initial: 40 mg orally once daily. Range: 10-80 mg once daily.
secondaryPreventionOfCardiovascularEvents:
40 mg orally once daily.
pediatricHeterozygousFamilialHypercholesterolemia:
Initial: 10 mg orally once daily. Max: 20 mg once daily for ages 8-13 years; 40 mg once daily for ages 14-18 years.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
8-13 years: Initial 10 mg once daily, max 20 mg once daily for heterozygous familial hypercholesterolemia.
Adolescent:
14-18 years: Initial 10 mg once daily, max 40 mg once daily for heterozygous familial hypercholesterolemia.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed.
Moderate:
Consider starting at 10 mg once daily if severe renal impairment (CrCl <30 mL/min).
Severe:
Initial 10 mg once daily, titrate cautiously. Max 20 mg once daily recommended by some guidelines.
Dialysis:
No specific dose adjustment needed for patients on dialysis, but monitor closely. Administer after dialysis.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
Use with caution. Consider lower starting dose (e.g., 10 mg once daily).
Severe:
Contraindicated in active liver disease or unexplained persistent elevations of serum transaminases.
Pharmacology
Mechanism of Action
Pravastatin is a competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis. This inhibition leads to a decrease in hepatic cholesterol synthesis, which in turn upregulates the expression of LDL receptors on hepatocyte surfaces, increasing the clearance of LDL-C from the blood. It also reduces VLDL and triglyceride levels and increases HDL-C.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 17% (oral)
Tmax:
1-1.5 hours
FoodEffect:
Food slightly decreases bioavailability but does not significantly affect lipid-lowering efficacy; can be taken with or without food.
Distribution:
Vd:
Approximately 0.47 L/kg
ProteinBinding:
Approximately 50%
CnssPenetration:
Limited
Elimination:
HalfLife:
1.5-2 hours
Clearance:
Not available
ExcretionRoute:
Feces (approximately 70%), Urine (approximately 20%)
Unchanged:
Approximately 20% (urine), 7% (feces)
Pharmacodynamics
OnsetOfAction:
Within 1 week
PeakEffect:
4 weeks (for lipid-lowering effect)
DurationOfAction:
24 hours (due to once-daily dosing)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Chest pain
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine output
Muscle pain, tenderness, or weakness, which may be more likely to occur if you:
+ Have low thyroid function
+ Have kidney problems
+ Take certain other medications
+ Are 65 years or older
Severe muscle problems can lead to kidney problems, and in rare cases, may be fatal. Contact your doctor immediately if you experience:
+ Abnormal muscle pain, tenderness, or weakness (with or without fever or feeling unwell)
+ Muscle problems that persist after stopping the medication
Liver problems, which can be fatal, have been reported with similar medications. Seek medical help right away if you experience:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Headache
Dizziness, tiredness, or weakness
Diarrhea, upset stomach, or vomiting
Common cold symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Chest pain
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine output
Muscle pain, tenderness, or weakness, which may be more likely to occur if you:
+ Have low thyroid function
+ Have kidney problems
+ Take certain other medications
+ Are 65 years or older
Severe muscle problems can lead to kidney problems, and in rare cases, may be fatal. Contact your doctor immediately if you experience:
+ Abnormal muscle pain, tenderness, or weakness (with or without fever or feeling unwell)
+ Muscle problems that persist after stopping the medication
Liver problems, which can be fatal, have been reported with similar medications. Seek medical help right away if you experience:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Headache
Dizziness, tiredness, or weakness
Diarrhea, upset stomach, or vomiting
Common cold symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine (could be signs of rhabdomyolysis).
- Yellowing of the skin or eyes (jaundice), dark urine, light-colored stools, severe stomach pain, nausea, or vomiting (could be signs of liver problems).
- Unusual tiredness or weakness.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you experienced.
Existing liver disease or elevated liver enzymes, as this may affect the medication's safety and efficacy.
Current use of gemfibrozil, as it may interact with this medication.
Pregnancy or potential pregnancy, as this medication may pose risks to the unborn baby. Your doctor will discuss the benefits and risks of using this medication during pregnancy.
* Breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. This information will help determine the safety of taking this medication with your other treatments and health conditions. Never start, stop, or modify the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you experienced.
Existing liver disease or elevated liver enzymes, as this may affect the medication's safety and efficacy.
Current use of gemfibrozil, as it may interact with this medication.
Pregnancy or potential pregnancy, as this medication may pose risks to the unborn baby. Your doctor will discuss the benefits and risks of using this medication during pregnancy.
* Breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. This information will help determine the safety of taking this medication with your other treatments and health conditions. Never start, stop, or modify the dose of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
To maximize the benefits of this medication, it is crucial to follow the diet and exercise plan recommended by your doctor. Adhering to the prescribed dosage is also vital, as taking more than the recommended amount may increase the risk of severe side effects.
If you have diabetes, it is essential to closely monitor your blood sugar levels while taking this medication. When taking cholestyramine or colestipol, ensure that you take them at least 4 hours before or 1 hour after this drug to minimize potential interactions.
To reduce the risk of liver disease, limit your alcohol consumption to no more than 2 drinks per day. Excessive alcohol consumption may increase your risk of liver disease.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Additionally, if you are of childbearing age, discuss birth control options with your doctor to prevent pregnancy while taking this medication.
To maximize the benefits of this medication, it is crucial to follow the diet and exercise plan recommended by your doctor. Adhering to the prescribed dosage is also vital, as taking more than the recommended amount may increase the risk of severe side effects.
If you have diabetes, it is essential to closely monitor your blood sugar levels while taking this medication. When taking cholestyramine or colestipol, ensure that you take them at least 4 hours before or 1 hour after this drug to minimize potential interactions.
To reduce the risk of liver disease, limit your alcohol consumption to no more than 2 drinks per day. Excessive alcohol consumption may increase your risk of liver disease.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Additionally, if you are of childbearing age, discuss birth control options with your doctor to prevent pregnancy while taking this medication.
Overdose Information
Overdose Symptoms:
- Limited data on specific overdose symptoms. Expected to be an exaggeration of known side effects, such as muscle pain or liver enzyme elevations.
What to Do:
There is no specific antidote for pravastatin overdose. Treatment should be symptomatic and supportive. Contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Gemfibrozil (increased risk of myopathy/rhabdomyolysis)
Major Interactions
- Cyclosporine (increased pravastatin exposure, increased risk of myopathy/rhabdomyolysis)
- Colchicine (increased risk of myopathy/rhabdomyolysis)
- Niacin (high dose, >1g/day) (increased risk of myopathy/rhabdomyolysis)
- Fibrates (e.g., fenofibrate) (increased risk of myopathy/rhabdomyolysis)
Moderate Interactions
- Clarithromycin (potential for increased pravastatin exposure)
- Erythromycin (potential for increased pravastatin exposure)
- Diltiazem (potential for increased pravastatin exposure)
- Verapamil (potential for increased pravastatin exposure)
- Amiodarone (increased risk of myopathy)
- Warfarin (potential for increased INR, monitor INR)
Minor Interactions
- Antacids (decreased pravastatin absorption if taken simultaneously, separate by 1 hour)
- Grapefruit juice (minimal interaction compared to other statins, but large quantities may slightly increase exposure)
Monitoring
Baseline Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and assess treatment efficacy.
Timing: Prior to initiation of therapy.
Liver Function Tests (ALT, AST)
Rationale: To establish baseline liver enzyme levels and monitor for drug-induced hepatotoxicity.
Timing: Prior to initiation of therapy.
Creatine Kinase (CK)
Rationale: To establish baseline CK levels, especially in patients at increased risk for myopathy (e.g., renal impairment, hypothyroidism, history of muscle disorders, concomitant medications).
Timing: Prior to initiation of therapy (optional, but recommended in high-risk patients).
Routine Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Frequency: 4-12 weeks after initiation or dose titration, then every 3-12 months or as clinically indicated.
Target: LDL-C reduction based on individual risk assessment and guideline recommendations (e.g., <100 mg/dL, <70 mg/dL, or specific percentage reduction).
Action Threshold: Failure to achieve target LDL-C, or unexpected lipid profile changes.
Liver Function Tests (ALT, AST)
Frequency: As clinically indicated (e.g., if symptoms of liver injury occur). Routine periodic monitoring is generally not recommended unless clinically indicated, based on current guidelines.
Target: Within normal limits.
Action Threshold: Persistent elevations >3 times the upper limit of normal (ULN). Discontinue pravastatin if persistent elevations occur.
Creatine Kinase (CK)
Frequency: As clinically indicated (e.g., if muscle pain, tenderness, or weakness occurs). Routine periodic monitoring is not recommended.
Target: Within normal limits.
Action Threshold: CK levels >10 times ULN, or significant muscle symptoms with any CK elevation. Discontinue pravastatin.
Symptom Monitoring
- Unexplained muscle pain
- Muscle tenderness
- Muscle weakness
- Malaise
- Fever
- Dark urine (suggestive of myoglobinuria)
- Unusual fatigue
- Loss of appetite
- Upper right quadrant abdominal pain
- Nausea
- Vomiting
- Yellowing of skin or eyes (jaundice)
Special Patient Groups
Pregnancy
Contraindicated. Pravastatin can cause fetal harm when administered to a pregnant woman. Cholesterol and its derivatives are essential for fetal development. Inhibition of HMG-CoA reductase could potentially cause fetal harm.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity due to interference with essential cholesterol synthesis for fetal development.
Second Trimester:
Continued risk of interference with fetal development.
Third Trimester:
Continued risk of interference with fetal development.
Lactation
Contraindicated. It is unknown whether pravastatin is excreted in human milk, but a small amount is excreted in rat milk. Because of the potential for serious adverse reactions in nursing infants, women taking pravastatin should not breastfeed.
Infant Risk:
High risk (potential for serious adverse effects due to interference with lipid metabolism).
Pediatric Use
Approved for heterozygous familial hypercholesterolemia in patients 8 years and older. Dosing varies by age group. Safety and efficacy in younger children or for other indications are not established.
Geriatric Use
No overall differences in efficacy or safety have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution, considering potential for polypharmacy and renal impairment.
Clinical Information
Clinical Pearls
- Pravastatin is unique among statins for its minimal metabolism by the CYP450 system, particularly CYP3A4. This makes it a preferred choice for patients on medications that are strong CYP3A4 inhibitors (e.g., certain antifungals, macrolides, protease inhibitors) where other statins might have significant interactions.
- Take pravastatin in the evening, as cholesterol synthesis is highest overnight.
- Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately, as this could be a sign of myopathy or rhabdomyolysis.
- Unlike some other statins, pravastatin is hydrophilic, which may contribute to its lower CNS penetration and potentially different side effect profile (e.g., less cognitive side effects, though evidence is mixed).
Alternative Therapies
- Other HMG-CoA reductase inhibitors (statins): Atorvastatin, Rosuvastatin, Simvastatin, Lovastatin, Fluvastatin, Pitavastatin.
- PCSK9 inhibitors (e.g., evolocumab, alirocumab) for severe hypercholesterolemia.
- Ezetimibe (cholesterol absorption inhibitor).
- Bile acid sequestrants (e.g., cholestyramine, colesevelam).
- Fibrates (e.g., fenofibrate, gemfibrozil) for hypertriglyceridemia.
- Niacin (nicotinic acid).
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (20mg generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic) or Tier 2 (Preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.