Pravastatin 10mg 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, HMG-CoA reductase inhibitor
Pharmacologic Class
HMG-CoA reductase inhibitor (statin)
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 cholesterol your body makes. 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 feel well. It's essential to follow your doctor's or healthcare provider's advice on dosage and duration of treatment.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep the lid tightly closed and store all medications in a secure location, out of the reach of children and pets.
What to Do If You Miss 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 the 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 feel well. It's essential to follow your doctor's or healthcare provider's advice on dosage and duration of treatment.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep the lid tightly closed and store all medications in a secure location, out of the reach of children and pets.
What to Do If You Miss 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 the missed one.
Lifestyle & Tips
- Maintain a cholesterol-lowering diet (low in saturated and trans fats, cholesterol).
- Engage in regular physical activity as recommended by your doctor.
- Achieve and maintain a healthy weight.
- Quit smoking.
- Limit alcohol consumption.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 10-20 mg once daily, usually at bedtime. Max: 80 mg once daily.
Dose Range:
10 - 80 mg
Condition-Specific Dosing:
primaryHypercholesterolemia:
Initial: 10-20 mg once daily. Maintenance: 10-80 mg once daily.
secondaryPreventionOfCardiovascularEvents:
Initial: 40 mg once daily.
heterozygousFamilialHypercholesterolemia:
Initial: 10-20 mg once daily. Maintenance: 10-80 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
8-13 years (Heterozygous Familial Hypercholesterolemia): Initial 10 mg once daily. Max 20 mg once daily.
Adolescent:
14-17 years (Heterozygous Familial Hypercholesterolemia): Initial 10 mg once daily. Max 40 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed.
Moderate:
Consider initial dose of 10 mg once daily if CrCl < 60 mL/min/1.73mΒ².
Severe:
Consider initial dose of 10 mg once daily if CrCl < 30 mL/min/1.73mΒ².
Dialysis:
No specific dose adjustment needed; Pravastatin is not significantly removed by hemodialysis. Administer after dialysis.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
Use with caution; consider lower initial doses (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 reduces hepatic cholesterol synthesis, leading to an upregulation of LDL receptors on hepatocyte surfaces, which increases the uptake and catabolism of circulating LDL-C. It also inhibits VLDL production.
Pharmacokinetics
Absorption:
Bioavailability:
34% (absolute)
Tmax:
1-1.5 hours
FoodEffect:
Food decreases bioavailability but not clinical efficacy; can be taken with or without food.
Distribution:
Vd:
0.47 L/kg
ProteinBinding:
50%
CnssPenetration:
Limited
Elimination:
HalfLife:
1.8-2.6 hours
Clearance:
Not available
ExcretionRoute:
Fecal (70%), Renal (20%)
Unchanged:
20% (renal), 7% (fecal)
Pharmacodynamics
OnsetOfAction:
Within 1 week (lipid-lowering effects)
PeakEffect:
4 weeks (maximal lipid-lowering effects)
DurationOfAction:
24 hours (due to once-daily dosing)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediate medical attention:
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 or changes in urine output
Muscle-Related Side Effects
This medication may cause muscle pain, tenderness, or weakness, especially if you have low thyroid function, kidney problems, or are taking certain other medications. Your risk may also be higher if you are 65 or older. In rare cases, severe muscle problems can lead to kidney damage, and even death. 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 your doctor has instructed you to stop taking this medication
Liver-Related Side Effects
Drugs like this one have been associated with liver problems, which can be fatal. Seek medical help right away if you notice:
Dark urine
Tiredness
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you're bothered by or experience any of the following:
Headache
Dizziness, tiredness, or weakness
Diarrhea, upset stomach, or vomiting
Signs of a common cold
Reporting Side Effects
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 immediate medical attention:
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 or changes in urine output
Muscle-Related Side Effects
This medication may cause muscle pain, tenderness, or weakness, especially if you have low thyroid function, kidney problems, or are taking certain other medications. Your risk may also be higher if you are 65 or older. In rare cases, severe muscle problems can lead to kidney damage, and even death. 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 your doctor has instructed you to stop taking this medication
Liver-Related Side Effects
Drugs like this one have been associated with liver problems, which can be fatal. Seek medical help right away if you notice:
Dark urine
Tiredness
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you're bothered by or experience any of the following:
Headache
Dizziness, tiredness, or weakness
Diarrhea, upset stomach, or vomiting
Signs of a common cold
Reporting Side Effects
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.
- Yellowing of the skin or eyes (jaundice).
- Unusual tiredness or weakness.
- Loss of appetite, stomach pain, nausea, or vomiting.
- Swelling in your hands or feet.
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. Be sure to describe the allergic reaction you experienced.
If you have liver disease or elevated liver enzymes, as this may affect how your body processes the medication.
If you are taking gemfibrozil, as this can interact with the medication.
If you are pregnant or think you might be pregnant, as this medication may harm an unborn baby. Your doctor will help you weigh the benefits and risks of taking this medication during pregnancy.
If you are breastfeeding, as you should not breastfeed while taking this medication.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes:
All prescription medications you are currently taking
Over-the-counter medications, such as pain relievers or antihistamines
Natural products, including herbal supplements or vitamins
* Any health problems you have, as they may interact with the medication
Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety. This list is not exhaustive, and your doctor and pharmacist need to be aware of all your medications and health conditions to provide the best possible care.
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. Be sure to describe the allergic reaction you experienced.
If you have liver disease or elevated liver enzymes, as this may affect how your body processes the medication.
If you are taking gemfibrozil, as this can interact with the medication.
If you are pregnant or think you might be pregnant, as this medication may harm an unborn baby. Your doctor will help you weigh the benefits and risks of taking this medication during pregnancy.
If you are breastfeeding, as you should not breastfeed while taking this medication.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes:
All prescription medications you are currently taking
Over-the-counter medications, such as pain relievers or antihistamines
Natural products, including herbal supplements or vitamins
* Any health problems you have, as they may interact with the medication
Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety. This list is not exhaustive, and your doctor and pharmacist need to be aware of all your medications and health conditions to provide the best possible care.
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 avoid any potential interactions.
To minimize the risk of liver disease, it is recommended that you 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, you may need to use birth control to prevent pregnancy while taking this medication. It is essential to discuss this with your doctor to determine the best course of action.
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 avoid any potential interactions.
To minimize the risk of liver disease, it is recommended that you 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, you may need to use birth control to prevent pregnancy while taking this medication. It is essential to discuss this with your doctor to determine the best course of action.
Overdose Information
Overdose Symptoms:
- No specific symptoms reported for pravastatin overdose in humans. The most likely adverse effects would be an exaggeration of known side effects, such as muscle pain or liver enzyme elevations.
What to Do:
There is no specific antidote. Treatment should be symptomatic and supportive. Monitor liver function and CK levels. Contact a poison control center immediately (e.g., 1-800-222-1222 in the US).
Drug Interactions
Contraindicated Interactions
- Gemfibrozil (increased risk of myopathy/rhabdomyolysis)
- Cyclosporine (high doses of pravastatin, increased risk of myopathy/rhabdomyolysis)
Major Interactions
- Fibrates (e.g., fenofibrate): Increased risk of myopathy/rhabdomyolysis. Use with caution, consider lower pravastatin dose.
- Niacin (lipid-lowering doses β₯1 g/day): Increased risk of myopathy/rhabdomyolysis. Use with caution.
- Colchicine: Increased risk of myopathy/rhabdomyolysis. Use with caution.
- Cyclosporine: Increased pravastatin exposure. Limit pravastatin dose to 20 mg/day.
Moderate Interactions
- Clarithromycin, Erythromycin: May slightly increase pravastatin levels (less significant than with other statins). Monitor for myopathy.
- Diltiazem, Verapamil: May slightly increase pravastatin levels. Monitor for myopathy.
- Warfarin: May slightly increase INR. Monitor INR upon initiation or discontinuation of pravastatin.
Minor Interactions
- Antacids (magnesium/aluminum hydroxide): Decreased pravastatin absorption if taken simultaneously. Administer pravastatin 1 hour before antacids.
- Cholestyramine/Colestipol: Decreased pravastatin absorption. Administer pravastatin 1 hour before or 4 hours after bile acid sequestrants.
Monitoring
Baseline Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and assess treatment efficacy.
Timing: Before initiating therapy
Liver Function Tests (ALT, AST)
Rationale: To establish baseline liver enzyme levels and monitor for drug-induced hepatotoxicity.
Timing: Before initiating therapy
Creatine Kinase (CK)
Rationale: To establish baseline CK levels, especially in patients at increased risk for myopathy (e.g., history of muscle disorders, hypothyroidism, renal impairment, concomitant medications).
Timing: Before initiating therapy (if indicated)
Routine Monitoring
Lipid Panel
Frequency: 4-12 weeks after initiation or dose adjustment, then every 3-12 months or as clinically indicated.
Target: LDL-C reduction based on risk assessment and guideline recommendations (e.g., >50% reduction for high-intensity, 30-49% for moderate-intensity).
Action Threshold: Failure to achieve target LDL-C, or if lipid levels worsen, consider dose adjustment or alternative therapy.
Liver Function Tests (ALT, AST)
Frequency: Periodically, or if symptoms suggestive of liver injury occur. Routine monitoring is no longer universally recommended unless clinically indicated.
Target: Within normal limits.
Action Threshold: Persistent elevations >3 times the upper limit of normal (ULN); discontinue pravastatin.
Creatine Kinase (CK)
Frequency: Only if muscle symptoms (pain, tenderness, weakness) develop.
Target: Within normal limits.
Action Threshold: CK >10 times ULN, or if muscle symptoms are severe or accompanied by dark urine; discontinue pravastatin immediately. If CK is 5-10 times ULN, monitor closely and consider discontinuation.
Symptom Monitoring
- Unexplained muscle pain, tenderness, or weakness (myalgia, myopathy)
- Dark urine (rhabdomyolysis)
- Unusual fatigue or weakness
- Loss of appetite
- Upper abdominal pain
- Nausea, vomiting
- Yellowing of skin or eyes (jaundice)
Special Patient Groups
Pregnancy
Contraindicated. Statins can cause fetal harm when administered to pregnant women. Cholesterol and its derivatives are essential for fetal development.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity due to interference with cholesterol synthesis, which is critical for cell membrane formation and steroid hormone synthesis.
Second Trimester:
Continued risk of fetal harm.
Third Trimester:
Continued risk of fetal harm.
Lactation
Contraindicated. Pravastatin is excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants and the disruption of lipid metabolism, breastfeeding is not recommended.
Infant Risk:
High (L5 - Contraindicated)
Pediatric Use
Approved for use in children aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Dosing is age-dependent. Safety and efficacy in children younger than 8 years have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be at increased risk for myopathy, and renal function should be considered.
Clinical Information
Clinical Pearls
- Pravastatin is a hydrophilic statin, which may contribute to its lower potential for drug-drug interactions via CYP450 enzymes compared to lipophilic statins (e.g., simvastatin, atorvastatin).
- It is primarily eliminated via renal and biliary excretion, making it a preferred statin in patients with significant hepatic impairment (though still contraindicated in active liver disease).
- While less prone to CYP interactions, caution is still warranted with cyclosporine, fibrates, and high-dose niacin due to increased risk of myopathy.
- Administering pravastatin at bedtime is generally recommended as cholesterol synthesis is highest at night, but it can be taken at any time of day.
- Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately.
Alternative Therapies
- Other HMG-CoA reductase inhibitors (statins): Atorvastatin, Rosuvastatin, Simvastatin, Lovastatin, Fluvastatin, Pitavastatin
- PCSK9 inhibitors: Alirocumab, Evolocumab
- Cholesterol absorption inhibitors: Ezetimibe
- Bile acid sequestrants: Cholestyramine, Colestipol, Colesevelam
- Fibrates: Fenofibrate, Gemfibrozil
- Niacin (nicotinic acid)
- Adenosine triphosphate-citrate lyase (ACL) inhibitors: Bempedoic acid
- Selective peroxisome proliferator-activated receptor alpha (PPARΞ±) modulators: Pemafibrate (not FDA approved in US)
- Omega-3 fatty acid ethyl esters
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (10mg generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Preferred Generic) or Tier 2 (Non-Preferred Generic) on most formularies.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe and effective treatment, 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.