Pravastatin 40mg 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 Agents
Pharmacologic Class
HMG-CoA Reductase Inhibitors (Statins)
Pregnancy Category
Category X
FDA Approved
Oct 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Pravastatin is a medicine called a 'statin' that helps lower high cholesterol levels in your blood. High cholesterol can lead to heart disease and strokes. This medicine works by reducing the amount of 'bad' cholesterol (LDL) your body makes and increasing the 'good' cholesterol (HDL).
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 adhere to your doctor's or healthcare provider's guidance to ensure the medication works effectively.
Storing and Disposing of Your Medication
Store your medication 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 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 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 adhere to your doctor's or healthcare provider's guidance to ensure the medication works effectively.
Storing and Disposing of Your Medication
Store your medication 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 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 the missed one.
Lifestyle & Tips
- Continue a cholesterol-lowering diet (low in saturated fat and cholesterol) as recommended by your doctor.
- Engage in regular physical activity or exercise.
- Maintain a healthy weight.
- Avoid excessive alcohol consumption.
- Quit smoking.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
40 mg orally once daily, typically at bedtime.
Dose Range:
10 - 80 mg
Condition-Specific Dosing:
primaryHypercholesterolemia:
Initial 10-20 mg once daily; usual range 10-80 mg once daily. 40 mg is a common maintenance dose.
primaryPreventionOfCoronaryEvents:
40 mg once daily.
secondaryPreventionOfCoronaryEvents:
40 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for routine use. For heterozygous familial hypercholesterolemia (HeFH) in patients 8-13 years: 10-20 mg once daily.
Adolescent:
For heterozygous familial hypercholesterolemia (HeFH) in patients 14-18 years: 10-40 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, but monitor.
Moderate:
Initial 10 mg once daily; titrate carefully. Max 20 mg/day for severe impairment.
Severe:
Initial 10 mg once daily; titrate carefully. Max 20 mg/day.
Dialysis:
Initial 10 mg once daily; titrate carefully. Administer after dialysis.
Hepatic Impairment:
Mild:
No specific adjustment needed, but monitor LFTs.
Moderate:
Initial 10 mg once daily; titrate carefully. Use with caution.
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, an enzyme that catalyzes the early, rate-limiting step in cholesterol biosynthesis (the conversion of HMG-CoA to mevalonate). This inhibition leads to a decrease in hepatic cholesterol synthesis, which in turn upregulates LDL receptors on hepatocyte surfaces, increasing the uptake and catabolism of circulating LDL-C. It also inhibits hepatic production of VLDL-C.
Pharmacokinetics
Absorption:
Bioavailability:
~17%
Tmax:
1-1.5 hours
FoodEffect:
Food decreases bioavailability but does not significantly affect the lipid-lowering efficacy.
Distribution:
Vd:
~0.5 L/kg
ProteinBinding:
~50%
CnssPenetration:
Limited
Elimination:
HalfLife:
1.5-2 hours
Clearance:
Not available (primarily hepatic clearance)
ExcretionRoute:
Approximately 20% renal, 70% fecal/biliary
Unchanged:
~20% (renal)
Pharmacodynamics
OnsetOfAction:
Within 1 week (lipid-lowering effects)
PeakEffect:
4 weeks (maximal lipid-lowering effects)
DurationOfAction:
24 hours (allows once-daily dosing)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention 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 help 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
Difficulty urinating or changes in urine output
Muscle pain, tenderness, or weakness, especially if you have low thyroid function, kidney problems, or are taking certain other medications, or are 65 or older. In rare cases, severe muscle problems can lead to kidney problems, and even death. If you experience abnormal muscle pain, tenderness, or weakness (with or without fever or feeling unwell), contact your doctor immediately.
If muscle problems persist after your doctor has instructed you to stop taking this medication, seek medical attention right away.
Liver Problems
Drugs similar to this one have been associated with liver problems, which can be fatal. If you experience any of the following symptoms, contact your doctor immediately:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Other Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. 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
Symptoms 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 medical help 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
Difficulty urinating or changes in urine output
Muscle pain, tenderness, or weakness, especially if you have low thyroid function, kidney problems, or are taking certain other medications, or are 65 or older. In rare cases, severe muscle problems can lead to kidney problems, and even death. If you experience abnormal muscle pain, tenderness, or weakness (with or without fever or feeling unwell), contact your doctor immediately.
If muscle problems persist after your doctor has instructed you to stop taking this medication, seek medical attention right away.
Liver Problems
Drugs similar to this one have been associated with liver problems, which can be fatal. If you experience any of the following symptoms, contact your doctor immediately:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Other Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. 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
Symptoms 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)
- Dark-colored urine
- Unusual fatigue or weakness
- Loss of appetite
- Upper right abdominal pain
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 may be pregnant, as this medication may pose risks to the 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 disclose all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
As well as any health problems you have, to avoid potential interactions. Your doctor and pharmacist will help you determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change 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. 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 may be pregnant, as this medication may pose risks to the 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 disclose all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
As well as any health problems you have, to avoid potential interactions. Your doctor and pharmacist will help you determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change 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, adhere to the diet and exercise plan recommended by your doctor. It is crucial to take this medication exactly as prescribed by your doctor. Do not exceed the recommended dosage, as this may increase your risk of experiencing severe side effects.
If you have diabetes, it is vital to closely monitor your blood sugar levels while taking this medication. When taking cholestyramine or colestipol, administer these medications at least 4 hours before or 1 hour after taking this drug to ensure optimal absorption.
To minimize potential risks, limit your alcohol consumption to no more than 2 drinks per day. Excessive alcohol consumption may increase your risk of developing 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 potential, discuss birth control options with your doctor to prevent pregnancy while taking this medication. Your doctor will help you determine the best course of action to ensure your safety and the effectiveness of the treatment.
To maximize the benefits of this medication, adhere to the diet and exercise plan recommended by your doctor. It is crucial to take this medication exactly as prescribed by your doctor. Do not exceed the recommended dosage, as this may increase your risk of experiencing severe side effects.
If you have diabetes, it is vital to closely monitor your blood sugar levels while taking this medication. When taking cholestyramine or colestipol, administer these medications at least 4 hours before or 1 hour after taking this drug to ensure optimal absorption.
To minimize potential risks, limit your alcohol consumption to no more than 2 drinks per day. Excessive alcohol consumption may increase your risk of developing 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 potential, discuss birth control options with your doctor to prevent pregnancy while taking this medication. Your doctor will help you determine the best course of action to ensure your safety and the effectiveness of the treatment.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported. The most likely 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 for pravastatin overdose. Treatment should be symptomatic and supportive. Contact a poison control center immediately (e.g., Call 1-800-222-1222 in the US).
Drug Interactions
Contraindicated Interactions
- Gemfibrozil (increased risk of myopathy/rhabdomyolysis)
Major Interactions
- Cyclosporine (significantly increases pravastatin exposure, increased risk of myopathy/rhabdomyolysis)
- Colchicine (increased risk of myopathy/rhabdomyolysis)
- Fibrates (other than gemfibrozil, e.g., fenofibrate - increased risk of myopathy/rhabdomyolysis, use with caution)
Moderate Interactions
- Niacin (lipid-lowering doses, increased risk of myopathy/rhabdomyolysis)
- Macrolide antibiotics (e.g., clarithromycin, erythromycin - less significant than with other statins, but monitor for myopathy)
- Azole antifungals (e.g., fluconazole, itraconazole - less significant than with other statins, but monitor for myopathy)
- Rifampin (may decrease pravastatin levels, monitor lipid response)
Minor Interactions
- Bile acid sequestrants (e.g., cholestyramine, colestipol - administer pravastatin 1 hour before or 4 hours after)
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 with predisposing factors for myopathy (e.g., renal impairment, hypothyroidism, genetic muscle disorders, history of statin-induced myopathy).
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.
Target: Individualized based on patient risk factors and guidelines (e.g., LDL-C reduction goals).
Action Threshold: If lipid goals not met, consider dose titration or alternative therapy. If lipid levels are excessively low, consider dose reduction.
Liver Function Tests (ALT, AST)
Frequency: Not routinely recommended unless clinically indicated (e.g., symptoms suggestive of liver injury).
Target: Within normal limits.
Action Threshold: If persistent elevations >3 times the upper limit of normal (ULN), discontinue pravastatin. If elevations are <3x ULN, monitor closely.
Creatine Kinase (CK)
Frequency: Not routinely recommended unless patient develops muscle symptoms.
Target: Within normal limits.
Action Threshold: If CK levels are significantly elevated (>10 times ULN) or if muscle symptoms are severe, discontinue pravastatin immediately. If CK levels are elevated but <10 times ULN and symptoms are mild, monitor closely or consider temporary discontinuation.
Symptom Monitoring
- Unexplained muscle pain
- Muscle tenderness
- Muscle weakness
- Dark urine (suggestive of rhabdomyolysis)
- Unusual fatigue
- Yellowing of skin or eyes (jaundice)
- Abdominal pain
- Loss of appetite
Special Patient Groups
Pregnancy
Pravastatin is contraindicated in pregnancy (Pregnancy Category X). It can cause fetal harm by interfering with cholesterol synthesis, which is essential for fetal development.
Trimester-Specific Risks:
First Trimester:
Risk of major congenital malformations due to interference with cholesterol synthesis.
Second Trimester:
Continued risk of developmental abnormalities.
Third Trimester:
Continued risk of developmental abnormalities.
Lactation
Pravastatin is contraindicated during breastfeeding (Lactation Risk L5). It is unknown if pravastatin is excreted in human milk, but other statins are. Due to the potential for serious adverse reactions in the nursing infant, breastfeeding is not recommended.
Infant Risk:
High risk; potential for serious adverse effects due to interference with lipid metabolism.
Pediatric Use
Use is limited to specific conditions like heterozygous familial hypercholesterolemia (HeFH) in children aged 8 years and older. Dosing is age-dependent and should be carefully monitored by a specialist. Safety and efficacy in children younger than 8 years have not been established.
Geriatric Use
No specific dose adjustment is required based on age alone. However, elderly patients may be at increased risk for myopathy and should be monitored closely for adverse effects. Use with caution in patients with multiple comorbidities or polypharmacy.
Clinical Information
Clinical Pearls
- Pravastatin is a hydrophilic (water-soluble) statin, which may contribute to its lower potential for certain drug interactions (less reliance on CYP450 enzymes) and potentially lower incidence of CNS-related side effects compared to lipophilic statins (e.g., simvastatin, atorvastatin).
- While often taken at bedtime, pravastatin's relatively longer half-life means it can be taken at any time of day, though consistency is key.
- Unlike some other statins, pravastatin is not extensively metabolized by CYP3A4, reducing the risk of interactions with strong CYP3A4 inhibitors (e.g., grapefruit juice, certain antifungals, macrolides).
- Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately, as these could be signs of myopathy or rhabdomyolysis.
- Lifestyle modifications (diet, exercise) are crucial adjuncts to statin therapy and should be emphasized.
Alternative Therapies
- Other HMG-CoA Reductase Inhibitors (Statins): Atorvastatin, Rosuvastatin, Simvastatin, Lovastatin, Fluvastatin, Pitavastatin
- Cholesterol Absorption Inhibitors: Ezetimibe
- PCSK9 Inhibitors: Alirocumab, Evolocumab
- Bile Acid Sequestrants: Cholestyramine, Colestipol, Colesevelam
- Fibrates: Fenofibrate, Gemfibrozil (used for high triglycerides, but also affect cholesterol)
- Niacin (Nicotinic Acid)
- Adenosine Triphosphate-Citrate Lyase (ACL) Inhibitors: Bempedoic Acid
- Selective Peroxisome Proliferator-Activated Receptor Alpha (PPARΞ±) Modulators: Fenofibric Acid
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (generic 40mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.