Pravastatin 80mg 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 (Statin)
Pregnancy Category
Category X
FDA Approved
Nov 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. 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. It's essential to continue taking this medication as prescribed by your doctor or healthcare provider, even if you're feeling well.
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. It's essential to continue taking this medication as prescribed by your doctor or healthcare provider, even if you're feeling well.
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
- Take this medication exactly as prescribed, usually once daily at bedtime.
- 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 pravastatin without consulting your doctor, even if you feel well.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 40 mg orally once daily at bedtime. Max: 80 mg orally once daily.
Dose Range:
10 - 80 mg
Condition-Specific Dosing:
primaryHypercholesterolemia:
Initial: 40 mg orally once daily. Max: 80 mg orally once daily.
heterozygousFamilialHypercholesterolemia:
Initial: 40 mg orally once daily. Max: 80 mg orally once daily.
homozygousFamilialHypercholesterolemia:
20 mg orally once daily (adjunct to other lipid-lowering treatments).
preventionOfCardiovascularEvents:
40 mg orally once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
8-13 years (Heterozygous Familial Hypercholesterolemia): Initial 10 mg orally once daily, max 20 mg orally once daily.
Adolescent:
14-18 years (Heterozygous Familial Hypercholesterolemia): Initial 10 mg orally once daily, max 40 mg orally once daily.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment generally needed.
Moderate:
Consider initial dose of 10 mg orally once daily, titrate carefully.
Severe:
CrCl < 30 mL/min: Consider initial dose of 10 mg orally once daily, titrate carefully. Max 20 mg/day.
Dialysis:
No specific dose adjustment for patients on dialysis, but monitor closely. Administer after dialysis.
Hepatic Impairment:
Mild:
No dose adjustment generally needed.
Moderate:
Use with caution. Contraindicated in active liver disease.
Severe:
Contraindicated in active liver disease.
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. This inhibition reduces cholesterol synthesis in the liver, leading to an upregulation of LDL receptors on hepatocyte surfaces, which increases the uptake and catabolism of circulating LDL-C. It also inhibits hepatic synthesis of VLDL-C.
Pharmacokinetics
Absorption:
Bioavailability:
17% (absolute)
Tmax:
1-1.5 hours
FoodEffect:
Food decreases bioavailability but does not significantly affect lipid-lowering efficacy. Can be taken with or without food.
Distribution:
Vd:
0.47 L/kg
ProteinBinding:
Approximately 50%
CnssPenetration:
Limited
Elimination:
HalfLife:
1.8-2.6 hours
Clearance:
Not available
ExcretionRoute:
Fecal (approximately 70%), Renal (approximately 20%)
Unchanged:
Approximately 20% (renal), 50% (fecal)
Pharmacodynamics
OnsetOfAction:
Within 1 week
PeakEffect:
Approximately 4 weeks
DurationOfAction:
Not applicable (daily dosing for continuous effect)
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
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
+ Experience abnormal muscle pain, tenderness, or weakness (with or without fever or feeling unwell)
+ Have muscle problems that persist after stopping the medication
Liver problems, which can be life-threatening, and may cause:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
Headache
Dizziness, tiredness, or weakness
Diarrhea, upset stomach, or vomiting
* Common cold symptoms
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
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
+ Experience abnormal muscle pain, tenderness, or weakness (with or without fever or feeling unwell)
+ Have muscle problems that persist after stopping the medication
Liver problems, which can be life-threatening, and may cause:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
Headache
Dizziness, tiredness, or weakness
Diarrhea, upset stomach, or vomiting
* Common cold symptoms
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 urine
- Severe stomach pain
- Unusual tiredness or weakness
- Loss of appetite
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 and its symptoms.
If you have liver disease or elevated liver enzymes, as this may affect the medication's safety and efficacy.
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 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 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 and its symptoms.
If you have liver disease or elevated liver enzymes, as this may affect the medication's safety and efficacy.
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 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 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, 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, administer these medications at least 4 hours before or 1 hour after taking 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 this risk.
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 the need for birth control 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, administer these medications at least 4 hours before or 1 hour after taking 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 this risk.
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 the need for birth control with your doctor to prevent pregnancy while taking this medication.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported. The most likely adverse effects would be exaggerated side effects such as muscle pain or liver enzyme elevations.
What to Do:
In case of suspected overdose, contact a poison control center immediately or seek emergency medical attention. Treatment is symptomatic and supportive. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Contraindicated Interactions
- Gemfibrozil (increased risk of myopathy/rhabdomyolysis)
Major Interactions
- Cyclosporine (significantly increases pravastatin exposure, max pravastatin 20 mg/day)
- Fibrates (e.g., fenofibrate, bezafibrate - increased risk of myopathy/rhabdomyolysis)
- Niacin (lipid-lowering doses, >1g/day - increased risk of myopathy/rhabdomyolysis)
- Colchicine (increased risk of myopathy/rhabdomyolysis, especially in renal/hepatic impairment)
- Daptomycin (increased risk of myopathy/rhabdomyolysis)
Moderate Interactions
- Clarithromycin (potential for increased pravastatin levels, monitor)
- Erythromycin (potential for increased pravastatin levels, monitor)
- Rifampin (may decrease pravastatin levels via OATP inhibition, clinical significance uncertain)
- Warfarin (monitor INR, slight increase in anticoagulant effect reported)
Minor Interactions
- Antacids (may decrease pravastatin absorption, separate administration by 2 hours)
- Grapefruit juice (minimal interaction compared to other statins, but large quantities may slightly increase levels)
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. Statins can cause transaminase elevations.
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: Individualized based on patient risk factors and guideline recommendations (e.g., LDL-C reduction goals).
Action Threshold: Failure to meet lipid goals, or unexpected lipid profile changes.
Liver Function Tests (ALT, AST)
Frequency: Routine periodic monitoring is no longer universally recommended unless clinically indicated (e.g., symptoms suggestive of liver injury).
Target: Within normal limits.
Action Threshold: Persistent elevations >3 times the upper limit of normal (ULN). Consider dose reduction or discontinuation.
Creatine Kinase (CK)
Frequency: Only if muscle symptoms (e.g., pain, tenderness, weakness) develop.
Target: Within normal limits.
Action Threshold: Significant elevation (>5-10 times ULN) or any elevation accompanied by muscle symptoms. Discontinue pravastatin if rhabdomyolysis is suspected.
Symptom Monitoring
- Unexplained muscle pain
- Muscle tenderness
- Muscle weakness
- Dark urine (cola-colored)
- Fatigue
- Yellowing of skin or eyes (jaundice)
- Abdominal pain
- Unusual tiredness
- Loss of appetite
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.
Trimester-Specific Risks:
First Trimester:
Potential for serious developmental abnormalities due to interference with cholesterol synthesis, which is critical for cell membranes 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, women taking pravastatin should not breastfeed.
Infant Risk:
High risk. Potential for disruption of lipid metabolism in the infant.
Pediatric Use
Pravastatin is approved for use in pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia. Dosing is age- and weight-dependent. Safety and efficacy in children younger than 8 years have not been established.
Geriatric Use
No overall differences in efficacy or safety have been observed between elderly and younger patients. However, elderly patients may be at increased risk for myopathy, and dose adjustments may be considered based on renal function and concomitant medications. Use with caution and monitor closely.
Clinical Information
Clinical Pearls
- Pravastatin is unique among statins for its minimal metabolism by CYP450 enzymes, reducing the risk of drug interactions with CYP inhibitors (e.g., many antifungals, macrolides, protease inhibitors).
- It is more hydrophilic than lipophilic statins (e.g., simvastatin, atorvastatin), which may contribute to lower CNS penetration and potentially a lower incidence of CNS-related side effects.
- Administer at bedtime for optimal efficacy, as cholesterol synthesis is highest at night.
- Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately.
- Liver function tests are recommended at baseline, but routine monitoring during therapy is generally not needed unless clinically indicated or symptoms of liver injury arise.
Alternative Therapies
- Other HMG-CoA Reductase Inhibitors (Statins): Atorvastatin, Rosuvastatin, Simvastatin, Lovastatin, Fluvastatin, Pitavastatin
- PCSK9 Inhibitors: Alirocumab, Evolocumab
- Cholesterol Absorption Inhibitors: Ezetimibe
- Fibrates: Fenofibrate, Gemfibrozil
- Niacin (Nicotinic Acid)
- Bile Acid Sequestrants: Cholestyramine, Colestipol, Colesevelam
- Adenosine Triphosphate-Citrate Lyase (ACL) Inhibitors: Bempedoic Acid
- Omega-3 Fatty Acid Esters: Icosapent ethyl, Omega-3-acid ethyl esters
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 80mg)
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 your 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 medication taken, the amount, and the time it happened.