Lovastatin 40mg Tablets
It is used to lower bad cholesterol and raise good cholesterol (HDL).It is used to lower triglycerides.It is used to slow the progress of heart disease.It is used to prevent heart attacks.It is used to prevent chest pain.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
Aug 1987
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lovastatin is a medicine called a 'statin' that helps lower high cholesterol and triglycerides 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 Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. If you are taking this medication once daily, take it with your evening meal.
It's essential to continue taking this medication as prescribed by your doctor or healthcare provider, even if you start to feel well. Do not stop taking the medication without consulting your doctor.
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 all medications in a secure location, out of the reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs in your area.
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 get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. If you are taking this medication once daily, take it with your evening meal.
It's essential to continue taking this medication as prescribed by your doctor or healthcare provider, even if you start to feel well. Do not stop taking the medication without consulting your doctor.
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 all medications in a secure location, out of the reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs in your area.
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
- Take this medication exactly as prescribed, usually once daily with your evening meal.
- Continue to follow a cholesterol-lowering diet (low in saturated fat and cholesterol) as recommended by your doctor.
- Engage in regular physical activity as advised by your healthcare provider.
- Limit alcohol consumption.
- Avoid consuming large amounts of grapefruit or grapefruit juice while taking this medication, as it can increase the risk of side effects.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg once daily with the evening meal
Dose Range:
10 - 80 mg
Condition-Specific Dosing:
initialDose:
20 mg once daily with the evening meal for most patients requiring significant LDL-C reduction. 10 mg once daily for patients requiring less aggressive reduction.
maintenanceDose:
10-80 mg once daily with the evening meal. Doses should be adjusted at intervals of 4 weeks or more.
severeHypercholesterolemia:
Initial dose of 40 mg once daily with the evening meal.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in pediatric patients. Use generally not recommended.)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
For patients with severe renal insufficiency (creatinine clearance < 30 mL/min), doses above 20 mg/day should be carefully considered and, if deemed necessary, implemented cautiously.
Dialysis:
Not specifically studied, but caution advised. Doses above 20 mg/day should be carefully considered.
Hepatic Impairment:
Mild:
Caution advised, monitor LFTs.
Moderate:
Caution advised, monitor LFTs. Contraindicated in active liver disease.
Severe:
Contraindicated in active liver disease or unexplained persistent elevations of serum transaminases.
Pharmacology
Mechanism of Action
Lovastatin is a prodrug that is hydrolyzed to its active beta-hydroxyacid form, lovastatin acid. Lovastatin acid 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 (conversion of HMG-CoA to mevalonate). This inhibition leads to a decrease in hepatic cholesterol synthesis, which in turn upregulates the expression of LDL receptors on hepatocyte surfaces, increasing the uptake and catabolism of circulating LDL-C. It also reduces VLDL and triglyceride levels and increases HDL-C.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 30% (oral, active form)
Tmax:
2-4 hours (for active metabolites)
FoodEffect:
Absorption is increased by 30% when administered with food, particularly with the evening meal. This is why it's recommended to take it with food.
Distribution:
Vd:
Not readily available, but extensively distributed to tissues.
ProteinBinding:
>95% (lovastatin acid)
CnssPenetration:
Limited (crosses blood-brain barrier to a small extent)
Elimination:
HalfLife:
Approximately 3 hours (for active metabolites)
Clearance:
Not readily available, but primarily hepatic clearance.
ExcretionRoute:
Approximately 83% via feces (biliary excretion), 10% via urine.
Unchanged:
<5% (unchanged drug in urine)
Pharmacodynamics
OnsetOfAction:
Lipid-lowering effects typically seen within 2 weeks.
PeakEffect:
Maximal therapeutic response usually achieved within 4-6 weeks.
DurationOfAction:
Effects persist as long as therapy is continued.
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, 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
Fever or chills
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 like 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 Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Back pain
Joint pain
Flu-like symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 experience any of the following symptoms, 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
Fever or chills
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 like 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 Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Back pain
Joint pain
Flu-like symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 feeling unwell) - contact your doctor immediately.
- Dark-colored urine (like tea or cola) - contact your doctor immediately.
- Yellowing of your skin or the whites of your eyes (jaundice).
- Unusual tiredness or weakness.
- Loss of appetite.
- Pain in your upper right stomach area.
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:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease or elevated liver enzymes, as this may affect your ability to take this medication.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. Certain medications, such as those used to treat hepatitis C, HIV, and infections, should not be taken with this drug. There are many other medications that may interact with this drug, so it is crucial to disclose all medications you are taking.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant, as it may harm the fetus.
If you are breastfeeding. You should not breastfeed while taking this medication, as it may pass into your breast milk and harm your baby.
This list is not exhaustive, and it is your responsibility to ensure that it is safe to take this medication with all your other medications and health conditions. To do this:
Inform your doctor and pharmacist about all your medications (prescription and OTC), natural products, vitamins, and health problems.
* Check with your doctor before starting, stopping, or changing the dose of any medication to ensure your safety while taking this drug.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease or elevated liver enzymes, as this may affect your ability to take this medication.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. Certain medications, such as those used to treat hepatitis C, HIV, and infections, should not be taken with this drug. There are many other medications that may interact with this drug, so it is crucial to disclose all medications you are taking.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant, as it may harm the fetus.
If you are breastfeeding. You should not breastfeed while taking this medication, as it may pass into your breast milk and harm your baby.
This list is not exhaustive, and it is your responsibility to ensure that it is safe to take this medication with all your other medications and health conditions. To do this:
Inform your doctor and pharmacist about all your medications (prescription and OTC), natural products, vitamins, and health problems.
* Check with your doctor before starting, stopping, or changing the dose of any medication to ensure your safety while taking this drug.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have diabetes (high blood sugar), you will need to closely monitor your blood sugar levels. Regular blood tests should be performed as directed by your doctor, and you should discuss the results with them. Adhere to the diet and exercise plan recommended by your doctor. Do not exceed the prescribed dosage, as taking more than directed may increase the risk of severe side effects. Avoid consuming grapefruit and grapefruit juice while taking this medication. Before consuming alcohol, consult with your doctor. If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. This drug can cause harm to an unborn baby, so if you may become pregnant, it is crucial to use birth control while taking this medication. If you become pregnant, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported with lovastatin. The most likely symptoms would be an exaggeration of known side effects, such as muscle pain or liver enzyme elevations.
What to Do:
In case of overdose, call your poison control center at 1-800-222-1222. Treatment should be symptomatic and supportive. Hemodialysis is unlikely to be beneficial due to high protein binding.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, cobicistat)
- Gemfibrozil
- Cyclosporine
- Danazol
Major Interactions
- Amiodarone (max lovastatin 40 mg/day)
- Verapamil (max lovastatin 20 mg/day)
- Diltiazem (max lovastatin 20 mg/day)
- Grapefruit juice (large quantities, >1 quart/day)
- Colchicine (increased risk of myopathy/rhabdomyolysis)
- Niacin (lipid-lowering doses, e.g., >1 g/day) - increased risk of myopathy/rhabdomyolysis
- Other fibrates (e.g., fenofibrate) - increased risk of myopathy/rhabdomyolysis
Moderate Interactions
- Warfarin (monitor INR, may potentiate anticoagulant effect)
- Rifampin (may decrease lovastatin levels)
- Digoxin (may slightly increase digoxin levels)
Minor Interactions
- Not typically listed for statins in this detail, but general caution with other drugs metabolized by CYP3A4.
Monitoring
Baseline Monitoring
Fasting Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and assess the need for therapy.
Timing: Prior to initiation of therapy.
Liver Function Tests (ALT, AST)
Rationale: To establish baseline liver enzyme levels and rule out active liver disease.
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).
Timing: Prior to initiation of therapy (optional, but recommended in high-risk patients).
Routine Monitoring
Fasting Lipid Panel
Frequency: 4-6 weeks after initiation or dose adjustment, then every 6-12 months or as clinically indicated.
Target: Individualized based on patient risk factors and treatment goals (e.g., LDL-C < 100 mg/dL or < 70 mg/dL for very high risk).
Action Threshold: If lipid goals not met, consider dose adjustment or alternative therapy. If lipid levels are excessively low, consider dose reduction.
Liver Function Tests (ALT, AST)
Frequency: Periodically (e.g., 6-12 months) or as clinically indicated. More frequent monitoring may be needed if dose is increased or if symptoms suggest liver injury.
Target: Within normal limits.
Action Threshold: If persistent elevations >3 times the upper limit of normal (ULN), discontinue therapy. If elevations are 1-3 times ULN, continue with caution and monitor more frequently.
Creatine Kinase (CK)
Frequency: Not routinely recommended unless muscle symptoms (pain, tenderness, weakness) develop.
Target: Within normal limits.
Action Threshold: If CK levels are significantly elevated (>10 times ULN) or if muscle symptoms are severe, discontinue therapy immediately. If CK is elevated but <10 times ULN and symptoms are mild, consider temporary discontinuation or dose reduction and re-evaluation.
Symptom Monitoring
- Unexplained muscle pain, tenderness, or weakness (especially if accompanied by malaise or fever)
- Dark-colored urine (suggestive of rhabdomyolysis)
- Yellowing of skin or eyes (jaundice)
- Unusual fatigue or weakness
- Loss of appetite
- Upper right abdominal pain
Special Patient Groups
Pregnancy
Contraindicated. Lovastatin can cause fetal harm when administered to a pregnant woman. Cholesterol and its derivatives are essential for fetal development.
Trimester-Specific Risks:
First Trimester:
High risk of teratogenicity due to essential role of cholesterol in early fetal development.
Second Trimester:
High risk of fetal harm.
Third Trimester:
High risk of fetal harm.
Lactation
Contraindicated. It is not known whether lovastatin is excreted in human milk. However, because of the potential for serious adverse reactions in nursing infants, women taking lovastatin should not breastfeed.
Infant Risk:
High risk (potential for serious adverse reactions, including interference with infant lipid metabolism).
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.
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 caution should be exercised. No specific dose adjustment is required based solely on age.
Clinical Information
Clinical Pearls
- Always advise patients to take lovastatin with the evening meal, as food enhances absorption and cholesterol synthesis is highest at night.
- Emphasize the importance of reporting any unexplained muscle pain, tenderness, or weakness immediately, as this could be a sign of rhabdomyolysis.
- Strongly caution patients against consuming large amounts of grapefruit or grapefruit juice due to the risk of increased lovastatin levels and adverse effects.
- Remind patients that statin therapy is an adjunct to, not a substitute for, lifestyle modifications (diet, exercise, weight management).
- Ensure baseline and periodic monitoring of liver function tests, especially if symptoms of liver injury develop.
Alternative Therapies
- Other HMG-CoA Reductase Inhibitors (Statins): Atorvastatin, Simvastatin, Pravastatin, Rosuvastatin, Fluvastatin, Pitavastatin
- Cholesterol Absorption Inhibitors: Ezetimibe
- PCSK9 Inhibitors: Alirocumab, Evolocumab
- Fibrates: Fenofibrate, Gemfibrozil (note: gemfibrozil is contraindicated with lovastatin)
- Bile Acid Sequestrants: Cholestyramine, Colestipol, Colesevelam
- Niacin (Nicotinic Acid)
- Omega-3 Fatty Acid Esters
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (40mg generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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.