Lovastatin 20mg 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 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 disease, heart attacks, and strokes.
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're 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. Don't stop taking it without consulting your doctor first.
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, don't 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 explore local 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. Avoid taking two doses at the same time or taking extra doses to make up for a 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're 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. Don't stop taking it without consulting your doctor first.
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, don't 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 explore local 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. Avoid taking two doses at the same time or taking extra doses to make up for a 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:
Initial: 20 mg once daily with the evening meal. Maintenance: 10-80 mg once daily with the evening meal.
Dose Range:
10 - 80 mg
Condition-Specific Dosing:
hypercholesterolemia:
Initial: 20 mg once daily with the evening meal. Range: 10-80 mg once daily.
homozygous_familial_hypercholesterolemia:
40 mg once daily with the evening meal, or 80 mg once daily in divided doses (40 mg twice daily).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for routine use. For heterozygous familial hypercholesterolemia in patients 10-17 years: Initial 10 mg once daily with evening meal, max 40 mg/day.
Adolescent:
For heterozygous familial hypercholesterolemia in patients 10-17 years: Initial 10 mg once daily with evening meal, max 40 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
Creatinine clearance < 30 mL/min: Doses > 20 mg/day should be carefully considered and implemented only if clinically necessary and with careful monitoring.
Dialysis:
No specific recommendations, but use with caution and monitor closely due to potential for increased exposure.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
Use with caution. Contraindicated in active liver disease or unexplained persistent elevations of serum transaminases.
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-hydroxy acid form. This active metabolite competitively inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme that catalyzes the 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 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 can increase HDL-C.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 30% (active metabolite)
Tmax:
2-4 hours (active metabolite)
FoodEffect:
Absorption is increased by 30% when taken with food, particularly the evening meal. This is why it's recommended to take it with the evening meal.
Distribution:
Vd:
Not readily available, but extensively distributed to tissues.
ProteinBinding:
>95%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3 hours (active metabolite)
Clearance:
Not readily available, but primarily hepatic.
ExcretionRoute:
Feces (approximately 83%), urine (approximately 10%)
Unchanged:
Less than 5% (active metabolite)
Pharmacodynamics
OnsetOfAction:
Within 2 weeks
PeakEffect:
4-6 weeks
DurationOfAction:
Maintained with continued 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
Fever or chills
Difficulty urinating or changes in urine output
Muscle pain, tenderness, or weakness, especially if you have a history of low thyroid function, kidney problems, or are taking certain medications, or are 65 or older. In rare cases, severe muscle problems can lead to kidney issues, 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: A Rare but Serious Side Effect
Drugs like this one have been associated with liver problems, which can be fatal. If you notice 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. 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
Reporting 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
Fever or chills
Difficulty urinating or changes in urine output
Muscle pain, tenderness, or weakness, especially if you have a history of low thyroid function, kidney problems, or are taking certain medications, or are 65 or older. In rare cases, severe muscle problems can lead to kidney issues, 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: A Rare but Serious Side Effect
Drugs like this one have been associated with liver problems, which can be fatal. If you notice 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. 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
Reporting 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 malaise (flu-like symptoms). Report these immediately.
- Dark-colored urine.
- Yellowing of the skin or eyes (jaundice).
- Unusual fatigue or weakness.
- Loss of appetite.
- Upper stomach pain.
- Nausea or vomiting.
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 the symptoms that occurred.
If you have liver disease or elevated liver enzymes, as this may affect the safety and efficacy of the 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 unborn baby.
* If you are breastfeeding. Do 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 crucial to inform your doctor and pharmacist about all your medications, health problems, and concerns. Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety.
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 the symptoms that occurred.
If you have liver disease or elevated liver enzymes, as this may affect the safety and efficacy of the 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 unborn baby.
* If you are breastfeeding. Do 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 crucial to inform your doctor and pharmacist about all your medications, health problems, and concerns. Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety.
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), it is crucial 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 to ensure optimal management of your condition.
To minimize the risk of severe side effects, do not exceed the prescribed dosage. Taking more than the recommended amount may increase your chances of experiencing adverse effects. Additionally, avoid consuming grapefruit and grapefruit juice while taking this medication. If you plan to drink alcohol, consult with your doctor beforehand to discuss any potential risks.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. It is also important to note that this drug may pose a risk to an unborn baby. If you are of childbearing potential, use effective birth control methods while taking this medication. If you become pregnant or suspect you may be pregnant, contact your doctor immediately to discuss the best course of action.
To minimize the risk of severe side effects, do not exceed the prescribed dosage. Taking more than the recommended amount may increase your chances of experiencing adverse effects. Additionally, avoid consuming grapefruit and grapefruit juice while taking this medication. If you plan to drink alcohol, consult with your doctor beforehand to discuss any potential risks.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. It is also important to note that this drug may pose a risk to an unborn baby. If you are of childbearing potential, use effective birth control methods while taking this medication. If you become pregnant or suspect you may be pregnant, contact your doctor immediately to discuss the best course of action.
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:
In case of suspected overdose, contact a poison control center or emergency medical services immediately. Call 1-800-222-1222 for the Poison Control Center. Treatment is generally supportive, with monitoring of liver function and CK levels.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, cobicistat-containing products)
- Gemfibrozil
- Cyclosporine
- Danazol
Major Interactions
- Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil, amiodarone, dronedarone, ranolazine)
- Colchicine (increased risk of myopathy/rhabdomyolysis)
- Fusidic acid (increased risk of myopathy/rhabdomyolysis)
- Niacin (lipid-lowering doses âĨ1 g/day, increased risk of myopathy/rhabdomyolysis)
- Other fibrates (e.g., fenofibrate, increased risk of myopathy/rhabdomyolysis)
- Warfarin (may enhance anticoagulant effect)
Moderate Interactions
- Grapefruit juice (large quantities, >1 quart/day)
- Rifampin (CYP3A4 inducer, may decrease lovastatin levels)
- Digoxin (may increase digoxin levels)
- Oral contraceptives (may increase levels of norethindrone and ethinyl estradiol)
Minor Interactions
- Not specifically categorized as minor, but general caution with other drugs metabolized by or affecting CYP3A4.
Monitoring
Baseline Monitoring
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, as statins can cause transaminase elevations.
Timing: Prior to initiation of therapy.
Creatine Kinase (CK)
Rationale: To establish baseline in patients at increased risk for myopathy (e.g., renal impairment, hypothyroidism, genetic muscle disorders, prior statin intolerance).
Timing: Prior to initiation of therapy (if indicated).
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 and treatment goals (e.g., LDL-C reduction of 30-50% or to specific target levels).
Action Threshold: Failure to achieve target lipid levels, or if lipid levels worsen, consider dose adjustment or alternative therapy.
Liver Function Tests (ALT, AST)
Frequency: Periodically as clinically indicated. Routine periodic monitoring of LFTs is no longer universally recommended unless clinically indicated (e.g., symptoms suggestive of liver injury).
Target: Within normal limits or stable.
Action Threshold: Persistent elevations >3 times the upper limit of normal (ULN); discontinue therapy.
Creatine Kinase (CK)
Frequency: Not routinely monitored unless patient develops muscle symptoms.
Target: Within normal limits.
Action Threshold: Significant elevation (>10 times ULN) or if associated with muscle pain/weakness; discontinue therapy. If CK is elevated but <10x ULN and symptoms are mild, consider dose reduction or temporary interruption.
Symptom Monitoring
- Unexplained muscle pain, tenderness, or weakness (myalgia, myopathy)
- Dark urine (rhabdomyolysis)
- Fatigue
- Loss of appetite
- Upper right abdominal pain
- Nausea
- Vomiting
- Yellowing of skin or eyes (jaundice)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. 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 fetal development.
Second Trimester:
Continued risk of fetal harm.
Third Trimester:
Continued risk of fetal harm.
Lactation
Contraindicated during breastfeeding. It is unknown if lovastatin is excreted in human milk, but other statins are. Due to the potential for serious adverse reactions in nursing infants, women taking lovastatin should not breastfeed.
Infant Risk:
L5 (Contraindicated) - Potential for serious adverse effects in the infant, including interference with lipid metabolism.
Pediatric Use
Use is generally limited to specific conditions like heterozygous familial hypercholesterolemia in adolescents (10-17 years) where diet and other non-pharmacological measures are insufficient. Dosing is lower than adults, and careful monitoring is required. Not established for use in children younger than 10 years.
Geriatric Use
No specific dose adjustment is required based on age alone. However, older patients may be at increased risk for myopathy and other adverse effects, especially if they have comorbidities or are on multiple medications. Monitor closely for adverse reactions.
Clinical Information
Clinical Pearls
- Always advise patients to take lovastatin with the evening meal, as food enhances its 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 myopathy or rhabdomyolysis.
- Counsel patients to avoid large quantities of grapefruit juice due to the risk of increased lovastatin levels and side effects.
- Lovastatin is a prodrug; it needs to be metabolized to its active form.
- Regular monitoring of lipid levels is crucial to assess treatment efficacy, and LFTs should be checked at baseline and if clinically indicated (e.g., symptoms of liver injury).
- Ensure a thorough medication history is taken to identify potential drug interactions, especially with strong and moderate CYP3A4 inhibitors.
Alternative Therapies
- Other HMG-CoA reductase inhibitors (statins): Atorvastatin, Rosuvastatin, Simvastatin, Pravastatin, Fluvastatin, Pitavastatin
- Ezetimibe (cholesterol absorption inhibitor)
- PCSK9 inhibitors (e.g., evolocumab, alirocumab)
- Fibrates (e.g., fenofibrate, gemfibrozil - primarily for triglycerides)
- Niacin (nicotinic acid - for various lipid abnormalities)
- Bile acid sequestrants (e.g., cholestyramine, colesevelam)
- Omega-3 fatty acid ethyl esters (for severe hypertriglyceridemia)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (20mg 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 is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with a separate patient information leaflet, so it's a good idea to check with your pharmacist for more information. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.