Lovastatin 10mg 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
Pregnancy Category
Category X
FDA Approved
Aug 1987
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lovastatin is a medicine 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 amount of 'good' cholesterol (HDL).
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions 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.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well. It's essential to complete the full course of treatment as prescribed.
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 pharmacist or healthcare provider. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore 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, follow your doctor's instructions 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.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well. It's essential to complete the full course of treatment as prescribed.
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 pharmacist or healthcare provider. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore 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 lovastatin with your evening meal, as food helps your body absorb it better.
- Continue to follow a cholesterol-lowering diet (low in saturated fat and cholesterol) as recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Maintain a healthy weight.
- Limit alcohol consumption.
- Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the levels of lovastatin in your body and 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. For patients requiring large reductions in LDL-C (>45%), 40 mg once daily may be initiated. 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 evening meal. Range: 10-80 mg once daily.
homozygousFamilialHypercholesterolemia:
40 mg once daily with evening meal, or 80 mg/day in two divided doses (40 mg in morning, 40 mg in evening).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 10 years of age. For heterozygous familial hypercholesterolemia in adolescent patients (10-17 years): Initial 10 mg once daily with evening meal. Max 40 mg once daily.
Adolescent:
Initial 10 mg once daily with evening meal. Max 40 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
CrCl < 30 mL/min: Doses above 20 mg/day should be carefully considered and, if deemed necessary, implemented cautiously.
Dialysis:
Not dialyzable. Dosing considerations as per severe renal impairment.
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
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-hydroxyacid form. This active metabolite 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. Inhibition of this enzyme reduces cholesterol synthesis in the liver, which in turn upregulates LDL receptors on hepatocyte surfaces, leading to increased clearance of LDL-C from the blood. It also reduces hepatic production of VLDL-C.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 30% (active metabolite)
Tmax:
2-4 hours (active metabolite)
FoodEffect:
Absorption is increased by 30% when administered with food, particularly 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, primarily hepatic clearance.
ExcretionRoute:
Feces (83%), Urine (10%)
Unchanged:
Less than 5% (urine)
Pharmacodynamics
OnsetOfAction:
Within 2 weeks
PeakEffect:
4-6 weeks
DurationOfAction:
Maintained with continued dosing
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help 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 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
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine output
Muscle pain, tenderness, or weakness, especially if you:
+ Have low thyroid function
+ Have kidney problems
+ Take certain other medications
+ Are 65 or older
Severe muscle problems can lead to kidney problems, and in rare cases, 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 stopping the medication
Liver problems, which can be life-threatening, may occur with this medication. Seek medical help right away if you experience:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. 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
Back pain
Joint pain
Flu-like symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 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
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine output
Muscle pain, tenderness, or weakness, especially if you:
+ Have low thyroid function
+ Have kidney problems
+ Take certain other medications
+ Are 65 or older
Severe muscle problems can lead to kidney problems, and in rare cases, 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 stopping the medication
Liver problems, which can be life-threatening, may occur with this medication. Seek medical help right away if you experience:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. 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
Back pain
Joint pain
Flu-like symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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:
- Muscle pain, tenderness, or weakness, especially if accompanied by fever or feeling unwell. This could be a sign of a serious muscle problem (rhabdomyolysis).
- Dark-colored urine (like tea or cola).
- 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.
- 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 symptoms you experienced.
If you have liver disease or elevated liver enzymes.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. Specifically, certain drugs used to treat hepatitis C, HIV, infections, and other conditions should not be taken with this medication.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
* If you are breastfeeding. You should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe use. Before starting, stopping, or changing the dose of any medication, consult with your doctor to verify that it is safe to do so in conjunction with this medication.
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 symptoms you experienced.
If you have liver disease or elevated liver enzymes.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. Specifically, certain drugs used to treat hepatitis C, HIV, infections, and other conditions should not be taken with this medication.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
* If you are breastfeeding. You should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe use. Before starting, stopping, or changing the dose of any medication, consult with your doctor to verify that it is safe to do so in conjunction with this medication.
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. As directed by your doctor, have your blood work checked regularly and discuss the results with your doctor. 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 dosage prescribed by your doctor. 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. This drug may also pose a risk to an unborn baby. If you are of childbearing age, it is crucial to use birth control while taking this medication to prevent pregnancy. If you become pregnant, notify your doctor immediately to discuss the best course of action.
To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. 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. This drug may also pose a risk to an unborn baby. If you are of childbearing age, it is crucial to use birth control while taking this medication to prevent pregnancy. If you become pregnant, notify your doctor immediately to discuss the best course of action.
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 suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive, as lovastatin is highly protein-bound and not significantly removed by hemodialysis.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, cobicistat)
- Gemfibrozil
- Cyclosporine
- Danazol (high doses)
- Amiodarone (doses > 20 mg lovastatin)
- Verapamil (doses > 20 mg lovastatin)
- Diltiazem (doses > 20 mg lovastatin)
- Grapefruit juice (large quantities)
Major Interactions
- Other fibrates (e.g., fenofibrate) - increased risk of myopathy/rhabdomyolysis
- Niacin (lipid-lowering doses âĨ1 g/day) - increased risk of myopathy/rhabdomyolysis
- Colchicine - increased risk of myopathy/rhabdomyolysis
- Warfarin - enhanced anticoagulant effect (monitor INR)
- Ranolazine - increased lovastatin exposure
- Daptomycin - increased risk of myopathy/rhabdomyolysis (consider temporary discontinuation of statin)
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., fluconazole, verapamil, diltiazem, amiodarone, dronedarone, ranolazine) - dose limitation for lovastatin
- Amlodipine - dose limitation for lovastatin
- Ticagrelor - increased lovastatin exposure
- Oral contraceptives - increased estrogen levels
Minor Interactions
- Digoxin - slight increase in digoxin levels (monitor)
- Antacids - may decrease lovastatin absorption (separate administration)
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 pre-existing liver disease, as statins can cause transaminase elevations.
Timing: Prior to initiation of therapy.
Creatine Kinase (CK)
Rationale: To establish baseline levels, especially in patients with predisposing factors for myopathy (e.g., renal impairment, hypothyroidism, history of muscle toxicity with other lipid-lowering agents).
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: 4-6 weeks after initiation or dose titration, then every 6-12 months or as clinically indicated.
Target: LDL-C reduction based on individual risk assessment and guideline recommendations (e.g., <100 mg/dL, <70 mg/dL).
Action Threshold: Failure to achieve target LDL-C, consider dose adjustment or alternative therapy. If lipid levels are not responding as expected, assess adherence and diet.
Liver Function Tests (ALT, AST)
Frequency: At baseline, then as clinically indicated. Routine periodic monitoring is no longer universally 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) occur, discontinue lovastatin. If elevations are 1-3 times ULN, monitor closely or consider dose reduction/discontinuation.
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 lovastatin immediately. If CK elevations are 5-10 times ULN, monitor closely and consider discontinuation.
Symptom Monitoring
- Unexplained muscle pain, tenderness, or weakness (especially if accompanied by malaise or fever)
- Dark-colored urine (tea-colored)
- Yellowing of the skin or eyes (jaundice)
- Unusual fatigue or weakness
- Loss of appetite
- Upper right abdominal pain
- Nausea or vomiting
Special Patient Groups
Pregnancy
Lovastatin is contraindicated in pregnancy (Pregnancy Category X). Cholesterol and its derivatives are essential for fetal development. Statins may cause fetal harm by decreasing the synthesis of cholesterol and possibly other biologically active substances derived from cholesterol. There are reports of congenital anomalies following in utero exposure to statins.
Trimester-Specific Risks:
First Trimester:
Highest risk of teratogenicity due to critical organ development.
Second Trimester:
Continued risk of interfering with fetal development.
Third Trimester:
Continued risk of interfering with fetal development.
Lactation
Lovastatin is contraindicated during breastfeeding. It is unknown if lovastatin is excreted in human milk, but a small amount of another statin (pravastatin) has been shown to pass into breast milk. Because of the potential for serious adverse reactions in nursing infants, women taking lovastatin should not breastfeed.
Infant Risk:
L5 (Contraindicated) - Potential for serious adverse effects on the infant, including interference with lipid metabolism and growth.
Pediatric Use
Use is generally limited to adolescent patients (10-17 years) with heterozygous familial hypercholesterolemia, after failure of diet therapy. Dosing is lower than adults, and careful monitoring is required. Not recommended for children under 10 years of age due to insufficient data on long-term safety and efficacy.
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. Consider starting at lower doses and titrating cautiously.
Clinical Information
Clinical Pearls
- Always advise patients to take lovastatin with the evening meal for optimal absorption and efficacy.
- Emphasize the importance of dietary and lifestyle modifications (low-cholesterol diet, exercise) as they are foundational to lipid management.
- Strongly caution patients against consuming grapefruit or grapefruit juice due to the significant interaction with CYP3A4, which can lead to increased lovastatin levels and higher risk of myopathy.
- Educate patients on the signs and symptoms of myopathy/rhabdomyolysis (muscle pain, weakness, dark urine) and liver injury (jaundice, fatigue, abdominal pain) and instruct them to report these immediately.
- Lovastatin is a prodrug; its active form is lovastatin acid.
- Consider genetic testing for CYP3A4 variants in patients with unexpected responses or adverse effects, although not routinely recommended.
- For patients on cyclosporine, danazol, gemfibrozil, or strong CYP3A4 inhibitors, lovastatin is contraindicated. For other interacting drugs (e.g., amiodarone, verapamil, diltiazem), specific dose limitations apply.
Alternative Therapies
- Other HMG-CoA reductase inhibitors (statins): Atorvastatin, Rosuvastatin, Simvastatin, Pravastatin, Fluvastatin, Pitavastatin (differ in potency, metabolism, and drug interactions).
- Cholesterol absorption inhibitors: Ezetimibe
- PCSK9 inhibitors: Alirocumab, Evolocumab
- Fibrates: Fenofibrate, Gemfibrozil (primarily for triglycerides)
- Niacin (Nicotinic Acid): (primarily for HDL and triglycerides)
- Bile acid sequestrants: Cholestyramine, Colestipol, Colesevelam
- Omega-3 fatty acid ethyl esters: Icosapent ethyl, Omega-3-acid ethyl esters (primarily for triglycerides)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 10mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Preferred Generic) or Tier 2 (Non-Preferred Generic) on most insurance formularies.
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.