Amlodipine-Atorvastatin 10/80mg Tab
It is used to treat high blood pressure.It is used to lower bad cholesterol, lower triglycerides, and raise good cholesterol (HDL).It is used to treat some types of chest pain (angina). It is used to lower the chance of having to go to the hospital for chest pain (angina) or heart failure (weak heart); needing certain heart procedures; or heart attack, stroke, or death in some people.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antihypertensive, Antilipemic
Pharmacologic Class
Calcium Channel Blocker (Dihydropyridine), HMG-CoA Reductase Inhibitor
Pregnancy Category
Category X
FDA Approved
Jan 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a combination of two drugs: Amlodipine and Atorvastatin. Amlodipine helps relax blood vessels, which lowers blood pressure and improves blood flow. Atorvastatin helps lower 'bad' cholesterol (LDL) and triglycerides, and raises 'good' cholesterol (HDL), reducing the risk of heart disease and stroke. It's used for people who need both blood pressure control and cholesterol lowering.
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. You can take this medication with or without food. It's essential to swallow the tablet whole; do not break or crush it. If you have difficulty swallowing the tablet, consult your doctor for guidance. Take your medication at the same time every day to establish a routine. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, 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. Instead, consult 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 almost time for your next dose (less than 12 hours), skip the missed dose and resume your regular 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. You can take this medication with or without food. It's essential to swallow the tablet whole; do not break or crush it. If you have difficulty swallowing the tablet, consult your doctor for guidance. Take your medication at the same time every day to establish a routine. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, 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. Instead, consult 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 almost time for your next dose (less than 12 hours), skip the missed dose and resume your regular 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 the same time each day, with or without food.
- Do not stop taking this medication without consulting your doctor, even if you feel well.
- Continue to follow a heart-healthy diet (low in saturated fat, cholesterol, and sodium).
- Engage in regular physical activity as recommended by your doctor.
- Limit or avoid alcohol consumption, as it can increase the risk of liver problems with atorvastatin.
- Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the levels of both drugs in your body and increase side effects.
- Inform your doctor immediately if you become pregnant or plan to become pregnant, as this medication is harmful to a fetus.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Amlodipine 10 mg / Atorvastatin 80 mg orally once daily. This is a high-strength combination, typically used for patients already controlled on individual components at these doses or requiring aggressive lipid lowering and blood pressure control.
Dose Range:
2.5 - 80 mg
Condition-Specific Dosing:
initialTherapy:
Not typically used for initial therapy. Patients should be titrated on individual components first. If initiating, consider lower strengths (e.g., 5/10 mg, 5/20 mg) based on individual patient needs and tolerability.
hypertensionAndDyslipidemia:
For patients requiring both blood pressure and lipid management, the dose should be individualized based on the efficacy and tolerability of each component. The 10/80mg strength is for patients requiring 10mg amlodipine and 80mg atorvastatin.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Atorvastatin is approved for heterozygous familial hypercholesterolemia in patients âĨ10 years, and amlodipine for hypertension in patients 6-17 years, but this specific combination is not typically used or studied in pediatric populations).
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment is necessary for either amlodipine or atorvastatin.
Moderate:
No dosage adjustment is necessary for either amlodipine or atorvastatin.
Severe:
No dosage adjustment is necessary for either amlodipine or atorvastatin.
Dialysis:
Amlodipine is not dialyzable. Atorvastatin is not dialyzable. No dosage adjustment needed for patients on dialysis.
Hepatic Impairment:
Mild:
Amlodipine: Initial dose adjustment may be considered (e.g., 2.5 mg). Atorvastatin: Use with caution. Monitor LFTs.
Moderate:
Amlodipine: Initial dose adjustment may be considered (e.g., 2.5 mg). Atorvastatin: Contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases.
Severe:
Amlodipine: Initial dose adjustment may be considered (e.g., 2.5 mg). Atorvastatin: Contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases.
Pharmacology
Mechanism of Action
Amlodipine is a dihydropyridine calcium channel blocker (CCB) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. This leads to peripheral arterial vasodilation, reducing peripheral vascular resistance and blood pressure. Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that catalyzes the conversion of 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. This inhibition leads to a reduction in hepatic cholesterol synthesis, which in turn increases the number of LDL receptors on the hepatocyte surface, enhancing the uptake and catabolism of LDL. It also reduces VLDL and triglyceride levels and increases HDL-C.
Pharmacokinetics
Absorption:
Bioavailability:
Amlodipine: 64-90%. Atorvastatin: ~12% (systemic).
Tmax:
Amlodipine: 6-12 hours. Atorvastatin: 1-2 hours.
FoodEffect:
Amlodipine: Not affected by food. Atorvastatin: Food decreases the rate and extent of absorption by approximately 25% and 9% respectively, but LDL-C reduction is similar whether taken with or without food.
Distribution:
Vd:
Amlodipine: 21 L/kg. Atorvastatin: ~381 L.
ProteinBinding:
Amlodipine: ~97.5%. Atorvastatin: >98%.
CnssPenetration:
Amlodipine: Limited. Atorvastatin: Limited.
Elimination:
HalfLife:
Amlodipine: 30-50 hours. Atorvastatin: ~14 hours (parent drug); 20-30 hours (active metabolites).
Clearance:
Amlodipine: Not available. Atorvastatin: Not available.
ExcretionRoute:
Amlodipine: 60% urine (inactive metabolites), 20-25% feces. Atorvastatin: Primarily biliary/fecal (parent drug and metabolites).
Unchanged:
Amlodipine: ~10% in urine. Atorvastatin: <2% in urine.
Pharmacodynamics
OnsetOfAction:
Amlodipine: 24-48 hours (for full BP effect). Atorvastatin: 2 weeks (for significant lipid lowering).
PeakEffect:
Amlodipine: 7-10 days (for steady-state BP effect). Atorvastatin: 4 weeks (for maximal lipid lowering).
DurationOfAction:
Amlodipine: 24 hours. Atorvastatin: 24 hours.
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
Signs of a urinary tract infection (UTI), including:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Changes in balance
+ Drooping on one side of the face
+ Blurred eyesight
Severe dizziness or fainting
Shortness of breath, significant weight gain, or swelling in the arms or legs
New or worsening chest pain
Confusion or memory problems
Stiff muscles, shakiness, or abnormal muscle movements
Muscle-Related Side Effects
This medication may cause muscle pain, tenderness, or weakness, especially in people with low thyroid function, kidney problems, or those taking certain other medications. The risk may also be higher in individuals 65 years or older. In rare cases, severe muscle problems can lead to kidney issues, and even death. If you experience any of the following, contact your doctor immediately:
Abnormal muscle pain, tenderness, or weakness (with or without fever or feeling unwell)
Muscle problems that persist after stopping the medication
Liver-Related Side Effects
Liver problems, including fatal cases, have been reported with this medication. Seek medical attention right away if you notice:
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, although many people may not experience any or may only have mild symptoms. If you notice any of the following, contact your doctor or seek medical help:
Joint pain
Diarrhea
Upset stomach
Dizziness, tiredness, or weakness
Nose or throat irritation
Trouble sleeping
Pain in arms or legs
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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
Signs of a urinary tract infection (UTI), including:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Changes in balance
+ Drooping on one side of the face
+ Blurred eyesight
Severe dizziness or fainting
Shortness of breath, significant weight gain, or swelling in the arms or legs
New or worsening chest pain
Confusion or memory problems
Stiff muscles, shakiness, or abnormal muscle movements
Muscle-Related Side Effects
This medication may cause muscle pain, tenderness, or weakness, especially in people with low thyroid function, kidney problems, or those taking certain other medications. The risk may also be higher in individuals 65 years or older. In rare cases, severe muscle problems can lead to kidney issues, and even death. If you experience any of the following, contact your doctor immediately:
Abnormal muscle pain, tenderness, or weakness (with or without fever or feeling unwell)
Muscle problems that persist after stopping the medication
Liver-Related Side Effects
Liver problems, including fatal cases, have been reported with this medication. Seek medical attention right away if you notice:
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, although many people may not experience any or may only have mild symptoms. If you notice any of the following, contact your doctor or seek medical help:
Joint pain
Diarrhea
Upset stomach
Dizziness, tiredness, or weakness
Nose or throat irritation
Trouble sleeping
Pain in arms or legs
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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 (could be a sign of a serious muscle problem called rhabdomyolysis).
- Yellowing of the skin or eyes (jaundice), dark urine, severe stomach pain, or unusual tiredness (could be signs of liver problems).
- Severe dizziness, lightheadedness, or fainting (could be signs of very low blood pressure).
- Swelling in your ankles, feet, or hands (peripheral edema), which is a common side effect of amlodipine but should be reported if severe or bothersome.
- Allergic reactions such as rash, itching, swelling of the face, lips, tongue, or throat, or difficulty breathing.
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, such as foods or drugs. 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 currently taking any of the following medications:
+ Cyclosporine
+ Gemfibrozil
+ Glecaprevir plus pibrentasvir
+ Letermovir
+ Tipranavir plus ritonavir
If you are taking any of the following medications, as they may interact with this drug:
+ Cimetidine
+ Ketoconazole
+ Spironolactone
If you are pregnant or think you might be pregnant. It is crucial to note that you should 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 vital to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They 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 first consulting 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, such as foods or drugs. 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 currently taking any of the following medications:
+ Cyclosporine
+ Gemfibrozil
+ Glecaprevir plus pibrentasvir
+ Letermovir
+ Tipranavir plus ritonavir
If you are taking any of the following medications, as they may interact with this drug:
+ Cimetidine
+ Ketoconazole
+ Spironolactone
If you are pregnant or think you might be pregnant. It is crucial to note that you should 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 vital to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They 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 first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, be cautious when driving or engaging in activities that require alertness, as it may affect you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position and exercise caution when navigating stairs.
Regular blood tests, as directed by your doctor, are crucial to monitor your condition. Additionally, check your blood pressure as instructed by your healthcare provider. If you have diabetes, it is vital to closely monitor your blood sugar levels.
Before using any over-the-counter (OTC) products, consult with your doctor, especially those that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
Limit your alcohol consumption to no more than 2 drinks per day, as excessive alcohol consumption may increase your risk of liver disease. If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor.
Adhere to the diet and exercise plan recommended by your doctor. If you are taking this medication for chest pain, note that it is intended to prevent or reduce the frequency of chest pain attacks, rather than treating acute episodes of chest pain.
Be aware that, although rare, new or worsening chest pain can occur when starting this medication or increasing the dose. In some cases, this may lead to a heart attack, particularly in individuals with severe coronary artery disease. Discuss this risk 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 medication may harm an unborn baby. If you are of childbearing potential, use birth control while taking this medication. If you become pregnant, notify your doctor immediately.
When starting this medication, be cautious when driving or engaging in activities that require alertness, as it may affect you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position and exercise caution when navigating stairs.
Regular blood tests, as directed by your doctor, are crucial to monitor your condition. Additionally, check your blood pressure as instructed by your healthcare provider. If you have diabetes, it is vital to closely monitor your blood sugar levels.
Before using any over-the-counter (OTC) products, consult with your doctor, especially those that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
Limit your alcohol consumption to no more than 2 drinks per day, as excessive alcohol consumption may increase your risk of liver disease. If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor.
Adhere to the diet and exercise plan recommended by your doctor. If you are taking this medication for chest pain, note that it is intended to prevent or reduce the frequency of chest pain attacks, rather than treating acute episodes of chest pain.
Be aware that, although rare, new or worsening chest pain can occur when starting this medication or increasing the dose. In some cases, this may lead to a heart attack, particularly in individuals with severe coronary artery disease. Discuss this risk 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 medication may harm an unborn baby. If you are of childbearing potential, use birth control while taking this medication. If you become pregnant, notify your doctor immediately.
Overdose Information
Overdose Symptoms:
- Amlodipine: Excessive peripheral vasodilation with marked and possibly prolonged systemic hypotension and reflex tachycardia. Severe, prolonged systemic hypotension leading to shock and death.
- Atorvastatin: No specific symptoms reported for overdose. Limited data on human overdose.
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). For amlodipine overdose, support cardiovascular function, monitor cardiac and respiratory function, elevate extremities, and manage fluid volume. Vasopressors may be helpful. Calcium gluconate may reverse calcium channel blockade effects. Atorvastatin overdose management is supportive.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., Itraconazole, Ketoconazole, Clarithromycin, Telithromycin, Nefazodone, HIV protease inhibitors such as Nelfinavir, Ritonavir, Lopinavir/Ritonavir, Tipranavir/Ritonavir, Fosamprenavir/Ritonavir, Saquinavir/Ritonavir, Darunavir/Ritonavir, Atazanavir, Indinavir, etc.) with Atorvastatin due to increased risk of myopathy/rhabdomyolysis.
- Cyclosporine, Gemfibrozil, Niacin (lipid-lowering doses âĨ1 g/day), Colchicine with Atorvastatin due to increased risk of myopathy/rhabdomyolysis.
Major Interactions
- Other fibrates (e.g., Fenofibrate) with Atorvastatin (increased risk of myopathy/rhabdomyolysis).
- Erythromycin, Azithromycin (with Atorvastatin, increased risk of myopathy).
- Diltiazem, Verapamil (with Amlodipine, increased hypotensive effect; with Atorvastatin, increased atorvastatin levels).
- Amiodarone (with Atorvastatin, increased risk of myopathy).
- Digoxin (Amlodipine may increase digoxin levels; Atorvastatin may increase digoxin levels).
- Warfarin (Atorvastatin may potentiate anticoagulant effect; Amlodipine may increase INR in some patients).
- Grapefruit juice (large quantities, >1.2 liters/day) with both Amlodipine and Atorvastatin (increases drug levels).
Moderate Interactions
- Cimetidine (with Amlodipine, minor effect on pharmacokinetics).
- Antacids (with Atorvastatin, decreased atorvastatin levels, but not clinically significant).
- Oral contraceptives (Atorvastatin may increase levels of norethindrone and ethinyl estradiol).
- Rifampin (with Atorvastatin, decreased atorvastatin levels; with Amlodipine, may decrease amlodipine levels).
- St. John's Wort (may decrease levels of both components).
Minor Interactions
- Beta-blockers (additive hypotensive effect with Amlodipine).
- Diuretics (additive hypotensive effect with Amlodipine).
Monitoring
Baseline Monitoring
Liver Function Tests (LFTs)
Rationale: To establish baseline liver function before initiating atorvastatin, as it can cause transaminase elevations.
Timing: Prior to initiation of therapy.
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Rationale: To establish baseline lipid profile and guide therapy for dyslipidemia.
Timing: Prior to initiation of therapy.
Blood Pressure (BP)
Rationale: To establish baseline blood pressure and assess the need for amlodipine.
Timing: Prior to initiation of therapy.
Renal Function (SCr, eGFR)
Rationale: To assess kidney function, although dose adjustments are generally not needed, it's important for overall patient assessment.
Timing: Prior to initiation of therapy.
Creatine Kinase (CK)
Rationale: Consider if patient has predisposing factors for myopathy (e.g., renal impairment, hypothyroidism, genetic muscle disorders, history of statin-associated myopathy).
Timing: Prior to initiation of therapy (if indicated).
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, as clinically indicated (e.g., monthly until controlled, then every 3-6 months).
Target: <130/80 mmHg or individualized target.
Action Threshold: Persistent elevation above target or symptomatic hypotension.
Lipid Panel (LDL-C, Total Cholesterol, 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 cardiovascular risk (e.g., LDL-C <100 mg/dL, <70 mg/dL, or <55 mg/dL depending on risk category).
Action Threshold: Failure to achieve target lipid levels, or unexpected significant changes.
Liver Function Tests (LFTs)
Frequency: Prior to initiation, at 6 and 12 weeks after initiation or dose elevation of atorvastatin, then periodically (e.g., annually) or as clinically indicated.
Target: AST/ALT <3 times upper limit of normal (ULN).
Action Threshold: Persistent elevations of AST or ALT >3 times ULN; discontinue if symptoms of liver injury develop.
Creatine Kinase (CK)
Frequency: As clinically indicated (e.g., if muscle pain, tenderness, or weakness occurs).
Target: Normal range.
Action Threshold: Significant elevation (>5-10 times ULN) or if accompanied by muscle symptoms; consider discontinuing therapy.
Symptom Monitoring
- Muscle pain, tenderness, or weakness (especially if accompanied by malaise or fever) - indicative of myopathy/rhabdomyolysis.
- Unexplained fatigue, anorexia, right upper quadrant pain, dark urine, or jaundice - indicative of liver injury.
- Dizziness, lightheadedness, syncope - indicative of hypotension.
- Peripheral edema (swelling of ankles/feet), flushing, headache, palpitations - common side effects of amlodipine.
- New onset or worsening of diabetes (rare, but reported with statins).
Special Patient Groups
Pregnancy
Contraindicated. Atorvastatin is Category X, meaning it is contraindicated in pregnancy due to the potential for fetal harm. Cholesterol and other products of the cholesterol biosynthesis pathway are essential for fetal development. Amlodipine is Category C, but the combination product is classified based on the most severe component.
Trimester-Specific Risks:
First Trimester:
Atorvastatin: Potential for serious developmental abnormalities due to interference with cholesterol synthesis, which is critical for fetal development.
Second Trimester:
Atorvastatin: Continued risk of fetal harm.
Third Trimester:
Atorvastatin: Continued risk of fetal harm.
Lactation
Contraindicated. Atorvastatin is classified as L5 (Contraindicated) due to the potential for serious adverse effects in the infant and the unknown effects on lipid metabolism in the infant. Amlodipine is L3 (Moderately Safe), but the combination is contraindicated.
Infant Risk:
High risk of adverse effects due to atorvastatin's potential to interfere with infant lipid metabolism and unknown long-term effects. Amlodipine is present in breast milk but generally considered low risk.
Pediatric Use
The safety and efficacy of Amlodipine-Atorvastatin combination tablets have not been established in pediatric patients. While individual components (amlodipine for hypertension in children âĨ6 years, atorvastatin for familial hypercholesterolemia in children âĨ10 years) may be used, the combination product is generally not recommended for pediatric use.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution, generally starting at lower doses and titrating slowly, especially with amlodipine due to potential for increased hypotensive effects and peripheral edema. Atorvastatin dose adjustments are not typically needed based on age alone, but monitor for muscle-related adverse events.
Clinical Information
Clinical Pearls
- This combination product is intended for patients who require both blood pressure control with amlodipine and lipid lowering with atorvastatin, and who are already controlled on or require the specific doses provided.
- Emphasize the importance of lifestyle modifications (diet, exercise) as an adjunct to pharmacotherapy.
- Educate patients about the signs and symptoms of myopathy/rhabdomyolysis and liver injury, and to report them immediately.
- Strictly advise patients to avoid grapefruit and grapefruit juice due to significant drug interactions.
- Due to the Category X pregnancy classification for atorvastatin, ensure women of childbearing potential are using effective contraception and are aware of the risks.
- Administer once daily, preferably at the same time each day. Can be taken with or without food.
Alternative Therapies
- Individual therapy with Amlodipine and Atorvastatin (allows for more flexible dose titration of each component).
- Other calcium channel blockers (e.g., felodipine, nifedipine) for hypertension.
- Other HMG-CoA reductase inhibitors (e.g., rosuvastatin, simvastatin, pravastatin) for dyslipidemia.
- Other classes of antihypertensives (e.g., ACE inhibitors, ARBs, diuretics, beta-blockers).
- Other classes of lipid-lowering agents (e.g., PCSK9 inhibitors, ezetimibe, fibrates, niacin, bile acid sequestrants).
Cost & Coverage
Average Cost:
Varies widely, typically $30-$150 per 30 tablets
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 details. 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.