Amlodipine-Atorvastatin 5/40mg Tabs

Amlodipine: A dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and myocardial cells. This leads to peripheral arterial vasodilation and reduction in peripheral vascular resistance, thereby lowering blood pressure. Atorvastatin: A selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that catalyzes the conversion of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) to mevalonate, a precursor of sterols, including cholesterol. This inhibition leads to a reduction in hepatic cholesterol synthesis and an increase in the number of hepatic LDL receptors on the cell surface, enhancing uptake and catabolism of LDL.

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 immediately or seek emergency 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 damage, 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. If you notice any of the following symptoms, contact your doctor right away:

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 side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Joint pain
Diarrhea
Upset stomach
Dizziness, tiredness, or weakness
Nose or throat irritation
Trouble sleeping
Pain in arms or legs

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.

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 symptoms you experienced.
If you have liver disease or elevated liver enzymes.
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:
+ Cimetidine
+ Ketoconazole
+ Spironolactone
If you are pregnant or think you might be pregnant. Note that this medication is not recommended during pregnancy.
If you are breastfeeding. You should not breastfeed while taking this medication.

Please note that this list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this drug affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.

Regular blood tests, as directed by your doctor, are crucial to monitor your condition. Discuss any concerns or questions with your doctor. 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 taking 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 an attack as it occurs.

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 heart blood vessel disease. Discuss these risks 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 age, use birth control while taking this drug. If you become pregnant, notify your doctor immediately.

• Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, clarithromycin, telithromycin, nefazodone, HIV protease inhibitors such as nelfinavir, ritonavir, lopinavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir, fosamprenavir/ritonavir) with Atorvastatin (risk of myopathy/rhabdomyolysis)
• Cyclosporine (with Atorvastatin, risk of myopathy/rhabdomyolysis)
• Gemfibrozil (with Atorvastatin, risk of myopathy/rhabdomyolysis)
• Active liver disease or unexplained persistent elevations of serum transaminases (with Atorvastatin)

• Other fibrates (e.g., fenofibrate) (increased risk of myopathy/rhabdomyolysis with Atorvastatin)
• Niacin (lipid-lowering doses ≥1 g/day) (increased risk of myopathy/rhabdomyolysis with Atorvastatin)
• Colchicine (increased risk of myopathy/rhabdomyolysis with Atorvastatin)
• Fusidic acid (increased risk of myopathy/rhabdomyolysis with Atorvastatin)
• Grapefruit juice (large quantities, >1.2 liters/day) (increases plasma concentrations of both Amlodipine and Atorvastatin)
• Diltiazem (increases Amlodipine and Atorvastatin exposure)
• Verapamil (increases Amlodipine exposure)
• Rifampin (decreases Amlodipine exposure, may decrease Atorvastatin exposure)
• Digoxin (Atorvastatin may increase digoxin levels)
• Warfarin (Atorvastatin may affect INR)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole) (may increase Amlodipine and Atorvastatin levels)
• Amiodarone (may increase Amlodipine levels)
• Simvastatin, Lovastatin (additive myopathy risk if used with Atorvastatin, though typically not co-administered)
• Oral contraceptives (Atorvastatin may increase levels of ethinyl estradiol and norethindrone)
• Antacids (decrease Atorvastatin absorption, administer 2 hours apart)

• Cimetidine (no significant interaction with Amlodipine)
• Magnesium/Aluminum hydroxide antacids (no significant interaction with Amlodipine)

• Muscle pain, tenderness, or weakness (especially if accompanied by malaise or fever)
• Unusual fatigue or weakness
• Dark urine
• Yellowing of skin or eyes (jaundice)
• Abdominal pain, nausea, vomiting
• Swelling in ankles, feet, or hands (edema)
• Dizziness or lightheadedness
• Chest pain or discomfort

Contraindicated. Atorvastatin can cause fetal harm when administered to a pregnant woman. Cholesterol and other products of the cholesterol biosynthesis pathway are essential for fetal development. There are no adequate and well-controlled studies of amlodipine in pregnant women.

Contraindicated. Atorvastatin is excreted into breast milk and could potentially cause serious adverse reactions in a nursing infant. Amlodipine is present in human milk; however, the effect on the breastfed infant or on milk production is unknown. Due to the potential for serious adverse reactions in the breastfed infant from atorvastatin, breastfeeding is not recommended.

Safety and efficacy of the combination product have not been established in pediatric patients. Atorvastatin monotherapy may be used in some pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia, but the combination is generally not recommended.

No overall differences in safety or effectiveness have been observed between elderly and younger patients for either component. However, elderly patients may be more sensitive to the effects of amlodipine (e.g., peripheral edema) and may have an increased risk of statin-associated myopathy. Initiate with caution and titrate slowly.

• This fixed-dose combination is convenient for patients who require both amlodipine and atorvastatin at the specific doses provided.
• Emphasize the importance of lifestyle modifications (diet, exercise) as an adjunct to pharmacotherapy.
• Educate patients on the signs and symptoms of myopathy/rhabdomyolysis and liver injury, and to report them immediately.
• Grapefruit juice can significantly increase levels of both drugs; advise patients to avoid it.
• Administering atorvastatin at any time of day is acceptable, but consistency is key for adherence.
• Monitor for peripheral edema, a common side effect of amlodipine, especially at higher doses.

• Other calcium channel blockers (e.g., felodipine, nifedipine, diltiazem, verapamil)
• Other statins (e.g., rosuvastatin, simvastatin, pravastatin, lovastatin, fluvastatin, pitavastatin)
• Other antihypertensive classes (e.g., ACE inhibitors, ARBs, diuretics, beta-blockers)
• Other lipid-lowering agents (e.g., ezetimibe, PCSK9 inhibitors, fibrates, niacin, bile acid sequestrants)

If your symptoms or health issues persist or worsen, it is 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 it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.