Amlodipine-Atorvastatin 5/10mg Tabs

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 and an increase in the number of LDL receptors on the hepatocyte surface, enhancing the uptake and catabolism of LDL.

Serious Side Effects: Seek Medical Attention Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to pass urine
+ Fever
+ Lower stomach pain
+ Pelvic pain
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Drooping on one side of the face
+ Blurred eyesight
Severe dizziness or passing out
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 if you have low thyroid function, kidney problems, or are taking certain other medications. The risk may also be higher if you are 65 or older. In rare cases, severe muscle problems can lead to kidney problems, and even death. If you experience any of the following symptoms, contact your doctor right away:

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

This medication can cause liver problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:

Dark urine
Tiredness
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes

Other Side Effects

Most people do not experience serious side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:

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 about side effects or want to report a side effect, contact your doctor or the FDA at 1-800-332-1088 or 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 should not be taken during pregnancy.
If you are breastfeeding. You should not breastfeed while taking this medication.

Please note that this is not an exhaustive list of all potential interactions. 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 to ensure safe use. 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 medication 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. 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.

Be aware that, although rare, new or worsening chest pain can occur after 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 medication. If you become pregnant, notify your doctor immediately.

• Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, clarithromycin, telithromycin, nefazodone, HIV protease inhibitors such as ritonavir, lopinavir/ritonavir, tipranavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, darunavir/ritonavir, nelfinavir) with Atorvastatin (due to increased risk of myopathy/rhabdomyolysis)
• Cyclosporine (with Atorvastatin)
• Gemfibrozil (with Atorvastatin)
• Active liver disease (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
• Grapefruit juice (large quantities, >1.2 liters/day) - increases plasma concentrations of both Amlodipine and Atorvastatin
• Rifampin, St. John's Wort, Efavirenz, Phenytoin, Carbamazepine, Phenobarbital (CYP3A4 inducers) - may decrease plasma concentrations of Amlodipine and Atorvastatin
• Digoxin - increased digoxin levels with Atorvastatin
• Oral contraceptives - increased AUC of norethindrone and ethinyl estradiol with Atorvastatin
• Warfarin - may cause slight decrease in prothrombin time with Atorvastatin (monitor INR)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, fluconazole) - may increase plasma concentrations of Amlodipine and Atorvastatin
• Amiodarone - increased risk of myopathy/rhabdomyolysis with Atorvastatin
• Azole antifungals (e.g., fluconazole) - increased Atorvastatin exposure
• Macrolide antibiotics (e.g., erythromycin) - increased Atorvastatin exposure
• Antacids (magnesium/aluminum hydroxide) - decreased plasma concentrations of Atorvastatin (administer 2 hours apart)
• Cimetidine - no significant interaction with Amlodipine

• Beta-blockers - additive hypotensive effects with Amlodipine (monitor BP)
• Diuretics - additive hypotensive effects with Amlodipine (monitor BP)
• Sildenafil - additive hypotensive effects with Amlodipine (monitor BP)

• 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, jaundice - indicative of liver injury
• Peripheral edema (swelling of ankles/feet)
• Headache, dizziness, flushing, palpitations (common amlodipine side effects)
• Excessive hypotension or syncope

Contraindicated. Atorvastatin can cause fetal harm. Discontinue immediately if pregnancy is detected.

Contraindicated. Atorvastatin is excreted in breast milk and can cause serious adverse reactions in nursing infants. Amlodipine is present in breast milk, but data on infant effects are limited. Due to the atorvastatin component, breastfeeding is not recommended.

Safety and efficacy not established for the combination product. Atorvastatin monotherapy may be used in certain pediatric dyslipidemia cases (e.g., heterozygous familial hypercholesterolemia in patients ≥10 years old). Amlodipine monotherapy is approved for hypertension in children ≥6 years old.

Use with caution. Amlodipine clearance may be reduced, leading to higher plasma concentrations; consider lower starting doses (e.g., 2.5 mg amlodipine component). Atorvastatin: No specific dose adjustment needed based on age alone, but increased susceptibility to myopathy may be present. Monitor closely for adverse effects.

• This combination simplifies therapy for patients requiring both blood pressure and lipid management, potentially improving adherence.
• Administer once daily at any time of day, with or without food. Consistency in timing is helpful for adherence.
• Counsel patients on the importance of lifestyle modifications (diet, exercise) as they are crucial adjuncts to pharmacotherapy.
• Educate patients about muscle pain/weakness and liver injury symptoms, and to report them immediately.
• Avoid large quantities of grapefruit juice (>1.2 liters/day) due to potential for increased drug levels.
• Due to the long half-life of amlodipine, blood pressure effects may take several days to stabilize after dose adjustments.
• Atorvastatin's lipid-lowering effects are typically maximal after 2-4 weeks of therapy.

• Separate prescriptions of Amlodipine and Atorvastatin (allows for more flexible dosing of each component).
• Other antihypertensive classes (e.g., ACE inhibitors, ARBs, beta-blockers, diuretics) combined with other statins (e.g., rosuvastatin, simvastatin).
• Non-pharmacological interventions (diet, exercise, weight loss, smoking cessation).

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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.