Amlodipine-Atorvastatin 10/10mg Tab

Amlodipine: A dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. This leads to peripheral arterial vasodilation and reduction in peripheral vascular resistance, lowering blood pressure. Atorvastatin: A selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 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 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. Seek medical attention right away if you notice any of the following symptoms:

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, contact your doctor 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 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 allergic reaction you experienced.
If you have liver disease or elevated liver enzymes, as this may affect the medication's safety and efficacy.
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.

Please note that this is not an exhaustive list of all potential drug interactions or health concerns. It is vital to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure your safety while taking this medication. Never start, stop, or change the dose 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.

When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing 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 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 the pain 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 coronary artery disease. Consult your doctor if you experience any concerns.

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.

• Strong CYP3A4 inhibitors (e.g., Itraconazole, Ketoconazole, Clarithromycin, Ritonavir, Telithromycin) with Atorvastatin (risk of myopathy/rhabdomyolysis)
• Cyclosporine, Gemfibrozil, Lopinavir/Ritonavir, Tipranavir/Ritonavir, Telaprevir, Boceprevir, Glecaprevir/Pibrentasvir, Elbasvir/Grazoprevir with Atorvastatin (risk of myopathy/rhabdomyolysis)

• Strong CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin) with Amlodipine (increased amlodipine exposure, hypotension risk)
• Other fibrates (e.g., Fenofibrate) with Atorvastatin (increased risk of myopathy/rhabdomyolysis)
• Colchicine with Atorvastatin (increased risk of myopathy/rhabdomyolysis)
• Grapefruit juice (large quantities) with Amlodipine and Atorvastatin (increased drug levels)
• Digoxin (increased digoxin levels with amlodipine)
• Simvastatin (co-administration with Atorvastatin is not recommended due to additive risk of myopathy)

• Moderate CYP3A4 inhibitors (e.g., Erythromycin, Diltiazem, Verapamil) with Amlodipine and Atorvastatin
• CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, St. John's Wort) with Amlodipine and Atorvastatin (decreased drug levels)
• Oral contraceptives (increased AUC of norethindrone and ethinyl estradiol with atorvastatin)
• Warfarin (potential for increased INR with atorvastatin)
• Antacids (decreased atorvastatin levels)
• Cholestyramine/Colestipol (decreased atorvastatin absorption if given concurrently)

• Cimetidine (minor effect on amlodipine pharmacokinetics)
• Sildenafil (additive hypotensive effects with amlodipine)

• Peripheral edema (Amlodipine)
• Headache (Amlodipine)
• Dizziness (Amlodipine)
• Flushing (Amlodipine)
• Palpitations (Amlodipine)
• Muscle pain, tenderness, or weakness (Myalgia, Myopathy, Rhabdomyolysis - Atorvastatin)
• Unexplained fatigue (Atorvastatin)
• Dark urine (Atorvastatin)
• Yellowing of skin or eyes (Jaundice - Atorvastatin)
• Abdominal pain (Atorvastatin)
• Nausea/Vomiting (Atorvastatin)

Contraindicated. Atorvastatin can cause fetal harm when administered to a pregnant woman. Discontinue immediately if pregnancy is detected.

Not recommended. Atorvastatin is excreted into breast milk and has the potential for serious adverse reactions in breastfed infants. Amlodipine is also present in breast milk. Advise women not to breastfeed during treatment.

Safety and efficacy of the combination product have not been established in pediatric patients. Individual components may be used in specific pediatric populations under strict medical guidance.

No overall differences in safety or effectiveness were observed between elderly and younger patients. However, elderly patients may be more sensitive to the hypotensive effects of amlodipine and may have increased risk of myopathy with atorvastatin. Use with caution, generally starting at lower doses and titrating slowly.

• 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. However, consistency in timing is often preferred.
• Counsel patients on the importance of lifestyle modifications (diet, exercise) as they are crucial adjuncts to pharmacotherapy.
• Educate patients about symptoms of myopathy (muscle pain, weakness) and liver injury (jaundice, dark urine) and to report them immediately.
• Avoid large quantities of grapefruit juice due to potential for increased drug levels of both amlodipine and atorvastatin.
• Due to the Atorvastatin component, this drug is contraindicated in pregnancy and breastfeeding.

• Individual Amlodipine and Atorvastatin tablets (allows for more flexible dosing of each component)
• Other calcium channel blockers (e.g., Nifedipine, Diltiazem)
• Other HMG-CoA reductase inhibitors (e.g., Rosuvastatin, Simvastatin, Pravastatin)
• Other antihypertensive classes (e.g., ACE inhibitors, ARBs, Thiazide 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'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 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 details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.