Amlodipine / Atorvastatin

Amlodipine/atorvastatin is a combination tablet for people who need both a blood-pressure/angina medicine and a cholesterol-lowering medicine at the same time.

• High blood pressure (hypertension): The amlodipine component lowers blood pressure, reducing the risk of strokes and heart attacks
• Chronic stable angina: Amlodipine relieves chest pain that comes on with exertion
• Vasospastic angina (Prinzmetal's or variant angina): Amlodipine treats chest pain caused by coronary artery spasm
• Coronary artery disease (CAD): In patients with recently documented CAD by imaging (angiography) and without heart failure or severely reduced heart function, amlodipine is used to reduce risk
• High cholesterol and lipid disorders (hyperlipidemia, mixed dyslipidemia): Atorvastatin lowers LDL cholesterol and other harmful lipids as an add-on to diet
• Cardiovascular disease prevention: Atorvastatin is used as adjunct therapy to diet to prevent cardiovascular events in people at elevated risk

Amlodipine is a calcium channel blocker that prevents calcium from entering the smooth muscle cells that line artery walls. When calcium is blocked, those muscles relax and the arteries widen. This reduces blood pressure, eases the heart's workload, and — in angina — restores blood flow through coronary arteries. Atorvastatin is a statin (HMG-CoA reductase inhibitor) that blocks the main enzyme the liver uses to produce cholesterol. With less cholesterol being made, the liver pulls more LDL (bad) cholesterol out of the blood through special receptors, lowering circulating LDL levels.

The two drugs work entirely independently on different targets, so combining them in one tablet does not change how each drug performs compared to taking them separately.

These tablets are taken once daily by mouth, at any time of day, with or without food. The dose of each component — amlodipine and atorvastatin — is chosen separately by your prescriber and may be adjusted over time based on how well your blood pressure, angina, and cholesterol are controlled.

• Your prescriber may start the amlodipine component at a lower dose if you are elderly, small in frame, or have liver problems, and increase gradually
• LDL cholesterol reduction from atorvastatin is the same regardless of the time of day you take the tablet
• Always follow your prescriber's exact dosing instructions — do not change your dose without talking to them first

Most side effects are mild to moderate; here are the ones most commonly reported:

• Swelling (edema) — most common with amlodipine, more likely at higher doses
• Dizziness
• Flushing (warmth, redness)
• Palpitations (noticeable heartbeat)
• Fatigue
• Nausea or diarrhea
• Muscle aches or pain (myalgia)
• Nasopharyngitis (runny nose, sore throat) — reported with atorvastatin

Seek medical attention right away if you have severe or unexplained muscle pain, weakness, or tenderness (especially with fever or dark urine), signs of liver problems (yellowing of skin/eyes, severe fatigue), or any signs of a serious allergic reaction (swelling of face/throat, hives, trouble breathing).

• Muscle damage (myopathy and rhabdomyolysis): The atorvastatin component can, rarely, cause serious muscle breakdown. Stop the medication and call your doctor immediately if you have unexplained muscle pain, tenderness, or weakness. Risk is higher in older adults, people with kidney problems or hypothyroidism, and those taking certain other medications.
• Immune-mediated muscle disease (IMNM): A rare autoimmune muscle condition linked to statin use. Unlike typical muscle side effects, it may not improve after stopping the statin and can require immune-suppressing treatment.
• Liver problems: Atorvastatin can cause abnormal liver enzyme levels. Liver tests should be checked before and during treatment. Seek care immediately for yellowing of skin or eyes, severe abdominal pain, or dark urine. Do not take this medicine if you have active liver failure or decompensated cirrhosis.
• Worsening angina or heart attack: Starting or increasing the amlodipine dose can occasionally worsen angina or trigger a heart attack, especially in people with severe coronary artery disease. Contact your doctor if chest pain gets worse.
• Low blood pressure (hypotension): Amlodipine can cause symptomatic low blood pressure, particularly in people with severe aortic stenosis (a narrowed heart valve). Seek medical help if you feel faint or severely dizzy.
• Blood sugar changes: Atorvastatin has been associated with modest increases in blood sugar and HbA1c. Discuss this with your doctor if you have diabetes or are at risk.

This combination interacts with a number of common medicines and one food — always give your pharmacist and prescriber a full list of everything you take:

• Cyclosporine and gemfibrozil: Should not be combined with atorvastatin — significantly raises the risk of serious muscle damage
• Certain HIV/HCV antivirals (e.g., tipranavir/ritonavir, glecaprevir/pibrentasvir, lopinavir/ritonavir, nelfinavir): some combinations are not recommended; others require a lower atorvastatin dose — check with your prescriber
• Azole antifungals (e.g., itraconazole, ketoconazole, voriconazole) and certain antibiotics (e.g., clarithromycin, erythromycin): raise atorvastatin blood levels and increase muscle-damage risk
• CYP3A4 inhibitors (moderate or strong): Can raise amlodipine levels — watch for increased swelling or low blood pressure
• Rifampin: Must be taken at the same time as atorvastatin (not separately) to avoid a large drop in atorvastatin blood levels
• Sildenafil (Viagra): Can add to the blood-pressure-lowering effect of amlodipine — monitor for dizziness or faintness
• High-dose niacin, fibrates (other than gemfibrozil), and colchicine: Increase the risk of muscle problems with atorvastatin — your prescriber should weigh the risks and benefits
• Large amounts of grapefruit juice (more than 1.2 liters/day): Raises atorvastatin levels — avoid excessive intake
• Digoxin: Atorvastatin can raise digoxin levels — monitoring recommended
• Oral contraceptives: Atorvastatin can increase levels of norethindrone and ethinyl estradiol — factor this in when choosing contraception
• Cyclosporine or tacrolimus (immunosuppressants): Amlodipine can raise their levels — frequent blood-level monitoring is recommended

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

• Active liver failure or decompensated cirrhosis: Do not take this medicine
• Allergy: Do not take if you are allergic to amlodipine, atorvastatin, or any tablet ingredient; severe allergic reactions including anaphylaxis and serious skin reactions have been reported
• Pregnancy: Atorvastatin may harm the fetus — stop it as soon as pregnancy is recognized and discuss alternatives with your doctor. Amlodipine has limited pregnancy data; poorly controlled high blood pressure in pregnancy also carries risks — your prescriber will help you weigh these
• Breastfeeding: Breastfeeding is not recommended while taking this combination tablet
• Liver disease or elevated liver enzymes: Tell your prescriber before starting; active liver problems are a contraindication
• Older adults: Amlodipine is cleared more slowly in elderly patients — a lower starting dose may be appropriate; atorvastatin also reaches higher levels in older adults
• Children: The safety and effectiveness of the combination tablet have not been established in pediatric populations. Amlodipine alone has been studied in children ages 6–17 for high blood pressure; atorvastatin alone has established use in children 10 and older with certain inherited cholesterol disorders
• Severe aortic stenosis: Amlodipine can cause low blood pressure — tell your prescriber
• Uncontrolled hypothyroidism or kidney problems: These increase the risk of muscle damage with atorvastatin — discuss with your prescriber

If too much amlodipine is taken, severe widening of blood vessels can cause marked low blood pressure and a rapid heartbeat. Because amlodipine is highly bound to proteins in the blood, dialysis is unlikely to help remove it — treatment focuses on supporting blood pressure and monitoring the heart. There is no specific antidote for atorvastatin overdose; treatment is supportive. If you suspect an overdose, seek emergency medical help immediately.

Amlodipine relaxes and widens peripheral arteries, lowering blood pressure in both lying-down and standing positions without significantly changing heart rate with regular daily use. Its blood-pressure-lowering effect is maintained for at least 24 hours after each once-daily dose. Atorvastatin and its active metabolites work primarily in the liver — the main site of cholesterol production — reducing LDL cholesterol levels in a dose-related way; the cholesterol-lowering effect is the same whether the tablet is taken in the morning or evening.

After swallowing the tablet, amlodipine reaches peak blood levels slowly — in about 6 to 12 hours — and has a very long half-life of 30 to 50 hours, which is why once-daily dosing works and it takes about 7 to 8 days to reach steady levels. Atorvastatin is absorbed much faster, peaking at 1 to 2 hours, with a plasma half-life of about 14 hours; however, its cholesterol-lowering activity lasts 20 to 30 hours because of active metabolites. Both drugs are extensively processed by the liver. Food can slightly reduce atorvastatin absorption from this combination tablet but does not meaningfully affect the degree of LDL lowering, so the tablet can be taken with or without food.

Store at 25°C (77°F); excursions permitted to 15°C –30°C (59°F –86°F) .