Amlodipine besylate and Atorvastatin calcium 10 mg; 10 mg Tablet, Film Coated, 60-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Dihydropyridine Calcium Channel Blocker class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Amlodipine is used to treat high blood pressure and certain types of angina (chest pain) and coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Amlodipine is in a class of medications called calcium channel blockers. It lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard. It controls chest pain by increasing the supply of blood to the heart. If taken regularly, amlodipine controls chest pain, but it does not stop chest pain once it starts. Your doctor may prescribe a different medication to take when you have ches...
Read the full MedlinePlus article ↗- Your doctor has decided you need both a blood-pressure medicine (amlodipine) and a cholesterol-lowering medicine (atorvastatin) at the same time. Combining them into one tablet mak...
- Why am I taking two different medicines in one pill?
- You can take it at any time of day that works for you — morning, noon, or night — and you don't need food with it. Food can slightly slow how quickly atorvastatin is absorbed, but...
- Does it matter what time of day I take it, or whether I take it with food?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII H1109Z9J4N
A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
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UNII 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
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UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 8MDF5V39QO
A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
14 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $2.17 | $130.21 / 60 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Amlodipine and atorvastatin 10 mg/1; 10 mg 00378-4517-93 | Mylan | 30 tablets | $0.996 | — | Availability likely | — |
| Amlodipine and Atorvastatin 10 mg/1; 10 mg 60505-3479-03 | Apotex | 30 tablets | $0.996 | AB | Availability likely | — |
| Amlodipine and Atorvastatin 10 mg/1; 10 mg 62332-0762-30 | Alembic | 30 tablets | $0.996 | AB | Availability likely | — |
| Amlodipine and Atorvastatin 10 mg/1; 10 mg 66993-0270-30 | Prasco | 30 tablets | $0.996 | AB | Availability likely | — |
| Caduet 10 mg/1; 10 mg 00069-7810-30 | Pfizer | 30 tablets | — | AB | FDA listed | — |
| Amlodipine besylate and Atorvastatin calcium 10 mg/1; 10 mgthis 43598-0321-60 | Dr. | 60 tablets | — | AB | FDA listed | — |
| Amlodipine and Atorvastatin 10 mg/1; 10 mg 46708-0762-30 | Alembic | 30 tablets | — | AB | FDA listed | — |
| Amlodipine and Atorvastatin 10 mg/1; 10 mg 71335-2924-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Amlodipine and Atorvastatin 10 mg/1; 10 mg 71335-3076-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 43598-0321-05 | 500 TABLET, FILM COATED in 1 BOTTLE (43598-321-05) | — | — | 2014-03-17 | Active |
| 43598-0321-30 | 30 TABLET, FILM COATED in 1 BOTTLE (43598-321-30) | $1.39 / ea | $41.55 | 2014-03-17 | Active |
| 43598-0321-60 You're viewing this | 60 TABLET, FILM COATED in 1 BOTTLE (43598-321-60) | — | — | 2014-03-17 | Active |
| 43598-0321-90 | 90 TABLET, FILM COATED in 1 BOTTLE (43598-321-90) | $1.39 / ea | $124.66 | 2014-03-17 | Active |
You're viewing one of 4 pack sizes for this product.
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What NDC number is used to bill for this package of Amlodipine besylate and Atorvastatin calcium 10 mg; 10 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
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| NDC identity (package / product / labeler codes) | ✓ Available |
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| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine Amlodipine besylate and atorvastatin calcium tablets are a combination of amlodipine besylate, a calcium channel blocker, and atorvastatin calcium, a HMG CoA-reductase inhibitor, indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure (1.1).
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Amlodipine is indicated for the treatment of Coronary Artery Disease (1.2). Atorvastatin is indicated as an adjunct therapy to diet for prevention of cardiovascular disease (1.3) and hyperlipidemia (1.4).
1.1Hypertension Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents.
1.2Coronary Artery Disease (CAD) Chronic Stable Angina Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina) Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina.
Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <4…
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Amlodipine besylate and atorvastatin calcium Dosage of amlodipine besylate and atorvastatin calcium must be individualized on the basis of both effectiveness and tolerance for each individual component in the treatment of hypertension/angina and hyperlipidemia. Select doses of amlodipine and atorvastatin independently. Amlodipine besylate and atorvastatin calcium may be substituted for its individually titrated components.
Patients may be given the equivalent dose of amlodipine besylate and atorvastatin calcium or a dose of amlodipine besylate and atorvastatin calcium with increased amounts of amlodipine, atorvastatin, or both for additional antianginal effects, blood pressure lowering, or lipid-lowering effect. Amlodipine besylate and atorvastatin calcium may be used to provide additional therapy for patients already on one of its components. Amlodipine besylate and atorvastatin calcium may be used to initiate treatment in patients with hyperlipidemia and either hypertension or angina.
Amlodipine The usual initial antihypertensive oral dose of amlodipine is 5 mg once daily, and the maximum dose is 10 mg once daily. Pediatric (age > 6 years), small adult, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine to other antihypertensive therapy. Adjust dosage according to blood pressure goals.
In general, wait 7 to 14 days between titration steps. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently. Angina: The recommended dose of amlodipine for chronic stable or vasospastic angina is 5 to 10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency.
Most patients will require 10 mg for adequate effect. Coronary Artery Disease : The recommended dose range of amlodipine for patients with CAD is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg [see Clinical Studies ( 14.4 ) ].
Pediatrics: The effective antihypertensive oral dose of amlodipine in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients [see Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.1 ) ]. Atorvastatin (Hyperlipidemia) Hyperlipidemia and Mixed Dyslipidemia: The recommended starting dose of atorvastatin is 10 or 20 mg once daily.
Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of atorvastatin is 10 to 80 mg once daily. Atorvastatin can be administered as a single dose at any time of the day, with or without food.
The starting dose and maintenance doses of atorvastatin should be individualized according to patient characteristics such as goal of therapy and response. After initiation and/or upon titration of atorvastatin, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly. Homozygous Familial Hypercholesterolemia: The dosage range of atorvastatin in patients with HoFH is 10 to 80 mg daily.
Atorvastatin should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable. Concomitant Lipid-Lowering Therapy: Atorvastatin may be used with bile acid resins. Monitor for signs of myopathy in patients receiving the combination of HMG-CoA reductase inhibitors (statins) and fibrates [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7 ) ].
Patients with Renal Impairment: Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin; thus, dosage adjustment in patients with renal dysfunction is not necessary [see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.3 ) ]. Use with Cyclosporine, Clarithromycin, Itraconazole, Letermovir, or Certain Protease Inhibitors: In patients taking cyclosporine or the human i…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Amlodipine besylate and atorvastatin calcium tablets are formulated for oral administration in the following strength combinations: Amlodipine besylate and atorvastatin calcium tablets 2.5 mg/10 mg are white to off-white, round, film coated tablets debossed ‘R’ on one side and ‘407’ on other side. Amlodipine besylate and atorvastatin calcium tablets 2.5 mg/20 mg are white to off-white, round, film coated tablets debossed ‘R’ on one side and ‘408’ on other side. Amlodipine besylate and atorvastatin calcium tablets 2.5 mg/40 mg are white to off-white, round, film coated tablets debossed ‘R’ on one side and ‘409’ on other side.
Amlodipine besylate and atorvastatin calcium tablets 5 mg/10 mg are white to off-white, oval shaped, film coated tablets debossed ‘R’ on one side and ‘410’ on other side. Amlodipine besylate and atorvastatin calcium tablets 5 mg/20 mg are white to off-white, oval shaped, film coated tablets debossed ‘R’ on one side and ‘411’ on other side. Amlodipine besylate and atorvastatin calcium tablets 5 mg/40 mg are white to off-white, oval shaped, film coated tablets debossed ‘R’ on one side and ‘412’ on other side.
Amlodipine besylate and atorvastatin calcium tablets 5 mg/80 mg are white to off-white, oval shaped, film coated tablets debossed ‘R’ on one side and ‘413’ on other side. Amlodipine besylate and atorvastatin calcium tablets 10 mg/10 mg are blue, oval shaped, film coated tablets debossed ‘R’ on one side and ‘414’ on other side. Amlodipine besylate and atorvastatin calcium tablets 10 mg/20 mg are blue, oval shaped, film coated tablets debossed ‘R’ on one side and ‘415’ on other side.
Amlodipine besylate and atorvastatin calcium tablets 10 mg/40 mg are blue, oval shaped, film coated tablets debossed ‘R’ on one side and ‘416’ on other side. Amlodipine besylate and atorvastatin calcium tablets 10 mg/80 mg are blue, oval shaped, film coated tablets debossed ‘R’ on one side and ‘417’ on other side. Combinations of atorvastatin with 2.5 mg and 5 mg amlodipine are film-coated white, and combinations of atorvastatin with 10 mg amlodipine are film-coated blue.
Tablets contain amlodipine besylate equivalent to amlodipine 2.5, 5, or 10 mg and atorvastatin calcium equivalent to atorvastatin 10, 20, 40, or 80 mg ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS • Active Liver Disease, Which May Include Unexplained Persistent Elevations in Hepatic Transaminase Levels • Pregnancy [see Use in Specific Populations ( 8.1 ) ] • Lactation [see Use in Specific Populations ( 8.2 ) ] Active liver disease ( 4 ) Pregnancy ( 4 ) Lactation ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Myopathy and Rhabdomyolysis: Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness. Amlodipine besylate and atorvastatin calcium therapy should be discontinued if myopathy is diagnosed or suspected ( 2 , 5.1 , 8.5 ). Immune-Mediated Necrotizing Myopathy (IMNM): Monitor for myalgia and treat ( 5.2 ).
Hepatic Transaminitis: Monitor liver enzymes before and during treatment ( 5.3 ). Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely ( 5.5 ).
Angina or myocardial infarction may occur with initiation or dose increase ( 5.4 ).
5.1Myopathy and Rhabdomyolysis Amlodipine and atorvastatin may cause myopathy (muscle pain, tenderness, or weakness with creatine kinase (CK) above ten times the upper limit of normal) and rhabdomyolysis (with or without acute renal failure secondary to myoglobinuria). Rare fatalities have occurred as a result of rhabdomyolysis with statin use, including amlodipine and atorvastatin. Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher amlodipine and atorvastatin dosage [see Drug Interactions ( 7.3 )].
Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Amlodipine and atorvastatin exposure may be increased by drug interactions due to inhibition of cytochrome P450 enzyme 3A4 (CYP3A4) and/or transporters (e.g., breast cancer resistant protein [BCRP], organic anion-transporting polypeptide [OATP1B1/OATP1B3] and P-glycoprotein [P-gp]), resulting in an increased risk of myopathy and rhabdomyolysis. Concomitant use of cyclosporine, gemfibrozil, tipranavir plus ritonavir or glecaprevir plus pibrentasvir with amlodipine and atorvastatin is not recommended.
Amlodipine and atorvastatin dosage modifications are recommended for patients taking certain anti-viral, azole antifungals, or macrolide antibiotic medications [see Dosage and Administration ( 2 )]. Cases of myopathy/rhabdomyolysis have been reported with atorvastatin co-administered with lipid modifying doses (>1 gram/day) of niacin, fibrates, colchicine, and ledipasvir plus sofosbuvir. Consider if the benefit of use of these products outweighs the increased risk of myopathy and rhabdomyolysis [see Drug Interactions (7.3)].
Concomitant intake of large quantities, more than 1.2 liters daily, of grapefruit juice is not recommended in patients taking amlodipine and atorvastatin tablets[see Drug Interactions ( 7.3 )]. Discontinue amlodipine and atorvastatin tablets if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Muscle symptoms and CK increases may resolve if amlodipine and atorvastatin tablets are discontinued.
Temporarily discontinue amlodipine and atorvastatin tablets in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis (e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy). Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the amlodipine and atorvastatin dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
5.2Immune-Mediated Necrotizing Myopathy There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Additional neuromuscular and serologic testing may be necessary.
Treatment with immunosuppr…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 ) ] Liver enzyme abnormalities [see Warnings and Precautions ( 5.3 ) ] Most common adverse reaction (3% greater than placebo) to amlodipine is edema ( 6.1 ). Most common adverse reactions leading to atorvastatin discontinuation were myalgia and diarrhea ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Dr.
Reddy’s Laboratories, Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Amlodipine besylate and atorvastatin calcium Amlodipine besylate and atorvastatin calcium has been evaluated for safety in 1,092 patients in double-blind placebo-controlled studies treated for co-morbid hypertension and dyslipidemia.
In general, treatment with amlodipine besylate and atorvastatin calcium was well tolerated. For the most part, adverse reactions have been mild or moderate in severity. In clinical trials with amlodipine besylate and atorvastatin calcium, no adverse reactions peculiar to this combination have been observed.
Adverse reactions are similar in terms of nature, severity, and frequency to those reported previously with amlodipine and atorvastatin. The following information is based on the clinical experience with amlodipine and atorvastatin. Amlodipine Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials.
In general, treatment with amlodipine was well tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine (N=1,730) at doses up to 10 mg to placebo (N=1,250), discontinuation of amlodipine because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%).
The most commonly reported side effects more frequent than placebo are dizziness and edema. The incidence (%) of side effects that occurred in a dose-related manner are as follows: 2.5 mg N=275 Amlodipine 5 mg N=296 10 mg N=268 Placebo N=520 Edema 1.8 3 10.8
0.6Dizziness 1.1 3.4 3.4
1.5Flushing 0.7 1.4 2.6 0 Palpitations 0.7 1.4 4.5
0.6Other adverse reactions that were not clearly dose related but were reported at an incidence greater than 1% in placebo-controlled clinical trials include the following: Amlodipine (%) (N=1730) Placebo (%) (N=1250) Fatigue 4.5
2.8Nausea 2.9
1.9Abdominal Pain 1.6
0.3Somnolence 1.4
0.6Edema, flushing, palpitations, and somnolence appear to be more common in women than in men. The following events occurred in <1% but >0.1% of patients treated with amlodipine in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship: Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis.
Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo. Gastrointestinal: anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia. General: allergic reaction, asthenia, 2 back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease.
Musculoskeletal System: arthralgia, arthrosis, muscle cramps, 2 myalgia. Psychiatric: sexual dysfunction (male 2 and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization. Respiratory System: dyspnea, 2 epi…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Data from a drug-drug interaction study involving 10 mg of amlodipine and 80 mg of atorvastatin in healthy subjects indicate that the pharmacokinetics of amlodipine are not altered when the drugs are co-administered. The effect of amlodipine on the pharmacokinetics of atorvastatin showed no effect on the C max : 91% (90% confidence interval: 80 to 103%), but the AUC of atorvastatin increased by 18% (90% confidence interval: 109 to 127%) in the presence of amlodipine, which is not clinically meaningful.
No drug interaction studies have been conducted with amlodipine besylate and atorvastatin calcium and other drugs, although studies have been conducted in the individual amlodipine and atorvastatin components, as described below: Amlodipine Increased Risk of Myopathy and Rhabdomyolysis ( 2 , 5.1 , 7.3 , 12.3 ) Cyclosporine, tipranavir plus ritonavir, glecaprevir plus pibrentasvir Avoid atorvastatin Clarithromycin, itraconazole, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir,letermovir Do not exceed 20 mg atorvastatin daily Nelfinavir Do not exceed 40 mg atorvastatin daily Lopinavir plus ritonavir, simeprevir, fibric acid derivatives, erythromycin, azole antifungals, lipid-modifying doses of niacin, colchicine Consider the risk/benefit of concomitant use with atorvastatin Other Lipid-Lowering Medications: Increased risk of myopathy (7) .
Rifampin should be simultaneously co-administered with atorvastatin ( 7.4 ). Oral Contraceptives: Norethindrone and ethinyl estradiol may be increased ( 7.5 ). Digoxin: Patients should be monitored appropriately ( 7.5 ).
7.1Impact of Other Drugs on Amlodipine CYP3A Inhibitors Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment [see Clinical Pharmacology ( 12.3 ) ]. CYP3A Inducers No information is available on the quantitative effects of CYP3A inducers on amlodipine.
Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers. Sildenafil Monitor for hypotension when sildenafil is co-administered with amlodipine [see Clinical Pharmacology ( 12.2 ) ].
7.2Impact of Amlodipine on Other Drugs Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate [see Clinical Pharmacology ( 12.3 ) ]. Atorvastatin The risk of myopathy during treatment with statins is increased with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine, or strong CYP3A4 inhibitors (e.g., clarithromycin, HIV and HCV protease inhibitors, and itraconazole) [see Warnings and Precautions (5.1) and Clinical Pharmacology ( 12.3 ) ].
7.3Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Atorvastatin is a substrate of CYP3A4 and transporters (e.g., OATP1B1/1B3, P-gp, or BCRP). Atorvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP3A4 and transporters. Table 3 includes a list of drugs that may increase exposure to atorvastatin and may increase the risk of myopathy and rhabdomyolysis when used concomitantly and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].
Table 3: Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Cyclosporine or Gemfibrozil Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin and cyclosporine, an inhibitor of CYP3A4 and OATP1B1 [ see Clinical Pharmacolo…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Hepatic Impairment: Plasma concentrations of atorvastatin markedly increased in patients with active liver disease ( 8.6 ,12.3 ). Females of reproductive potential: Advise females of reproductive potential to use effective contraception during treatment with amlodipine besylate and atorvastatin calcium ( 8.3 ).
8.1Pregnancy Risk Summary Amlodipine besylate and atorvastatin calcium tablets are contraindicated in women who are pregnant. Atorvastatin Atorvastatin is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit of lipid lowering drugs during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, atorvastatin may cause fetal harm when administered to a pregnant woman.
Amlodipine besylate and atorvastatin calcium tablets should be discontinued as soon as pregnancy is recognized [see Contraindications ( 4 ) ]. Limited published data on the use of atorvastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. In animal reproduction studies in rats and rabbits there was no evidence of embryo-fetal toxicity or congenital malformations at doses up to 30 and 20 times, respectively, the human exposure at the MRHD of 80 mg, based on body surface area (mg/m 2 ).
In rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development was observed at doses ≥6 times the MRHD ( see Data ). Amlodipine The limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy ( see Clinical Considerations ).
In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20 times MRHD, respectively. However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose ( see Data ).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.
Data Human Data Atorvastatin Limited published data on atorvastatin calcium from observational studies, meta-analyses and case reports have not shown an increased risk of major congenital malformations or miscarriage. Rare reports of congenital anomalies have been received following intrauterine exposure to other HMG-CoA reductase inhibitors. In a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population.
The number of cases is adequate to exclude a ≥3 to 4-fold increase in…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Amlodipine besylate and atorvastatin calcium tablets are contraindicated in women who are pregnant. Atorvastatin Atorvastatin is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit of lipid lowering drugs during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, atorvastatin may cause fetal harm when administered to a pregnant woman.
Amlodipine besylate and atorvastatin calcium tablets should be discontinued as soon as pregnancy is recognized [see Contraindications ( 4 ) ]. Limited published data on the use of atorvastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. In animal reproduction studies in rats and rabbits there was no evidence of embryo-fetal toxicity or congenital malformations at doses up to 30 and 20 times, respectively, the human exposure at the MRHD of 80 mg, based on body surface area (mg/m 2 ).
In rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development was observed at doses ≥6 times the MRHD ( see Data ). Amlodipine The limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy ( see Clinical Considerations ).
In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20 times MRHD, respectively. However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose ( see Data ).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.
Data Human Data Atorvastatin Limited published data on atorvastatin calcium from observational studies, meta-analyses and case reports have not shown an increased risk of major congenital malformations or miscarriage. Rare reports of congenital anomalies have been received following intrauterine exposure to other HMG-CoA reductase inhibitors. In a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population.
The number of cases is adequate to exclude a ≥3 to 4-fold increase in congenital anomalies over the background incidence. In 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Animal Data Atorvastatin Atorvastatin crosses the rat placenta and reaches a level in fetal liver equiv…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of amlodipine besylate and atorvastatin calcium have not been established in pediatric populations. Amlodipine Amlodipine (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see Clinical Studies ( 14.1 ) ]. The effect of amlodipine on blood pressure in patients less than 6 years of age is not known.
Atorvastatin Heterozygous Familial Hypercholesterolemia (HeFH) Safety and effectiveness of atorvastatin have been established in patients 10 years to 17 years of age with HeFH as an adjunct to diet to reduce total cholesterol, LDL-C, and apo B levels when, after an adequate trial of diet therapy, the following are present: • LDL-C ≥190 mg/dL, or • LDL-C ≥160 mg/dL and a positive family history of FH, or premature CVD in a first, or second-degree relative, or two or more other CVD risk factors are present. Use of atorvastatin for this indication is supported by evidence from [see Dosage and Administration ( 2 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.11 )] : • A placebo-controlled clinical trial of 6 months duration in 187 boys and postmenarchal girls, 10 years to 17 years of age.
Patients treated with 10 mg or 20 mg daily atorvastatin had an adverse reaction profile generally similar to that of patients treated with placebo. In this limited controlled study, there was no significant effect on growth or sexual maturation in boys or on menstrual cycle length in girls • A three year open-label uncontrolled trial that included 163 pediatric patients 10 to 15 years of age with HeFH who were titrated to achieve a target LDL-C <130 mg/dL. The safety and efficacy of atorvastatin in lowering LDL-C appeared generally consistent with that observed for adult patients, despite limitations of the uncontrolled study design.
Advise postmenarchal girls of contraception recommendations, if appropriate for the patient [see Use in Specific Populations ( 8.1 ) ]. The long-term efficacy of atorvastatin therapy initiated in childhood to reduce morbidity and mortality in adulthood has not been established. The safety and efficacy of atorvastatin have not been established in pediatric patients younger than 10 years of age with HeFH.
Homozygous Familial Hypercholesterolemia (HoFH) Clinical efficacy of atorvastatin with dosages up to 80 mg/day for 1 year was evaluated in an uncontrolled study of patients with HoFH including 8 pediatric patients [see Clinical Studies ( 14.10 ) ].
🧓 Geriatric Use ▾
8.5Geriatric Use Safety and effectiveness of amlodipine besylate and atorvastatin calcium have not been established in geriatric populations. Amlodipine Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40 to 60%, and a lower initial dose may be required [see Dosage and Administration ( 2 ) ]. Atorvastatin Of the 39,828 patients who received atorvastatin in clinical studies, 15,813 (40%) were ≥65 years old and 2,800 (7%) were ≥75 years old.
No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older adults cannot be ruled out. Advanced age (≥65 years) is a predisposing factor for myopathy.
🆘 Overdosage ▾
10 OVERDOSAGE There is no information on overdosage with amlodipine besylate and atorvastatin calcium in humans. Amlodipine Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited.
Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the MRHD on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension. If overdose should occur with amlodipine, initiate active cardiac and respiratory monitoring.
Perform frequent blood pressure measurements. Should hypotension occur,provide cardiovascular support including elevation of the extremities and administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with specific attention to circulating volume and urine output.
As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit. Atorvastatin There is no specific treatment for atorvastatin overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
Because of extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Amlodipine besylate and atorvastatin calcium is a combination of two drugs, a dihydropyridine calcium channel blocker (amlodipine) and an HMG-CoA reductase inhibitor (atorvastatin). The amlodipine component of amlodipine besylate and atorvastatin calcium inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. The atorvastatin component of amlodipine besylate and atorvastatin calcium is 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.
Amlodipine Amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells.
Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
The precise mechanisms by which amlodipine relieves angina have not been fully delineated, but are thought to include the following: Exertional Angina: In patients with exertional angina, amlodipine reduces the total peripheral resistance (afterload) against which the heart works and reduces the rate pressure product, and thus myocardial oxygen demand, at any given level of exercise. Vasospastic Angina: Amlodipine has been demonstrated to block constriction and restore blood flow in coronary arteries and arterioles in response to calcium, potassium epinephrine, serotonin, and thromboxane A2 analog in experimental animal models and in human coronary vessels in vitro .
This inhibition of coronary spasm is responsible for the effectiveness of amlodipine in vasospastic (Prinzmetal’s or variant) angina. Atorvastatin Atorvastatin is 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. In animal models, atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL; atorvastatin also reduces LDL production and the number of LDL particles.
12.2Pharmacodynamics Amlodipine Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation resulting in a reduction of supine and standing blood pressures. These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing. Although the acute intravenous administration of amlodipine decreases arterial blood pressure and increases heart rate in hemodynamic studies of patients with chronic stable angina, chronic oral administration of amlodipine in clinical trials did not lead to clinically significant changes in heart rate or blood pressures in normotensive patients with angina.
With chronic once daily oral administration, antihypertensive effectiveness is maintained for at least 24 hours. Plasma concentrations correlate with effect in both young and elderly patients. The magnitude of reduction in blood pressure with amlodipine is also correlated with the height of pretreatment elevation; thus, individuals with moderate hypertension (diastolic pressure 105 to 114 mmHg) had about a 50% greater response than pa…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Amlodipine besylate and atorvastatin calcium is a combination of two drugs, a dihydropyridine calcium channel blocker (amlodipine) and an HMG-CoA reductase inhibitor (atorvastatin). The amlodipine component of amlodipine besylate and atorvastatin calcium inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. The atorvastatin component of amlodipine besylate and atorvastatin calcium is 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.
Amlodipine Amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells.
Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
The precise mechanisms by which amlodipine relieves angina have not been fully delineated, but are thought to include the following: Exertional Angina: In patients with exertional angina, amlodipine reduces the total peripheral resistance (afterload) against which the heart works and reduces the rate pressure product, and thus myocardial oxygen demand, at any given level of exercise. Vasospastic Angina: Amlodipine has been demonstrated to block constriction and restore blood flow in coronary arteries and arterioles in response to calcium, potassium epinephrine, serotonin, and thromboxane A2 analog in experimental animal models and in human coronary vessels in vitro .
This inhibition of coronary spasm is responsible for the effectiveness of amlodipine in vasospastic (Prinzmetal’s or variant) angina. Atorvastatin Atorvastatin is 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. In animal models, atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL; atorvastatin also reduces LDL production and the number of LDL particles.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Amlodipine besylate and atorvastatin calcium tablets contain amlodipine besylate USP and atorvastatin calcium equivalent to amlodipine and atorvastatin in the dose strengths described below. Amlodipine besylate and atorvastatin calcium tablets 2.5 mg/10 mg are white to off-white, round, film coated tablets debossed ‘R’ on one side and ‘407’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s. Bottles of 30 NDC 43598-323-30 Bottles of 60 NDC 43598-323-60 Bottles of 90 NDC 43598-323-90 Bottles of 500 NDC 43598-323-05 Amlodipine besylate and atorvastatin calcium tablets 2.5 mg/20 mg are white to off-white, round, film coated tablets debossed ‘R’ on one side and ‘408’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.
Bottles of 30 NDC 43598-320-30 Bottles of 60 NDC 43598-320-60 Bottles of 90 NDC 43598-320-90 Bottles of 500 NDC 43598-320-05 Amlodipine besylate and atorvastatin calcium tablets 2.5 mg/40 mg are white to off-white, round, film coated tablets debossed ‘R’ on one side and ‘409’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s. Bottles of 30 NDC 43598-317-30 Bottles of 60 NDC 43598-317-60 Bottles of 90 NDC 43598-317-90 Bottles of 500 NDC 43598-317-05 Amlodipine besylate and atorvastatin calcium tablets 5 mg/10 mg are white to off-white, oval shaped, film coated tablets debossed ‘R’ on one side and ‘410’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.
Bottles of 30 NDC 43598-322-30 Bottles of 60 NDC 43598-322-60 Bottles of 90 NDC 43598-322-90 Bottles of 500 NDC 43598-322-05 Amlodipine besylate and atorvastatin calcium tablets 5 mg/20 mg are white to off-white, oval shaped, film coated tablets debossed ‘R’ on one side and ‘411’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s. Bottles of 30 NDC 43598-319-30 Bottles of 60 NDC 43598-319-60 Bottles of 90 NDC 43598-319-90 Bottles of 500 NDC 43598-319-05 Amlodipine besylate and atorvastatin calcium tablets 5 mg/40 mg are white to off-white, oval shaped, film coated tablets debossed ‘R’ on one side and ‘412’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.
Bottles of 30 NDC 43598-316-30 Bottles of 60 NDC 43598-316-60 Bottles of 90 NDC 43598-316-90 Bottles of 500 NDC 43598-316-05 Amlodipine besylate and atorvastatin calcium tablets 5 mg/80 mg are white to off-white, oval shaped, film coated tablets debossed ‘R’ on one side and ‘413’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s. Bottles of 30 NDC 43598-314-30 Bottles of 60 NDC 43598-314-60 Bottles of 90 NDC 43598-314-90 Bottles of 500 NDC 43598-314-05 Amlodipine besylate and atorvastatin calcium tablets 10 mg/10 mg are blue, oval shaped, film coated tablets debossed ‘R’ on one side and ‘414’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.
Bottles of 30 NDC 43598-321-30 Bottles of 60 NDC 43598-321-60 Bottles of 90 NDC 43598-321-90 Bottles of 500 NDC 43598-321-05 Amlodipine besylate and atorvastatin calcium tablets 10 mg/20 mg are blue, oval shaped, film coated tablets debossed ‘R’ on one side and ‘415’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s. Bottles of 30 NDC 43598-318-30 Bottles of 60 NDC 43598-318-60 Bottles of 90 NDC 43598-318-90 Bottles of 500 NDC 43598-318-05 Amlodipine besylate and atorvastatin calcium tablets 10 mg/40 mg are blue, oval shaped, film coated tablets debossed ‘R’ on one side and ‘416’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.
Bottles of 30 NDC 43598-315-30 Bottles of 60 NDC 43598-315-60 Bottles of 90 NDC 43598-315-90 Bottles of 500 NDC 43598-315-05 Amlodipine besylate and atorvastatin calcium tablets 10 mg/80 mg are blue, oval shaped, film coated tablets debossed ‘R’ on one side and ‘417’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s. Bottles of 30 NDC 43598-313-30 Bottles of 60 NDC 43598-313-60 Bottl…
📋 Description ▾
11 DESCRIPTION Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C 20 H 25 ClN 2 O 5 •C 6 H 6 O 3 S.
The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C 66 H 68 CaF 2 N 4 O 10 . The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below.
Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal.
Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium. 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium.
2.5mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium. 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium. 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium.
5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium. 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium. 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium.
10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium. 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium. 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.
Each film-coated tablet also contains colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium bicarbonate, sodium lauryl sulfate, Opadry- II White 85G18490 (Polyethylene glycol, polyvinyl alcohol, lecithin, talc and titanium dioxide), or Opadry- II Blue 85G50642 (FD&C Blue No.2, polyethylene glycol, polyvinyl alcohol, lecithin, talc and titanium dioxide).
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Information for Patients Because of the risk of myopathy with statins, the drug class to which atorvastatin belongs, advise patients to report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Advise patients taking atorvastatin that cholesterol is a chronic condition and they should adhere to their medication along with their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program as appropriate, and periodic testing of a fasting lipid panel to determine goal attainment.
Advise patients about substances they should not take concomitantly with atorvastatin [see Warnings and Precautions ( 5.1 ) ]. Patients should inform other healthcare professionals prescribing a new medication that they are taking amlodipine besylate and atorvastatin calcium. Muscle Pain: Advise patients starting therapy with amlodipine besylate and atorvastatin calcium of the risk of myopathy and to report promptly any unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing amlodipine besylate and atorvastatin calcium.
The risk of this occurring is increased when taking certain types of medication or consuming larger quantities (>1 liter) of grapefruit juice. They should discuss all medication, both prescription and over the counter, with their healthcare professional. Liver Enzymes: Advise patients treated with amlodipine besylate and atorvastatin calcium to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
Embryofetal Toxicity: Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment and to inform their healthcare provider of a known or suspected pregnancy while using amlodipine besylate and atorvastatin calcium [ see Contraindications ( 4 ) and Use in Specific Populations ( 8.1 , 8.3 ) ] . Lactation: Advise women not to breastfeed during treatment with amlodipine besylate and atorvastatin calcium [ see Contraindications ( 4 ) and Use in Specific Populations ( 8.2 ) ].