ATORVASTATIN CALCIUM 80 mg Tablet, Film Coated, 90-count
Other active recalls for Atorvastatin Calcium (different manufacturers) — 6 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the HMG-CoA Reductase Inhibitor class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Atorvastatin is used to reduce the risk of heart attack and stroke decrease the amount of cholesterol (a fat-like substance that can build up and clog blood vessels causing heart attacks or strokes or other health problems) Atorvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing how much cholesterol your body makes. This lowers the amount of cholesterol that can build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.
Read the full MedlinePlus article ↗- It mainly lowers your LDL — the "bad" cholesterol — and triglycerides, while nudging your HDL ("good" cholesterol) a little higher. Over time, keeping those numbers in a healthier...
- What exactly is atorvastatin supposed to do for me?
- Honestly, no — the cholesterol-lowering effect is the same whether you take it in the morning or at night, and whether you eat beforehand or not. The most important thing is that y...
- Does it matter what time of day I take it, or whether I eat first?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Atorvastatin Calcium — tap one for details:
Atorvastatin Calcium may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
-
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.
-
UNII D9C330MD8B
Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII 1Z74184RGV
Egg phospholipids are naturally derived fats from eggs that help mix oil and water-based ingredients together. They work as emulsifiers in medicines, keeping the formula stable and uniform.
-
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
-
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.
-
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
-
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.
-
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.
-
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.
-
UNII 45P3261C7T
Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
-
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.
-
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.
-
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.
-
UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
16 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $0.0927 | $8.34 / 90 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Atorvastatin Calcium 80 mg 00093-5057-05 | Teva | 500 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 00378-3953-05 | Mylan | 500 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 00480-3588-10 | Teva | 1000 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 00904-6293-04 | Major | 1 tablet | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 16571-0139-09 | Rising | 90 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 16714-0176-01 | NORTHSTAR | 90 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 31722-0427-05 | Camber | 500 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin calcium 80 mg 33342-0318-10 | Macleods | 90 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 42385-0943-01 | Laurus | 100 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 42571-0175-10 | Micro | 1000 tablets | $0.069 | AB | Discontinued | — |
| Atorvastatin Calcium 80 mg 43598-0103-05 | Dr. | 500 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 43598-0833-05 | Dr. | 500 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 50228-0454-05 | ScieGen | 500 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 50268-0096-12 | AvPAK | 1 tablet | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 51079-0211-03 | Mylan | 1 tablet | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 55111-0124-05 | Dr. | 500 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 67877-0514-05 | Ascend | 500 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 68084-0590-25 | American | 1 tablet | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 70377-0080-11 | Biocon | 90 tablets | $0.069 | AB | Availability likely | — |
| atorvastatin calcium 80 mg 70710-1770-00 | Zydus | 1000 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin calcium 80 mg 72205-0025-05 | Novadoz | 500 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 72603-0285-01 | NorthStar | 90 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin calcium 80 mg 72603-0406-02 | NorthStar | 100 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin calcium 80 mg 75834-0258-01 | NIVAGEN | 1000 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 82009-0004-10 | Quallent | 1000 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 82009-0179-10 | Quallent | 1000 tablets | $0.069 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 63304-0830-05 | Sun | 500 tablets | $0.072 | — | FDA listed | — |
| Atorvastatin Calcium 80 mg 16729-0047-15 | Accord | 90 tablets | $0.079 | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 69097-0947-05 | Cipla | 90 tablets | $0.079 | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 68180-0638-02 | Lupin | 500 tablets | $0.079 | — | Discontinued | — |
| Lipitor 80 mg 58151-0158-77 | Viatris | 90 tablets | $19.004 | AB | Availability likely | — |
| Atorvastatin Calcium 80 mg 00615-8009-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 48433-0010-03 | Safecor | 1 tablet | — | AB | FDA listed | — |
| Atorvastatin calcium 80 mg 50090-6054-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 50090-6061-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 50090-6505-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 50090-6506-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 80 mg 50090-6970-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 50090-7358-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 50090-7359-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 50090-7532-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 50090-7533-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| atorvastatin calcium 80 mg 50090-7724-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| atorvastatin calcium 80 mg 50090-7725-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 51655-0747-52 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 51655-0881-30 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 55154-4384-06 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 55154-7289-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 59651-0609-55 | Aurobindo | 15000 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 80 mg 60290-0042-01 | Umedica | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 60505-2671-00 | Apotex | 10 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 63187-0656-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 63187-0907-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 63629-8472-01 | Bryant | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 80 mg 67046-1593-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 67046-1666-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 68071-2018-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 68071-2276-09 | NuCare | 90 tablets | — | — | FDA listed | — |
| Atorvastatin Calcium 80 mg 68071-2765-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 68071-3874-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 68071-3961-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 80 mg 68071-4962-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 69097-0911-05 | Cipla | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 80 mg 70518-3304-00 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
| Atorvastatin calcium 80 mg 70518-3848-00 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 80 mg 70518-4473-00 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 80 mg 70756-0250-30 | Lifestar | 30 tablets | — | AB | FDA listed | — |
| atorvastatin calcium 80 mg 70771-1878-00 | Zydus | 1000 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 71205-0098-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 80 mg 71205-0335-20 | Proficient | 20 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 71209-0093-04 | Cadila | 90 tablets | — | — | FDA listed | — |
| Atorvastatin calcium 80 mg 71335-1336-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 71335-2225-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 71335-2407-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 71335-2582-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 80 mg 71335-9646-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mgthis 71610-0036-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 71610-0633-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 71610-0746-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 72162-1556-09 | Bryant | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 72189-0537-30 | Direct_Rx | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 76420-0948-00 | Asclemed | 1000 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 80 mg 77771-0454-05 | Radha | 500 tablets | — | AB | FDA listed | — |
| atorvastatin calcium 80 mg 82137-0019-01 | Lepu | 90 tablets | — | — | FDA listed | — |
| Atorvastatin Calcium 80 mg 55154-0284-06 | Cardinal | 1 tablet | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71610-0036-15 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-036-15) | 2018-01-26 | Active |
| 71610-0036-30 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-036-30) | 2018-01-26 | Active |
| 71610-0036-45 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-036-45) | 2018-01-26 | Active |
| 71610-0036-60 You're viewing this | 90 TABLET, FILM COATED in 1 BOTTLE (71610-036-60) | 2018-01-31 | Active |
You're viewing the largest of 4 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 71610-0036-60?
What is the difference between NDC 71610-0036-60 and NDC 71610-0036-15?
What NDC number is used to bill for this package of ATORVASTATIN CALCIUM 80 mg Tablet, Film Coated?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| 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. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.
Atorvastatin calcium tablet is an HMG-CoA reductase inhibitor indicated as an adjunct therapy to diet to: Reduce the risk of MI, stroke, revascularization procedures, and angina in adult patients without CHD, but with multiple risk factors ( 1.1 ). Reduce the risk of MI and stroke in adult patients with type 2 diabetes without CHD, but with multiple risk factors ( 1.1 ). Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in adult patients with CHD ( 1.1 ).
Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia ( 1.2 ). Reduce elevated TG in adult patients with hypertriglyceridemia and primary dysbetalipoproteinemia ( 1.2 ). Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) ( 1.2 ).
Reduce elevated total-C, LDL-C, and apo B levels in pediatric patients 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trial of diet therapy ( 1.2 ). Limitations of Use: Atorvastatin calcium tablets has not been studied in Fredrickson Types I and V dyslipidemias ( 1.3 ).
1.1Prevention of Cardiovascular Disease in Adults In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: Reduce the risk of myocardial infarction Reduce the risk of stroke Reduce the risk for revascularization procedures and angina In adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium tablets are indicated to: Reduce the risk of myocardial infarction Reduce the risk of stroke In adult patients with clinically evident coronary heart disease, atorvastatin calcium tablets are indicated to: Reduce the risk of non-fatal myocardial infarction Reduce the risk of fatal and non-fatal stroke Reduce the risk for revascularization procedures Reduce the risk of hospitalization for CHF Reduce the risk of angina
1.2Hyperlipidemia Atorvastatin calcium tablets are indicated: As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in adult patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia ( Fredrickson Types IIa and IIb); As an adjunct to diet for the treatment of adult patients with elevated serum TG levels ( Fredrickson Type IV); For the treatment of adult patients with primary dysbetalipoproteinemia ( Fredrickson Type III) who do not respond adequately to diet; To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable; As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) if after an adequate trial of diet therapy the following findings are present: a.
LDL-C remains ≥ 190 mg/dL or b. LDL-C remains ≥ 160 mg/dL and:…
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Dose range: 10 to 80 mg once daily ( 2.1 ). Recommended start dose: 10 or 20 mg once daily ( 2.1 ). Patients requiring large LDL-C reduction (>45%) may start at 40 mg once daily ( 2.1 ). Pediatric patients with HeFH: starting dose: 10 mg once daily; dose range: 10 to 20 mg/day for patients 10 years to 17 years of age ( 2.2 ).
2.1Hyperlipidemia and Mixed Dyslipidemia The recommended starting dose of atorvastatin calcium tablets 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 calcium tablets is 10 to 80 mg once daily.
Atorvastatin calcium tablets 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 calcium tablets should be individualized according to patient characteristics such as goal of therapy and response. After initiation and/or upon titration of atorvastatin calcium tablets, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.
2.2Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 Years to 17 Years of age) The recommended starting dose of atorvastatin calcium tablets is 10 mg/day; the usual dose range is 10 to 20 mg orally once daily [see Clinical Studies (14.6) ]. Doses should be individualized according to the recommended goal of therapy [see Indications and Usage (1.2) and Clinical Pharmacology (12) ] . Adjustments should be made at intervals of 4 weeks or more.
2.3Homozygous Familial Hypercholesterolemia The dosage of atorvastatin calcium tablets in patients with homozygous HoFH is 10 to 80 mg daily. Atorvastatin calcium tablets should be used as an adjunct to other Lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
2.4Concomitant Lipid-Lowering Therapy Atorvastatin calcium tablets may be used with bile acid resins. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution [see Warnings and Precautions (5.1) and Drug Interactions (7) ] .
2.5Dosage in Patients with Renal Impairment Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin calcium tablets; thus, dosage adjustment in patients with renal dysfunction is not necessary [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ] .
2.6Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or Certain Protease Inhibitors In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis C protease inhibitor (telaprevir), therapy with atorvastatin calcium tablets should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing atorvastatin calcium tablets and the lowest dose necessary employed. In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with atorvastatin calcium tablets should be limited to 20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin calcium is employed.
In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, therapy with atorvastatin calcium tablets should be limited to 40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin calcium tablets is employed [see Warnings and Precautions (5.1) and Drug Interactions (7) ] .
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Atorvastatin calcium tablets are yellow, oval shape, biconvex, film coated, and are available in four strengths (see Table 1 ). Table 1: Atorvastatin Calcium Tablet Strengths and Identifying Features Tablet Strength Identifying Features 10 mg of atorvastatin “SG” on one side and “152” on the other 20 mg of atorvastatin “SG” on one side and “153” on the other 40 mg of atorvastatin “SG” on one side and “154” on the other 80 mg of atorvastatin “SG” on one side and “155” on the other Tablets: 10, 20, 40, and 80 mg of atorvastatin ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS Active Liver Disease, Which May Include Unexplained Persistent Elevations in Hepatic Transaminase Levels Hypersensitivity To Any Component of This Medication Pregnancy [see Use in Specific Populations (8.1) ]. Lactation [see Use in Specific Populations (8.2) ]. Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ( 4 ).
Hypersensitivity to any component of this medication ( 4 ). Pregnancy ( 4, 8.1, 8.3 ) Lactation ( 4, 8.2 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase when higher doses are used concomitantly with cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors). Predisposing factors include advanced age (> 65), uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported.
Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness. Atorvastatin calcium therapy should be discontinued if myopathy is diagnosed or suspected ( 5.1 , 8.5 ). Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur.
Check liver enzyme tests before initiating therapy and as clinically indicated thereafter ( 5.2 ). A higher incidence of hemorrhagic stroke was seen in patients without CHD but with stroke or TIA within the previous 6 months in the atorvastatin calcium 80 mg group vs. placebo ( 5.5 ).
5.1Skeletal Muscle Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with atorvastatin calcium and with other drugs in this class. A history of renal impairment may be a risk factor for the development of rhabdomyolysis. Such patients merit closer monitoring for skeletal muscle effects.
Atorvastatin, like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values >10 times ULN. The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis. 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; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents. Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK. Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing atorvastatin calcium.
Atorvastatin calcium therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. The risk of myopathy during treatment with drugs in this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, the hepatitis C protease inhibitor telaprevir, combinations of HIV protease inhibitors, including saquinavir plus ritonavir, lopinavir plus ritonavir, tipranavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, and fosamprenavir plus ritonavir, niacin, or azole antifungals.
Physicians considering combined therapy with atorvastatin calcium and fibric acid derivatives, erythromycin, clarithromycin, a combination of saquinavir plus ritonavir, lopinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, azole antifungals, or lipid-modifying doses of niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug.
Lower starting and maintenance doses of atorvastatin should be considered when taken concomitantly with the aforementioned drugs [ see Drug Interactions (7) ] . Periodic creatine phosphokinase (CPK) determinations may be considered in suc…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Rhabdomyolysis and myopathy [see Warnings and Precautions (5.1) ] Liver enzyme abnormalities [see Warnings and Precautions (5.2) ] The most commonly reported adverse reactions (incidence ≥ 2%) in patients treated with atorvastatin calcium in placebo-controlled trials regardless of causality were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experiences Because clinical trials are conducted under widely varying conditions, the 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 clinical practice. In the atorvastatin calcium placebo-controlled clinical trial database of 16,066 patients (8755 atorvastatin calcium vs. 7311 placebo; age range 10 to 93 years, 39% women, 91% Caucasians, 3% Blacks, 2% Asians, 4% other) with a median treatment duration of 53 weeks, 9.7% of patients on atorvastatin calcium and 9.5% of the patients on placebo discontinued due to adverse reactions regardless of causality.
The five most common adverse reactions in patients treated with atorvastatin calcium that led to treatment discontinuation and occurred at a rate greater than placebo were: myalgia (0.7%), diarrhea (0.5%), nausea (0.4%), alanine aminotransferase increase (0.4%), and hepatic enzyme increase (0.4%). The most commonly reported adverse reactions (incidence ≥ 2% and greater than placebo) regardless of causality, in patients treated with atorvastatin calcium in placebo controlled trials (n=8755) were: nasopharyngitis (8.3%), arthralgia (6.9%), diarrhea (6.8%), pain in extremity (6.0%), and urinary tract infection (5.7%).
Table 3 summarizes the frequency of clinical adverse reactions, regardless of causality, reported in ≥ 2% and at a rate greater than placebo in patients treated with atorvastatin calcium (n=8755), from seventeen placebo-controlled trials. Table 3. Clinical adverse reactions occurring in ≥ 2% and at a rate greater than placebo in patients treated with atorvastatin calcium (n=8755), from seventeen placebo-controlled trials.
Adverse Reaction* Any dose N=8755 10 mg N=3908 20 mg N=188 40 mg N=604 80 mg N=4055 Placebo N=7311 Nasopharyngitis 8.3 12.9 5.3 7.0 4.2
8.2Arthralgia 6.9 8.9 11.7 10.6 4.3
6.5Diarrhea 6.8 7.3 6.4 14.1 5.2
6.3Pain in extremity 6.0 8.5 3.7 9.3 3.1
5.9Urinary tract infection 5.7 6.9 6.4 8.0 4.1
5.6Dyspepsia 4.7 5.9 3.2 6.0 3.3
4.3Nausea 4.0 3.7 3.7 7.1 3.8
3.5Musculoskeletal pain 3.8 5.2 3.2 5.1 2.3
3.6Muscle Spasms 3.6 4.6 4.8 5.1 2.4
3.0Myalgia 3.5 3.6 5.9 8.4 2.7
3.1Insomnia 3.0 2.8 1.1 5.3 2.8
2.9Pharyngolaryngeal pain 2.3 3.9 1.6 2.8 0.7 2.1 * Adverse Reaction > 2% in any dose greater than placebo Other adverse reactions reported in placebo-controlled studies include: Body as a whole: malaise, pyrexia; Digestive system: abdominal discomfort, eructation, flatulence, hepatitis, cholestasis; Musculoskeletal system: musculoskeletal pain, muscle fatigue, neck pain, joint swelling; Metabolic and nutritional system: transaminases increase, liver function test abnormal, blood alkaline phosphatase increase, creatine phosphokinase increase, hyperglycemia; Nervous system: nightmare; Respiratory system: epistaxis; Skin and appendages: urticaria; Special senses: vision blurred, tinnitus; Urogenital system: white blood cells urine positive.
Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) In ASCOT [see Clinical Studies (14.1) ] involving 10,305 participants (age range 40 to 80 years, 19% women; 94.6% Caucasians, 2.6% Africans, 1.5% South Asians, 1.3% mixed/other) treated with atorvastatin calcium 10 mg daily (n=5,168) or placebo (n=5,137), the safety and tolerabilit…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS 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 CYP 3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, and itraconazole) [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] . Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis ( 2.6 , 5.1 , 7 , 12.3 ) Interacting Agents Prescribing Recommendations Cyclosporine, HIV protease inhibitors (tipranavir plus ritonavir), hepatitis C protease inhibitor (telaprevir) Avoid atorvastatin HIV protease inhibitor (lopinavir plus ritonavir) Use with caution and lowest dose necessary Clarithromycin, itraconazole, HIV protease inhibitors (saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir) Do not exceed 20 mg atorvastatin daily HIV protease inhibitor (nelfinavir) Hepatitis C protease inhibitor (boceprevir) Do not exceed 40 mg atorvastatin daily Other Lipid-Lowering Medications: Use with fibrate products or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects.
Caution should be used when prescribing with atorvastatin calcium ( 7 ). Digoxin: Patients should be monitored appropriately ( 7.8 ). Oral Contraceptives: Values for norethindrone and ethinyl estradiol may be increased ( 7.9 ).
Rifampin should be simultaneously co-administered with atorvastatin calcium ( 7.7 ).
7.1Strong Inhibitors of CYP 3A4 Atorvastatin calcium is metabolized by cytochrome P450 3A4. Concomitant administration of atorvastatin calcium with strong inhibitors of CYP 3A4 can lead to increases in plasma concentrations of atorvastatin. The extent of interaction and potentiation of effects depend on the variability of effect on CYP 3A4.
Clarithromycin Atorvastatin AUC was significantly increased with concomitant administration of atorvastatin calcium 80 mg with clarithromycin (500 mg twice daily) compared to that of atorvastatin calcium alone [see Clinical Pharmacology (12.3) ] . Therefore, in patients taking clarithromycin, caution should be used when the atorvastatin calcium dose exceeds 20 mg [see Dosage and Administration (2.6) , and Warnings and Precautions (5.1) ]. Combination of Protease Inhibitors Atorvastatin AUC was significantly increased with concomitant administration of atorvastatin calcium with several combinations of HIV protease inhibitors, as well as with the hepatitis C protease inhibitor telaprevir, compared to that of atorvastatin calcium alone [see Clinical Pharmacology (12.3) ] .
Therefore, in patients taking the HIV protease inhibitor tipranavir plus ritonavir, or the hepatitis C protease inhibitor telaprevir, concomitant use of atorvastatin calcium should be avoided. In patients taking the HIV protease inhibitor lopinavir plus ritonavir, caution should be used when prescribing atorvastatin calcium and the lowest dose necessary should be used. In patients taking the HIV protease inhibitors saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, the dose of atorvastatin calcium should not exceed 20 mg and should be used with caution [see Dosage and Administration (2.6) and Warnings and Precautions (5.1) ] .
In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, the dose of atorvastatin calcium should not exceed 40 mg and close clinical monitoring is recommended. Itraconazole Atorvastatin AUC was significantly increased with concomitant administration of atorvastatin calcium 40 mg and itraconazole 200 mg [see Clinical Pharmacology (12.3) ] . Therefore, in patients taking itraconazole, caution should be used when the atorvastatin calcium dose exceeds 20 mg [see Dosage and Administration (2.6) and Warnings and Precautions (5.1) ] .
7.2Grapefruit Juice Contains one or more components that inhibit CYP 3A4 and can increase p…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Hepatic impairment: Plasma concentrations markedly increased in patients with chronic alcoholic liver disease ( 8.6, 12.3 ). Females of reproductive potential: Advise females of reproductive potential to use effective contraception during treatment with atorvastatin calcium ( 8.3 ).
8.1Pregnancy Risk Summary Atorvastatin calcium 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 calcium may cause fetal harm when administered to a pregnant woman. Atorvastatin calcium 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 maximum recommended human dose (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).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data 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 ≥3to 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 crosses the rat placenta and reaches a level in fetal liver equivalent to that of maternal plasma. Atorvastatin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 300mg/kg/day and 100mg/kg/day, respectively.
Atorvastatin was not teratogenic in rats at doses up to 300mg/kg/day or in rabbits at doses up to 100mg/kg/day. These doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure at the MRHD based on surface area (mg/m 2 ). In rats, the maternally toxic dose of 300mg/kg resulted in increased post-implantation loss and decreased fetal body weight.
At the maternally toxic doses of 50 and 100mg/kg/day in rabbits, there was increased post-implantation loss, and at 100mg/kg/day fetal body weights were decreased. In a study in pregnant rats administered 20, 100, or 225 mg/kg/day from gestation day 7 through to lactation day 20 (weaning), there was decreased survival at birth, postnatal day 4, weaning, and post-weaning in pups of mothers dosed with 225mg/kg/day, a dose at which maternal toxicity was observed. Pup body weight was decreased through postnatal day 21at 100 mg/kg/day, and through postnatal day 91 at 225 mg/kg/day.
Pup development was delayed (rotorod performance at 100mg/kg/dayand acoustic startle a…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Atorvastatin calcium 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 calcium may cause fetal harm when administered to a pregnant woman. Atorvastatin calcium 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 maximum recommended human dose (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).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data 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 ≥3to 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 crosses the rat placenta and reaches a level in fetal liver equivalent to that of maternal plasma. Atorvastatin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 300mg/kg/day and 100mg/kg/day, respectively.
Atorvastatin was not teratogenic in rats at doses up to 300mg/kg/day or in rabbits at doses up to 100mg/kg/day. These doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure at the MRHD based on surface area (mg/m 2 ). In rats, the maternally toxic dose of 300mg/kg resulted in increased post-implantation loss and decreased fetal body weight.
At the maternally toxic doses of 50 and 100mg/kg/day in rabbits, there was increased post-implantation loss, and at 100mg/kg/day fetal body weights were decreased. In a study in pregnant rats administered 20, 100, or 225 mg/kg/day from gestation day 7 through to lactation day 20 (weaning), there was decreased survival at birth, postnatal day 4, weaning, and post-weaning in pups of mothers dosed with 225mg/kg/day, a dose at which maternal toxicity was observed. Pup body weight was decreased through postnatal day 21at 100 mg/kg/day, and through postnatal day 91 at 225 mg/kg/day.
Pup development was delayed (rotorod performance at 100mg/kg/dayand acoustic startle at 225 mg/kg/day; pinnae detachment and eye-opening at 225mg/kg/day). These doses correspond to 6 times (100 mg/kg) and 22times (225 mg/kg) the human exposure at the MRHD, based on AUC.
🧒 Pediatric Use ▾
8.4Pediatric Use Heterozygous Familial Hypercholesterolemia (HeFH) The safety and effectiveness of atorvastatin calcium have been established in pediatric 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 calcium for this indication is supported by evidence from [see Dosage and Administration (2.2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.6) ]: 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 calcium 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 15years of age with HeFH who were titrated to achieve a target LDL-C < 130 mg/dL. The safety and efficacy of atorvastatin calcium 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) , (8.3) ] . The long-term efficacy of atorvastatin calcium therapy initiated in childhood to reduce morbidity and mortality in adulthood has not been established.
The safety and efficacy of atorvastatin calcium have not been established in pediatric patients younger than 10 years of age with HeFH. Homozygous Familial Hypercholesterolemia (HoFH) Clinical efficacy of atorvastatin calcium with dosages up to 80mg/day for 1 year was evaluated in an uncontrolled study of patients with HoFH including 8 pediatric patients [see Clinical Studies (14.5) ].
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 39,828 patients who received atorvastatin calcium 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. Since advanced age (≥65 years) is a predisposing factor for myopathy, atorvastatin calcium should be prescribed with caution in the elderly.
🆘 Overdosage ▾
10 OVERDOSAGE There is no specific treatment for atorvastatin calcium overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin calcium clearance.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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. In animal models, atorvastatin calcium 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 calcium also reduces LDL production and the number of LDL particles.
12.2Pharmacodynamics Atorvastatin calcium, as well as some of its metabolites, are pharmacologically active in humans. The liver is the primary site of action and the principal site of cholesterol synthesis and LDL clearance. Drug dosage, rather than systemic drug concentration, correlates better with LDL-C reduction. Individualization of drug dosage should be based on therapeutic response [see Dosage and Administration (2) ] .
12.3Pharmacokinetics Absorption: Atorvastatin calcium is rapidly absorbed after oral administration; maximum plasma concentrations occur within 1 to 2 hours. Extent of absorption increases in proportion to atorvastatin calcium dose. The absolute bioavailability of atorvastatin (parent drug) is approximately 14% and the systemic availability of HMG-CoA reductase inhibitory activity is approximately 30%.
The low systemic availability is attributed to presystemic clearance in gastrointestinal mucosa and/or hepatic first-pass metabolism. Although food decreases the rate and extent of drug absorption by approximately 25% and 9%, respectively, as assessed by C max and AUC, LDL-C reduction is similar whether atorvastatin calcium is given with or without food. Plasma atorvastatin calcium concentrations are lower (approximately 30% for C max and AUC) following evening drug administration compared with morning.
However, LDL-C reduction is the same regardless of the time of day of drug administration [see Dosage and Administration (2) ] . Distribution: Mean volume of distribution of atorvastatin calcium is approximately 381 liters. Atorvastatin calcium is ≥98% bound to plasma proteins.
A blood/plasma ratio of approximately 0.25 indicates poor drug penetration into red blood cells. Based on observations in rats, atorvastatin calcium is likely to be secreted in human milk [see Contraindications (4) and Use in Specific Populations (8.2) ] . Metabolism: Atorvastatin calcium is extensively metabolized to ortho- and parahydroxylated derivatives and various beta-oxidation products.
In vitro inhibition of HMG-CoA reductase by ortho- and parahydroxylated metabolites is equivalent to that of atorvastatin calcium. Approximately 70% of circulating inhibitory activity for HMG-CoA reductase is attributed to active metabolites. In vitro studies suggest the importance of atorvastatin calcium metabolism by cytochrome P450 3A4, consistent with increased plasma concentrations of atorvastatin calcium in humans following co-administration with erythromycin, a known inhibitor of this isozyme [see Drug Interactions (7.1) ].
In animals, the ortho-hydroxy metabolite undergoes further glucuronidation. Excretion: Atorvastatin calcium and its metabolites are eliminated primarily in bile following hepatic and/or extra-hepatic metabolism; however, the drug does not appear to undergo enterohepatic recirculation. Mean plasma elimination half-life of atorvastatin calcium in humans is approximately 14 hours, but the half-life of inhibitory activity for HMG-CoA reductase is 20 to 30 hours due to the contribution of active metabolites.
Less than 2% of a dose of atorvastatin calcium is recovered in urine following oral administration. Specific Populations Geriatric: Plasma concentrations of atorvastatin calcium are higher (approximately 40% for C max and 30% for AUC) in healthy elderly subjects (age ≥65 years) than in young adults. Cl…
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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. In animal models, atorvastatin calcium 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 calcium also reduces LDL production and the number of LDL particles.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 80 mg Tablets: Yellow, oval shape, biconvex, film coated tablets, debossed with SG on one side and 155 on other side. Bottles of 15 NDC 71610-036-15 Bottles of 30 NDC 71610-036-30 Bottles of 45 NDC 71610-036-45 Bottles of 90 NDC 71610-036-60 Storage Store at 20°C to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.
📋 Description ▾
11 DESCRIPTION Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.
Atorvastatin calcium is [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).The empirical formula of atorvastatin calcium is C 66 H 68 Ca F 2 N 4 O 10 and its molecular weight is 1155.36. Its structural formula is: Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. 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.
Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: anhydrous lactose, NF; colloidal silicon dioxide, NF; copovidone, NF; croscarmellose sodium, NF; magnesium stearate, NF; mannitol, USP; silicified microcrystalline cellulose, NF; sodium bicarbonate, USP; sodium carbonate anhydrous, NF; sodium lauryl sulfate, NF; lecitihin, polyvinyl alcohol part hydrolyzed, talc, titanium dioxide, xanthan gum and iron oxide yellow. Figure-01 Figure-02 Figure-03 chemical-structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advisethe patient to read the FDA-approved patient labeling (Patient Information). Patients taking atorvastatin calcium should be advised 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. Patients should be advised about substances they should not take concomitantly with atorvastatin [see Warnings and Precautions (5.1) ] .
Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking atorvastatin calcium.
17.1Muscle Pain All patients starting therapy with atorvastatin calcium should be advised of the risk of myopathy and told 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 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.
17.2Liver Enzymes It is recommended that liver enzyme tests be performed before the initiation of atorvastatin calcium and if signs or symptoms of liver injury occur. All patients treated with atorvastatin calcium should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
17.3Embryofetal 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 [see Contraindications (4) and Use in Specific Populations (8.1 , 8.3) ] .
17.4Lactation Advise women not to breastfeed during treatment with atorvastatin calcium [see Contraindications (4) and Use in Specific Populations (8.2) ]. Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway Suite 130, Sunrise, FL 33323 Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 USA Rev: 10/17