ATORVASTATIN CALCIUM 40 mg Tablet, Film Coated
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.
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UNII Y882YXF34X
Calcium acetate is a mineral salt made from calcium and acetic acid. In medicines, it acts as a binder to hold ingredients together and can help control the acidity level of the formulation.
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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 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.
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UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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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 Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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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 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.
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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.
10 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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.037 | $1.85 / 50 tablet |
| Medicaid paysCMS SDUD · 12 mo | $1.84 | $92.09 / 50 tablet |
| Medicare drug plans payPart D · Q2 2026 | $0.0927 | $4.64 / 50 tablet |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Atorvastatin Calcium 40 mg 00093-5058-10 | Teva | 1000 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 00378-3952-05 | Mylan | 500 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 00480-3587-10 | Teva | 1000 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 00904-6292-06 | Major | 1 tablet | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 16571-0138-09 | Rising | 90 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 16714-0175-01 | NORTHSTAR | 90 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 31722-0426-05 | Camber | 500 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin calcium 40 mg 33342-0317-10 | Macleods | 90 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 42385-0942-01 | Laurus | 100 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 42571-0174-10 | Micro | 1000 tablets | $0.037 | AB | Discontinued | — |
| Atorvastatin Calcium 40 mg 43598-0101-05 | Dr. | 500 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 43598-0832-05 | Dr. | 500 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 50228-0453-10 | ScieGen | 1000 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mgthis 50268-0095-15 | AvPAK | 1 tablet | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 51079-0210-20 | Mylan | 1 tablet | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 55111-0123-05 | Dr. | 500 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 67877-0513-05 | Ascend | 500 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 68084-0099-01 | American | 1 tablet | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 70377-0079-11 | Biocon | 90 tablets | $0.037 | AB | Availability likely | — |
| atorvastatin calcium 40 mg 70710-1772-00 | Zydus | 1000 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin calcium 40 mg 70756-0249-12 | Lifestar | 1000 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin calcium 40 mg 72205-0024-05 | Novadoz | 500 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 72603-0284-01 | NorthStar | 90 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin calcium 40 mg 72603-0405-02 | NorthStar | 100 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin calcium 40 mg 75834-0257-01 | NIVAGEN | 1000 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 82009-0003-10 | Quallent | 1000 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 82009-0178-10 | Quallent | 1000 tablets | $0.037 | AB | Availability likely | — |
| Atorvastatin Calcium 40 mg 63304-0829-05 | Sun | 500 tablets | $0.040 | — | FDA listed | +9% |
| Atorvastatin Calcium 40 mg 16729-0046-15 | Accord | 90 tablets | $0.068 | AB | FDA listed | +85% |
| Atorvastatin Calcium 40 mg 69097-0946-05 | Cipla | 90 tablets | $0.068 | AB | FDA listed | +85% |
| Lipitor 40 mg 58151-0157-77 | Viatris | 90 tablets | $19.114 | AB | Availability likely | +51503% |
| Atorvastatin Calcium 40 mg 00615-8008-05 | NCS | 15 tablets | — | AB | Discontinued | — |
| Atorvastatin Calcium 40 mg 42708-0005-30 | QPharma, | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 42708-0108-30 | QPharma, | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 42708-0144-30 | QPharma, | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 43063-0453-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 48433-0009-20 | Safecor | 1 tablet | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 50090-5207-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 50090-5208-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 50090-5632-00 | A-S | 30 tablets | — | — | FDA listed | — |
| Atorvastatin calcium 40 mg 50090-5915-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 50090-6440-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 50090-6441-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 50090-7384-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 50090-7385-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| atorvastatin calcium 40 mg 50090-7726-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| atorvastatin calcium 40 mg 50090-7727-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 50090-7806-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 50090-7807-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 51655-0465-52 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 55154-4166-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 55154-6646-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 55154-7628-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 59651-0608-62 | Aurobindo | 30000 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 40 mg 60290-0041-01 | Umedica | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 60505-2580-00 | Apotex | 10 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 40 mg 60760-0726-30 | St. | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 60760-0734-30 | St. | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 60760-0882-30 | St. | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 63187-0109-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 40 mg 67046-1529-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 40 mg 68071-2302-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 68071-2991-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| atorvastatin calcium 40 mg 68071-2994-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 68071-3267-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 68071-3595-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 68071-3628-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 68071-3667-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 68071-3882-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 40 mg 68071-3948-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 68071-4837-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 68071-5091-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 68071-5194-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 40 mg 68788-8094-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 68788-8574-09 | Preferred | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 68788-8887-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 69097-0899-05 | Cipla | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 70518-1322-01 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 40 mg 70518-3273-00 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
| Atorvastatin calcium 40 mg 70518-4321-00 | REMEDYREPACK | 100 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 40 mg 70518-4474-00 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 70518-4592-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| atorvastatin calcium 40 mg 70771-1877-00 | Zydus | 1000 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 71205-0264-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Atorvastatin Calcium 40 mg 71205-0731-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 40 mg 71205-0765-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 71209-0092-04 | Cadila | 90 tablets | — | — | FDA listed | — |
| Atorvastatin Calcium 40 mg 71335-1011-01 | Bryant | 30 tablets | — | — | Discontinued | — |
| Atorvastatin Calcium 40 mg 71335-1126-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 71335-2493-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 71335-2591-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 40 mg 71335-2697-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 40 mg 71335-9711-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 71335-9723-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 71610-0163-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 71610-0745-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 72162-2238-09 | Bryant | 90 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 72189-0557-30 | Direct_rx | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 40 mg 72789-0089-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 76420-0946-00 | Asclemed | 1000 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 77771-0453-10 | Radha | 1000 tablets | — | AB | FDA listed | — |
| atorvastatin calcium 40 mg 82137-0018-01 | Lepu | 90 tablets | — | — | FDA listed | — |
| Atorvastatin Calcium 40 mg 82804-0026-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 40 mg 82804-0056-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 82868-0029-30 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin calcium 40 mg 82868-0048-30 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Atorvastatin Calcium 40 mg 87441-0013-01 | Unit | 30 tablets | — | 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?
🗺️ Medicaid utilization & spend
📊 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 |
|---|---|---|---|
| 50268-0095-15 You're viewing this | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-095-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-095-11) | 2016-06-28 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Atorvastatin Calcium Tablets are indicated: To reduce the risk of: 1. Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD 2.MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD 3. Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: 1.
Adults with primary hyperlipidemia. 2. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: 1. Primary dysbetalipoproteinemia 2.
Hypertriglyceridemia Atorvastatin calcium tablets are a 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 has not been studied in Fredrickson Types I and V dyslipidemias ( 1.3 ).
⏱️ 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 ).
2.1Important Dosage Information Take Atorvastatin calcium tablet orally once daily at any time of the day, with or without food. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium tablets, and adjust the dosage if necessary.
2.2Recommended Dosage in Adult Patients The recommended starting dosage of atorvastatin calcium is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily. Patients who require reduction in LDL-C greater than 45% may be started at 40 mg once daily.
2.3Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HeFH The recommended starting dosage of atorvastatin calcium is 10 mg once daily. The dosage range is 10 mg to 20 mg once daily.
2.4Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HoFH The recommended starting dosage of atorvastatin calcium is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily.
2.5Dosage Modifications Due to Drug Interactions Concomitant use of atorvastatin with the following drugs requires dosage modification of atorvastatin [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. Anti-Viral Medications In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed atorvastatin calcium 20 mg once daily. In patients taking nelfinavir, do not exceed atorvastatin calcium 40 mg once daily.
Select Azole Antifungals or Macrolide Antibiotics In patients taking clarithromycin or itraconazole, do not exceed atorvastatin calcium 20 mg once daily. For additional recommendations regarding concomitant use of atorvastatin calcium with other anti-viral medications, azole antifungals or macrolide antibiotics, see Drug Interactions (7.1).
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Atorvastatin calcium tablets, USP: 10 mg of atorvastatin calcium tablets, USP: white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “A10” on the other side. 20 mg of atorvastatin calcium tablets, USP: white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV20” on the other side. 40 mg of atorvastatin calcium tablets, USP: white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV40” on the other side.
80 mg of atorvastatin calcium tablets, USP: white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV80” on the other side. Tablets 10 mg, 20 mg, 40 mg, and 80 mg of atorvastatin ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)] Hypersensitivity to atorvastatin or any excipients in atorvastatin calcium tablets. Hypersensitivity reactions, including anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported [see Adverse Reactions (6.2)]. Acute liver failure or decompensated cirrhosis (4).
Hypersensitivity to atorvastatin or any excipient in atorvastatin calcium tablets (4).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Myopathy and Rhabdomyolysis : Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher atorvastatin calcium dosage. Discontinue atorvastatin calcium tablets if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue atorvastatin calcium in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis.
Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing atorvastatin calcium dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever (2.5, 5.1, 7.1, 8.5, 8.6). Immune-Mediated Necrotizing Myopathy (IMNM) : Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use.
Discontinue atorvastatin calcium tablets if IMNM is suspected (5.2). Hepatic Dysfunction : Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred.
Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue atorvastatin calcium tablets (5.3).
5.1Myopathy and Rhabdomyolysis Atorvastatin calcium may cause myopathy (muscle pain, tenderness, or weakness associated with elevated creatine kinase [CK]) and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis in patients treated with statins, including 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 (including other lipid-lowering therapies), and higher atorvastatin calcium dosage [ see Drug Interactions (7.1) and Use in Specific Populations (8.5, 8.6) ].
Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Atorvastatin calcium 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 atorvastatin is not recommended.
Atorvastatin calcium dosage modifications are recommended for patients taking certain anti-viral, azole antifungals, or macrolide antibiotic medications [see Dosage and Administration (2.5)]. 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 (7.1)].
Concomitant intake of large quantities, more than 1.2 liters daily, of grapefruit juice is not recommended in patients taking atorvastatin calcium [see Drug Interactions (7.1)]. Discontinue atorvastatin calcium tablets if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK elevations may resolve if atorvastatin calcium tablets are discontinued.
Temporarily discontinue atorvastatin calcium 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 atorvastatin dosage. Instruct pati…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1)] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2)] Hepatic Dysfunction [see Warnings and Precautions (5.3)] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4)] Most common adverse reactions (incidence ≥ 5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 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, 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 practice. In the atorvastatin calcium placebo-controlled clinical trial database of 16,066 patients (8,755 atorvastatin calcium vs. 7,311 placebo; age range 10 to 93 years, 39% women, 91% White, 3% Black, 2% Asian, 4% other) with a median treatment duration of 53 weeks, the 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%).
Table 1 summarizes adverse reactions reported in ≥ 2% and at a rate greater than placebo in patients treated with atorvastatin calcium (n=8,755), from seventeen placebo-controlled trials. Other adverse reactions reported in placebo-controlled trials 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 Elevations in Liver Enzyme Tests Persistent elevations in serum transaminases, defined as more than 3 times the ULN and occurring on 2 or more occasions, occurred in 0.7% of patients who received atorvastatin calcium in clinical trials.
The incidence of these abnormalities was 0.2%, 0.2%, 0.6%, and 2.3% for 10, 20, 40, and 80 mg, respectively. One patient in clinical trials developed jaundice. Increases in liver enzyme tests in other patients were not associated with jaundice or other clinical signs or symptoms.
Upon dose reduction, drug interruption, or discontinuation, transaminase levels returned to or near pretreatment levels without sequelae. Eighteen of 30 patients with persistent liver enzyme elevations continued treatment with a reduced dose of atorvastatin calcium. Treating to New Targets Study (TNT) In TNT, [see Clinical Studies (14.1)] 10,001 patients (age range 29 to 78 years, 19% women; 94% White, 3% Black, 1% Asian, 2% other) with clinically evident CHD were treated with atorvastatin calcium 10 mg daily (n=5006) or atorvastatin calcium 80 mg daily (n=4995).
In the high-dose atorvastatin calcium group there were more patients with serious adverse reactions (1.8%) and discontinuations due to adverse reactions (9.9%) as compared to the lowdose group (1.4%; 8.1%, respectively) during a median follow-up of 4.9 years. Persistent transaminase elevations (≥3 x ULN twice within 4 to 10 days) occurred in 1.3% of individuals with atorvastatin calcium 80 mg and in 0.2% of individuals with atorvastatin calcium 10 mg. Elevations of CK (≥ 10 x ULN) were higher in the high-dose atorvastatin calcium group (0.3%) compared to the low-dose…
🔄 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 ( 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 ( 7.7 ).
7.1Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Calcium Atorvastatin calcium is a substrate of CYP3A4 and transporters (e.g., OATP1B1/1B3, P-gp, or BCRP). atorvastatin calcium plasma levels can be significantly increased with concomitant administration of inhibitors of CYP3A4 and transporters. Table 2 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)].
1 1
7.2Drug Interactions that may Decrease Exposure to Atorvastatin Calcium Table 3 presents drug interactions that may decrease exposure to atorvastatin calcium and instructions for preventing or managing them. 1
7.3Atorvastatin Calcium Effects on Other Drugs Table 4 presents atorvastatin calcium effect on other drugs and instructions for preventing or managing them. 1
👥 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 ( 8.3 )
8.1Pregnancy Risk Summary Discontinue atorvastatin calcium when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Atorvastatin calcium decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin calcium may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1)].
In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations.
Published data from prospective and retrospective observational cohort studies with atorvastatin calcium tablets use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data). In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered atorvastatin at doses that resulted in 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/m2).
In rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development delay were 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 to 4% and 15 to 20%, respectively.
Data Human Data A Medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus.
There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births.
Animal Data Atorvastatin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 300 mg/kg/ day and 100 mg/kg/day, respectively. Atorvastatin was not teratogenic in rats at doses up to 300 mg/kg/day or in rabbits at doses up to 100 mg/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/m2).
In rats, the maternally toxic dose of 30…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Discontinue atorvastatin calcium when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Atorvastatin calcium decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin calcium may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1)].
In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations.
Published data from prospective and retrospective observational cohort studies with atorvastatin calcium tablets use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data). In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered atorvastatin at doses that resulted in 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/m2).
In rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development delay were 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 to 4% and 15 to 20%, respectively.
Data Human Data A Medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus.
There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births.
Animal Data Atorvastatin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 300 mg/kg/ day and 100 mg/kg/day, respectively. Atorvastatin was not teratogenic in rats at doses up to 300 mg/kg/day or in rabbits at doses up to 100 mg/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/m2).
In rats, the maternally toxic dose of 300 mg/kg resulted in increased post-implantation loss and decreased fetal body weight. At the maternally toxic doses of 50 and 100 mg/kg/day in rabbits, there was increased post-implantation loss, and at 100 mg/kg/day fetal body weights were decreased. In a study in pregnant rats administered 20, 100, or 2…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of atorvastatin calcium as an adjunct to diet to reduce LDL-C have been established pediatric patients 10 years of age and older with HeFH. Use of atorvastatin calcium for this indication is based on a double-blind, placebo-controlled clinical trial in 187 pediatric patients 10 years of age and older with HeFH. In this limited controlled trial, there was no significant effect on growth or sexual maturation in the boys or girls, or on menstrual cycle length in girls.
The safety and effectiveness of atorvastatin calcium as an adjunct to other LDL-C-lowering therapies to reduce LDL-C have been established pediatric patients 10 years of age and older with HoFH. Use of atorvastatin calcium for this indication is based on a trial without a concurrent control group in 8 pediatric patients 10 years of age and older with HoFH [see Clinical Studies (14)]. The safety and effectiveness of atorvastatin calcium have not been established in pediatric patients younger than 10 years of age with HeFH or HoFH, or in pediatric patients with other types of hyperlipidemia (other than HeFH or HoFH).
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of atorvastatin calcium tablets-treated patients in clinical trials, 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 patients and younger patients. Advanced age (≥65 years) is a risk factor for atorvastatin calcium tablets-associated myopathy and rhabdomyolysis.
Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. Monitor geriatric patients receiving atorvastatin calcium tablets for the increased risk of myopathy [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].
🆘 Overdosage ▾
10 OVERDOSAGE No specific antidotes for atorvastatin are known. Contact Poison Control (1-800-222-1222) for latest recommendations. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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 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 Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10, 20, 40 and 80 mg atorvastatin. 10 mg tablets Atorvastatin calcium tablets, 10 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “A10” on the other side. NDC 50268-093-15 10 tablets per card, 5 cards per carton.
20 mg tablets Atorvastatin calcium tablets, 20 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV20” on the other side. NDC 50268-094-15 10 tablets per card, 5 cards per carton. 40 mg tablets Atorvastatin calcium tablets, 40 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV40” on the other side.
NDC 50268-095-15 10 tablets per card, 5 cards per carton. 80 mg tablets Atorvastatin calcium tablets, 80 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV80” on the other side. NDC 50268-096-12 5 tablets per card, 4 cards per carton.
Dispensed in Unit Dose Package. For Institutional Use Only. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Dispense in a tight container [see USP].
📋 Description ▾
11 DESCRIPTION Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate.
The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 *C3H8O2 and its molecular weight is 1231.46 g/mol. Its structural formula is: Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol.
Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide. chemical-structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Myopathy and Rhabdomyolysis Advise patients that atorvastatin may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication or consuming large quantities of grapefruit juice and they should discuss all medication, both prescription and over the counter, with their healthcare provider.
Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.1), Drug Interactions (7.1)]. Hepatic Dysfunction Inform patients that atorvastatin calcium tablets may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions (5.3)].
Increases in HbA1c and Fasting Serum Glucose Levels Inform patients that increases in HbA1c and fasting serum glucose levels may occur with atorvastatin calcium tablets. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions (5.4)]. Pregnancy Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus.
Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if atorvastatin calcium tablets should be discontinued [see Use in Specific Populations (8.1)]. Lactation Advise patients that breastfeeding is not recommended during treatment with atorvastatin calcium tablets [see Use in Specific Populations (8.2)]. All registered trademarks in this document are the property of their respective owners.
Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. 06/23 AV Rev.
11/23 (M) AvPAK