What is Atorvastatin Calcium?
Atorvastatin Calcium is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Atorvastatin Calcium reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).
Atorvastatin Calcium is used to treat high cholesterol, and to lower the risk of stroke, heart attack, or other heart complications in people with type 2 diabetes, coronary heart disease, or other risk factors.
Atorvastatin Calcium is used in adults and children who are at least 10 years old.
Atorvastatin Calcium may also be used for purposes not listed in this medication guide.
Atorvastatin Calcium indications
Reduce the amount of cholesterol in blood.
Slow the progression of atherosclerosis (hardening) of the arteries that nourish the heart, causing so-called coronary heart disease (CHD).
Reduce the development of new atherosclerosis.
It is indicated:
As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in 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 patients with elevated serum TG levels (Fredrickson Type IV);.
For the treatment of 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 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 boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia 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:
there is a positive family history of premature cardiovascular disease or
two or more other CVD risk factors are present in the pediatric patient.
How should I use Atorvastatin Calcium?
Use Atorvastatin Calcium as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Atorvastatin Calcium. Talk to your pharmacist if you have questions about this information.
- Take Atorvastatin Calcium by mouth with or without food.
- Swallow Atorvastatin Calcium whole. Do not break, crush, or chew before swallowing.
- Taking Atorvastatin Calcium at the same time each day will help you remember to take it.
- Eating grapefruit or drinking grapefruit juice may increase the amount of Atorvastatin Calcium in your blood, which may increase your risk for serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice. Avoid large amounts of grapefruit or grapefruit juice (eg, more than 1 quart daily). Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking Atorvastatin Calcium.
- Continue to take Atorvastatin Calcium even if you feel well. Do not miss any doses.
- If you miss a dose of Atorvastatin Calcium, take it as soon as possible if you remember within 12 hours of the missed dose. If it is more than 12 hours since the missed dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Atorvastatin Calcium.
Uses of Atorvastatin Calcium in details
Use: Labeled Indications
Heterozygous familial hypercholesterolemia: To reduce elevated total cholesterol (total-C), LDL cholesterol (LDL-C), apolipoprotein B (apo B), and triglyceride levels, and to increase HDL cholesterol in patients with primary hypercholesterolemia.
Heterozygous familial hypercholesterolemia (pediatrics): To reduce total-C, LDL-C, and apo B levels in pediatric patients 10 to 17 years of age with heterozygous familial hypercholesterolemia with LDL-C ≥190 mg/dL, LDL-C ≥160 mg/dL with positive family history of premature cardiovascular disease (CVD), or LDL-C ≥160 mg/dL with 2 or more other CVD risk factors.
Homozygous familial hypercholesterolemia: To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable.
Prevention of atherosclerotic cardiovascular disease:
Primary prevention of atherosclerotic cardiovascular disease (ASCVD): To reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adult patients without a history of coronary heart disease (CHD) but who have multiple CHD risk factors.
Secondary prevention in patients with established ASCVD: To reduce the risk of MI, stroke, revascularization procedures, and angina in patients with a history of CHD.
Off Label Uses
Transplantation, post heart or post kidney
Based on the 2010 International Society of Heart and Lung Transplantation guidelines for the care of heart transplant recipients, Atorvastatin Calcium is effective and recommended following heart transplant, regardless of cholesterol levels, to reduce cardiac allograft vasculopathy and improve long-term outcomes.
Based on the 2013 Kidney Disease: Improving Global Outcomes clinical practice guideline for lipid management in chronic kidney disease, Atorvastatin Calcium is suggested following kidney transplant to reduce cardiovascular events (eg, myocardial infarction, stroke, cardiovascular death).
Atorvastatin Calcium description
Atorvastatin Calcium 10: Each tablet contains Atorvastatin Calcium equivalent to 10 mg Atorvastatin Calcium.
Atorvastatin Calcium 20 mg: Each tablet contains Atorvastatin Calcium equivalent to 20 mg Atorvastatin Calcium.
Atorvastatin Calcium 40 mg: Each tablet contains Atorvastatin Calcium equivalent to 40 mg Atorvastatin Calcium.
Atorvastatin Calcium 80 mg: Each tablet contains atorvastin calcium equivalent to 80 mg Atorvastatin Calcium.
Atorvastatin Calcium is a white, elliptical film coated tablet containing Atorvastatin Calcium. Atorvastatin Calcium is a synthetic lipid-lowering agent, which 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.
The empirical formula of Atorvastatin Calcium is (C33H34FN2O5)2Ca·3H2O and its molecular weight is 1209.42.
Atorvastatin Calcium is a white to off-white crystalline powder, practically insoluble in aqueous solutions of pH 4 and below. It is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol.
Atorvastatin Calcium dosage
The treatment by Atorvastatin Calcium is with a standard diet for patients with hypercholesterolemia. The dose is determined individually, depending on the initial cholesterol levels. This medication is taken orally. The initial dose is usually 10 mg 1 time / day. The effect is manifested within 2 weeks, and the maximum effect is for 4 weeks. If necessary, the dose can be gradually increased every 4 weeks or more. The maximum daily dose is 80 mg.
Atorvastatin Calcium interactions
See also:
What other drugs will affect Atorvastatin Calcium?
When this drug applied simultaneously with:
- digoxin slightly increased concentration of digoxin in plasma.
- itraconazole greatly increases the concentration of Atorvastatin Calcium in plasma, apparently due to inhibition of itraconazole its metabolism in the liver that occurs with the participation of isoenzyme CYP3A4; increased risk of myopathy.
- colestipol may decrease the concentration of Atorvastatin Calcium in plasma, with lipid-lowering effect is enhanced.
- antacids containing magnesium hydroxide and aluminum hydroxide, reduce the concentration of Atorvastatin Calcium by approximately 35%.
- cyclosporine, fibrates (including gemfibrozil), azole antifungals derivatives, nicotinic acid increases the risk of myopathy.
- erythromycin, clarithromycin moderately increased concentrations of Atorvastatin Calcium in plasma, increases the risk of myopathy.
- ethinyl estradiol, norethisterone (norethindrone) slightly increases the concentration of ethinyl estradiol, norethisterone and (norethindrone) in blood plasma.
- protease inhibitors increases the concentration of Atorvastatin Calcium in plasma, as protease inhibitors are inhibitors of the CYP3A4 isoenzyme.
Diltiazem, verapamil, isradipine inhibit isoenzyme CYP3A4, which participates in the metabolism of Atorvastatin Calcium, so that while the use of these calcium channel blockers may increase the concentration of Atorvastatin Calcium in plasma and increased risk of myopathy.
Atorvastatin Calcium side effects
See also:
What are the possible side effects of Atorvastatin Calcium?
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.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Atorvastatin Calcium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions associated with Atorvastatin Calcium therapy reported since market introduction, that are not listed above, regardless of causality assessment, include the following: anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), rhabdomyolysis, fatigue, tendon rupture, hepatic failure, dizziness, memory impairment, depression, and peripheral neuropathy.
Pediatric Patients (ages 10-17 years)
In a 26-week controlled study in boys and postmenarchal girls, the safety and tolerability profile of Atorvastatin Calcium 10 to 20 mg daily was generally similar to that of placebo.
Atorvastatin Calcium contraindications
See also:
What is the most important information I should know about Atorvastatin Calcium?
Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
Hypersensitivity to any component of this medication
Pregnancy
Women who are pregnant or may become pregnant. Atorvastatin Calcium may cause fetal harm when administered to a pregnant woman. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. There are no adequate and well-controlled studies of Atorvastatin Calcium use during pregnancy; however in rare reports, congenital anomalies were observed following intrauterine exposure to statins. In rat and rabbit animal reproduction studies, Atorvastatin Calcium revealed no evidence of teratogenicity. Atorvastatin Calcium SHOULD BE ADMINISTERED TO WOMEN OF CHILDBEARING AGE ONLY WHEN SUCH PATIENTS ARE HIGHLY UNLIKELY TO CONCEIVE AND HAVE BEEN INFORMED OF THE POTENTIAL HAZARDS. If the patient becomes pregnant while taking this drug, Atorvastatin Calcium should be discontinued immediately and the patient apprised of the potential hazard to the fetus.
Nursing mothers
It is not known whether Atorvastatin Calcium is excreted into human milk; however a small amount of another drug in this class does pass into breast milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require Atorvastatin Calcium treatment should not breastfeed their infants.
Active ingredient matches for Atorvastatin Calcium:
Atorvastatin Calcium
| Unit description / dosage (Manufacturer) | Price, USD |
| Atorvastatin Calcium tablet, film coated 20 mg/1 (Legacy Pharmaceutical Packaging (US)) | |
| Atorvastatin Calcium tablet, film coated 80 mg/1 (Watson Laboratories, Inc. (US)) | |
| Atorvastatin Calcium tablet, film coated 10 mg/1 (Greenstone LLC (US)) | |
| Atorvastatin Calcium tablet, film coated 40 mg/1 (Legacy Pharmaceutical Packaging (US)) | |
| Atorvastatin Calcium tablet 40 mg/1 (Dr. Reddy's Laboratories Limited (US)) | |
| Atorvastatin Calcium tablet 10 mg/1 (Ncs Health Care Of Ky, Inc Dba Vangard Labs (US)) | |
| Atorvastatin Calcium tablet 20 mg/1 (State of Florida DOH Central Pharmacy (US)) | |
| Atorvastatin Calcium tablet, film coated 20 mg/301 (Northwind Pharmaceuticals (US)) | |
| Atorvastatin Calcium tablet 80 mg/1 (Dr. Reddy's Laboratories Limited (US)) | |
| Atorvastatin Calcium tablet, film coated 10 mg/301 (Northwind Pharmaceuticals (US)) | |
| Atorvastatin Calcium tablet, film coated 80 mg/301 (Northwind Pharmaceuticals (US)) | |
List of Atorvastatin Calcium substitutes (brand and generic names): | |
| Aarpik | |
| Aarpik 10 mg Tablet (Mefro Pharmaceuticals Pvt Ltd) | $ 0.08 |
| Aarpik 20 mg Tablet (Mefro Pharmaceuticals Pvt Ltd) | $ 0.16 |
| ATOSAR 10 (India) | |
| 10 mg x 100's (Sarthak) | $ 0.87 |
| ATOSAR 10 tab 10 mg x 10's (Sarthak) | $ 0.09 |
| Bvas | |
| Bvas 20 mg Tablet (Biomax Laboratories) | $ 0.16 |
| Bvas 10 mg Tablet (Biomax Laboratories) | $ 0.08 |
| Caduet FC | |
| Caduet FC 10+5 Tablet (Pfizer Limited (Pharmacia India Pvt Ltd)) | $ 0.71 |
| HARTOR (India) | |
| 10 mg x 10's (United Biotech) | |
| 20 mg x 10's (United Biotech) | |
| Hartor 10mg TAB / 10 (United Biotech) | |
| Hartor 20mg TAB / 10 (United Biotech) | |
| HARTOR tab 10 mg x 10's (United Biotech) | |
| HARTOR tab 20 mg x 10's (United Biotech) | |
| Hartor 10mg TAB / 10 (United Biotech) | |
| Hartor 20mg TAB / 10 (United Biotech) | |
| Nurovas | |
| Nurovas 20 mg Tablet (Modgal Pharmaceuticals (P) Ltd.) | $ 0.10 |
| Nurovas 10 mg Tablet (Modgal Pharmaceuticals (P) Ltd.) | $ 0.06 |
| Stator EZ | |
| Stator EZ 5+10 Tablet (Abbott Healthcare Pvt Ltd (AHPL)) | $ 0.10 |
| Stator EZ 10+10 Tablet (Abbott Healthcare Pvt Ltd (AHPL)) | $ 0.14 |
| Vasta EZ | |
| Vasta EZ 10+10 Tablet (Sunij Pharma Pvt Ltd) | $ 0.06 |
| VASTA EZ 10 MG/10 MG TABLET 1 strip / 10 tablets each (Sunij Pharma Pvt Ltd) | $ 0.71 |
| Vasta EZ 10 mg/10 mg Tablet (Sunij Pharma Pvt Ltd) | $ 0.07 |
| X’tor | |
| Zenolip | |
| Zenolip 10 mg Tablet (Wintech Pharmaceuticals) | $ 0.07 |
References
- DailyMed. "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "atorvastatin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "atorvastatin". http://www.drugbank.ca/drugs/DB01076 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Atorvastatin Calcium are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Atorvastatin Calcium. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
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Information checked by Dr. Sachin Kumar, MD Pharmacology
