Atorvastatin

(a tore' va sta tin)

PCI / LCIContraindication for pregnancy & lactation (breast feeding)

Molecule Info

| See TERMINOLOGY & ABBREVIATIONS |

Major Developments

Recent major changes with U.S. FDA:

Dosage and Administration          10/2012

Warnings and Precautions           10/2012

Drug Interactions                             02/2012

Indication(s)

Atorvastatin is an inhibitor of HMG-CoA reductase (statin) indicated as an adjunct therapy to diet to:

  • Reduce the risk of MI, stroke, revascularization procedures, and angina in patients without CHD, but with multiple risk factors.
  • Reduce the risk of MI and stroke in patients with type 2 diabetes without CHD, but with multiple risk factors.
  • Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in patients with CHD.
  • 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.
  • Reduce elevated TG in patients with hypertriglyceridemia and primary dysbetalipoproteinemia.
  • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH).
  • Reduce elevated total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy.

Limitations of Use: Atorvastatin has not been studied in Fredrickson Types I and V dyslipidemias.

Dosage & Administration

  • Dose range: 10 to 80 mg once daily.
  • Recommended start dose: 10 or 20 mg once daily.
  • Patients requiring large LDL-C reduction (>45%) may start at 40 mg once daily.
  • Pediatric starting dose: 10 mg once daily; maximum recommended dose: 20 mg once daily.

Overdosage

Symptomatic and supportive treatment.

Contraindications

  •  Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels.
  • Women who are pregnant or may become pregnant.
  • Nursing mothers.
  • Hypersensitivity to any component of this medication

Warning & 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 therapy should be discontinued if myopathy is diagnosed or suspected.
  • Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter.
  • 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 80 mg group vs. placebo.

Adverse Drug Reaction(s)

Headache, flatulence, diarrhoea, nausea, vomiting, anorexia, xerostomia, angioedema, myalgia, rash/pruritus, alopecia, allergy, infection, chest pain.
Potentially Fatal: Thrombocytopenia. Rhabdomyolysis with acute renal failure.

Drug Interactions

Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis
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) and Hepatitis C protease inhibitor (boceprevir) Do not exceed 40 mg atorvastatin daily

Lab Interference

Biochemical abnormalities of liver function tests.

Pregnancy Category (FDA)

Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Pharmacology

Atorvastatin competitively inhibits HMG-CoA reductase, the enzyme that catalyses the conversion of HMG-CoA to mevalonic acid. This results in the induction of the LDL receptors, leading to lowered LDL-cholesterol concentration.
Absorption: Rapid from the GI tract (oral).
Distribution: Protein-binding: 98%.
Metabolism: Extensively hepatic; converted to active inhibitors of HMG-CoA reductase.
Excretion: Faeces (as metabolites); 14 hr (elimination half-life).

ATC Classification

C10AA05 - atorvastatin; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

 

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Brand/Product Info


Total Products : 55                                                       
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
ANZITOR 10 Square Pharmaceuticals Ltd. Atorvastatin 10mg Tablet 5x10's: 600.00 MRP
ANZITOR 20 Square Pharmaceuticals Ltd. Atorvastatin 20mg Tablet 3x10's: 600.00 MRP
ANZITOR 40 Square Pharmaceuticals Ltd. Atorvastatin 40mg Tablet 1x10's: 280.00 MRP
ASTIN Jayson Pharmaceuticals Ltd. Atorvastatin 10mg & 20mg Film Coated Tablet 10mg x30's, 20mgx 10's: 241.20, 150.50 IP
ASTIVA Supreme Pharmaceuticals Ltd. Atorvastatin 10mg & 20mg Film Coated Tablet 10's each: 75.00 & 140.00 MRP
ATASIN ACI Ltd. Atorvastatin 10mg & 20mg & 40mg Film Coated Tablet 10mg x30's, 20mg x20's, 40mg x10's: 301.20, 361.40 & 240.90 MRP
ATOLIP Ziska Pharmaceuticals Ltd. Atorvastatin 10mg Film Coated Tablet 30's: 240.00 MRP
ATORVAST Medimet Pharmaceuticals Ltd Atorvastatin 10mg Film Coated Tablet 30's: 240.00 MRP
ATOVA 10 Beximco Pharmaceuticals Ltd Atorvastatin Calcium Trihydrate INN eq. to Atorvastatin 10mg Tablet 30's: 300.00 MRP
ATOVA 20 Beximco Pharmaceuticals Ltd Atorvastatin Calcium Trihydrate INN eq. to Atorvastatin 20mg Tablet 20's: 360.00 MRP
ATOVA 40 Beximco Pharmaceuticals Ltd Atorvastatin Calcium Trihydrate INN eq. to Atorvastatin 40mg Tablet 20's: 480.00 MRP
ATOVEX R A K Pharmaceuticals Pvt. Ltd. Atorvastatin 10mg & 20mg & 40mg Film Coated Tablet 10mg x30's, 20mg x20's, 40mg x10's: 300.00, 320.00 & 220.00 MRP
ATOVIN Alco Pharma Ltd Atorvastatin 10mg Film Coated Tablet 10's: 100.00 MRP
ATV Delta Pharma Limited Atorvastatin 10mg & 20mg Film Coated Tablet 10mg x30's, 20mgx 10's: 150.00 & 100.00 MRP
AVAS Opsonin Pharma Limited Atorvastatin 10mg & 20mg & 40mg Film Coated Tablet 10mg x30's, 20mg x10's, 40mg x10's: 300.00, 180.00 & 240.00 MRP
AVASTATIN Edruc Limited Atorvastatin 10mg Film Coated Tablet 10mg x10's: 80.00 IP
AVOCARD The White Horse Pharma Atorvastatin 10mg & 20mg & 40mg Film Coated Tablet 30's each: 300.00, 320.00 & 660.00 MRP
AZTOR Sun Pharmaceutical (Bangladesh) Ltd. Atorvastatin 10mg & 20mg & 40mg Film Coated Tablet 10mg x50's, 20mg x30's, 40mg x30's: 502.50, 543.00 & 720.00 MRP
CLOLES-10 Doctors Chemical Works Ltd Atorvastatin 10mg Film Coated Tablet 30's: 240.00 MRP
COLOSTAT IBN SINA Pharmaceutical Industry Ltd. Atorvastatin 10mg & 20mg Film Coated Tablet 30's each: 300.00, 451.80 IP
DIVASTIN Drug International Ltd Atorvastatin 10mg & 20mg, & 40mg Film Coated Tablet 10mg x30's, 20mg x20's, 40mg x20's: 300.00, 360.00 & 480.00 MRP
G-ATROVAST Gonoshasthaya Pharmaceuticals Ltd Atorvastatin 10mg & 20mg Film Coated Tablet 30's each: 210.30 & 361.80 MRP
LIPEX-10 Orion Pharma Ltd. Atorvastatin 10mg & 20mg Film Coated Tablet 10mg x30's, 20mg x20's: 270.00 & 301.20 MRP
LIPICON Eskayef Bangladesh Ltd Atorvastatin Calcium Trihydrate INN equivalent to Atorvastatin 10mg, 20mg & 40mg Film Coated Tablet 10mg x40's, 20mg x20's & 40mg x10's MRP: 400.00, 360.00 & 240.00
LIPICUT Rangs Pharmaceuticals Ltd. Atorvastatin 10mg & 20mg Film Coated Tablet 10mg x30's, 20mg x20's: 240.00 & 300.00 MRP
LIPIGENT Pacific Pharmaceuticals Ltd. Atorvastatin 10mg & 20mg Film Coated Tablet 10mg x30's, 20mg x20's: 300.00 & 360.00 MRP
LIPINOR Rephco Laboratories Ltd. Atorvastatin 10mg Film Coated Tablet 30's: 210.00 MRP
LIPITIN General Pharmaceuticals Ltd Atorvastatin 10mg & 20mg Film Coated Tablet 10mg x30's, 20mg x20's: 301.20 & 180.70 MRP
LIPLO Globe Pharmaceuticals Ltd Atorvastatin 10mg & 20mg Film Coated Tablet 10's each: 100.00 & 150.00 MRP
LIPOBI 10 Nipa Pharmaceuticals Ltd. Atorvastatin 10mg Film Coated Tablet 30's: 240.00 MRP
LIPOSTAT Navana Pharmaceuticals Limited Atorvastatin 10mg & 20mg Film Coated Tablet 30's each: 210.00 & 360.00 MRP
LIPOVAST Sharif Pharmaceuticals Ltd. Atorvastatin 10mg Film Coated Tablet 30's: 300.00 MRP
LIPTOR The Acme Laboratories Ltd. Atorvastatin 10mg & 20mg & 40mg Film Coated Tablet 10mg x20's, 20mg x10's, 40mg x10's: 200.80, 180.60 & 240.90 MRP
LIVAS Techno Drugs Atorvastatin 10mg & 20mg Film Coated Tablet 10mg x30's, 20mg x20's: 300.00 MRP
LOCOL Popular Pharmaceuticals Ltd. Atorvastatin 10mg & 20mg & 40mg Film Coated Tablet 30's each: 301.21, 542.10 & 750.00 MRP
ORVA Sanofi Atorvastatin 10mg & 20mg Film Coated Tablet 30's each: 301.20 & 450.00 MRP
ORVATIN Kemiko Pharmaceuticals Ltd Atorvastatin 10mg & 20mg Film Coated Tablet 20's each: 160.00 & 340.00 MRP
STACOR Unimed & Unihealth Manufacturers Ltd. Atorvastatin 10mg & 20mg & 40mg Film Coated Tablet 10mg x30's, 20mg x20's, 40mg x10's: 300.00, 360.00 & 240.00 MRP
TAVEN Renata Limited Atorvastatin 10mg & 20mg Film Coated Tablet 30's each: 301.20 & 541.80 MRP
TCL-R Aristopharma Ltd. Atorvastatin 10mg & 20mg Film Coated Tablet 10mg x30's, 20mg x10's: 300.00 & 180.00 MRP
Tiginor 10 Incepta Pharmaceuticals Limited Atorvastatin Calcium Trihydrate INN equivalent to Atorvastatin 10mg Tablet 10x3's:MRP 300 Tk
Tiginor 20 Incepta Pharmaceuticals Limited Atorvastatin Calcium Trihydrate INN equivalent to Atorvastatin 20mg Tablet 20's:MRP 360 Tk
Tiginor 40 Incepta Pharmaceuticals Limited Atorvastatin Calcium Trihydrate INN equivalent to Atorvastatin 40mg Tablet 20's:MRP 480 Tk
TORVAS Kumudini Pharma Ltd Atorvastatin 10mg Film Coated Tablet 30's: 270.00 MRP
TROVA Biopharma Laboratories Ltd Atorvastatin 10mg & 20mg Film Coated Tablet 10mg x30's, 20mg x10's: 240.90 & 150.60 MRP
VASS 10 Sandoz/Novartis Atorvastatin Calcium Trihydrate INN equivalent to Atorvastatin 10mg Film Coated Tablet 3x10's, MRP 360
VASS 20 Sandoz/Novartis Atorvastatin Calcium Trihydrate INN equivalent to Atorvastatin 20mg Film Coated Tablet 2x10's, MRP 400
VASS 40 Sandoz/Novartis Atorvastatin Calcium Trihydrate INN equivalent to Atorvastatin 40mg Film Coated Tablet 1x10's, MRP 250
VASTIN Pharmadesh Laboratories Limited Atorvastatin 10mg Film Coated Tablet 20's: 160.60 MRP
XELITOR Novo Healthcare and Pharma Ltd. Atorvastatin 10mg & 20mg & 40mg Film Coated Tablet 10mg x30's, 20mg x20's, 40mg x20's: 240.00, 361.40 & 481.81 MRP
XELPID 10 Healthcare Pharmacuticals Ltd. Atorvastatin Calcium Trihydrate INN equivalent to Atorvastatin 10mg Tablet 30's MRP 300 Tk
XELPID 20 Healthcare Pharmacuticals Ltd. Atorvastatin Calcium Trihydrate INN equivalent to Atorvastatin 20mg Tablet 10's MRP 180 Tk
XELPID 40 Healthcare Pharmacuticals Ltd. Atorvastatin Calcium Trihydrate INN equivalent to Atorvastatin 40mg Tablet 10's MRP 240 Tk
XEROVA Beacon Pharmaceuticals Limited Atorvastatin 10mg & 20mg Film Coated Tablet 10mg x30's, 20mg x20's: 300.90 & 360.00 MRP
ZAPITOR Apex Pharmaceuticals Ltd. Atorvastatin 10mg & 20mg Film Coated Tablet 10mg x30's, 20mg x20's: 300.00 & 360.00 MRP

Gen. MedInfo

Why is Atorvastatin prescribed?

Atorvastatin is used along with diet, exercise, and weight loss to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. Atorvastatin is also used to decrease the amount of cholesterol (a fat-like substance) and other fatty substances in the blood. Atorvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

How should Atorvastatin be used?

Atorvastatin comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take atorvastatin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take atorvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of atorvastatin and gradually increase your dose, not more than once every 2 to 4 weeks.

Continue to take atorvastatin even if you feel well. Do not stop taking atorvastatin without talking to your doctor.

Other uses for Atorvastatin

Atorvastatin may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions to follow?

Before taking atorvastatin,
  • inform your doctor and pharmacist if you are allergic to atorvastatin or any other medications.
  • inform your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antifungal medications such as itraconazole and ketoconazole (Nizoral); cimetidine; clarithromycin; colchicine; digoxin; diltiazem; erythromycin; efavirenz; oral contraceptives (birth control pills); other cholesterol-lowering medications such as fenofibrate, gemfibrozil, and niacin; certain protease inhibitors such as darunavir, fosamprenavir, lopinavir, nelfinavir, saquinavir, ritonavir and tipranavir; medications that suppress the immune system such as cyclosporine (Neoral, Sandimmune); rifampin (Rimactane); spironolactone, and telaprevir. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • inform your doctor if you have liver disease. Your doctor will order laboratory tests to see how well your liver is working even if you do not think you have liver disease. Your doctor will probably inform you not to take atorvastatin if you have or have had liver disease or if the tests show you may be developing liver disease.
  • inform your doctor if you consume more than 2 alcoholic beverages daily, if you have ever had liver disease, and if you have or have ever had muscle aches or weakness; diabetes; seizures; low blood pressure; or thyroid or kidney disease.
  • inform your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking atorvastatin, stop taking atorvastatin and call your doctor immediately. Atorvastatin may harm the fetus. 
  • do not breast-feed while you are taking Atorvastatin. 
  • if you are having surgery, including dental surgery, inform the doctor or dentist that you are taking atorvastatin. If you are hospitalized due to serious injury or infection, inform the doctor who treats you that you are taking atorvastatin.
  • ask your doctor about the safe use of alcoholic beverages while you are taking atorvastatin. Alcohol can increase the risk of serious side effects.

What special dietary instructions to follow?

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the US National Cholesterol Education Program (NCEP) website for additional dietary information at http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

Avoid drinking large amounts [more than 1.2 liter (approximately 1 quart) per day] of grapefruit juice while taking atorvastatin.

What to do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is less than 12 hours until your next scheduled dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can Atorvastatin cause?

Atorvastatin may cause side effects. inform your doctor if any of these symptoms are severe or do not go away:
  • diarrhea
  • constipation
  • gas
  • headache
  • joint pain
  • forgetfulness or memory loss
  • confusion
  • muscle pain, tenderness, or weakness
  • lack of energy
  • fever
  • chest pain
  • nausea
  • extreme tiredness
  • weakness
  • unusual bleeding or bruising
  • loss of appetite
  • pain in the upper right part of the stomach
  • flu-like symptoms
  • dark colored urine
  • yellowing of the skin or eyes
  • rash
  • hives
  • itching
  • difficulty breathing or swallowing
  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • hoarseness

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor or get emergency medical help immediately.

Atorvastatin may cause other side effects. Consult your doctor if you have any unusual problems while taking Atorvastatin.

 Ref: MedlinePlus, U.S. Natl. Library of Medicine


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

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