Atorvastatin

Atorvastatin calcium tablets are indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD 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: Adults with primary hyperlipidemia. …

• Take orally once daily with or without food
• Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium tablets, and adjust dosage if necessary
• Adults : Recommended starting dosage is 10 or 20 mg once daily; dosage range is 10 mg to 80 mg once daily
• Patients requiring LDL-C reduction >45% may start at 40 mg once daily
• Pediatric Patients Aged 10 Years of Age and Older with HeFH: Recommended starting dosage is 10 mg once daily; dosage range is 10 to 20 mg once daily
• Pediatric Patients Aged 10 Years of Age and Older with HoFH: Recommended starting dosage is 10 to 20 mg once daily; dosage range is 10 to 80 mg once daily
• See full prescribing information for atorvastatin calcium tablets dosage modifications due to drug interactions
• Important Dosage Information Take atorvastatin calcium tablets 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
• Recommended Dosage in Adult Patients The recommended starting dosage of atorvastatin calcium tablets are 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
• Recommended Dosage
• In Pediatric Patients 10 Years of Age and Older with HeFH The recommended starting dosage of atorvastatin calcium tablets are 10 mg once daily

Atorvastatin calcium tablets, USP: 10 mg of atorvastatin: white coloured, oval shaped, biconvex, film-coated tablets with “MA” on one side and “1” on other side. 20 mg of atorvastatin: white coloured, oval shaped, biconvex, film-coated tablets with “MA” on one side and “2” on other side. …

• 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. …

Of the total number of atorvastatin calcium -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 -associated myopathy and rhabdomyolysis. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Myopathy and Rhabdomyolysis Advise patients that atorvastatin calcium 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 , Drug Interactions ] . …

• Acute liver failure or decompensated cirrhosis [see Warnings and Precautions ] Hypersensitivity to atorvastatin or any excipients in atorvastatin calcium
• Hypersensitivity reactions, including anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported [see Adverse Reactions ]
• Acute liver failure or decompensated cirrhosis
• Hypersensitivity to atorvastatin or any excipient in atorvastatin calcium

See full prescribing information for details regarding concomitant use of atorvastatin calcium with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis ( 2.5 , 7.1 ). Rifampin: May reduce atorvastatin plasma concentrations. Administer simultaneously with atorvastatin calcium ( 7.2 ). Oral Contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider this effect when selecting an oral contraceptive (7.3 ). Digoxin: May increase digoxin plasma levels; monitor patients appropriately ( 7.3 ). …

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 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. …

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 Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary Discontinue atorvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. atorvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ] . …

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.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.