Atorvin

Atorvin

atorvastatin

Manufacturer:

Unison

Distributor:

Medline

Marketer:

Medline
Concise Prescribing Info
Contents
Atorvastatin Ca
Indications/Uses
Dyslipidemias or primary prevention of CV disease (atherosclerotic). Primary prevention of CV disease (high risk for CVD). Secondary prevention of CV disease. Prevention of atherosclerotic CV disease (ASCVD) (primary & secondary prevention). Heterozygous familial hypercholesterolemia (HeFH) in adolescent patients (10-17 yr, females >1 yr postmenarche) having LDL-C ≥190 mg/dL, LDL-C ≥160 mg/dL w/ positive family history of premature CV disease (CVD) w/ ≥2 other CVD risk factors.
Dosage/Direction for Use
Primary prevention: Individualized dose according to the baseline LDL-C conc, recommended goal of therapy, & patient response. Adjustments should be made at intervals of 2-4 wk (4 wk for childn). HeFH Childn 10-17 yr (female >1 yr postmenarche) 10 mg once daily. Max: 20 mg/day. Hypercholesterolemia (heterozygous familial & nonfamilial) & mixed hyperlipidemia (Fredrickson types IIa & IIb) Adult Initially 10 or 20 mg once daily. Patients requiring >45% reduction in LDL-C Initially at 40 mg once daily. Dose range: 10-80 mg once daily. Homozygous familial hypercholesterolemia Adult 10-80 mg once daily. Prevention of CVD/reduce risk of ASCVD Primary: Adult ≥21 yr w/ LDL-C ≥190 mg/dL: High intensity therapy: 80 mg once daily. May reduce to 40 mg once daily, if unable to tolerate. Adult 40-75 yr w/ type 1 or 2 diabetes w/ an estimated 10-year ASCVD risk ≥7.5% High-intensity therapy: 80 mg once daily. Adult 40-75 yr w/ an estimated 10-year ASCVD risk ≥7.5% Moderate- to high-intensity therapy: 10-80 mg once daily. Secondary prevention: Patients >75 yr or not a candidate for high intensity therapy Moderate-intensity therapy: 10-20 mg once daily, ≤75 yr High-intensity therapy: 80 mg once daily. May reduce dose to 40 mg once daily.
Administration
May be taken with or without food: May take w/o regard to time of day. Avoid excessive consumption (>1 L/day) of grapefruit juice. 
Contraindications
Hypersensitivity. Active liver disease. Unexplained persistent elevations of serum transaminases. Pregnancy & lactation.
Special Precautions
Secondary cause of hyperlipidemia should be ruled out prior to therapy. Chylomicron elevation (Fredrickson type I and V). Monitor liver function by periodic laboratory assessment. May cause hepatic dysfunction. Caution in patients who consume large amounts of ethanol or have a history of liver disease; contraindicated in patients w/ active liver disease or unexplained persistant elevations of serum transaminases. Rhabdomyolysis w/ acute renal failure has occurred. Concurrent use of lipid lowering agents which may cause rhabdomyolysis (fibric acid derivatives or niacin at dose ≥1 g/day) or potent CYP3A4 inhibitors. Ensure patient is on the lowest effective atorvastatin dose. Consider dose adjustment in concurrent use of clarithromycin or combination PIs (eg, lopinavir/ritonavir or ritonavir/saquinavir). Avoid use of cyclosporine, gemfibrozil, telaprevir, & tipranavir/ritonavir. Discontinue treatment if markedly elevated CPK levels (≥10 times of ULN) occur or myopathy is diagnosed. Increased risk of hemorrhagic stroke in patients w/ recent stroke or TIA receiving long-term therapy. Continuation of HMG-CoA reductase inhibitor therapy in the perioperative period.
Adverse Reactions
Diarrhea, arthralgia, nasopharyngitis, hemorrhagic stroke, insomnia, malaise, nightmares, urticaria, DM, hyperglycemia, nausea, dyspepsia, abdominal distress, cholestasis, eructation, flatulence, UTI, urine abnormality, increased serum transaminases, abnormal hepatic function tests, hepatitis, increased serum alkaline phosphatase, limb pain, myalgia, musculoskeletal pain, muscle spasm, increased creatine phosphokinase, joint swelling, muscle fatigue, neck pain, blurred vision, tinnitus, pharyngolaryngeal pain, epistaxis, fever.
Drug Interactions
Concomitant use w/ bosutinib, conivaptan, cyclosporin, fusidic acid, gemfibrozil, idelalisib, pazopanib, pimozide, posaconazole, red yeast rice, telaprevir, tipranavir. May increase the levels/effects of aliskiren, aripiprazole, cimetidine, daptomycin, digoxin, diltiazem, dofetilide, flibanserin, hydrocodone, ketoconazole, lomitapide, midazolam, nimodipine, pazopanib, pimozide, repaglinide, spironolactone, trabectedin, verapamil. Increased levels/effects by amiodarone, aprepitant, azithromycin, boceprevir, clarithromycin, cobicistat, colchicine, cyclosporine, CYP3A4 inhibitors (moderate & strong), cyproterone, danazol, dasatinib, diltiazem, dronedarone, elthombopag, erythromycin, fenofibrate & derivatives, fluconazole, fusidic acid, gemfibrozil, grapefruit juice, itraconazole, ketoconazole, mifepristone, niacin, niacinamide, ritonavir, dasabuvir, PIs, quinine, raltegravir, red yeast rice, telithromycin, ticagrelor, verapamil, voriconazole. May decrease the levels/effects of dabigatran etexilate, lanthanum. Levels/effects may be decreased by antacids, bile acid sequestrants, bosentan, CYP3A4 inducers (moderate/strong), deferasirox, efavirenz, etravirine, fosphenytoin, phenytoin, rifamycin derivatives, St. John's Wort, tocilizumab.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Atorvin FC tab 10 mg
Packing/Price
10 × 10's;3 × 10's
Form
Atorvin FC tab 80 mg
Packing/Price
10 × 10's;3 × 10's
Form
Atorvin FC tab 40 mg
Packing/Price
10 × 10's;3 × 10's
Form
Atorvin FC tab 20 mg
Packing/Price
10 × 10's;3 × 10's
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