Atorvastatin we care

Atorvastatin we care

atorvastatin

Manufacturer:

Mega Lifesciences

Distributor:

Maxxcare
Concise Prescribing Info
Contents
Atorvastatin
Indications/Uses
As an adjunct to diet due to inadequate response to diet restricted in saturated fat & cholesterol, & other nonpharmacologic measures alone; can be started simultaneously w/ diet in patients w/ CHD or CHD-multiple risk factors. CV disease prevention: Reduces risk of MI, stroke, revascularization procedures & angina in adults w/o clinically evident CHD, but w/ CHD-multiple risk factors (eg, age, smoking, HTN, low HDL-C or a family history of early CHD); reduces risk of MI & stroke in patients w/ type 2 diabetes & w/o clinically evident CHD but w/ multiple CHD risk factors (eg, retinopathy, albuminuria, smoking, or HTN). Reduces risk of non-fatal MI, fatal & non-fatal stroke, for revascularization procedures, hospitalization for CHF, & angina in patients w/ clinically evident CHD. Hyperlipidemia: Primary hypercholesterolemia (heterozygous familial & nonfamilial) & mixed dyslipidemia (Fredrickson type IIa & IIb) as an adjunct to diet; patients w/ elevated serum triglyceride levels (Fredrickson type IV) as an adjunct to diet; primary dysbetalipoproteinemia (Fredrickson type III) in patients w/o adequate response to diet; total cholesterol & LDL-cholesterol (LDL-C) reduction in homozygous familial hypercholesterolemia as adjunct to other lipid-lowering treatments (eg, LDL apheresis); total cholesterol, LDL-C & apolipoprotein B level reduction for heterozygous familial hypercholesterolemia in boys & postmenarchal girls 10-17 yr as an adjunct to diet, if an adequate trial of diet therapy the following findings are present: LDL C remains ≥190 mg/dL, or LDL-C remains ≥160 mg/dL & w/ positive family history of premature CV disease or ≥2 other CV disease risk factors present in ped patients.
Dosage/Direction for Use
Hyperlipidemia (heterozygous familial & nonfamilial) & mixed dyslipidemia (Fredrickson type IIa & IIb) Individualized dosage. Initially 10 or 20 mg once daily. Patient who require a large reduction in LDL-C (>45%) Initially 40 mg once daily. Dosage range: 10-80 mg once daily. Heterozygous familial hypercholesterolemia Ped 10-17 yr Individualized dosage. Initially 10 mg/day adjust at ≥4 wk intervals. Max: 20 mg/day. Homozygous familial hypercholesterolemia Initially 10-80 mg daily. Concomitant therapy: w/ cyclosporine: Max: 10 mg once daily. W/ clarithromycin, itraconazole, combination of ritonavir plus saquinavir or lopinavir plus ritonavir: Max: 20 mg.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Hypersensitivity. Patients w/ active liver disease or unexplained persistent serum transaminase elevation (>3x upper limit of normal). Women of childbearing potential; pregnancy & lactation.
Special Precautions
Conditions where major lipoprotein abnormality is chylomicron elevation (Fredrickson type I & IV). May be used w/ bile acid resins. Combination w/ fibrates. Temporarily w/hold or discontinue in patients w/ acute, serious conditions suggestive of myopathy or predisposing risk factors to renal failure secondary to rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, & uncontrolled seizures. Biochemical liver function abnormalities; perform liver function tests prior to & at 12 wk following initiation of therapy & any dose elevation, & periodically thereafter; generally, liver enzyme changes in 1st 3 mth of treatment; monitor patients w/ increased transaminase levels until abnormalities resolve; reduce dose or w/draw treatment if ALT or AST increase of >3x upper limit of normal persists; patients who consume substantial quantities of alcohol &/or w/ history of liver disease; contraindicated in active liver disease or unexplained persistent transaminase elevations. May blunt adrenal &/or gonadal steroid production; concomitant use w/ drugs that may decrease levels or activity of endogenous steroid hormones (eg, ketoconazole, spironolactone, & cimetidine). Increased risk in patients w/ prior haemorrhagic stroke or lacunar infarct; consider potential risk of haemorrhagic stroke before initiating treatment. Risk of myopathy; observe for unexplained muscle pain, tenderness or weakness. Use appropriate birth control measures in women of childbearing potential; do not use during pregnancy; lactation. Pre-pubertal patients or childn <10 yr.
Adverse Reactions
Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; abdominal pain, constipation, diarrhea, dyspepsia, nausea, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; abnormal liver function test, increased blood creatine phosphokinase; insomnia; headache; asthenia. Elevated serum ALT levels.
Drug Interactions
Increased risk of myopathy in concurrent use w/ fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine, or strong CYP 3A4 inhibitors (clarithromycin, HIV protease inhibitors & itraconazole). Increased plasma conc w/ strong CYP 3A4 inhibitors. Increased AUC w/ concomitant administration of atorvastatin (80 mg) w/ clarithromycin (500 mg bd); in concomitant use of atorvastatin (40 mg) w/ ritonavir plus saquinavir (400 mg bd) or atorvastatin (20 mg) w/ lopinavir plus ritonavir (400 mg plus 100 mg bd); w/ concomitant use of atorvastatin (<10 mg) w/ itraconazole (200 mg); w/ concomitant use of atorvastatin (10 mg) w/ cyclosporin 5.2 mg/kg/day. Plasma conc may be increased w/ excessive grapefruit consumption (>1.2 L/day). Variable plasma conc reduction in concomitant use w/ cytochrome P450 3A4 inducers (eg, efavirenz, rifampin). Increased steady-state plasma digoxin conc. Increased AUC values of norethindrone & ethinyl estradiol. Caution w/ combination of fibrates; concomitant use w/ drugs that may decrease levels or activity of endogenous steroid hormones (eg, ketoconazole, spironolactone, & cimetidine.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Atorvastatin we care FC tab 20 mg
Packing/Price
10 × 10's
Form
Atorvastatin we care FC tab 10 mg
Packing/Price
10 × 10's
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