Rhea Atorvastatin

Rhea Atorvastatin

atorvastatin

Manufacturer:

Pfizer

Distributor:

Philusa
Concise Prescribing Info
Contents
Atorvastatin Ca
Indications/Uses
Adjunct to diet for the treatment of patients w/ elevated total cholesterol, LDL-cholesterol, apolipoprotein B & triglycerides; increase HDL-cholesterol in patients w/ primary hypercholesterolemia (heterozygous familial & non-familial hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson Types IIa & IIb), elevated serum TG levels (Fredrickson Type IV); dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet. Reduction of total cholesterol & LDL-cholesterol in patients w/ homozygous familial hypercholesterolemia. Reduce risk of fatal CHD & non-fatal MI, stroke, revascularization procedures & angina pectoris in patients w/o clinically evident CV disease & w/ or w/o dyslipidemia but w/ multiple risk factors for CHD. Reduce risk of non-fatal MI, fatal & non-fatal stroke, revascularization procedures, hospitalization for CHF & angina in patients w/ clinically evident CHD. Reduce risk of CV disease in patients w/ diabetes w/ moderately decreased eGFR. Reduce risk of major CV events (including stroke) in patients w/ clinically evident CHD & chronic kidney disease not requiring dialysis. Reduce rate of GFR decline & progression of chronic kidney disease in patients w/ clinically evident CHD &/or diabetes w/ microalbuminuria. Adjunct to diet to reduce total cholesterol, LDL-cholesterol & apolipoprotein B levels in boy & post-menarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia.
Dosage/Direction for Use
10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Homozygous familial hypercholesterolemia 80 mg. Severe dyslipidemia Childn 4-17 yr Initially 10 mg once daily, may be increased to 80 mg daily. Individualized dosage; adjust at intervals of ≥4 wk. Co-administration w/ cyclosporine, telaprevir or tipranavir/ritonavir Max: 10 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases >3 times the upper limit of normal. Pregnancy & lactation.
Special Precautions
Perform liver function tests before initiation of treatment & periodically thereafter. Patients who consume substantial quantities of alcohol &/or w/ history of liver disease. Concomitant use w/ cyclosporine, fibric acid derivatives, erythromycin, niacin, azole antifungals, colchicine, telaprevir, boceprevir or the combination of tipranavir/ritonavir. Concurrent use w/ fusidic acid is not recommended. Temporarily withheld or discontinue if acute, serious condition suggestive of myopathy or w/ risk factor predisposing to the development of renal failure secondary to rhabdomyolysis. Hemorrhagic stroke. Endocrine function. Women of childbearing potential.
Adverse Reactions
Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; diarrhea, dyspepsia, nausea, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; abnormal liver function test, increased blood creatine phosphokinase.
Drug Interactions
Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, lipid-modifying doses of niacin or CYP3A4 inhibitors (eg, erythromycin & azole antifungals). Increased bioavailability w/ OATP1B1 inhibitors (eg, cyclosporine). Higher/increased plasma conc w/ erythromycin or clarithromycin; PIs; diltiazem HCl; grapefruit juice. Increased AUC w/ itraconazole. Reduced/decreased/lower plasma conc w/ CYP3A4 inducers (eg, efavirenz, rifampin); oral antacid susp containing Mg & Al hydroxides; colestipol. Increased digoxin conc. Increased AUC of norethindrone & ethinyl estradiol. Myopathy w/ colchicine. Increased risk of rhabdomyolysis w/ fusidic acid.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Rhea Atorvastatin tab 10 mg
Packing/Price
100's (P1,456/box)
Form
Rhea Atorvastatin tab 20 mg
Packing/Price
100's (P1,848/box)
Form
Rhea Atorvastatin tab 80 mg
Packing/Price
100's (P3,136/box)
Form
Rhea Atorvastatin tab 40 mg
Packing/Price
100's (P2,548/box)
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