Apo-Atorvastatin

Apo-Atorvastatin

atorvastatin

Manufacturer:

Apotex

Distributor:

Pharmaforte
Concise Prescribing Info
Contents
Atorvastatin Ca
Indications/Uses
Adjunct to lifestyle changes, including diet, for reduction of elevated total cholesterol (C), LDL-C, apolipoprotein B & triglycerides (TG) in adults, adolescents & childn ≥10 yr w/ primary & heterozygous familial hypercholesterolemia, combined (mixed) hyperlipidemia (Fredrickson types IIa & IIb), elevated serum TG levels (Fredrickson type IV) & dysbetalipoproteinemia (Fredrickson type III). Adjunct to other lipid-lowering treatments in adults w/ homozygous familial hypercholesterolemia. Prevention of CV diseases in high-risk patients (adult hypertensives w/o clinically evident CHD, but w/ at least 3 additional risk factors for CHD; adults w/ type 2 DM w/o clinically evident CHD, but w/ multiple risk factors for CHD; adults w/ clinically evident CHD).
Dosage/Direction for Use
Individualized dosage. Initially 10-20 mg once daily. Patients who require a large reduction in LDL-C (>45%) Initially 40 mg once daily. Dosage range is 10-80 mg once daily. Prevention of CV disease Primary prevention 10 mg once daily. Secondary prevention 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Homozygous familial hypercholesterolemia 80 mg. Childn ≥10 yr Hypercholesterolaemia Initially 10 mg/day w/ titration up to 20 mg/day. Combination w/ other medicinal compd Co-administration w/ cyclosporine, telaprevir or tipranavir/ritonavir: Max dose: 10 mg.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 x ULN. Pregnancy & lactation.
Special Precautions
Perform liver function tests before treatment & periodically thereafter. Patients who consume substantial quantities of alcohol &/or have a history of liver disease. Discontinue treatment if markedly elevated creatine phosphokinase (CPK) levels occur or myopathy is diagnosed/suspected. Monitoring patients w/ history of renal impairment. Childn <10 yr.
Adverse Reactions
Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; insomnia; headache; nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; asthenia; abnormal liver function test, increased blood CPK.
Drug Interactions
Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, lipid-modifying doses of niacin, CYP3A4 inhibitors (eg, erythromycin & azole antifungals), colchicine. Increased plasma conc w/ CYP3A4 inhibitors (eg, erythromycin, diltiazem, grapefruit juice). Increased bioavailability or AUC w/ OATP1B1 inhibitors (eg, cyclosporine), clarithromycin, protease inhibitors (eg ritonavir, saquinavir, lopinavir), itraconazole. Reduced plasma conc w/ CYP3A4 inducers (eg, efavirenz, rifampin), oral antacid suspension containing Mg & Al hydroxides, colestipol. Increased conc of digoxin. Increased AUC values of OCs containing norethindrone & ethinyl estradiol. Severe muscle problems eg, 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
Apo-Atorvastatin FC tab 10 mg
Packing/Price
30's
Form
Apo-Atorvastatin FC tab 20 mg
Packing/Price
30's
Form
Apo-Atorvastatin FC tab 80 mg
Packing/Price
30's
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