Manufacturer
Pfizer Manufacturing Deutschland GmbH.
Contents
Per 5/10 mg FC tab Amlodipine besylate 5 mg, atorvastatin Ca 10 mg.
Indication
Patients for whom treatment w/ both amlodipine & atorvastatin is appropriate: Amlodipine component 1st-line treatment of HTN & myocardial ischemia whether due to fixed obstruction (stable angina) &/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of coronary vasculature. Monotherapy or in combination w/ other antianginal drugs in patient w/ angina that is refractory to nitrates &/or adequate doses of β-blockers. Atorvastatin component Adjunct to diet for patients w/ elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, triglycerides (TG) & to increase HDL-cholesterol in patients w/ primary hypercholesterolemia (heterozygous familial & nonfamilial), combined (mixed) hyperlipidemia (Fredrickson types IIa & IIb), elevated serum TG levels (Fredrickson type IV) & for patients w/ dysbetalipoproteinemia (Fredrickson type III) who do not respond adequately to diet. Reduction of total-C & LDL-C in patients w/ homozygous familial hypercholesterolemia when response to diet & other non-pharmacological measures are inadequate. Prevention of CV disease w/o clinically evident CHD but w/ multiple risk factors eg, age, smoking, HTN, low HDL-C, or family history of early CHD for reduction of the risk of MI, stroke & revascularisation procedures & angina. In type 2 diabetes w/o clinically evident CHD but w/ multiple risk factors eg, retinopathy, albuminuria, smoking or HTN for reduction of the risk of MI & stroke. In patients w/ clinically evident CHD for reduction of the risk of non-fatal MI, fatal & non-fatal stroke, revascularisation procedures, hospitalisation for CHF & angina.
Instruction
May be taken with or without food.
Drug interaction
Amlodipine: Increased systemic exposure in elderly hypertensive patient w/ diltiazem. Increased plasma conc by strong CYP3A4 inhibitors. Increased risk of hypotension w/ clarithromycin. Lowered plasma conc w/ CYP3A4 inducers. Increased BP-lowering w/ grapefruit juice. Affects trough conc of cyclosporine. Increased tacrolimus blood levels. Increased exposure of mechanistic target of rapamycin inhibitors. Atorvastatin: Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, niacin, erythromycin, azole antifungals. Increased plasma conc by CYP450 3A4 inhibitors, erythromycin or clarithromycin, PIs, diltiazem, grapefruit juice. Increased bioavailability w/ OATP1B1 inhibitors. Increased AUC w/ itraconazole. Reduced plasma conc by CYP450 3A4 inducers, Mg- & Al hydroxide-containing antacids, colestipol. Increased digoxin conc. Increased AUC values for norethindrone & ethinyl estradiol. Increased risk of rhabdomyolysis w/ fusidic acid. Cases of myopathy w/ colchicine. Severe myositis & myoglobinuria w/ fibrates.
Malaysia
