Tukon

Amlodipine: Essential HTN. Prevention of CV disease in adults w/o clinically evident CHD, but w/ multiple risk factors for CHD eg, age, smoking, HTN, low HDL-C, or a family history of early CHD. Reduces risk of MI or stroke. Reduces risk for revascularization procedures & angina in patients w/ type 2 diabetes, & w/o clinically evident CHD, but w/ multiple risk factors for CHD eg, retinopathy, albuminuria, smoking, or HTN. Atorvastatin: Reduces risk of MI; stroke in patients w/ clinically evident CHD; non-fatal MI; fatal & non-fatal stroke; revascularization procedures; angina; hospitalization for CHF. Adjunct therapy to diet for reducing elevated total-C, LDL-C, Apo B, & triglyceride levels & to increase HDL-C in patients w/ primary hypercholesterolemia (heterozygous familial & nonfamilial); mixed dyslipidemia (Fredrickson Types IIa & IIb); elevated serum triglyceride levels (Fredrickson Type IV); primary dysbetalipoproteinemia (Fredrickson Type III). Adjunct to other lipid-lowering treatments to reduce total-C & LDL-C in patients w/ homozygous familial hypercholesterolemia. Adjunct to diet to reduce total-C, LDL-C, & Apo B levels in boys & postmenarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL-C ≥190 mg/dL or LDL-C ≥160 mg/dL, & +ve family history of premature CV disease or ≥2 other CV disease risk factors are present.

Adult 1 tab once daily.

May be taken with or without food.

Hypersensitivity. Atorvastatin: Active liver disease or unexplained persistent elevations in hepatic transaminases. Pregnancy & lactation.

Should be used during pregnancy only if potential benefit justifies potential risk to the fetus. Discontinue nursing during treatment. Atorvastatin: Temporarily w/hold or discontinue treatment in any patient w/ acute, serious condition suggestive of myopathy or having a risk factor predisposing to development of renal failure secondary to rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, & uncontrolled seizures). Associated w/ biochemical abnormalities of liver function. Perform LFTs prior to & at 12 wk following initiation of therapy or elevation in dose, & semi-annually thereafter. Patients who consume substantial quantities of alcohol &/or have history of liver disease. Patients w/ recent stroke or transient ischemic attack. Concomitant use w/ drugs that may decrease levels or activity of endogenous steroid hormones eg, ketoconazole, spironolactone & cimetidine. Amlodipine: Possibility of increased frequency, duration &/or severity of angina or acute MI on starting Ca channel blocker therapy or at the time of dosage increase in patients w/ severe obstructive CAD. Patients w/ severe aortic stenosis; severe hepatic impairment.

Atorvastatin: Nasopharyngitis, arthralgia, diarrhea, pain in extremity, UTI, dyspepsia, nausea, muscle spasms, myalgia, insomnia & pharyngolaryngeal pain. Amlodipine: Dizziness, flushing, headache, edema, palpitation, fatigue, abdominal pain & somnolence.

Atorvastatin: Increased risk of myopathy w/ cyclosporine, fibric acid derivatives (gemfibrozil, fenofibrate), lipid-modifying doses of niacin (nicotinic acid), or strong CYP3A4 inhibitors [eg, clarithromycin, erythromycin, HIV PIs (eg, ritonavir, lopinavir), & azole antifungals (eg, itraconazole)]. Increased plasma conc w/ strong CYP3A4 inhibitors (eg, erythromycin, grapefruit juice). Increased bioavailability w/ OATP1B1 inhibitors (eg, cyclosporine). Increased AUC w/ diltiazem. Reduced plasma conc w/ antacid; colestipol; cimetidine; CYP3A4 inducers (eg, efavirenz, rifampin). Significant reduction in atorvastatin plasma conc w/ delayed administration of atorvastatin after administration of rifampin; simultaneous co-administration w/ rifampin is recommended. Increased plasma digoxin conc. Increased AUC values of norethindrone & ethinyl estradiol. Reduced plasma conc of antipyrine. Increased AUC & decreased C_max w/ amlodipine. Amlodipine: Strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir) may increase plasma conc. Closely monitor BP when co-administered w/ CYP3A4 inducers.

Calcium Antagonists / Dyslipidaemic Agents

C10BX03 - atorvastatin and amlodipine ; Belongs to the class of HMG CoA reductase inhibitors, other combinations.

Rx