Caduet

Patients for whom treatment w/ both amlodipine & atorvastatin is considered 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 patients w/ angina refractory to nitrates &/or adequate doses of β-blockers. Atorvastatin component Adjunct to diet for patients w/ elevated total cholesterol (total-C), LDL-C, Apo B, triglycerides (TG) & to increase HDL-C in patients w/ primary hypercholesterolemia (heterozygous familial & nonfamilial), combined (mixed) hyperlipidemia (Fredrickson types IIa & IIb), elevated serum TG levels (Fredrickson type IV) & patients w/ dysbetalipoproteinemia (Fredrickson type III) who inadequately respond to diet. Reduction of total-C & LDL-C in patients w/ HoFH when response to diet & other non-pharmacological measures are inadequate. Prevention of CV complications in patients w/o clinically evident CV disease but w/ multiple CHD risk factors eg, smoking, HTN, diabetes, low HDL-C, or family history of early CHD to reduce risk of fatal CHD, non-fatal MI, stroke, revascularization procedures & angina pectoris. Patients w/ clinically evident CHD to reduce risk of non-fatal MI, fatal & non-fatal stroke, revascularization procedures, hospitalization for CHF & angina.

Dosage range of amlodipine/atorvastatin: 5 mg/10 mg once daily to max: 10 mg/80 mg once daily.

May be taken with or without food.

Hypersensitivity to dihydropyridines, amlodipine, atorvastatin. Active liver disease or unexplained persistent elevations of serum transaminases >3 times ULN. Women of childbearing potential who are not using adequate contraceptive measures. Pregnancy & lactation.

Discontinue use if markedly elevated creatine phosphokinase (CPK) levels occur; myopathy is diagnosed or suspected. Temporarily withheld or discontinue use if acute, serious conditions suggestive of myopathy or risk factor predisposing to renal failure secondary to rhabdomyolysis development occur. NYHA class III-IV heart failure of non-ischemic etiology; increased risk for recurrent hemorrhagic stroke; increased HbA1c & fasting serum glucose levels; immune-mediated necrotizing myopathy. Substantial alcohol consumption &/or history of hepatic disease. Perform LFTs prior to initiation & periodically thereafter. Reduce dose or discontinue use if increased ALT or AST >3 times ULN persist. Not recommended to be used concurrently w/ fusidic acid. Avoid use w/ cyclosporine, HIV PIs, hepatitis C PIs. Concurrent use w/ fibric acid derivatives, erythromycin, immunosuppressives, azole antifungals, HCV NS5A/NS5B inhibitors, letermovir, niacin ≥1 g daily. Not to be used in hepatic impairment. Women of childbearing potential should use effective contraception. Childn. Atorvastatin: Induce de novo or aggravate preexisting myasthenia gravis or ocular myasthenia.

Nausea. Amlodipine: Headache, dizziness, somnolence; palpitations; flushing; abdominal pain; oedema, fatigue. Atorvastatin: Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; diarrhoea, dyspepsia, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; abnormal LFT, increased blood CPK.

Amlodipine: Increased systemic exposure in elderly hypertensive patients 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. Affected trough conc of cyclosporine. Increased tacrolimus blood levels. Increased exposure of mTOR 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 AUC w/ itraconazole. Increased exposure w/ OATP1B1, OATP1B3, MDR1, BCRP, P-gp, MRP2, OAT2 inhibitors. 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.

Calcium Antagonists / Dyslipidaemic Agents

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

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