Caduet

Per 5/10 mg FC tab Amlodipine besylate 5 mg, atorvastatin Ca 10 mg. Per 5/20 mg FC tab Amlodipine besylate 5 mg, atorvastatin Ca 20 mg. Per 10/10 mg FC tab Amlodipine besylate 10 mg, atorvastatin Ca 10 mg. Per 10/20 mg FC tab Amlodipine besylate 10 mg, atorvastatin Ca 20 mg

Patients for whom treatment w/ both amlodipine & atorvastatin is appropriate. Amlodipine: HTN & can be used as a sole agent to control BP in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination w/ a thiazide diuretic, β-adrenoreceptor blocking agent, or an ACE inhibitor. Myocardial ischemia whether due to fixed obstruction (stable angina) &/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) or coronary vasculature. May be used where the clinical presentation suggests a possible vasospastic/vasoconstriction has not been confirmed. As monotherapy or in combination w/ other antianginal drugs in patients w/ angina that is refractory to nitrates &/or adequate doses of β-blockers. Atorvastatin: Adjunct to diet for the reduction of elevated total & LDL-C, apolipoprotein B & triglycerides in patients w/ primary hypercholesterolemia, combined (mixed) hyperlipidemia & heterozygous & homozygous familial hypercholesterolemia when response to diet & other non-pharmacological measures are inadequate.

Amlodipine/atorvastatin: 5 mg/10 mg up to a max dose of 10 mg/80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia (atorvastatin studies) Atorvastatin 10 mg once daily. Homozygous familial hypercholesterolemia (atorvastatin studies) Atorvastatin 80 mg. Childn 6-17 yr Amlodipine: 2.5-5 mg once daily. Heterozygous familial hypercholesterolemia 10-17 yr Atorvastatin: Individualized dose. Initially 10 mg/day. Max dose: 20 mg/day. Adjustments should be made at intervals of ≥4 wk.

May be taken with or without food.

Known hypersensitivity to dihydropyridines, amlodipine, atorvastatin. Active liver disease or unexplained persistent elevations of serum transaminases >3x ULN. Pregnancy & lactation, women of childbearing potential not using adequate contraceptive measures.

Severe obstructive CAD. Perform LFTs prior to treatment & periodically thereafter. Reduce doe or w/draw treatment should an increase in ALT or AST >3x ULN persist. Patients who consume substantial quantities of alcohol &/or have history of liver disease. Discontinue therapy if markedly elevated creatine phosphokinase levels occur or myopathy is diagnosed or suspected. Temporary suspension of atorvastatin during fusidic acid therapy. Hemorrhagic stroke. Concomitant use of HMG-CoA reductase inhibitor w/ ketoconazole, spironolactone & cimetidine. β-blocker w/drawal, CNS toxicity. Women of childbearing potential should use adequate contraceptive measures. Not recommended in childn.

Epistaxis; nausea; dizziness; fatigue. Amlodipine: Headache, somnolence; palpitations; flushing; abdominal pain; oedema; vasodilatation; asthenia. Atorvastatin: Nasopharyngitis, hyperglycaemia; pharyngolaryngeal pain; diarrhoea, dyspepsia, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; abnormal liver function test, increased blood creatine phosphokinase; nightmare; blurred vision; tinnitus; abdominal discomfort, eructation; hepatitis, cholestasis; urticaria; muscle fatigue, neck pain; malaise, pyrexia; positive WBC urine; anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, SJS & TEN), rhabdomyolysis; thrombocytopenia; tendon rupture; wt gain; hypoesthesia, amnesia, dysgeusia; pancreatitis; myositis, back pain; chest pain, peripheral oedema.

Amlodipine: Increased systemic exposure in elderly hypertensive patients (69-87 yr) w/ diltiazem. Increased plasma conc w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir). Increased risk of hypotension w/ clarithromycin. Lower plasma conc w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Increased bioavailability w/ grapefruit juice. Affects trough conc of cyclosporine. Increased tacrolimus blood levels. Increased exposure of mechanistic target of rapamycin inhibitors (eg, sirolimus, temsirolimus, everolimus). Atorvastatin: Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, niacin, erythromycin, azole antifungals. Increased plasma conc w/ CYP3A4 inhibitors, erythromycin or clarithromycin, PIs, diltiazem, excessive grapefruit juice consumption (>1.2 L/day). Increased bioavailability w/ OATP1B1 inhibitors (eg, cyclosporine). Increased AUC w/ itraconazole. Decreased plasma conc w/ CYP3A4 inducers (eg, efavirenz, rifampin), antacids containing Mg & Al hydroxide; colestipol. Increased digoxin conc. Increased AUC values for OCs (eg, norethindrone, ethinyl estradiol). Increased risk of rhabdomyolysis w/ fusidic acid. Cases of myopathy w/ colchicine.

Calcium Antagonists / Anti-Anginal Drugs / Dyslipidaemic Agents

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

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