Caduet

Caduet

amlodipine + atorvastatin

Manufacturer:

Viatris

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 5 mg/10 mg FC tab Amlodipine besylate 5 mg, atorvastatin Ca 10 mg. Per 5 mg/20 mg FC tab Amlodipine besylate 5 mg, atorvastatin Ca 20 mg. Per 5 mg/40 mg FC tab Amlodipine besylate 5 mg, atorvastatin Ca 40 mg. Per 10 mg/10 mg FC tab Amlodipine besylate 10 mg, atorvastatin Ca 10 mg. Per 10 mg/20 mg FC tab Amlodipine besylate 10 mg, atorvastatin Ca 20 mg. Per 10 mg/40 mg FC tab Amlodipine besylate 10 mg, atorvastatin Ca 40 mg
Indications/Uses
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 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-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) & for patients w/ dysbetalipoproteinemia (Fredrickson type III) who do not respond adequately 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 disease in adult patients w/o clinically evident CHD but w/ multiple risk factors eg, age, smoking, HTN, low HDL-C, or family history of early CHD to reduce risk of MI, stroke, revascularisation procedures & angina. Patients w/ type 2 diabetes w/o clinically evident CHD but w/ multiple risk factors eg, retinopathy, albuminuria, smoking or HTN to reduce risk of MI & stroke. Patients w/ clinically evident CHD to reduce risk of non-fatal MI, fatal & non-fatal stroke, revascularisation procedures, hospitalisation for CHF & angina.
Dosage/Direction for Use
Dosage range of amlodipine/atorvastatin: 5 mg/10 mg once daily to max: 10 mg/80 mg once daily.
Administration
May be taken with or without food.
Contraindications
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.
Special Precautions
Discontinue use if markedly elevated creatine phosphokinase levels occur; myopathy is diagnosed or suspected; acute, serious conditions suggestive of myopathy or risk factor predisposing to renal failure secondary to rhabdomyolysis development. 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 liver disease. Perform LFTs prior to initiation & periodically thereafter. Reduce dose or discontinue use if increased ALT or AST of >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.
Adverse Reactions
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 creatine phosphokinase.
Drug Interactions
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. Affects 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 exposure 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.
MIMS Class
Calcium Antagonists / Dyslipidaemic Agents
ATC Classification
C10BX03 - atorvastatin and amlodipine ; Belongs to the class of HMG CoA reductase inhibitors, other combinations.
Presentation/Packing
Form
Caduet FC tab 10 mg/10 mg
Packing/Price
30's
Form
Caduet FC tab 10 mg/20 mg
Packing/Price
30's
Form
Caduet FC tab 10 mg/40 mg
Packing/Price
30's
Form
Caduet FC tab 5 mg/10 mg
Packing/Price
30's
Form
Caduet FC tab 5 mg/20 mg
Packing/Price
30's
Form
Caduet FC tab 5 mg/40 mg
Packing/Price
30's
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