Caduet

Caduet

amlodipine + atorvastatin

Manufacturer:

Pfizer
Concise Prescribing Info
Contents
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
Indications/Uses
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-cholesterol, 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.
Dosage/Direction for Use
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.
Administration
May be taken with or without food.
Contraindications
Known hypersensitivity to dihydropyridines, amlodipine, atorvastatin. Active liver disease or unexplained persistent elevations of serum transaminases >3x upper limit of normal. Pregnancy & lactation, women of childbearing potential not using adequate contraceptive measures.
Special Precautions
Severe obstructive CAD. Perform liver function tests prior to treatment & periodically thereafter. Reduce doe or w/draw treatment should an increase in ALT or AST >3 times the upper limit of normal 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 withdrawal, CNS toxicity. Women of childbearing potential should use adequate contraceptive measures. Not recommended in childn.
Adverse Reactions
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, musculoskeletalpain, 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, Stevens-Johnson syndrome & toxic epidermal necrolysis), rhabdomyolysis; thrombocytopenia; tendon rupture; wt gain; hypoesthesia, amnesia, dysgeusia; pancreatitis; myositis, back pain; chest pain, peripheral oedema.
Drug Interactions
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.
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
3 × 10's (Rp507,194/boks)
Form
Caduet FC tab 10 mg/20 mg
Packing/Price
3 × 10's (Rp860,087/boks)
Form
Caduet FC tab 5 mg/10 mg
Packing/Price
3 × 10's (Rp507,194/boks)
Form
Caduet FC tab 5 mg/20 mg
Packing/Price
3 × 10's (Rp860,087/boks)
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in