Concise Prescribing Info
Contents
Amlodipine besylate 5 mg, atorvastatin Ca trihydrate 20 mg
Indications/Uses
For patients who are prescribed the combination of amlodipine & atorvastatin. Amlodipine: HTN, MI due to persistent obstruction (stable angina) &/or vasospasm/vasoconstriction (Prinzmetal/other angina) or coronary artery. Atorvastatin: To decrease total cholesterol, LDL, apolipoprotein B, & triglycerides adjunctive to diet in patients w/ primary hypercholesterolemia who are unresponsive to proper diet & other non-pharmacological measures.
Dosage/Direction for Use
1-2 tab once daily. Amlodipine max dose: 10 mg once daily. Atorvastatin max dose: 80 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to dihydropyridine, amlodipine, atorvastatin. Hepatic disorder or unexplained persistent transaminase elevation >3x ULN. Pregnant & lactating women.
Special Precautions
Patients w/ severe obstructive coronary artery, heart failure NYHA class III-IV, active hepatic disorder or history of hepatic disorder, alcoholic, hemorrhagic stroke. Discontinue if CPK elevation occurs or diagnosed w/ myopathy. Risk of HbA1c elevation.
Adverse Reactions
Amlodipine: Headache, dizziness, drowsiness, palpitation, flushing, stomach pain, nausea, edema, fatigue, leucopenia, thrombocytopenia, hyperglycemia, insomnia, hypertonia, hypoaesthesia, peripheral neuropathy, syncope, dysgeusia, tremor, extrapyramidal symptoms, visual disturbances, tinnitus, hypotension, vasculitis, cough, dyspnea, rhinitis, change in bowel habit, dry mouth, gastritis, hyperplasia gingiva, pancreatitis, alopecia, hyperhidrosis, purpura, changes in skin color, urticaria, arthralgia, back pain, muscle spasm, myalgia, pollakiuria, nocturia, gynaecomastia, erectile dysfunction, asthenia, malaise, wt gain/loss. Atorvastatin: Chest pain, edema, malaise, photosensitivity, gastric disturbances, resp disturbances, arthritis, musculoskeletal pain, myopathy, pruritus, contact dermatitis, urogenital symptoms, CV symptoms (palpitation, syncope, arrhythmia), thrombocytopenia, lymphadenopathy.
Drug Interactions
CYP3A4 inhibitor (ketoconazole, itraconazole, ritonavir, clarithromycin), CYP3A4 inducer (rifampicin, hypericum perforatum), grapefruit juice, sildenafil, tacrolimus, mTOR inhibitor (sirolimus, temsirolimus, everolimus), P4503A4 cytochrome inhibitor (erythromycin, clarithromycin), OATP1B1 inhibitor (cyclosporine), protease inhibitor, diltiazem HCl, P4503A4 cytochrome inducer (efavirenz, rifampin), antacids, colestipol, digoxin, OCs, fusidic acid, colchicine.
MIMS Class
Calcium Antagonists / Anti-Anginal Drugs / Dyslipidaemic Agents
ATC Classification
C10BX03 - atorvastatin and amlodipine ; Belongs to the class of HMG CoA reductase inhibitors, other combinations.
Presentation/Packing
Form
Carduo tab
Packing/Price
3 × 10's
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