Amlodine HD

Amlodine HD

amlodipine + atorvastatin




InnoGen Pharmaceuticals
Concise Prescribing Info
Amlodipine besilate, atorvastatin Ca
Patients at increased CV risk due to HTN & dyslipidemia, &/or symptomatic CHD expressed as angina & dyslipidemia. Prevention of CV complications in hypertensive patients eg, reduce risk of death, nonfatal MI, stroke & risk revascularization procedures & angina pectoris.
Dosage/Direction for Use
Individualize starting & maintenance dose. Dose range: 5 mg/20 mg, 10 mg/20 mg. Max amlodipine dose: 10 mg/day; max atorvastatin dose: 80 mg/day. To be taken once daily.
May be taken with or without food.
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases >3x the upper limit of normal. Pregnancy & lactation.
Special Precautions
Discontinue in patients w/ myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis. Heart failure. Hepatic impairment & alcohol consumption. Women of child-bearing potential. Amlodipine besilate: Patients w/ hypotension, whose cardiac reserve is poor, & those w/ heart failure. Should not be used in cardiogenic shock, patients who recently suffered MI, or in acute unstable angina; to treat anginal attack in chronic stable angina. May increase risk of developing heart failure in patients w/ severe aortic stenosis. Exacerbation of angina w/ sudden w/drawal. Reduced dose in patients w/ hepatic impairment. Discontinue in patients experiencing ischaemic pain following administration. Atorvastatin Ca: Should not be given to patients w/ active liver disease or unexplained persistently raised serum-aminotransferase conc; discontinue if marked or persistent increases in serum-aminotransferase conc occur. Patients at risk of rhabdomyolysis, particularly those taking drugs that increase plasma conc of statins; discontinue if creatinine phosphokinase increases significantly or if myopathy is diagnosed. Concomitant use w/ fluvastatin, pravastatin, rosuvastatin, & simvastatin in patients w/ severe renal impairment. Avoid during pregnancy.
Adverse Reactions
Dizziness, headache. Amlodipine besilate: Flushing, fatigue, edema, abdominal pain, nausea, palpitations, somnolence. Hypotension, tachycardia; other GI disturbances, increased micturition frequency, lethargy, eye pain, mental depression; paradoxical increase in ischaemic chest pain, excessive fall in BP leading to cerebral or myocardial ischaemia or transient blindness; rashes (including erythema multiforme), fever, abnormalities in liver function including cholestasis; gingival hyperplasia, myalgia, tremor, impotence; bradycardia, hypotension. Atorvastatin Ca: GI disorders, myalgia, asthenia, nasopharyngitis, hyperglycemia, pharyngolaryngeal pain, epistaxis, musculoskeletal & connective tissue disorders. Skin rashes, blurred vision, insomnia, dysguesia; reversible increases in serum-aminotransferase conc; hepatitis, pancreatitis; hypersensitivity reactions including anaphylaxis & angioedema; myopathy.
Drug Interactions
May enhance antihypertensive effects of other anti-hypertensive drugs eg, β-blockers. Enhanced antihypertensive effects w/ aldesleukin & antipsychotics. May modify insulin & glucose responses w/ nifedipine. Quinidine; CYP450 inducers eg, carbamazepine, phenytoin, & rifampicin; CYP450 inhibitors eg, cimetidine & erythromycin. Atorvastatin Ca: Increased risk of myopathy w/ fibric acid derivatives (fibrates or gemfibrozil), & nicotinic acid. CYP450 inhibitors eg, ciclosporin, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV-PIs, nefazodone, amiodarone, & verapamil.
ATC Classification
C10BX03 - atorvastatin and amlodipine ; Belongs to the class of HMG CoA reductase inhibitors, other combinations.
Amlodine HD 10 mg/20 mg FC tab
Amlodine HD 5 mg/20 mg FC tab
Amlodine HD 5 mg/40 mg FC tab
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