Triveram

Triveram

Manufacturer:

Servier

Distributor:

Maxxcare
Concise Prescribing Info
Contents
Per 10/5/5 mg FC tab Atorvastatin Ca trihydrate 10.82 mg (equiv to atorvastatin 10 mg), perindopril arginine 5 mg (equiv to perindopril 3.4 mg), amlodipine besilate 6.94 mg (equiv to amlodipine 5 mg). Per 20/5/5 mg FC tab Atorvastatin Ca trihydrate 21.64 mg (equiv to atorvastatin 20 mg), perindopril arginine 5 mg (equiv to perindopril 3.4 mg), amlodipine besilate 6.94 mg (equiv to amlodipine 5 mg). Per 20/10/10 mg FC tab Atorvastatin Ca trihydrate 21.64 mg (equiv to atorvastatin 20 mg), perindopril arginine 10 mg (equiv to perindopril 6.79 mg), amlodipine besilate 13.87 mg (equiv to amlodipine 10 mg). Per 40/10/10 mg FC tab Atorvastatin Ca trihydrate 43.28 mg (equiv to atorvastatin 40 mg), perindopril arginine 10 mg (equiv to perindopril 6.79 mg), amlodipine besilate 13.87 mg (equiv to amlodipine 10 mg)
Indications/Uses
Essential HTN &/or stable CAD, in association w/ primary hypercholesterolaemia or mixed hyperlipidaemia.
Dosage/Direction for Use
Administration
Should be taken on an empty stomach: Take before morning meal.
Contraindications
Hypersensitivity to atorvastatin, perindopril, amlodipine, other ACE inhibitor, dihydropyridine derivative or statin. Active liver disease or unexplained persistent elevations of serum transaminases >3 times the upper limit of normal, severe hypotension, shock (including cardiogenic shock), left ventricle outflow tract obstruction (eg, hypertrophic obstructive cardiomyopathy & high grade aortic stenosis), haemodynamically unstable heart failure after acute MI, history of angioedema (Quincke's oedema) associated w/ previous ACE inhibitor therapy, hereditary or idiopathic angioedema. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2); sacubitril/valsartan; extracorporeal treatments leading to contact of blood w/ negatively charged surfaces, significant bilateral renal artery stenosis or stenosis of artery to a single functioning kidney. Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.
Special Precautions
Not suitable for initial therapy. Perform liver function test periodically. Monitor WBC counts periodically in collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainamide. Monitor BP, renal function & K in symptomatic hypotension, heart failure or ischemic heart or cerebrovascular disease. Alcohol consumption, history of liver disease, DM, aortic & mitral valve stenosis/hypertrophic cardiomyopathy, bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney, haemodialysis. Discontinue treatment in case of jaundice or marked elevations of hepatic enzymes, rhabdomyolysis, interstitial lung disease, hypersensitivity/angioedema. Stop treatment one day prior to surgery. Caution when co-administered w/ drugs that increase atorvastatin plasma conc, potent inhibitors of CYP3A4 or transport proteins (eg, ciclosporine, ketoconazole, ritonavir). Not recommended in combination w/ systemic fusidic acid, lithium; dual blockade of renin-angiotensin-aldosterone system; ACE-inhibitors & angiotensin II receptor blockers in diabetic nephropathy; primary hyperaldosteronism; galactose intolerance/glucose-galactose malabsorption. May impair ability to drive or use machines. Black patients. Hepatic & renal impairment. Not for use in childn & adolescent. Elderly.
Adverse Reactions
Oedema. Nasopharyngitis, hypersensitivity, hyperglycaemia, somnolence, dizziness, headache, dysgeusia, paraesthesia, vertigo, visual impairment, diplopia, tinnitus, palpitations, hypotension (& hypotension-related effects), flushing, pharyngolaryngeal pain, epistaxis, cough, dyspnoea, nausea, vomiting, upper & lower abdominal pain, dyspepsia, diarrhoea, constipation, change of bowel habit, flatulence, rash, pruritus, joint & ankle swelling, pain in extremity, arthralgia, muscle spasms, myalgia, back pain, asthenia, fatigue, abnormal liver function test, increased blood creatine kinase.
Drug Interactions
Contraindicated: Aliskiren (in diabetic & impaired renal patients), extracorporeal treatments, sacubitril/valsartan. Not recommended: CYP3A4 inhibitors, aliskiren, concomitant therapy w/ ACE inhibitor & angiotensin-receptor blocker, estramustine, lithium, co-trimoxazole, K-sparing diuretics (eg, triamterene, amiloride, eplerenone, spironolactone), K salts, dantrolene (infusion), grapefruit or grapefruit juice. Precautions: CYP3A4 inducers, digoxin, ezetimibe, fusidic acid, gemfibrozil/fibric acid derivatives, transport protein inhibitors, warfarin, antidiabetic agents (insulins, oral hypoglycaemic agents), baclofen, NSAIDs (including aspirin ≥3 g/day), colchicine, colestipol, OCs, gliptins (linagliptin, saxagliptin, sitagliptin, vildagliptin), sympathomimetics, TCAs/antipsychotics/anesth, gold, digoxin, atorvastatin, warfarin or cyclosporine, tacrolimus, antihypertensive agents & vasodilators.
ATC Classification
C10BX11 - atorvastatin, amlodipine and perindopril ; Belongs to the class of HMG CoA reductase inhibitors, other combinations.
Presentation/Packing
Form
Triveram 10/5/5 mg FC tab
Packing/Price
30's
Form
Triveram 40/10/10 mg FC tab
Packing/Price
30's
Form
Triveram 20/5/5 mg FC tab
Packing/Price
30's
Form
Triveram 20/10/10 mg FC tab
Packing/Price
30's
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