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, as substitution therapy in adult patients adequately controlled w/ atorvastatin, perindopril & amlodipine given concurrently at the same dose level as in the combination.
Dosage/Direction for Use
1 tab once daily as single dose. Co-administration w/ hepatitis C antiviral agents (eg, elbasvir/grazoprevir) or letermovir Max atorvastatin dose: 20 mg/day.
Administration
Should be taken on an empty stomach: Take before morning meal.
Contraindications
Hypersensitivity to atorvastatin, perindopril, amlodipine, other ACE inhibitors, dihydropyridine derivatives 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; obstruction of the outflow tract of the left ventricle (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. Significant bilateral renal artery stenosis or stenosis of artery to a single functioning kidney. Concomitant use w/ hepatitis C antivirals (eg, glecaprevir/pibrentasvir); 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. Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.
Special Precautions
Not suitable for initial therapy. Anaphylactoid reactions during haemodialysis using high-flux membranes. Temporarily withhold treatment in the presence of anaphylactoid reactions during LDL apheresis w/ dextran sulphate or desensitisation treatment. Discontinue in cases of hypersensitivity/angioedema/intestinal angioedema (monitor until complete resolution of symptoms); if jaundice or marked elevations of hepatic enzymes develop; if interstitial lung disease is suspected. Dual blockade of the renin-angiotensin-aldosterone system is not recommended. Not recommended in patients w/ primary hyperaldosteronism. Not to be used concomitantly w/ angiotensin II receptor blockers in patients w/ diabetic nephropathy. Hypotension; renovascular HTN; non-productive, persistent cough; hyperkalaemia. Patients who consume alcohol &/or have history of liver disease; w/ predisposing factors for rhabdomyolysis; DM; CHF; mitral valve stenosis or significant aortic stenosis. Patients w/ collagen vascular disease, on immunosuppressant therapy, treated w/ allopurinol or procainamide (periodically monitor WBC counts). Black patients. Perform liver function tests periodically. Discontinue 1 day prior to surgery. Not to be co-administered w/ systemic fusidic acid or w/in 7 days of stopping fusidic acid treatment. Not to be initiated until 36 hr after last dose. Not recommended in concomitant use w/ lithium. Concomitant use w/ other NEP inhibitors (eg, racecadotril) & ACE inhibitors; mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus; medicinal products that may increase atorvastatin plasma conc [eg, potent inhibitors of CYP3A4 or transport proteins eg, ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, letermovir & HIV PIs (eg, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir)]; gemfibrozil & other fibric acid derivatives, antivirals for HCV (eg, boceprevir, telaprevir, elbasvir/grazoprevir), erythromycin, niacin or ezetimibe; statins. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, glucose-galactose malabsorption or total lactase deficiency. May impair ability to drive or operate machinery. Not suitable for moderate to severe renal impairment (CrCl <60 mL/min). Hepatic impairment. Not recommended in childn & adolescents. Elderly.
Adverse Reactions
Headache; nausea, dyspepsia, diarrhoea, constipation; muscle spasms. Perindopril & amlodipine: Dizziness; visual impairment; dyspnoea; upper & lower abdominal pain; asthenia. Atorvastatin: Nasopharyngitis; hypersensitivity; hyperglycaemia; pharyngolaryngeal pain, epistaxis; flatulence; joint swelling, pain in extremity, arthralgia, myalgia, back pain; abnormal liver function test, increased blood creatine kinase. Perindopril: Dysgeusia, paraesthesia; tinnitus, vertigo; hypotension; cough; vomiting; rash, pruritus. Amlodipine: Oedema. Somnolence; diplopia; palpitations; flushing; change of bowel habit; ankle swelling; fatigue.
Drug Interactions
Higher frequency of adverse events w/ angiotensin II receptor-blockers or aliskiren. Increased risk of hyperkalaemia w/ aliskiren, K salts, K-sparing diuretics, ACE inhibitors, AIIA, NSAIDs, heparins, immunosuppressant agents (eg, ciclosporine or tacrolimus), trimethoprim. Atorvastatin & amlodipine: Not recommended: Bioavailability may be increased w/ grapefruit or grapefruit juice. Perindopril & amlodipine: Hypotensive effects may be increased w/ antihypertensive agents & vasodilators. Perindopril: May increase blood glucose-lowering effect of antidiabetic medicines eg, insulins, oral hypoglycaemic agents. Increased antihypertensive effect w/ baclofen. Antihypertensive effect may be attenuated w/ NSAIDs (eg, aspirin ≥3 g daily, COX-2 inhibitors & non-selective NSAIDs) & may be reduced w/ sympathomimetics. May increase risk of angioedema w/ racecadotril; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus. Increased risk of angioedema w/ gliptins eg, linagliptin, saxagliptin, sitagliptin, vildagliptin. May further reduce BP w/ TCAs/antipsychotics/anesth. Nitritoid reactions w/ injectable gold (Na aurothiomalate). Contraindicated: Risk of hyperkalaemia, worsening renal function & increased CV morbidity & mortality w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Increased risk of severe anaphylactoid reactions w/ extracorporeal treatments. May increase risk of angioedema w/ sacubitril/valsartan. Not recommended: Aliskiren. Higher frequency of hypotension, syncope, hyperkalaemia, & worsening renal function (including acute renal failure) w/ angiotensin-receptor blocker. Risk of increased adverse effects eg, angioneurotic oedema w/ estramustine. Reversible increased serum conc & toxicity of lithium. May increase risk of hyperkalaemia w/ co-trimoxazole. Hyperkalaemia w/ K-sparing diuretics (eg, triamterene, amiloride, eplerenone, spironolactone), K salts. Atorvastatin: Plasma conc may be increased w/ moderate CYP3A4 inhibitors (eg, erythromycin, diltiazem, verapamil & fluconazole) & may be reduced w/ inducers of cytochrome P450 3A (eg, rifampicin, St. John's wort). Increased steady-state digoxin conc. May increase risk of rhabdomyolysis w/ ezetimibe; fusidic acid; gemfibrozil/fibric acid derivatives. Increased systemic exposure w/ transport proteins eg, ciclosporine, letermovir. Decreased prothrombin time w/ warfarin. Myopathy has been reported w/ colchicine. Lowered plasma conc w/ colestipol. Increased plasma conc of norethindrone & ethinyl oestradiol. Contraindicated: Increased risk of myopathy w/ glecaprevir/pibrentasvir. Not recommended: Plasma conc may be increased & increased risk of myopathy w/ potent CYP3A4 inhibitors [eg, ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, antivirals for HCV (eg, elbasvir/grazoprevir) & HIV PIs (eg, ritonavir, lopinavir, atazanavir, indinavir, darunavir)]; inhibitors of transport proteins; other medicinal products that may induce myopathy eg, fibric acid derivatives & ezetimibe. Amlodipine: Exposure may be increased by strong or moderate CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil or diltiazem. Increased risk of hypotension w/ clarithromycin. Plasma conc may vary w/ strong CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Risk of increased tacrolimus blood levels. May increase exposure of mTOR inhibitors. Not recommended: Lethal ventricular fibrillation & CV collapse associated w/ hyperkalemia w/ dantrolene infusion.
MIMS Class
ACE Inhibitors/Direct Renin Inhibitors / Calcium Antagonists / Dyslipidaemic Agents
ATC Classification
C10BX11 - atorvastatin, amlodipine and perindopril ; Belongs to the class of HMG CoA reductase inhibitors, other combinations.
Presentation/Packing
Form
Triveram FC tab 10/5/5 mg
Packing/Price
30's
Form
Triveram FC tab 20/10/10 mg
Packing/Price
30's
Form
Triveram FC tab 20/5/5 mg
Packing/Price
30's
Form
Triveram FC tab 40/10/10 mg
Packing/Price
30's
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