Triveram Initio/Triveram/Triveram Forte

Per Triveram Initio FC tab Atorvastatin 10 mg, perindopril arginine 5 mg, amlodipine 5 mg. Per Triveram FC tab Atorvastatin 20 mg, perindopril arginine 5 mg, amlodipine 5 mg. Per Triveram Forte FC tab Atorvastatin 40 mg, perindopril arginine 10 mg, amlodipine 10 mg

Essential HTN &/or stable CAD, in association w/ primary hypercholesterolemia or mixed hyperlipidemia, as substitution therapy in adult patients adequately controlled w/ atorvastatin, perindopril & amlodipine given concurrently at the same dose level as in the combination.

1 tab as single dose once daily.

Should be taken on an empty stomach: Take in the morning before a meal. Avoid grapefruit & grapefruit juice.

Hypersensitivity to atorvastatin, perindopril, amlodipine, any other ACE inhibitor, dihydropyridine derivatives or statin. Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 x ULN. Severe hypotension. Shock (including cardiogenic shock). Obstruction of the outflow tract of the left ventricle eg, hypertrophic obstructive cardiomyopathy & high-grade aortic stenosis. Hemodynamically unstable heart failure after acute MI. History of angioedema (Quincke's edema) associated w/ previous ACE inhibitor therapy. Hereditary or idiopathic angioedema. Concomitant use w/ hepatitis C antivirals 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. Significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.

Discontinue if jaundice or marked elevations of hepatic enzymes develops; creatinine kinase (CK) levels are significantly elevated (>5 x ULN); muscular symptoms are severe & cause daily discomfort even if CK levels are elevated to ≤5 x ULN; CK levels >10 x ULN occur or rhabdomyolysis is diagnosed or suspected; ILD is suspected to has been developed; in case of hypersensitivity/angioedema. Not suitable for initial therapy. Not recommended in patients w/ primary aldosteronism. Dual blockade of RAAS through combination w/ ARBs or aliskiren is not recommended. Patients who consume substantial quantities of alcohol &/or have history of liver disease. Perform LFTs periodically especially on patients who develop any signs or symptoms suggestive of hepatic dysfunction. Monitor patients who develop increased transaminase levels. May cause myalgia, myositis & myopathy that may progress to rhabdomyolysis. Patients w/ pre-disposing factors for rhabdomyolysis eg, renal impairment, hypothyroidism, personal/familial history of hereditary muscular disorders, history of muscular toxicity w/ statin or fibrate, history of liver disease &/or where substantial quantities of alcohol are consumed, situations where an increase in plasma levels may occur. Closely monitor glycemic control during 1st mth of therapy in diabetic patients treated w/ oral antidiabetics or insulin. Patients w/ severe heart failure (NYHA class III & IV) & CHF. Symptomatic hypotension in patients who have been vol-depleted (eg, by diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting) or w/ severe renin-dependent HTN; symptomatic heart failure w/ or w/o associated renal insufficiency. Aortic & mitral valve stenosis; recent kidney transplantation; bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Hemodialysis patients; consider using dialysis membranes other than high flux or antihypertensive agents other than ACE inhibitors. Anaphylactoid reactions during LDL apheresis; temporarily w/hold ACE inhibitor prior to each apheresis. Anaphylactoid reactions during desensitization (eg, hymenoptera venom). Neutropenia/agranulocytosis, thrombocytopenia & anemia; extreme caution in patients w/ collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainamide, or combination of these complicating factors, especially w/ preexisting impaired renal function (periodic monitoring of WBC & report any sign of infection eg, sore throat, fever). Black patients. Cough. Discontinue 1 day prior to surgery. Risk factors for development of hyperkalemia eg, patients w/ renal insufficiency, worsening renal function, DM, intercurrent events particularly dehydration, acute cardiac decompensation, metabolic acidosis & concomitant use of K-sparing diuretics (eg, spironolactone, eplerenone, triamterene, or amiloride), K supplements or K-containing salt substitutes; other drugs associated w/ increases in serum K (eg, heparin). Not to be co-administered w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid treatment. Not to be initiated until 36 hr after last dose of sacubitril/valsartan. Not recommended in combination w/ lithium. Concomitant use w/ potent CYP3A4 or transport protein inhibitors eg, ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole & HIV PIs including ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir; gemfibrozil & other fibric acid derivatives, antivirals for hepatitis C (eg, boceprevir, telaprevir, elbasvir/grazoprevir), erythromycin, niacin or ezetimibe; other NEP inhibitors eg, racecadotril; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus. Not to be administered to patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Contains <1 mmol Na/tab. May impair ability to drive or operate machinery. Not suitable in moderate to severe renal impairment (CrCl <60 mL/min). Hepatic impairment. Women of childbearing potential should use appropriate contraception during treatment. Not recommended in childn & adolescents. Elderly >70 yr.

Headache; nausea, dyspepsia, diarrhea, constipation; muscle spasms. Perindopril & amlodipine: Dizziness; visual impairment; dyspnea; upper & lower abdominal pain; asthenia. Atorvastatin: Nasopharyngitis; hypersensitivity; hyperglycemia; pharyngolaryngeal pain, epistaxis; flatulence; joint swelling, pain in extremity, arthralgia, myalgia, back pain; abnormal LFT; increased blood creatine kinase. Perindopril: Dysgeusia, paresthesia; tinnitus, vertigo; hypotension (& effects related to hypotension); cough; vomiting; rash, pruritus. Amlodipine: Somnolence; diplopia; palpitations; flushing; change of bowel habit; ankle swelling; fatigue.

Increased risk of rhabdomyolysis w/ potent CYP3A4 or transport protein inhibitors eg, ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole & HIV PIs including ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir. May increase risk of myopathy w/ gemfibrozil & other fibric acid derivatives, antivirals for hepatitis C (eg, boceprevir, telaprevir, elbasvir/grazoprevir), erythromycin, niacin or ezetimibe. Reports of rhabdomyolysis w/ fusidic acid. Increased risk of angioedema w/ sacubitril/valsartan. May increase risk of angioedema w/ other NEP inhibitors eg, racecadotril; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus. May affect or be affected by immunosuppressants for auto-immune disorders or following transplant surgery eg, ciclosporin, tacrolimus; ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole; rifampicin, erythromycin, clarithromycin, telithromycin, fusidic acid, trimethoprim; colchicine; other medicines to regulate lipid levels eg, gemfibrozil, other fibrates, colestipol, ezetimibe; some Ca channel blockers for angina or high BP eg, diltiazem; medicines to regulate heart rhythm eg, digoxin, verapamil, amiodarone; medicines for HIV or liver disease eg, hepatitis C (eg, delavirdine, efavirenz, ritonavir, lopinavir, atazanavir, indinavir, darunavir, telaprevir, boceprevir & combination of elbasvir/grazoprevir); warfarin; OCs; stiripentol; cimetidine; phenazone; Al- & Mg-containing antacids; Hypericum perforatum or St John's wort; dantrolene (infusion); other medicines for high BP including aliskiren, ARBs (eg, valsartan); K-sparing drugs (eg, triamterene, amiloride, eplerenone, spironolactone), K supplements or K-containing salt substitutes, other drugs which can increase K in the body (eg, heparin & co-trimoxazole), estramustine; lithium; medicines most often used for diarrhea (eg, racecadotril) or to avoid rejection of transplanted organs (eg, sirolimus, everolimus, temsirolimus & other mTOR inhibitors); medicines for diabetes eg, insulin, metformin or gliptines; sacubitril/valsartan; baclofen; NSAIDs (eg, ibuprofen) or high-dose aspirin; vasodilators including nitrates; medicines for mental disorders eg, depression, anxiety, schizophrenia (eg, TCAs, antipsychotics); medicines for low BP, shock or asthma eg, ephedrine, noradrenaline or adrenaline; gold salts (especially IV); allopurinol; procainamide. Increased blood levels of amlodipine which can increase BP-lowering effect w/ grapefruit juice & grapefruit. Avoid drinking too much alcohol during treatment.

ACE Inhibitors/Direct Renin Inhibitors / Calcium Antagonists / Dyslipidaemic Agents

C10BX11 - atorvastatin, amlodipine and perindopril ; Belongs to the class of HMG CoA reductase inhibitors, other combinations.

Rx