Triveram Initio/Triveram

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

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 times 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. During pregnancy, while breastfeeding & in women of child-bearing potential not using appropriate contraception.

Discontinue in case of hypersensitivity/angioedema; jaundice or marked elevations of hepatic enzymes; significantly elevated creatine kinase (CK) levels (>5 x ULN); diagnosed or suspected rhabdomyolysis; aggravation of symptoms of myasthenia gravis or ocular myasthenia; suspected ILD. Consider discontinuation in case of muscular symptoms that are severe & cause daily discomfort even if CK levels are elevated to ≤5 x ULN. Not suitable for initial therapy. Not recommended in patients w/ primary hyperaldosteronism. Dual blockade of RAAS through combination w/ ACE inhibitors, ARBs or aliskiren is not recommended. Perform LFTs periodically especially in patients who develop any signs or symptoms suggestive of hepatic dysfunction. Monitor patients who develop increased transaminase levels until abnormalities resolve. Rarely, may cause myalgia, myositis, & myopathy that may progress to rhabdomyolysis. Caution & measure CK level prior to treatment in 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, elderly >70 yr, situations where an increase in plasma levels may occur, concomitant use of fibrates. Closely monitor glycemic control during 1st mth of treatment in diabetic patients treated w/ oral antidiabetics or insulin. Caution in patients w/ heart failure & CHF; w/ mitral valve stenosis or significant aortic stenosis that is not high grade. 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. No experience in patients w/ recent kidney transplantation. Increased risk of hypotension & renal insufficiency in patient w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Anaphylactoid reactions in patients dialysed w/ high flux membranes; consider using different type of dialysis membrane or different class of antihypertensives. Anaphylactoid reactions during LDL apheresis w/ dextran sulphate; temporarily w/hold ACE inhibitor prior to each apheresis. Anaphylactoid reactions during desensitization (eg, hymenoptera venom). Reports of 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/ pre-existing impaired renal function; periodic monitoring of WBC & reporting of any sign of infection (eg, sore throat, fever) is advised during use. May be less effective in lowering BP in black patients than in non-blacks. Reports of cough. Discontinue 1 day prior to surgery. Risk factors for development of hyperkalemia include patients w/ renal insufficiency, worsening renal function, elderly >70 yr, 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. Sacubitril/valsartan must not be initiated until 36 hr after taking last dose of perindopril therapy. If sacubitril/valsartan is stopped, perindopril therapy must not be initiated until 36 hr after last dose of sacubitril/valsartan. Not recommended in patients taking letermovir co-administered w/ ciclosporin. Not recommended in combination w/ lithium. Concomitant use w/ potent inhibitors of CYP3A4 or transport proteins eg, ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, letermovir & HIV PIs including ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir; gemfibrozil & other fibric acid derivatives, antivirals for hepatitis C (eg, boceprevir, telaprevir, elbasvir/grazoprevir, ledipasvir/sofosbuvir), erythromycin, niacin or ezetimibe; other NEP inhibitors eg, racecadotril; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus. Not to be administered to patients w/ galactose intolerance, glucose-galactose malabsorption or total lactase deficiency. Contains <1 mmol Na/tab. May impair ability to drive or operate machinery. Not suitable in patients w/ CrCl <60 mL/min (moderate to severe renal impairment). Caution in patients w/ hepatic impairment & who consume substantial quantities of alcohol &/or have history of liver disease. Women of childbearing potential should use appropriate contraception during treatment. Not recommended in childn & adolescents.

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: Edema. Somnolence; diplopia; palpitations; flushing; change of bowel habit; ankle swelling; fatigue.

Increased risk of rhabdomyolysis w/ potent inhibitors of CYP3A4 or transport proteins eg, ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, letermovir & 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, ledipasvir/sofosbuvir), 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; letermovir; 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 gliptins; 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 cause unpredictable increase in 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