Triveram Initio/Triveram/Triveram Forte

Triveram Initio/Triveram/Triveram Forte

Manufacturer:

Servier

Distributor:

Zuellig
Concise Prescribing Info
Contents
Triveram Initio Atorvastatin 10 mg, perindopril arginine 5 mg, amlodipine 5 mg. Triveram Atorvastatin 20 mg, perindopril arginine 5 mg, amlodipine 5 mg. Triveram Forte Atorvastatin 40 mg, perindopril arginine 10 mg, amlodipine 10 mg
Indications/Uses
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.
Dosage/Direction for Use
Administration
Should be taken on an empty stomach: Take in the morning before a meal. Avoid grapefruit & grapefruit juice.
Contraindications
Hypersensitivity to atorvastatin, perindopril arginine, amlodipine, 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 track 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/ HCV 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. Pregnancy & lactation.
Special Precautions
Patients who consume substantial quantities of alcohol &/or have history of liver disease. Perform LFTs periodically especially on patients who develop signs or symptoms suggestive of hepatic dysfunction. Monitor patients who develop increased transaminase levels. Discontinue in patients who develop jaundice or marked elevations of hepatic enzymes. Myalgia, myositis & myopathy that may progress to rhabdomyolysis. Patients w/ pre-disposing factors for rhabdomyolysis (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; conditions where an increase in plasma levels may occur). Discontinue if creatinine kinase levels are significantly elevated (>5 times ULN); muscular symptoms are severe & cause daily discomfort even if the CK levels are elevated to ≤5 x ULN; CK levels (>10 x ULN) occur or rhabdomyolysis is diagnosed or suspected; ILD occurs. Closely monitor glycemic control during the 1st mth of therapy in diabetic patients treated w/ oral antidiabetic agents or insulin. Patients w/ severe heart failure (NYHA class III & IV) & CHF. Symptomatic hypotension in patients who have been vol-depleted (eg, 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. Anaphylactoid reactions in patients dialysed w/ high flux membranes. Risk of angioedema in patients w/ history of angioedema unrelated to ACE inhibitor therapy. Anaphylactoid reactions during LDL apheresis w/ dextran sulphate; desensitization treatment (eg, hymenoptera venom). Risk of neutropenia/agranulocytosis, thrombocytopenia & anemia; extreme caution in patients w/ collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainamide especially w/ pre-existing 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 of hyperkalemia in patients w/ renal insufficiency, worsening renal function, DM, 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). Avoid concomitant use of ARBs in patients w/ diabetic nephropathy. Not recommended in patients w/ primary aldosteronism. Concomitant use w/ potent CYP3A4 inhibitors 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 HCV (boceprevir, telaprevir, elbasvir/grazoprevir), erythromycin, niacin & ezetimibe; other NEP inhibitors eg, racecadotril; mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus). Do not co-administer w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid treatment. Combination w/ lithium or dual blockage of RAAs (through combined use of ACE inhibitors, ARBs or aliskiren) is not recommended. Galactose intolerance, glucose-galactose malabsorption or total lactase deficiency. May impair ability to drive or operate machinery. Severe hepatic impairment. Not suitable for moderate to severe renal impairment (<60 mL/min). Women of childbearing potential should use appropriate contraceptive measures during treatment. Contraindicated in pregnancy & lactation. Elderly >70 yr. Childn & adolescents.
Adverse Reactions
Headache, dizziness; visual impairment; dyspnea; nausea, dyspepsia, diarrhea, constipation, upper & lower abdominal pain; muscle spasm; 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; change of bowel habit; ankle swelling; fatigue.
Drug Interactions
May affect or be affected by immunosuppressants (eg, cyclosporin, tacrolimus); ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole; rifampicin, erythromycin, clarithromycin, telithromycin, fusidic acid, trimethoprim; colchicine; gemfibrozil, other fibrates, colestipol, ezetimibe; Ca channel blockers (eg, diltiazem); digoxin, verapamil, amiodarone; letermovir; medicines used in the treatment of 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; antacids; St John's wort; dantrolene (infusion); antihypertensives 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 body (eg, heparin & co-trimoxazole), estramustine; lithium; racecadotril; mTor inhibitors (eg, sirolimus, everolimus, temsirolimus); antidiabetics (eg, insulin, metformin or gliptines); sacubitril/valsartan; baclofen; NSAIDs (eg, ibuprofen) or high dose aspirin; vasodilators including nitrates; TCAs, antipsychotics; ephedrine, noradrenaline or adrenaline; gold salts (IV admin); allopurinol; procainamide. Increased BP lowering effect w/ grapefruit juice & grapefruit. Avoid drinking too much alcohol.
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 Initio FC tab
Packing/Price
30's (P880/box)
Form
Triveram FC tab
Packing/Price
30's (P1,100.22/box)
Form
Triveram Forte FC tab
Packing/Price
30's (P1,717.19/box)
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