Triveram Initio/Triveram/Triveram Forte

Triveram Initio/Triveram/Triveram Forte

Manufacturer:

Servier

Distributor:

Zuellig
Concise Prescribing Info
Contents
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
Indications/Uses
Treatment of 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 of 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 child-bearing potential. Pregnancy & lactation.
Special Precautions
Patients who consume substantial quantities of alcohol &/or have history of liver disease. Perform periodically liver function tests especially on patients who develop signs & symptoms suggestive of hepatic dysfunction. Monitor patients who develop increased transaminase levels. Myalgia, myositis & myopathy that may progress to rhabdomyolysis. Patients w/ pre-disposing factors for rhabdomyolysis (renal impairment; hypothyroidism; 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; conditions where an increase in plasma levels may occur). Discontinue if interstitial lung disease occurs. Closely monitor glycemic control during 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 w/ patients who have been vol-depleted 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. History of angioedema. Anaphylactoid reactions during low-density lipoprotein apheresis w/ dextran sulphate (avoided by temporarily w/holding ACE inhibitor therapy prior to each apheresis); during desensitization treatment eg, hymenoptera venom (avoided when the ACE inhibitors were temporarily w/held). 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, age > 70 yr, DM, dehydration, acute cardiac decompensation, metabolic acidosis & concomitant use of K-sparing diuretics, K supplements or K-containing salt substitutes; other drugs associated w/ increases in serum K (eg, heparin). Concomitant use w/ potent CYP3A4 inhibitors or transport proteins; gemfibrozil & other fibric acid derivatives, erythromycin, niacin & ezetimibe, telaprevir or combination of tipranavir/ritonavir; 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, angiotensin II receptor blockers or aliskiren) is not recommended. Not recommended w/ primary aldosteronism. 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 (<60 mL/min).
Adverse Reactions
Edema; nasopharyngitis, hypersensitivity, hyperglycemia, somnolence, dizziness, headache, dysgeusia, paresthesia, visual impairment, diplopia, tinnitus, vertigo, palpitations, hypotension (& effects related to hypotension), flushing, pharyngolaryngeal pain, epistaxis, cough, dyspnea, nausea, vomiting, upper & lower abdominal pain, dyspepsia, diarrhea, constipation, change of bowel habit, flatulence, rash, pruritus, joint swelling, ankle swelling, pain in extremity, arthralgia, muscle spasms, myalgia, back pain, asthenia, fatigue, abnormal liver function test, increased blood creatine kinase.
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; some Ca channel blockers (eg, diltiazem); digoxin, verapamil, amiodarone; medicines used in the treatment of HIV (eg, delavirdine, efavirenz, ritonavir, lopinavir, atazanavir, indinavir, darunavir); warfarin; OCs; stiripentol; cimetidine; phenazone; antacids, St John's wort; dantrolene (infusion); antihypertensives including aliskiren, angiotensin II receptor blockers (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.
ATC Classification
C10BX11 - atorvastatin, amlodipine and perindopril ; Belongs to the class of HMG CoA reductase inhibitors, other combinations.
Presentation/Packing
Form
Triveram Initio 10 mg/5 mg/5 mg FC tab
Packing/Price
30's (P880/box)
Form
Triveram Forte 40 mg/10 mg/10 mg FC tab
Packing/Price
30's (P1,717.19/box)
Form
Triveram 20 mg/5 mg/5 mg FC tab
Packing/Price
30's (P1,100.22/box)
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