Triveram/Triveram Forte

Triveram/Triveram Forte

Manufacturer:

Servier

Distributor:

Zuellig
Concise Prescribing Info
Contents
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
Essential HTN &/or CAD, in association w/ primary hypercholesterolemia or mixed hyperlipidemia.
Dosage/Direction for Use
1 tab once daily. Not suitable for initial therapy.
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. Myalgia, myositis & myopathy that may progress to rhabdomyolysis. Cardiac failure. Symptomatic hypotension w/ patients who have been vol-depleted or w/ severe renin-dependent HTN. Aortic & mitral valve stenosis; bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Anaphylactoid reactions in patients dialysed w/ high flux membranes; during low-density apheresis w/ dextran sulphate; during desensitization treatment (eg, hymenoptera venom). History of angioedema. Collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainamide. Black patients. Cough. Hyperkalemia. Discontinue if interstitial lung disease occurs. Discontinue 1 day prior to surgery. Not recommended w/ primary aldosteronism. Perform periodically liver function tests. Closely monitor glycemic control during 1st mth of therapy in diabetic patients w/ oral antidiabetic agents or insulin. Periodic monitoring of WBC & report any sign of infection (eg, sore throat, fever). Concomitant use w/ potent CYP3A4 inhibitors or transport proteins; gemfibrozil & other fibric acid derivatives, erythromycin, niacin & ezetimibe, telaprevir or combination of tipranivir/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. Galactose intolerance, glucose-galactose malabsorption or total lactase deficiency. May impair ability to drive or operate machinery. Renal impairment.
Adverse Reactions
Nasopharyngitis, hypersensitivity, hyperglycemia, headache, pharyngolaryngeal pain, epistaxis, constipation, flatulence, dyspepsia, nausea, diarrhea, change of bowel habit, myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, ankle swelling, back pain, liver function test abnormal, blood creatine kinase increased, somnolence, dizziness, palpitations, flushing, abdominal pain, edema, fatigue, paresthesia, visual impairment, diplopia, tinnitus, vertigo, hypotension, cough, dyspnea, vomiting, dysgeusia, rash, pruritus, asthenia.
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 Forte FC tab 40 mg/10 mg/10 mg
Packing/Price
30's (P1,717.19/box)
Form
Triveram FC tab 20 mg/5 mg/5 mg
Packing/Price
30's (P1,100.22/box)
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