Triveram

Triveram

Manufacturer:

Servier

Distributor:

Maxxcare
Full Prescribing Info
Contents
Atorvastatin, perindopril arginine, amlodipine.
Description
Triveram 10/5/5 mg: One film-coated tablet contains 10.82 mg atorvastatin calcium trihydrate equivalent to 10 mg atorvastatin, 5 mg perindopril arginine equivalent to 3.40 mg perindopril and 6.94 mg amlodipine besilate equivalent to 5 mg amlodipine.
Triveram 20/5/5 mg: One film-coated tablet contains 21.64 mg atorvastatin calcium trihydrate equivalent to 20 mg atorvastatin, 5 mg perindopril arginine equivalent to 3.40 mg perindopril and 6.94 mg amlodipine besilate equivalent to 5 mg amlodipine.
Triveram 20/10/10 mg: One film-coated tablet contains 21.64 mg atorvastatin calcium trihydrate equivalent to 20 mg atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg perindopril and 13.87 mg amlodipine besilate equivalent to 10 mg amlodipine.
Triveram 40/10/10 mg: One film-coated tablet contains 43.28 mg atorvastatin calcium trihydrate equivalent to 40 mg atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg perindopril and 13.87 mg amlodipine besilate equivalent to 10 mg amlodipine.
Excipients/Inactive Ingredients: Excipient with known effect: lactose monohydrate (27.46 mg for Triveram 10/5/5 mg, 54.92 mg for Triveram 20/5/5 mg and 20/10/10 mg, and 109.84 mg for Triveram 40/10/10 mg).
Action
PROPERTIES: Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase.
Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (Angiotensin Converting Enzyme ACE).
Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.
Indications/Uses
Substitution therapy for treatment of essential hypertension and/or stable coronary artery disease, in association with primary hypercholesterolaemia or mixed hyperlipidaemia, in adult patients adequately controlled with atorvastatin, perindopril and amlodipine given concurrently at the same dose level.
Dosage/Direction for Use
One tablet once daily before a meal in the morning. Triveram is not suitable for initial therapy. If a change of posology is required, the dose could be modified or individual titration with free combination may be considered.
Elderly and patients with renal failure: frequent monitoring of creatinine and potassium. Clcr < 60 ml/min: not suitable.
Hepatic impairment: should be used with caution. Triveram is contraindicated in patients with active liver disease.
Children and adolescents: should not be used.
Contraindications
Hypersensitivity to the active substances or to any other ACE inhibitor or dihydropyridine derivatives or statin or to any of the excipients, active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal, during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures (see USE IN PREGNANCY & LACTATION), severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle (e.g., hypertrophic obstructive cardiomyopathy and high grade aortic stenosis), haemodynamically unstable heart failure after acute myocardial infarction, history of angioedema (Quincke's oedema) associated with previous ACE inhibitor therapy, hereditary or idiopathic angioedema, concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m2) (see INTERACTIONS), concomitant use with sacubitril/valsartan (see WARNINGS and INTERACTIONS), extracorporeal treatments leading to contact of blood with negatively charged surfaces (see INTERACTIONS), significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney (see WARNINGS).
Warnings
Special warnings and precaution for use: Liver effects: liver function tests should be performed periodically and in case of transaminase levels increased, the patient should be monitored until resolution. Stop treatment if jaundice or marked elevations of hepatic enzymes (serum transaminases exceeding 3 times the upper limit of normal) and in patients with active liver disease.
Use with caution in patients with hepatic impairment, who consume alcohol and/or have history of liver disease.
Skeletal muscle effects: stop treatment if elevation of CK levels > 10 x ULN or muscular symptoms with elevation of CK level > 5 x ULN occur, or if rhabdomyolysis is suspected. Caution should be exercised when Triveram is used with certain medicinal products that may increase the plasma concentration of atorvastatin and then the risk of rhabdomyolysis such as potent inhibitors of CYP3A4 or transport proteins (e.g. ciclosporine, ketoconazole, ritonavir). Co-administration with systemic fusidic acid or within 7 days of stopping the treatment is not recommended. If use essential, Triveram should be discontinued during fusidic acid treatment.
Interstitial lung disease: if suspected, treatment should be discontinued.
Diabetes Mellitus: In diabetic patients, glycemic control should be closely monitored during first month of treatment.
Patients with cardiac failure: use with caution.
Hypotension: monitor blood pressure, renal function and potassium in patients at high risk of symptomatic hypotension (volume depleted or who have severe renin-dependent hypertension) or with symptomatic heart failure (with or without renal insufficiency), or with ischemic heart or cerebrovascular disease. A transient hypotensive response is not a contraindication to further doses once the blood pressure has increased after volume expansion.
Aortic and mitral valve stenosis/hypertrophic cardiomyopathy: use with caution and see CONTRAINDICATIONS.
Kidney transplantation: no experience in case of recent transplantation.
Renovascular hypertension: Increased risk of hypotension and renal insufficiency in patient with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Diuretics may be a contributory factor. Loss of renal function may occur (minor changes in serum creatinine) even in patients with unilateral renal artery stenosis.
Renal impairment: monitor potassium and creatinine; individual dose titration with the monocomponents recommended if Clcr < 60 ml/min. In patients with renal artery stenosis, blood urea and creatinine may increase; with renovascular hypertension, risk of severe hypotension and renal insufficiency. Amlodipine may be used at normal doses in patients with renal failure. Amlodipine is not dialyzable.
Haemodialysis patients: use with caution.
Hypersensitivity/Angioedema: stop treatment and monitor until complete resolution of symptoms. Angioedema associated with laryngeal edema may be fatal. Combination with sacubitril/valsartan (contraindicated due to the increased risk of angioedema). Sacubitril/valsartan must not be initiated until 36 hours after taking the last dose of perindopril therapy. Perindopril therapy must not be started until 36 hours after the last dose of sacubitril/valsartan. Concomitant use of other NEP inhibitors (e.g. racecadotril) and ACE inhibitors may also increase the risk of angioedema. Concomitant use of mTOR inhibitors: Increased risk for angioedema.
Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis: rarely, patients have experienced life-threatening anaphylactoid reactions, temporarily withhold treatment prior to exams.
Anaphylactoid reactions during desensitization: temporarily withhold treatment prior to exams. These reactions reappeared upon inadvertent rechallenge.
Neutropenia/agranulocytosis/thrombocytopenia/anaemia: extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treated with allopurinol or procainamide, periodic monitor of white blood cell counts advised.
Race: perindopril may be less effective and cause a higher rate of angioedema than in non-black.
Cough: resolves after discontinuation.
Surgery/Anesthesia: stop treatment one day prior to surgery.
Hyperkalemia: frequent monitoring of blood potassium if renal insufficiency, worsening of renal function, age (>70 years), diabetes mellitus, dehydration, acute cardiac decompensation, metabolic acidosis, and concomitant use of potassium-sparing diuretics and potassium salts or supplements.
Combination with lithium: not recommended.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS is therefore not recommended. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Primary aldosteronism: Use not recommended in patients with primary hyperaldosteronism (not responding to drugs acting through inhibition of renin-angiotensin system).
Galactose intolerance/glucose-galactose malabsorption/Total lactase deficiency: should not be taken.
Sodium: 'sodium-free'.
Special Precautions
Effects on Ability to Drive or Operate Machinery: May be impaired if dizziness, headache, fatigue, weariness or nausea. Caution is recommended especially at the start of treatment.
Use In Pregnancy & Lactation
Pregnancy and Breastfeeding: Triveram is contraindicated during pregnancy and lactation.
Fertility: Reversible biochemical changes of spermatozoa in some patients treated by calcium channel blockers.
Adverse Reactions
Very common: Oedema.
Common: Nasopharyngitis, hypersensitivity, hyperglycaemia, somnolence, dizziness, headache, dysgeusia, paraesthesia, vertigo, visual impairment, diplopia, tinnitus, palpitations, hypotension (and effects related to hypotension), flushing, pharyngolaryngeal pain, epistaxis, cough, dyspnoea, nausea, vomiting, abdominal pain upper and lower, dyspepsia, diarrhoea, constipation, change of bowel habit, flatulence, rash, pruritus, joint swelling, ankle swelling, pain in extremity, arthralgia, muscle spasms, myalgia, back pain, asthenia, fatigue, liver function test abnormal, blood creatine kinase increased.
Uncommon: Rhinitis, eosinophilia, hypoglycaemia, hyponatraemia, hyperkalaemia reversible on discontinuation, anorexia, insomnia, mood altered (including anxiety), sleep disorder, depression, nightmares, tremor, syncope, hypoaesthesia, amnesia, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), vision blurred, tachycardia, vasculitis, bronchospasm, dry mouth, pancreatitis, eructation, hepatitis either cytolytic or cholestatic, urticaria, purpura, skin discolouration, hyperhidrosis, exanthema, alopecia, angioedema, pemphigoid, photosensitivity reactions, neck pain, muscle fatigue, micturition disorder, nocturia, pollakiuria, renal failure, erectile dysfunction, gynecomastia, chest pain, pain, malaise, oedema peripheral, pyrexia, blood urea increased, blood creatinine increased, weight increase, white blood cells urine positive, weight decrease, fall.
Rare: Thrombocytopenia, confusional state, neuropathy peripheral, cholestasis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, myopathy, myositis, rhabdomyolysis, tendinopathy sometimes complicated by rupture, hepatic enzymes increased, blood bilirubin increased.
Very rare: Leucopenia/neutropenia, agranulocytosis or pancytopenia, haemolytic anaemia in patients with a congenital deficiency of G-6PDH, haemoglobin decreased and haematocrit decreased, anaphylaxis, hypertonia, hearing loss, myocardial infarction secondary to excessive hypotension in high-risk patients, angina pectoris, stroke possible secondary to excessive hypotension in high-risk patients, eosinophilic pneumonia, gastritis, gingival hyperplasia, jaundice, hepatic failure, exfoliative dermatitis, renal failure acute.
Not known: Immune-mediated necrotizing myopathy, extrapyramidal disorder (extrapyramidal syndrome). Syndrome of inappropriate antidiuretic hormone secretion (SIADH) can be considered as a very rare complication associated with ACE inhibitor therapy.
Drug Interactions
Contraindicated: Aliskiren (in diabetic and impaired renal patients). Extracorporeal treatments, Sacubitril/valsartan.
Not recommended: CYP3A4 inhibitors, aliskiren, concomitant therapy with ACE inhibitor and angiotensin-receptor blocker, estramustine, lithium, Co-trimoxazole (trimethoprim/sulfamethoxazole), potassium sparing diuretics (e.g. triamterene, amiloride, eplerenone, spironolactone), potassium salts, dantrolene (infusion), grapefruit or grapefruit juice.
Precautions: CYP3A4 inducers, digoxin, ezetimibe, fusidic acid, gemfibrozil/fibric acid derivatives, transport protein inhibitors, warfarin, antidiabetic agents (insulins, oral hypoglycaemic agents), baclofen, non-steroidal anti-inflammatory medicinal products (NSAIDs) (including aspirin ≥ 3 g/day), colchicine, colestipol, oral contraceptives, gliptins (linagliptin, saxagliptin, sitagliptin, vildagliptin), sympathomimetics, tricyclic antidepressants/antipsychotics/anesthetics, gold, digoxin, atorvastatin, warfarin or cyclosporine, tacrolimus, antihypertensive agents and vasodilators.
ATC Classification
C10BX11 - atorvastatin, amlodipine and perindopril ; Belongs to the class of HMG CoA reductase inhibitors, other combinations.
Presentation/Packing
FC tab 10/5/5 mg (yellow, round, 7 mm diameter, with a curvature radius of 25 mm, engraved with "
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" on one face and "
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"on the other) x 30's. 20/5/5 mg (yellow, round, 8.8 mm diameter, with a curvature radius of 32 mm, engraved with "
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" on one face and "
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" on the other) x 30's. 20/10/10 mg (yellow, oblong-shaped, 12.7 mm length and 6.35 mm width, engraved with "
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" on one face and "
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"on the other) x 30's. 40/10/10 mg (yellow, oblong-shaped, 16 mm length and 8 mm width, engraved with "
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" on one face and "
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"on the other) x 30's.
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