Coveram

Coveram

perindopril + amlodipine

Manufacturer:

Servier

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per 5 mg/5 mg tab Perindopril arginine 5 mg, amlodipine besilate 5 mg. Per 5 mg/10 mg tab Perindopril arginine 5 mg, amlodipine besilate 10 mg. Per 10 mg/5 mg tab Perindopril arginine 10 mg, amlodipine besilate 5 mg. Per 10 mg/10 mg tab Perindopril arginine 10 mg, amlodipine besilate 10 mg
Indications/Uses
Substitution therapy for essential HTN &/or stable CAD in patients already controlled w/ perindopril & amlodipine given concurrently at the same dose level.
Dosage/Direction for Use
1 tab/day as single dose preferably in the morning.
Administration
Should be taken on an empty stomach: Avoid grapefruit & grapefruit juice.
Contraindications
Hypersensitivity. Perindopril: History of angioedema associated w/ previous ACE inhibitor therapy; hereditary or idiopathic angioedema; concomitant use w/ 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. Patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Pregnancy (2nd & 3rd trimester). Amlodipine: Severe hypotension; cardiogenic shock; obstruction of the outflow-tract of the left ventricle (eg, high-grade aortic stenosis); hemodynamically unstable heart failure after acute MI.
Special Precautions
Concomitant use w/ lithium, K-sparing drugs, K-supplements or dantrolene is not recommended. Renal impairment (CrCl <60 mL/min). Severe hepatic impairment. Galactose intolerance, glucose-galactose malabsorption or Lapp lactase deficiency. May affect ability to drive or operate machinery. Not recommended during pregnancy (1st trimester) & lactation. Do not use in childn & adolescents. Perindopril: Hypersensitivity/angioedema. Anaphylactoid reactions during LDL apheresis & desensitisation. Monitor WBC if used in patients w/ collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainamide. Renal vascular HTN. Dual blockade of renin-angiotensin-aldosterone system through the combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is not recommended. Primary aldosteronism. Monitor BP, renal function & serum K in patients at high risk of hypotension. Mitral valve stenosis & left ventricle outflow obstruction eg, aortic stenosis or hypertrophic cardiomyopathy; bilateral renal artery stenosis. Higher rate of angioedema in Black patients. Non-productive & persistent cough. Discontinue treatment 1 day prior to surgery. Patients at risk of hyperkalemia. Closely monitor glycemic control in diabetic patients treated w/ oral antidiabetic agents or insulin during the 1st mth of treatment. Must not be initiated until 36 hr after the last dose of sacubitril/valsartan. Increased risk of angioedema in patients taking concomitant NEP inhibitors (eg, racecadotril), ACE inhibitors & mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus). Amlodipine: Hypertensive crisis. Patients w/ severe heart failure (NYHA class II & IV), CHF. Slow dose titration & careful monitoring in patients w/ severe hepatic impairment. Elderly.
Adverse Reactions
Dizziness, headache; visual impairment; dyspnea; abdominal pain, nausea; diarrhea, constipation; muscle spasms; asthenia. Amlodipine: Somnolence, dizziness; diplopia; palpitations; flushing; change of bowel habit; joint swelling (ankle); fatigue. Perindopril: Dysgeusia, paresthesia; tinnitus, vertigo; hypotension; cough; vomiting, dyspepsia; pruritus, rash, exanthema.
Drug Interactions
Increased antihypertensive effect w/ baclofen, amifostine. Further BP reduction w/ nitroglycerine & other nitrates or vasodilators. Reduced antihypertensive effects w/ corticosteroids, tetracosactide, sympathomimetics. Increased risk of orthostatic hypotension w/ α-blockers, TCAs, antipsychotics & anesth. Perindopril: Increased risk of hyperkalemia w/ aliskiren, K salts, K-sparing diuretics, ACE inhibitors, AIIAs, NSAIDs including aspirin ≥3 g/day, heparins, immunosuppressant agents eg, ciclosporin or tacrolimus, trimethoprim & co-trimoxazole. Hemodialysis. Potentially lethal hyperkalemia w/ K sparing diuretics. Increased risk of angioedema w/ sacubitril/valsartan, estramustine, mTOR inhibitors & gliptines. Increased lithium conc & toxicity. Increased risk of hypoglycemia w/ antidiabetic agents. Increased risk of worsening of renal function w/ NSAIDs. Nitritoid reactions w/ inj gold (Na aurothiomalate). Amlodipine: Lethal ventricular fibrillation & CV collapse associated w/ hyperkalemia w/ IV dantrolene. CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Significant increase in exposure w/ strong or moderate CYP3A4 inhibitors. Increased blood levels of tacrolimus. Increased exposure of mTOR inhibitors. Increase trough conc of ciclosporin. Increased exposure of simvastatin. Increased BP lowering effects w/ grapefruit.
ATC Classification
C09BB04 - perindopril and amlodipine ; Belongs to the class of ACE inhibitors and calcium channel blockers. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Form
Coveram 5 mg/10 mg tab
Packing/Price
30's (P1,261.16/pack)
Form
Coveram 5 mg/5 mg tab
Packing/Price
30's (P1,122.22/pack)
Form
Coveram 10 mg/10 mg tab
Packing/Price
30's (P1,717.19/pack)
Form
Coveram 10 mg/5 mg tab
Packing/Price
30's (P1,606.47/pack)
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