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AceryCal

perindopril + amlodipine

Manufacturer:

Servier

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per 5/5 mg Perindopril arginine 5 mg, amlodipine 5 mg. Per 5/10 mg Perindopril arginine 5 mg, amlodipine 10 mg. Per 10/5 mg Perindopril arginine 10 mg, amlodipine 5 mg. Per 10/10 mg Perindopril arginine 10 mg, amlodipine 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
Administration
Should be taken on an empty stomach: Preferably taken in the morning.
Contraindications
Hypersensitivity to perindopril, amlodipine, any other ACE inhibitors, or to dihydropyridine derivatives. Perindopril: Patients w/ history of angioedema associated w/ previous ACE inhibitor therapy; hereditary or idiopathic angioedema. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). 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. 2nd & 3rd trimesters of pregnancy. Amlodipine: Severe hypotension; shock including cardiogenic shock; obstruction of the outflow-tract of the left ventricle (eg, high grade stenosis); haemodynamically unstable heart failure after acute MI.
Special Precautions
Concomitant use w/ lithium, K-sparing drugs or K supplements, or dantrolene is not recommended. Rare hereditary problems of galactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency. May impair ability to drive or operate machinery. Not recommended during the 1st trimester of pregnancy & during lactation. Should not be used in childn & adolescents. Perindopril: Reports of hypersensitivity/angioedema; neutropenia/agranulocytosis, thrombocytopenia & anaemia; non-productive, persistent cough. Anaphylactoid reactions during dialysis w/ high-flux membranes, LDL apheresis w/ dextran sulphate or desensitisation. Increased risk of hypotension & renal insufficiency in patient w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Dual blockade of the renin-angiotensin-aldosterone system w/ ACE inhibitors, angiotensin II receptor blockers or aliskiren. Not recommended in primary aldosteronism. Risk of symptomatic hypotension. Use w/ caution in patients w/ mitral valve stenosis & obstruction in the outflow of the left ventricle eg, aortic stenosis or hypertrophic cardiomyopathy. Discontinue treatment if jaundice or marked elevations of hepatic enzymes develops. Higher rate of angioedema in Black patients. Stop treatment 1 day prior to surgery. Risk of hyperkalemia. Monitor glycaemic control during the 1st mth of treatment in diabetic patients treated w/ oral antidiabetics or insulin. Patients w/ renal impairment. Amlodipine: Hypertensive crisis. Use w/ caution in patients w/ heart failure. Patients w/ hepatic impairment. Amlodipine is not dialysable. Elderly.
Adverse Reactions
Oedema, somnolence, dizziness, headache (especially at the beginning of the treatment), dysgeusia, paraesthesia, visual impairment (including diplopia), tinnitus, vertigo, palpitations, flushing, hypotension (& effects related to hypotension), dyspnoea, cough, abdominal pain, nausea, vomiting, dyspepsia, change of bowel habit, diarrheoa, constipation, pruritus, rash, exanthema, joint swelling (ankle swelling), muscle spasms, fatigue, asthenia.
Drug Interactions
Increased antihypertensive effect w/ baclofen; nitroglycerin & other nitrates or other vasodilators; α-blockers; amifostine; TCAs, antipsychotics, anaesth. Reduced antihypertensive effect w/ corticosteroids, tetracosactide. Perindopril: Higher frequency of adverse events w/ other ACE inhibitors, angiotensin II receptor blockers or aliskiren. Increased occurrence of hyperkalaemia w/ aliskiren, K salts, K-sparing diuretics, other ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparin, immunosuppressants; co-trimoxazole. Risk of hyperkalaemia, worsening of renal function & CV morbidity & mortality increase w/ aliskiren in diabetic or impaired renal patients. Increased risk of angioedema w/ sacubitril/valsartan; estramustine; racecadotril; mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus); gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin). Increased serum lithium conc & toxicity. Increased blood-glucose lowering effect of antidiabetic medicines. Increased hypotensive effect w/ non-K-sparing diuretics. Reduced antihypertensive effect w/ NSAIDs including aspirin ≥3 g/day; sympathomimetics. Nitritoid reactions w/ inj gold. Amlodipine: Avoid concomitant use w/ dantrolene infusion in patients susceptible to malignant hyperthermia & in the management of malignant hyperthermia. Reduced plasma conc w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Increased exposure w/ strong or moderate CYP3A4 inhibitors (eg, PIs, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem). Increased hypotensive effects w/ other antihypertensives; grapefruit or grapefruit juice. Risk of increased blood levels of tacrolimus. May increase exposure of mTOR inhibitors; simvastatin. Monitor ciclosporin levels in renal transplant patients on amlodipine.
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
AceryCal 10/10 mg FC tab
Packing/Price
30's
Form
AceryCal 5/10 mg FC tab
Packing/Price
30's
Form
AceryCal 5/5 mg FC tab
Packing/Price
30's
Form
AceryCal 10/5 mg FC tab
Packing/Price
30's
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