Coveram

Coveram

perindopril + amlodipine

Manufacturer:

Servier

Distributor:

DKSH
Concise Prescribing Info
Contents
Per 5/5 mg tab Perindopril arginine 5 mg equiv to perindopril 3.395 mg, amlodipine besylate 6.935 mg equiv to amlodipine 5 mg. Per 5/10 mg tab Perindopril arginine 5 mg equiv to perindopril 3.395 mg, amlodipine besylate 13.87 mg equiv to amlodipine 10 mg. Per 10/10 mg tab Perindopril arginine 10 mg equiv to perindopril 6.79 mg, amlodipine besylate 13.87 mg equiv to amlodipine 10 mg
Indications/Uses
Substitution therapy of 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.
Contraindications
Hypersensitivity to other ACE inhibitors & dihydropyridines. Patients w/ history of angioedema associated w/ previous ACE inhibitor therapy; hereditary or idiopathic angioedema; use w/ aliskiren in patients w/ DM or renal impairment; severe hypotension; shock including cardiogenic shock; obstruction of the outflow tract of the left ventricle; unstable angina pectoris (excluding Prinzmetal's angina), heart failure during the first 28 days after MI. Pregnancy (2nd & 3rd trimester).
Special Precautions
Withhold therapy prior to each LDL apheresis. Monitor WBC if used in patients w/ collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainide. Monitor BP, renal function & serum K if high risk of symptomatic hypotension. Aortic & mitral valve stenosis, hypertrophic cardiomyopathy. Renal & hepatic impairment, cardiac failure. Patients at risk of hyperkalemia. Diabetics. Discontinue 1 day prior to surgery. May affect ability to drive or operate machinery. Pregnancy (1st trimester) & lactation. Elderly, childn & adolescents.
Adverse Reactions
Somnolence, dizziness, headache, dysgeusia, paresthaesia, vertigo, visual disturbances, tinnitus, palpitations, flushing, hypotension, dyspnea, cough, abdominal pain, nausea, vomiting, dyspepsia, diarrhea, constipation, pruritus, rash, exanthema, ankle swelling, muscle cramps, oedema, peripheral oedema, fatigue, asthenia, allergic reactions, insomnia, mood changes, depression, sleep disturbances, tremor, hypoesthaesia, syncope, rhinitis, bronchospasm, altered bowel habits, dry mouth, angioedema of face, extremities, lips, mucous membranes, tongue, glottis &/or larynx, alopecia, purpura, skin discoloration, hyperhidrosis, urticaria, arthralgia, myalgia, back pain, micturition disorders, nocturia, increased urinary frequency, renal impairment, impotence, gynaecomastia, chest pain, pain, malaise, increased/decreased wt, confusion, serum bilirubin & liver enzymes elevation, leucopenia/neutropenia, agranulocytosis or pancytopenia, thrombocytopenia, haemolytic anaemia in patients w/ congenital deficiency of G6PDH, decrease in Hb & hematocrit, hyperglycemia, hypertonia, peripheral neuropathy, angina pectoris, MI, arrhythmia, stroke, vasculitis, eosinophilic pneumonia, gingival hyperplasia, pancreatitis, gastritis, hepatitis, jaundice, hepatitis either cytolitic or cholestatic, increased hepatic enzymes, Quincke's oedema, erythema multiform, Stevens-Johnson syndrome, exfoliative dermatitis, photosensitivity, acute renal failure.  
Drug Interactions
Lithium, K-sparing diuretics, K supplements or K-containing salt substitutes, dantrolene, estramustine. NSAIDs, insulin, hypoglycaemic agents, diuretics, sympathomimetics, Na aurothiomalate, CYP3A4 inducers or inhibitors, α- & β-blockers, baclofen, vasodilators, corticosteroids, tetracosactide, amifostine, TCA, antipsychotics, anaesth, grapefruit, diuretics, gold, antihypertensive agent.
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 tab 10/10 mg
Packing/Price
30's
Form
Coveram tab 5/10 mg
Packing/Price
30's
Form
Coveram tab 5/5 mg
Packing/Price
30's
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