Azoren

Azoren

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 20/5 mg FC tab Olmesartan medoxomil 20 mg, amlodipine 5 mg. Per 40/5 mg FC tab Olmesartan medoxomil 40 mg, amlodipine 5 mg. Per 40/10 mg FC tab Olmesartan medoxomil 40 mg, amlodipine 10 mg
Indications/Uses
Essential HTN in patients whose BP is inadequately controlled on olmesartan medoxomil or amlodipine monotherapy.
Dosage/Direction for Use
Administration
May be taken with or without food: Take at the same time each day. Swallow whole w/ a glass of water, do not chew.
Contraindications
Hypersensitivity to amlodipine, olmesartan medoxomil or to dihydropyridine derivatives. Severe hypotension, shock (eg, cardiogenic shock), left ventricle outflow tract obstruction (eg, high grade aortic stenosis), haemodynamically unstable heart failure after acute MI. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Severe hepatic insufficiency & biliary obstruction. 2nd & 3rd trimesters of pregnancy.
Special Precautions
Not recommended in primary aldosteronism. Other conditions w/ renin-angiotensin-aldosterone system stimulation eg, severe CHF or underlying renal disease; bilateral renal artery stenosis or artery stenosis to single functioning kidney; hyperkalaemia; aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy; severe heart failure (NYHA III-IV); sprue-like enteropathy. Excessive decreased BP in patients w/ ischaemic heart or cerebrovascular disease. Correct vol &/or Na depletion prior to therapy. Ethnic differences. Not to be used concomitantly w/ ACE inhibitors in patients w/ diabetic nephropathy. Not recommended in combination w/ aliskiren, lithium. Concomitant use w/ K supplements, K-sparing diuretics, K-containing salt substitutes or other medicinal increasing K level eg, heparin. May affect ability to drive & use machines. Not recommended in severe renal impairment (CrCl <20 mL/min). Kidney transplantation or end-stage renal disease. Mild to moderate hepatic impairment. Not recommended during 1st trimester of pregnancy & lactation. Childn & adolescents <18 yr. Elderly.
Adverse Reactions
Dizziness, headache; fatigue, oedema, peripheral & pitting oedema.
Drug Interactions
Increased BP-lowering effects w/ other antihypertensives. Increased risk of hypotension, hyperkalemia & decreased renal function w/ angiotensin-receptor blockers, ACE inhibitors or aliskiren. Increased serum K w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other medicinal products increasing serum K eg, heparin. Increased serum lithium conc & toxicity. Attenuated antihypertensive effect w/ NSAIDs including selective COX-2 inhibitors, acetylsalicylic acid (>3 g daily) & non-selective NSAIDs. Reduced systemic exposure, peak plasma conc & t½ w/ colesevelam HCl. Reduced bioavailability w/ Al Mg hydroxide antacids. Increased exposure w/ strong or moderate CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides, verapamil, diltiazem. Varied plasma conc w/ strong CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Increased bioavailability w/ grapefruit of grapefruit juice. Risk of hyperkalaemia w/ dantrolene infusion. Increased exposure to simvastatin & cyclosporine. Increased tacrolimus blood levels.
MIMS Class
Angiotensin II Antagonists / Calcium Antagonists
ATC Classification
C09DB02 - olmesartan medoxomil and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Azoren 20/5 mg FC tab
Packing/Price
30's
Form
Azoren 40/10 mg FC tab
Packing/Price
30's
Form
Azoren 40/5 mg FC tab
Packing/Price
30's
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