Olmetec Plus

Olmetec Plus

olmesartan + hydrochlorothiazide

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 20/12.5 mg FC tab Olmesartan medoxomil 20 mg, hydrochlorothiazide 12.5 mg. Per 40/12.5 mg FC tab Olmesartan medoxomil 40 mg, hydrochlorothiazide 12.5 mg
Indications/Uses
Essential HTN in patients whose BP is inadequately controlled by olmesartan medoxomil or hydrochlorothiazide alone.
Dosage/Direction for Use
1 tab once daily. Mild to moderate renal impairment Max: 20 mg once daily. Moderate hepatic impairment Initially 10 mg once daily, may be increased to max: 20 mg once daily.
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 olmesartan, hydrochlorothiazide or other sulphonamide-derived substances. Refractory hypokalaemia, hypercalcaemia, hyponatraemia, symptomatic hyperuricaemia. Cholestasis, biliary obstructive disorders. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Severe renal (CrCl <30 mL/min) & hepatic impairment. 2nd & 3rd trimesters of pregnancy.
Special Precautions
Not recommended in primary aldosteronism. Intravascular vol depletion, other conditions w/ renin-angiotensin-aldosterone system stimulation, renovascular HTN, dual blockade of renin-angiotensin-aldosterone system, diabetic nephropathy, aortic/mitral valve stenosis, obstructive hypertrophic cardiomyopathy, metabolic & endocrine effects, electrolyte imbalance, sprue-like enteropathy, acute myopia & secondary angle-closure glaucoma, non-melanoma skin cancer, excessive decreased BP in patients w/ ischaemic heart or cerebrovascular disease. History of allergy or bronchial asthma, SLE exacerbation or activation. Ethnic differences. +ve anti-doping test. Limit exposure to sunlight & UV rays. Not recommended in concomitant use w/ lithium. Concomitant use w/ K supplements, K-containing salt substitutes, K-sparing diuretics; heparin. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Kidney transplantation. Not to be used in cholestasis & biliary obstruction. Mild to moderate hepatic impairment. Not to be initiated during 1st trimester of pregnancy. Not recommended during lactation. Childn & adolescents <18 yr.
Adverse Reactions
Dizziness/lightheadedness, headache; asthenia, chest pain, fatigue, peripheral oedema.
Drug Interactions
Increased serum lithium conc & toxicity. Potentiated antihypertensive effect w/ baclofen, amifostine. Reduced antihypertensive effect w/ NSAIDs. Increased BP-lowering effect w/ other antihypertensives. Potentiated orthostatic hypotension by alcohol, barbiturates, narcotics or antidepressants. Olmesartan medoxomil: Increased risks of hypotension, hyperkalaemia & decreased renal function w/ ACE inhibitors, angiotensin II receptor blocker or aliskiren. Increased serum K levels w/ K-sparing diuretics, K supplements, K-containing salt substitutes; heparin, ACE inhibitors. Reduced systemic exposure, peak plasma conc & t½ w/ colesevelam HCl. Reduced bioavailability by Al Mg hydroxide antacids. Hydrochlorothiazide: Potentiated K-depleting effect w/ other kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G Na or salicylic acid derivatives. Increase serum Ca levels. Impaired absorption by cholestyramine & colestipol resins. Favoured onset of digitalis-induced cardiac arrhythmias. Periodic monitoring of serum K & ECG w/ class IA & III antiarrythmics, antipsychotics, bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidine, sparfloxacin, terfenadine, vincamine IV. Potentiated effect of non-depolarizing skeletal muscle relaxants eg, tubocurarine. Increased bioavailability by anticholinergics eg, atropine, biperiden. Influenced glucose tolerance w/ oral antidiabetic agents & insulin. Risk of lactic acidosis w/ metformin. Enhanced hyperglycaemic effect of β-blockers & diazoxide. Decreased pressor amines effect. Raised serum uric acid levels w/ uricosuric drugs. Increased hypersensitivity reactions to allopurinol. Increased risk of adverse effects by amantadine. Potentiated myelosuppressive effects of cytotoxic agents eg, cyclophosphamide, methotrexate. Enhanced toxic effects of salicylates. Risk of haemolytic anaemia w/ methyldopa. Increased risk of hyperuricaemia & gout-type complications w/ cyclosporine. Increased risk of tetracycline-induced increased urea.
MIMS Class
Angiotensin II Antagonists / Diuretics
ATC Classification
C09DA08 - olmesartan medoxomil and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Olmetec Plus 20/12.5 mg film-coated tab
Packing/Price
30's
Form
Olmetec Plus 40/12.5 mg film-coated tab
Packing/Price
30's
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