Olmetec Plus

Olmetec Plus

olmesartan + hydrochlorothiazide

Manufacturer:

Pfizer
Concise Prescribing Info
Contents
Per 20/12.5 mg tab Olmesartan medoxomil 20 mg, hydrochlorothiazide 12.5 mg. Per 40/12.5 mg tab Olmesartan medoxomil 40 mg, hydrochlorothiazide 12.5 mg
Indications/Uses
Essential HTN when BP is not adequately controlled on olmesartan medoxomil or hydrochlorothiazide alone.
Dosage/Direction for Use
Adult 1 tab once daily. Renal impairment (CrCl 30-60 mL/min) Dose of olmesartan medoxomil should not exceed 20 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to olmesartan medoxomil, hydrochlorothiazide or to other sulphonamide-derived substances. Severe renal impairment (CrCl <30 mL/min); refractory hypokalaemia & hypercalcaemia; cholestasis & biliary obstructive disorders. Do not co-administer aliskiren w/ olmesartan medoxomil-hydrochlorothiazide in patients w/ diabetes. 2nd & 3rd trimesters of pregnancy & lactation.
Special Precautions
Patients who are vol &/or Na depleted; bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney; history of allergy or bronchial asthma; aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy. Increased risk of severe hypotension & renal impairment. Serum K, creatinine & uric acid levels should be monitored periodically. Acute myopia & secondary angle-closure glaucoma. Sprue-like enteropathy. Impaired hepatic function or progressive liver disease; may cause electrolyte imbalance & impair glucose tolerance. Hyperuricemia may occur. Patients w/ DM, primary aldosteronism, heart failure or ischaemic cerebrovascular disease; may exacerbate SLE. Discontinue use of thiazides prior to carrying out tests for parathyroid function. May impair ability to drive or operate machinery. Childn ≤18 yr. Elderly.
Adverse Reactions
Olmesartan medoxomil: Dizziness, vertigo, syncope, palpitations, hypotension, orthostatic hypotension, rash, eczema, weakness, decreased/increased blood K. Thrombocytopenia, headache, angina pectoris, bronchitis, cough, pharyngitis, rhinitis, abdominal pain, diarrhea, vomiting, pruritus, exanthema, dyspepsia, gastroenteritis, nausea, arthritis, back & skeletal pain, haematuria, UTI, chest pain, fatigue, lethargy, malaise, flu-like symptoms, peripheral & angioneurotic oedema, allergic dermatitis, face oedema & urticaria, anaphylactic reaction, muscle cramp, myalgia, acute renal failure & insufficiency, asthenia, pain, increased creatinine phosphokinase, hypertriglyceridaemia, hyperuricaemia,  increased blood creatinine & urea, increased hepatic enzymes, hyperkalaemia, liver enzyme elevations. Hydrochlorothiazide: Anorexia, loss of appetite, gastric irritation, diarrhea, constipation, sialadenitis, pancreatitis, jaundice (intrahepatic cholestatic jaundice), xanthopsia, transient blurred vision, leukopenia, neutropenia/agranulocytosis, thrombocytopenia, aplastic anemia, haemolytic anaemia, bone marrow depression, photosensitivity reactions, rash, cutaneous SLE-like reactions, cutaneous lupus erythematosus reactivation, urticaria, necrotising angitis (vasculitis, cutaneous vasculitis), anaphylactic reactions, toxic epidermal necrolysis, fever, resp distress (including pneumonitis & pulmonary oedema), renal dysfunction, interstitial nephritis, muscle spasm, weakness, restlessness, light-headedness, vertigo, paraestheasiae, postural hypotension, cardiac arrhtyhmias, sleep disturbances, depression.
Drug Interactions
Aliskiren. Colesevelam HCl. K-depleting effect may be potentiated w/ kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, pen G Na or salicylic acid derivatives. Increase serum K levels w/ K-sparing diuretics, K supplements & heparin. Other antihypertensive drugs, reduced effects w/ NSAIDs, alcohol, barbiturates, narcotics or antidepressants, baclofen, amifostine, cholestyramine, colestipol resins, atropine, biperiden, lithium, digitalis glycoside, antiarrythmic & antidiabetic drugs, β-blockers & diazoxide, pressor amines (eg, noradrenaline), non-depolarizing skeletal muscle relaxants (eg, tubocurarine), antigout drugs (probenecid, sulfinpyrazone & allopurinol) Ca salts, amantadine, cytotoxic agents (eg, cyclophosphamide, methotrexate).
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 FC tab
Packing/Price
30's (Rp427,905/pak)
Form
Olmetec Plus 40/12.5 mg FC tab
Packing/Price
30's (Rp523,646/pak)
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