Olmetec Plus

Olmetec Plus

olmesartan + hydrochlorothiazide

Manufacturer:

Pfizer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Olmesartan medoxomil 20 mg, hydrochlorothiazide 12.5 mg
Indications/Uses
HTN. Patients whose BP is not adequately controlled by olmesartan medoxomil or hydrochlorothiazide alone.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to olmesartan medoxomil, hydrochlorothiazide, or other sulphonamide-derived substances. Anuria. Do not co-administer w/ aliskiren in patients w/ diabetes. Pregnancy.
Special Precautions
Symptomatic hypotension may occur following initiation of treatment in vol &/or Na-depleted patients. Increased risk of renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Risk of non-melanoma skin cancer. Limit exposure to sunlight & UV rays to minimize the risk of skin cancer. Not recommended in patients w/ more severe renal disease (CrCl <30 mL/min). Lactation. Childn & adolescents. Olmesartan medoxomil: Sprue-like enteropathy. Hyperkalemia; monitor serum electrolytes periodically. Hydrochlorothiazide: May precipitate azotemia in patients w/ renal disease. Idiosyncratic reaction resulting in acute transient myopia & acute angle-closure glaucoma. Minor alterations of fluid & electrolyte balance during therapy may precipitate hepatic coma in patients w/ impaired hepatic function or progressive liver disease. Hypersensitivity reaction in patients w/ or w/o history of allergy or bronchial asthma. Exacerbation or activation of SLE. Combination w/ lithium. May impair glucose tolerance; latent DM may manifest during therapy. Increases cholesterol & triglyceride levels. Hyperuricemia may occur or frank gout may precipitate. Perform periodic determination of serum electrolytes at appropriate intervals. Hypokalemia especially in patients w/ liver cirrhosis, experiencing brisk diuresis, receiving inadequate oral intake of electrolytes, & in concomitant therapy w/ corticosteroids or ACTH. Discontinue prior to parathyroid function test. Hypomagnesemia.
Adverse Reactions
Olmesartan medoxomil: Dizziness. Hydrochlorothiazide: Gastric irritation, sialadenitis, pancreatitis; jaundice (intrahepatic cholestatic jaundice); xanthopsia, transient blurred vision; leukopenia, agranulocytosis, thrombocytopenia, aplastic & hemolytic anemia; photosensitivity reactions, urticaria, necrotizing angiitis (vasculitis, cutaneous vasculitis), anaphylactic reactions, TEN; fever; resp distress (including pneumonitis & pulmonary edema); renal dysfunction, interstitial nephritis; muscle spasms, weakness; restlessness; non-melanoma skin cancer especially squamous cell carcinoma in white patients; hyperglycemia, glycosuria, hyperuricemia, electrolyte imbalance (including hyponatremia & hypokalemia), increases in cholesterol & triglycerides.
Drug Interactions
Increased BP lowering effect w/ other antihypertensives. Increased serum conc & toxicity of lithium. Olmesartan medoxomil: Increased risks of hypotension, hyperkalemia, & changes in renal function (including acute renal failure) w/ ACE inhibitors & aliskiren. May increase risk of worsening renal function & attenuated antihypertensive effect w/ NSAIDs including COX-2 inhibitors. Reduced systemic exposure & peak plasma conc w/ colesevelam HCl. Hydrochlorothiazide: Potentiation of orthostatic hypotension w/ alcohol, barbiturates or narcotics. Antidiabetics (oral agents & insulin). Impaired absorption w/ cholestyramine & colestipol resins. Greater risk of hypokalemia w/ corticosteroid & ACTH. May decrease effect of pressor amines (eg, noradrenaline). May potentiate effect of non-depolarizing skeletal muscle relaxants (eg, tubocurarine). Reduced diuretic, natriuretic & antihypertensive effects w/ NSAIDs.
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 FC tab 20 mg/12.5 mg
Packing/Price
30's (P1,680.9/pack)
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