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Esatec 20/Esatec 40

Esatec 20/Esatec 40

olmesartan

Manufacturer:

Unison

Distributor:

Unison

Marketer:

B.Grimm Pharma
Concise Prescribing Info
Contents
Olmesartan medoxomil
Indications/Uses
Dosage/Direction for Use
Adult Initially 10 mg once daily. May be increased to 20 mg once daily in patients whose BP is not adequately controlled. Max: 40 mg once daily or addition of hydrochlorothiazide therapy if additional BP reduction is required. Mild to moderate renal impairment (CrCl 20-60 mL/min) Max: 20 mg once daily. Moderate hepatic impairment Initially 10 mg once daily. Max: 20 mg once daily.
Administration
May be taken with or without food. Swallow w/ sufficient amount of fluid, do not chew.
Contraindications
Hypersensitivity. Biliary obstruction. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). 2nd & 3rd trimester of pregnancy.
Special Precautions
Discontinue treatment immediately & not to be restarted if patient develops severe, chronic diarrhea w/ substantial wt loss in absence of other apparent etiologies. Not recommended in patients w/ primary aldosteronism. Symptomatic hypotension in patients who are vol &/or Na depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting. Acute hypotension, azotemia, oliguria or acute renal failure in patients w/ severe CHF or underlying renal disease including renal artery stenosis. Increased risk of severe hypotension & renal insufficiency in patient w/ bilateral artery stenosis or stenosis of artery to single functioning kidney; hyperkalemia in elderly >70 yr, diabetic patients, those w/ renal insufficiency, concomitantly treated w/ other medicinal products increasing K levels, & intercurrent events. Excessive BP decrease in patients w/ ischemic heart disease or ischemic cerebrovascular disease resulting in MI or stroke. Patients w/ recent kidney transplant; aortic mitral valve stenosis or obstructive hypertrophic cardiomyopathy. Less BP lowering effect in black patients. Correct vol &/or Na depletion before administration. Close monitoring of serum K in patients w/ intercurrents events eg, dehydration, acute cardiac decompensation, metabolic acidosis, worsening or sudden worsening of renal function (eg, infectious disease), cellular lysis (eg, acute limb ischemia, rhabdomyolysis, extended trauma); renal function, electrolytes & BP if dual blockade therapy is considered. Not to be used concomitantly w/ ACE inhibitors & ARBs in patients w/ diabetic nephropathy. Not recommended in combination w/ lithium. Concomitant use w/ salt substitutes containing K, K-sparing diuretics, ACE inhibitors, AIIA, NSAIDs (including selective COX-2 inhibitors), heparin, immunosuppressor eg, ciclosporin or tacrolimus, trimethoprim; aliskiren. Not to be taken in patients w/ glucose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in severe renal (CrCl <20 mL/min) & hepatic impairment. End-stage renal impairment ie, CrCl <12 mL/min. Periodic monitoring of serum K & creatinine levels in patients w/ impaired renal function. Discontinue treatment immediately & start alternative therapy when pregnancy is diagnosed. Not recommended during 1st trimester of pregnancy & in lactation. Closely observe infants born from mothers taking AIIA for hypotension. Childn & adolescents <18 yr.
Adverse Reactions
Hypertriglyceridemia, hyperuricemia; dizziness, headache; bronchitis, pharyngitis, cough, rhinitis; gastroenteritis, diarrhea, abdominal pain, nausea, dyspepsia; arthritis, back & skeletal pain; hematuria, UTI; pain, chest pain, peripheral edema, flu-like symptoms, fatigue; increased hepatic enzymes, blood urea & creatine phosphokinase.
Drug Interactions
Increased BP lowering effect w/ other antihypertensives. Higher frequency of hypotension, hyperkalemia & decreased renal function including acute renal failure w/ ACE inhibitors, ARBs or aliskiren. Increased serum K w/ K sparing diuretics, K supplements, salt substitutes containing K or heparin. Reduced antihypertensive effect & occurrence of acute renal failure w/ NSAIDs including ASA >3 g daily & COX-2 inhibitors. Reduced systemic exposure, peak plasma conc & t½ w/ bile acid sequestrants eg, colesevelam HCl. Reduced bioavailability w/ antacid containing Al Mg hydroxide. Increased serum conc & toxicity of lithium.
MIMS Class
Angiotensin II Antagonists
ATC Classification
C09CA08 - olmesartan medoxomil ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Esatec 20 FC tab 20 mg
Packing/Price
3 × 10's
Form
Esatec 40 FC tab 40 mg
Packing/Price
3 × 10's
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