Characteristics:
This product is white film sheet, white after removing the coating.
Indications:
This product is suitable for the treatment of hypertension.
Usage And Dosage:
Dosage should be individualized. As a monotherapy agent, an initial dose of 20 mg, once daily, is generally recommended. The dose can be increased to 40 mg for patients who need further blood pressure reduction after 2 weeks of treatment.
Doses greater than 40 mg did not show a greater antihypertensive effect. Twice-daily dosing showed no advantage over once-daily dosing at the same daily dose.
This product can be taken with or without food. This product can be used in combination with other diuretics or with other antihypertensive drugs.
For the elderly with moderate to significant impairment of liver or kidney function (creatinine clearance rate [40 mL/ min]), there is no need for dosage adjustment (see pharmacokinetics for special population).
Olmesartan ester should be administered under careful medical supervision in patients with possible hypovolemic conditions (e.g., those treated with diuretics, especially those with impaired renal function), and a lower starting dose may be considered
Adverse Reaction:
The safety of olmesartan ester was evaluated in a controlled clinical trial of up to 3,275 patients, approximately 900 of whom had been treated for at least 6 months and more than 525 of whom had been treated for at least 1 year. Results showed that olmesartan ester was well tolerated with a rate of adverse events similar to that of the placebo group. Adverse events are usually mild and transient, and are not related to dose, sex, age, or race differences.
In placebo-controlled clinical trials, the only adverse event with a higher incidence of greater than 1% in patients treated with olmesartan ester was dizziness (3% versus 1%).
The incidence was similar to that in the placebo group, with more than 1% of adverse events including back pain, bronchitis, elevated creatine phosphokinase, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.
The incidence of cough was similar in the placebo group (0.7%) and in the Olmesartan ester group (0.9%).
Similar to the placebo group, the incidence of less than 1% or more than 0.5% of adverse events are: chest pain, fatigue, pain, peripheral edema, dizziness, abdominal pain, dyspepsia, gastroenteritis, nausea, tachycardia, hypercholesterolemia, hyperlipidemia, high uric acid hematic disease, joint pain, arthritis, muscle pain, bone pain, rashes and facial edema, etc. It is not clear whether these adverse events are related to the use of this product.
Laboratory findings: In clinical controlled trials, changes in clinically important laboratory parameters were rarely associated with olmesartan ester.
Hemoglobin and hematocrit: Slight decreases in hemoglobin and hematocrit were seen occasionally (by an average of about 0.3 g/dL and 0.3 volume percentage, respectively).
Liver function test: liver enzymes and/or blood bilirubin rise are occasionally seen, but will return to normal on its own.
Previous market experience: rare reports of angiotensin II receptor antagonists causing rhabdomyolysis.
Storage:
Shade and keep sealed.
Production:
Inspection:
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Certificates:
Audited Supplier 
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