Product Overview
[Drug Name]
Generic Name: Olmesartan Medoxomil Hydrochlorothiazide Tablets
Trade Name: YuanKeShu Olmesartan Medoxomil Hydrochlorothiazide Tablets 20mg: 12.5mg * 28 tablets
Pinyin Full Code: YuanKeShu AoMeiShaTanZuoQingLvZuoZuoPian 20mg: 12.5mg * 28 tablets
[Main Ingredients]
This product is a combination preparation consisting of olmesartan medoxomil and hydrochlorothiazide. Excipients: Lactose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, and film coating premix.
[Properties]
This product is a film-coated tablet that appears white after removal of the coating.
[Indications/Main Functions]
This product is indicated for the treatment of hypertension. It is indicated for patients whose blood pressure is not adequately controlled with olmesartan medoxomil or hydrochlorothiazide alone. This product is a fixed-dose combination preparation and is not indicated for the initial treatment of hypertension. This product can be used alone or in combination with other antihypertensive medications. Hypertension control is part of comprehensive cardiovascular risk management, which may include lipid control, diabetes management, antithrombotic therapy, smoking cessation, physical exercise, and sodium restriction. Increases in either systolic or diastolic blood pressure increase cardiovascular risk. The absolute risk increase per mmHg increase is greater at higher baseline blood pressure levels. The relative magnitude of risk reduction achieved by lowering blood pressure is similar among individuals with varying absolute cardiovascular risk. In patients with severe hypertension, even a small reduction in blood pressure can provide significant clinical benefit. In adults with hypertension, lowering blood pressure generally reduces the risk of cardiovascular events, primarily stroke and myocardial infarction. However, there is no controlled clinical evidence that this drug reduces cardiovascular risk.
[Specifications]
20mg: 12.5mg x 28 tablets
[Dosage and Administration]
In normovolemic patients, the recommended starting dose of olmesartan medoxomil as monotherapy is 20mg once daily. For patients who require further blood pressure reduction after two weeks of treatment, the dose can be increased to 40mg. Doses greater than 40 mg have not demonstrated a greater antihypertensive effect. Twice-daily dosing has not demonstrated superiority compared to once-daily dosing at the same daily dose. No starting dose adjustment is required for elderly patients, patients with moderate to significant renal impairment (creatinine clearance <40 mL/minute), or patients with moderate to significant hepatic impairment (see Special Populations in Pharmacokinetics). Initiation of hydroxychlorothiazide therapy in patients with potential volume depletion (e.g., those receiving diuretics, particularly those with renal impairment) must be conducted under close medical supervision, and a lower starting dose may be considered (see Precautions for Hypotension in Patients with Volume Depletion or Hyponatremia). The effective dose of hydrochlorothiazide is 12.5 mg to 50 mg once daily. Combination therapy is typically initiated after unsatisfactory efficacy with monotherapy with olmesartan medoxomil or hydrochlorothiazide. This drug is taken orally, one tablet once daily. It can be taken with or without food. The dose should be individualized. The dose may be adjusted at intervals of 2 to 4 weeks based on the antihypertensive effect. The antihypertensive effect of this drug is dose-dependent within the dose range of 10mg/12.5mg to 40mg/25mg. Olmesartan medoxomil hydrochlorothiazide tablets have an onset of antihypertensive effect within one week and reach maximum antihypertensive effect at four weeks. This drug can be used in combination with other antihypertensive medications. If the patient's creatinine clearance is >30mL/min, the standard dose of this drug can be used. For patients with more severe renal impairment, myeloid diuretics are preferred over thiazide diuretics; therefore, this drug is not recommended. No dose adjustment is required for patients with hepatic impairment (see Special Populations under [Pharmacokinetics]).
[Adverse Reactions]
See the package insert for details.
[Contraindications]
This drug is contraindicated in patients with allergies to its ingredients. Due to the presence of hydrochlorothiazide, it is contraindicated in patients with anuria or hypersensitivity to other sulfonamides. This drug should not be used in combination with aliskiren in patients with diabetes.
[Precautions]
See the package insert for details.
