Olmesartan Medoxomil and Amlodipine Tablets
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The company has production licenses for tablets, capsules, granules, suppositories, powders, injections, oral solutions, dry suspensions, and eye drops.
Product Description
Approval Number:
H20233880
Indications:
It is used for the treatment of essential hypertension. This fixed-dose combination is suitable for adult patients whose blood pressure control is not satisfactory with monotherapy of olmesartan medoxomil or amlodipine besylate.
Blood pressure reduction can reduce the risk of fatal and non-fatal cardiovascular events, mainly including stroke and myocardial infarction. The above benefits can be seen in controlled clinical trials of antihypertensive drugs of various pharmacological classifications, including the category to which this product belongs.
There is no evidence from controlled clinical trials that this product can reduce cardiovascular risk.
Hypertension control is part of the comprehensive management of cardiovascular risk. Comprehensive management measures may include: control of blood lipids, management of diabetes, antithrombotic therapy, smoking cessation, physical exercise, and restriction of sodium intake.
Numerous antihypertensive drugs from various pharmacological classifications with different mechanisms of action have shown in randomized controlled clinical trials that they can reduce cardiovascular morbidity and mortality. This indicates that these benefits are mainly attributed to the effect of blood pressure reduction rather than other pharmacological properties of the drugs. The most significant and consistent cardiovascular benefit is the reduction in the risk of stroke, but the decrease in the incidence of myocardial infarction and cardiovascular mortality is also common.
Both the increase in systolic blood pressure and diastolic blood pressure can increase cardiovascular risk. At higher baseline blood pressure levels, the absolute risk increase brought about by each millimeter of mercury increase in blood pressure is higher. In patients with severe hypertension, a slight reduction in blood pressure can bring significant clinical benefits. The relative degree of risk reduction obtained by reducing blood pressure is similar in populations with different absolute cardiovascular risks.
Administration:
The tablet should be swallowed with an adequate amount of water (e.g., a glass of water). The tablet should not be chewed and should be taken at the same time every day.
Adults
The recommended dose of this product is 1 tablet once a day.
This product can be used for patients whose blood pressure control is not satisfactory with monotherapy of 20 mg olmesartan medoxomil or 5 mg amlodipine besylate.
Before switching to the fixed-dose combination tablet, it is recommended to gradually adjust the dosage of the single component. According to the clinical situation, direct switching from monotherapy to the fixed-dose combination tablet can also be considered.
The maximum antihypertensive effect can be achieved within 2 weeks of administration. The dose can be increased as needed after 2 weeks. The maximum recommended dose of this product is no more than 2 tablets per day (i.e., 40 mg olmesartan medoxomil/10 mg amlodipine besylate).
For convenience, patients taking olmesartan medoxomil and amlodipine tablets can switch to this product containing the same dose.
This product can be taken with or without food.
Elderly patients (≥65 years old)
The recommended dose for elderly patients generally does not need to be adjusted. If the dose needs to be increased, caution should be exercised. The clearance rate of amlodipine in elderly patients decreases. Patients aged ≥75 years should start taking amlodipine at a dose of 2.5 mg alone or add amlodipine.
Patients with renal impairment
For patients with mild to moderate renal impairment (creatinine clearance 20-60 mL/min), the maximum recommended dose of olmesartan medoxomil is 20 mg once a day, because there is limited experience in treating with a larger dose in this patient population. Patients with severe renal impairment (creatinine clearance <20 mL/min) should not use this product.
For patients with moderate renal impairment, serum potassium and creatinine levels should be monitored during treatment.
Patients with liver function impairment
Patients with mild to moderate liver function impairment should use this product with caution.
For patients with moderate liver function impairment, the recommended starting dose of olmesartan medoxomil is 10 mg once a day, and the maximum dose should not exceed 20 mg once a day. For patients who have been treated with diuretics and/or other antihypertensive drugs and have liver function impairment, blood pressure and renal function changes should be closely monitored. There is no experience in treating patients with severe liver function impairment with olmesartan medoxomil.
Like all calcium antagonists, the half-life of amlodipine is prolonged in patients with liver function impairment, and the recommended dosage has not been determined. Therefore, these patients should use this product with caution. The pharmacokinetics of amlodipine in patients with severe liver impairment has not been studied. Patients with liver impairment should start treatment with the lowest dose of amlodipine and then gradually increase the dose. This product is contraindicated in patients with severe liver impairment.
Pediatric population
The safety and efficacy of this product in children and adolescents under 18 years old have not been determined. Currently, there is no available data.
Specifications:
20mg/5mg × 14 tablets
The company has production licenses for tablets, capsules, granules, suppositories, powders, injections, oral solutions, dry suspensions, and eye drops.
The main products cover cardiovascular diseases, diabetic complications, anti-tumor, calcium supplementation, digestive system, respiratory system, and orthopedics.
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