Regulatory Information
DUOPHARMA (SINGAPORE) PTE LTD
DUOPHARMA (SINGAPORE) PTE LTD
Therapeutic
Prescription Only
Formulation Information
TABLET
**DOSAGE AND ADMINISTRATION** _**Adults**_ _**Treatment of essential hypertension**_ The recommended dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. In cases where the target blood pressure is not achieved, telmisartan dose can be increased to a maximum of 80 mg once daily. Alternatively, telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure lowering effect with telmisartan. When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four – eight weeks after the start of treatment. In patients with severe hypertension treatment with telmisartan at doses up to 160 mg alone and in combination with hydrochlorothiazide 12.5 – 25 mg daily was well tolerated and effective. _**Cardiovascular risk reduction**_ The recommended dose of Corxeva Tablet is 80mg once a day and can be administered with or without food. It is not known whether doses lower than 80mg of telmisartan are effective in reducing the risk of cardiovascular morbidity. When initiating Corxeva therapy for cardiovascular risk reduction, monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary. Corxeva Tablet may be taken with or without food. _**Renal impairment**_ No posology adjustment is required for patients with renal impairment, including those on haemodialysis. Telmisartan is not removed from blood by hemofiltration. _**Hepatic impairment**_ In patients with mild to moderate hepatic impairment the posology should not exceed 40 mg once daily. _**Elderly**_ No dosing adjustment is necessary. _**Children and adolescents**_ The safety and efficacy of this product for use in children below 18 years have not been established.
ORAL
Medical Information
**INDICATIONS** _**Hypertension**_ Treatment of essential hypertension. _**Cardiovascular risk reduction**_ Reduction of the risk of non-fatal stroke or non-fatal myocardial infarction in patients 55 years or older at high risk of developing major cardiovascular events who cannot tolerate an angiotensin converting enzyme inhibitor (ACEI). High risk of cardiovascular events includes evidence of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or diabetes mellitus with evidence of end-organ damage.
**CONTRAINDICATIONS** ✔ Hypersensitivity to the active ingredient or any of the excipients ✔ Second and third trimesters of pregnancy ✔ Lactation ✔ Biliary obstructive disorders ✔ Severe hepatic impairment ✔ The concomitant use of this product with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to “warning and precautions” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) the use of the product is contraindicated.
C09CA07
telmisartan
Manufacturer Information
DUOPHARMA (SINGAPORE) PTE. LTD.
LABORATORIOS LICONSA S.A.
Active Ingredients
Documents
Package Inserts
Corxeva Tablet PI.pdf
Approved: August 31, 2023