Telmisartan

Visa No.: VD-23839-15

Product: Hypertel 40

API: Telmisartan

Product Category: Cardiovascular & Metabolism

Version approved leaflet: 277/QĐ-QLD_23/05/2022_175.1

INDICATIONS

• Treatment of essential hypertension.
• Prevention of cardiovascular morbidity and mortality in patients aged 55 years and older who are at high risk of cardiovascular disease.
   

DOSAGE AND ADMINISTRATION

Dosage:
Adult
Treatment of essential hypertension

• The recommended dose is 40 mg once daily. Some patients may respond to a dose of 20 mg once daily. The dose of telmisartan may be increased up to a maximum of 80 mg once daily to achieve target blood pressure.
• Telmisartan may be used in combination with thiazide diuretics such as hydrochlorothiazide. This combination has demonstrated a synergistic blood pressure–lowering effect.
• When dose escalation is required, it should be noted that the maximum antihypertensive effect is usually achieved 4–8 weeks after initiation of treatment.
• In patients with severe hypertension, treatment with telmisartan at doses up to 160 mg/day, either as monotherapy or in combination with hydrochlorothiazide 12.5–25 mg/day, has been well tolerated and effective.

Prevention of cardiovascular morbidity and mortality: The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg are effective in reducing cardiovascular morbidity and mortality. 
When initiating telmisartan for cardiovascular risk reduction, blood pressure should be monitored and, if necessary, therapy adjusted to achieve optimal blood pressure control.

Special populations
Renal impairment: No dose adjustment is required in patients with renal impairment, including those undergoing hemodialysis. Telmisartan is not removed by dialysis.
Hepatic impairment: In patients with mild to moderate hepatic impairment, the dose should not exceed 40 mg once daily.
Elderly: No dose adjustment is required.
Children and adolescents: The safety and efficacy of telmisartan in patients under 18 years of age have not been established.
Method of administration: Telmisartan may be taken with or without food.
 

CONTRAINDICATIONS

• Hypersensitivity to telmisartan or to any of the excipients.
• Second and third trimesters of pregnancy.
• Breast-feeding.
• Biliary obstructive disorders.
• Severe hepatic impairment.
• Concomitant use of telmisartan with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m²).
   

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children