MICARDIS®

Dosing and administration

MICARDIS®¹

Primary Hypertension

Dosage must be individualized. The usual starting dose of MICARDIS® tablets is 40 mg once a day. In cases where the target blood pressure is not achieved, telmisartan dose can be increased to a maximum of 80 mg once daily. Blood pressure response is dose-related over the range of 20-80 mg.¹

Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg MICARDIS® is required, a diuretic may be added.¹

No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored.¹

MICARDIS® tablets may be administered with other antihypertensive agents.¹

MICARDIS® tablets may be administered with or without food.¹

Cardiovascular Risk Reduction¹

The recommended dose of MICARDIS® tablets is 80 mg once a day and can be administered with or without food. It is not known whether doses lower than 80 mg of telmisartan are effective in reducing the risk of cardiovascular morbidity and mortality.¹

When initiating MICARDIS® therapy for cardiovascular risk reduction, monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary.¹

Special population¹

• Pregnancy¹

  Teratogenic Effects, Pregnancy Categories C (first trimester) and D (second and third trimesters).¹

• Nursing Mothers¹

  It is not known whether telmisartan is excreted in human milk, but telmisartan was shown to be present in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.¹

• Pediatric Use¹

  Safety and effectiveness in pediatric patients have not been established.¹

• Geriatric Use¹

  Of the total number of patients receiving MICARDIS® in hypertension clinical studies, 551 (19%) were 65 to 74 years of age and 130 (4%) were 75 years or older. No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.¹

  Of the total number of patients receiving MICARDIS® in the cardiovascular risk reduction study (ONTARGET), the percentage of patients ≥65 to <75 years of age was 42%; 15% of patients were ≥75 years old. No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.¹

• Hepatic Insufficiency¹

  Monitor carefully and up titrate slowly in patients with biliary obstructive disorders or hepatic insufficiency.¹

MICARDIS PLUS®²

Adults²

MICARDIS PLUS® should be taken once daily. The dose of telmisartan could be up-titrated before switching to MICARDIS PLUS®. Direct change from monotherapy to the fixed combinations may be considered.²

• MICARDIS PLUS® 40/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by MICARDIS® 40 mg or hydrochlorothiazide.
• MICARDIS PLUS® 80/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by MICARDIS® 80 mg or by MICARDIS PLUS® 40/12.5 mg.

Sodium or volume depletion should be corrected before treatment commencement with MICARDIS PLUS®.

The maximum antihypertensive effect is generally attained with MICARDIS PLUS® 4 – 8 weeks after the start of treatment.²

When necessary, MICARDIS PLUS® may be administered with another antihypertensive drug.²

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.²

Method of Administration²

MICARDIS® and MICARDIS PLUS® may be taken with or without food.²

Special Population²

• Renal impairment

  Due to the hydrochlorothiazide component, MICARDIS PLUS® must not be used in patients with severe renal dysfunction (creatinine clearance < 30 ml/min). Loop diuretics are preferred to thiazides in this population. Experience in patients with mild to moderate renal impairment is modest but has not suggested adverse renal effects and dose adjustment is not considered necessary. Periodic monitoring of renal function is advised.²

• Hepatic impairment

  In patients with mild to moderate hepatic impairment the posology should not exceed MICARDIS PLUS® 40/12.5 mg once daily. MICARDIS PLUS® is contraindicated in patients with severe hepatic impairment. Thiazides should be used with caution in patients with impaired hepatic function.²

• Elderly

  No dosage adjustment is necessary. With advanced age (≥ 65 years), one should be aware of possible renal impairment.²

• Children and adolescents

  Safety and efficacy of MICARDIS PLUS® have not been established in children and in adolescents up to 18 years. Use of MICARDIS PLUS® is not recommended in children and adolescents.²