Telmivas AM is indicated for the treatment of hypertension, alone or with other antihypertensive agents. It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
Dosage & Administration
Initial Therapy: Patient may be initiated on Telmivas AM tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started with 40/5 mg twice daily. Initial therapy with Telmivas AM is not recommended in patients ≥75 years old or with hepatic impairment. Add-on Therapy: Patients not adequately controlled with Amlodipine (or another dihydropyridine calcium channel blocker) alone or with Telmisartan (or another angiotensin receptor blocker) alone. Patients treated with 10 mg Amlodipine who experience adverse reactions such as edema, may be switched to Telmivas AM 40/5 mg tablets once daily, reducing the dose of Amlodipine without reducing the overall expected antihypertensive response. Replacement Therapy: Patients receiving Amlodipine and Telmisartan from separate tablets may instead receive Telmivas AM tablets containing the same component doses once daily.
Dosage must be individualized and may be increased after at least 2 weeks. The maximum recommended dose of Telmivas AM tablet is 80/10 mg once daily.
Use in Specific Population:
Pregnancy: Pregnancy Categories C (first trimester) and D (second and third trimesters). Lactation: It is not known whether Telmisartan and Amlodipine is excreted in human milk. Because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue the drug after taking into account the importance of the drug to the mother.
Pediatric use: Safety and effectiveness of Telmisartan & Amlodipine combination in pediatric patients have not been established. Geriatric use: Initial therapy with Telmisartan and Amlodipine combination is not recommended in patients ≥75 years old. Hepatic impairment: Initial therapy with Telmisartan and Amlodipine combination is not recommended in hepatically impaired patients.
• Avoid fetal or neonatal exposure.
• Hypotension: Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension.
• Titrate slowly in patients with hepatic or severe renal impairment.
• Heart failure: Monitor for worsening
• Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker
• Myocardial infarction: Uncommonly, initiating a CCB in patients with severe obstructive coronary artery disease may precipitate myocardial infarction or increased angina.
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