Amlodipine / Telmisartan

What it is and how it works

Mechanism of Action Telmisartan Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Telmisartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland.

Mechanism class: Angiotensin 2 Receptor Antagonists

Indications

Telmisartan and amlodipine tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including angiotensin II receptor blockers and dihydropyridine calcium channel blockers. There are no controlled trials demonstrating risk reduction with telmisartan and amlodipine tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.

Dosage and administration (summary)

Substitute telmisartan and amlodipine tablets for its individually titrated components for patients on amlodipine and telmisartan. Telmisartan and amlodipine tablets may also be given with increased amounts of amlodipine, telmisartan, or both, as needed. (2.2, 2.3) Use telmisartan and amlodipine tablets to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone Dosage may be increased after at least 2 weeks to a maximum dose of 80/10 mg once daily, usually by increasing one component at a time but both components can be raise…

Contraindications

Telmisartan and amlodipine tablets are contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine, or any other component of this product . Do not co-administer aliskiren with telmisartan and amlodipine tablets in patients with diabetes .

Warnings and precautions

Avoid fetal or neonatal exposure Hypotension: Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension. Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis Titrate slowly in patients with hepatic or severe renal impairment Heart failure: Monitor for worsening Avoid concomitant use with an ACE inhibitor Myocardial infarction: Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of telmisartan and amlodipine tablets, particularly in patients with severe obstruc…

Pregnancy

Pregnancy Pregnancy Category D . . Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Storage and supply

Telmisartan and amlodipine tablets are available in four strengths as 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg and 80 mg/10 mg: 40 mg/5 mg: Oval shaped biconvex, bilayer, uncoated tablets with one white to off white color layer and one blue color mottled layer debossed with ‘L389’.

Source: Telmisartan And Amlodipine (Telmisartan And Amlodipine) — US FDA prescribing information, 2023-01-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.