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Telmisartan and Amlodipine (Telmisartan / Amlodipine Besylate) - Summary




  • When pregnancy is detected, discontinue telmisartan and amlodipine tablets as soon as possible [see WARNING AND PRECAUTIONS]
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see WARNING AND PRECAUTIONS]


Telmisartan and amlodipine tablet is a fixed dose combination of telmisartan and amlodipine. Telmisartan and amlodipine tablets contain telmisartan, a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan and amlodipine tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB).

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. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). 

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. 

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. 

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Telmisartan and amlodipine tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Base the choice of telmisartan and amlodipine tablets as initial therapy for hypertension on an assessment of potential benefits and risks including whether the patient is likely to tolerate the starting dose of telmisartan and amlodipine tablets.

Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. Consider the patient's baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy when deciding whether to use telmisartan and amlodipine tablets as initial therapy. Individual blood pressure goals may vary based upon the patient's risk.

See all Telmisartan and Amlodipine indications & dosage >>


Published Studies Related to Telmisartan and Amlodipine (Telmisartan / Amlodipine)

Effects of telmisartan and amlodipine in combination on ambulatory blood pressure in stages 1-2 hypertension. [2010]
hypertension... CONCLUSION: These findings show that telmisartan and amlodipine in combination

Results of a comparative, phase III, 12-week, multicenter, prospective, randomized, double-blind assessment of the efficacy and tolerability of a fixed-dose combination of telmisartan and amlodipine versus amlodipine monotherapy in Indian adults with stage II hypertension. [2007]
II hypertension... CONCLUSIONS: Among these Indian patients with stage II hypertension, the FDC of

Telmisartan: a review of its use in hypertension. [2001]
CONCLUSION: Telmisartan is an effective antihypertensive agent with a tolerability profile

[Blood pressure lowering efficacy of telmisartan and amlodipine taking on the morning or at bedtime: ABPM results]. [Article in Chinese] [2013]
taking on the morning or at bedtime in hypertensive patients... CONCLUSION: Telmisartan/amlodipine administered either on the morning or at

Effect of tablets with a combination of telmisartan and amlodipine on patients with hypertension: the Cotalo study. [2013]
Fixed-dose combination (FDC) therapy with telmisartan 40 mg+amlodipine 5 mg (T40/A5) is expected to achieve tight blood pressure (BP) control because of the strong efficacy and long half-life of each drug. The aims of this study were to evaluate the 24-h antihypertensive efficacy of T40/A5 FDC therapy and to explore differences that may arise owing to different administration times in Japanese patients whose hypertension was not controlled by 5 mg of amlodipine per day...

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Clinical Trials Related to Telmisartan and Amlodipine (Telmisartan / Amlodipine)

CKD-828 Drug Interaction Study (Telmisartan) [Completed]
The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of Telmisartan between free combination of Telmisartan and S-amlodipine and Telmisartan monotherapy.

Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine [Completed]

Telmisartan, Amlodipine and Combination in Healthy Subjects [Completed]
To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose combination after single dose in healthy Chinese subjects. To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine, following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A5) tablet alone and in combination, in healthy Chinese subjects. To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy Chinese subjects.

Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease [Recruiting]
The aim of this current study was to assess the therapeutic effects of perindopril and telmisartan for hypertensive patients with NAFLD and make comparison between the therapeutic effects of these two kind of drugs. This study is a randomized parallel control clinical trial which would be carried out in Nanfang Hospital, Southern Medical University. About one hundred and eighty patients would be randomly assigned to perindopril,telmisartan and amlodipine three groups.

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Page last updated: 2015-08-10

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