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Telmisartan and Amlodipine (Telmisartan / Amlodipine Besylate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

Data from an 8-week, placebo-controlled, multidose, factorial trial provide estimates of the probability of reaching a blood pressure goal with telmisartan and amlodipine tablets compared to telmisartan or amlodipine monotherapy and placebo [see CLINICAL STUDIES ].

The figures below provide estimates of the likelihood of achieving systolic and diastolic blood pressure control with telmisartan and amlodipine tablets 80/10 mg tablets, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.

Figure 1a: Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8

Figure 1a: Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8

Figure 1b: Probability of Achieving Systolic Blood Pressure <130 mmHg at Week 8

Figure 1b: Probability of Achieving Systolic Blood Pressure <130 mmHg at Week 8

Figure 2a: Probability of Achieving Diastolic Blood Pressure <90 mmHg at Week 8

Figure 2a: Probability of Achieving Diastolic Blood Pressure <90 mmHg at Week 8

Figure 2b: Probability of Achieving Diastolic Blood Pressure <80 mmHg at Week 8

Figure 2b: Probability of Achieving Diastolic Blood Pressure <80 mmHg at Week 8

The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal at 8 weeks. For example, a patient with a baseline blood pressure of 160/110 mmHg has about a 16% likelihood of achieving a goal of <140 mmHg (systolic) and 16% likelihood of achieving <90 mmHg (diastolic) on placebo. The likelihood of achieving these same goals on telmisartan is about 46% (systolic) and 26% (diastolic). The likelihood of achieving these same goals on amlodipine is about 69% (systolic) and 22% (diastolic). These likelihoods rise to 79% for systolic and 55% for diastolic with telmisartan and amlodipine tablets.

DOSAGE AND ADMINISTRATION

General Considerations

Telmisartan is an effective treatment of hypertension in once daily doses of 20 to 80 mg while amlodipine is effective in doses of 2.5 to 10 mg.

Dosage must be individualized and may be increased after at least 2 weeks. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. The maximum recommended dose of telmisartan and amlodipine tablets is 80/10 mg once daily.

The adverse reactions of telmisartan are uncommon and independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter [see ADVERSE REACTIONS].

Telmisartan and amlodipine tablets may be taken with or without food.

Replacement Therapy

Patients receiving amlodipine and telmisartan from separate tablets may instead receive telmisartan and amlodipine tablets containing the same component doses once daily. When substituting for individual components, increase the dose of telmisartan and amlodipine tablets if blood pressure control has not been satisfactory.

Add-on Therapy for Patients with Hypertension Not Adequately Controlled on Antihypertensive Monotherapy

Telmisartan and amlodipine tablets may be used 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.

Patients treated with 10 mg amlodipine who experience any dose-limiting adverse reactions such as edema, may be switched to telmisartan and amlodipine tablets 40/5 mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response [see ADVERSE REACTIONS].

Initial Therapy

A patient may be initiated on telmisartan and amlodipine tablet if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose of telmisartan and amlodipine tablet is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started on telmisartan and amlodipine tablet 80/5 mg once daily.

Initial therapy with telmisartan and amlodipine tablet is not recommended in patients ≥75 years old or with hepatic impairment [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and USE IN SPECIFIC POPULATIONS (8.5, 8.6) ].

Correct imbalances of intravascular volume- or salt-depletion, before initiating therapy with telmisartan and amlodipine tablets [see WARNINGS AND PRECAUTIONS].

Dosing in Specific Populations

Renal Impairment

No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.

Hepatic Impairment

In most patients, initiate amlodipine therapy at 2.5 mg. Titrate slowly in patients with hepatic impairment.

Patients 75 Years of Age and Older

In most patients, initiate amlodipine therapy at 2.5 mg. Titrate slowly in patients 75 years of age and older.

DOSAGE FORMS AND STRENGTHS

Telmisartan and amlodipine tablets are formulated for oral administration in the following strength combinations:

40 mg/5 mg

Oval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54'  and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.

40 mg/10 mg

Oval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour may but have white specks, debossed with 'LU'.

80 mg/5 mg

Capsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.

80 mg/10 mg

Capsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.

HOW SUPPLIED/STORAGE AND HANDLING

Telmisartan and amlodipine tablets are available as

40 mg/5 mg

Oval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.

40 mg/10 mg

Oval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour may but have white specks, debossed with 'LU'.

80 mg/5 mg

Capsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.

80 mg/10 mg

Capsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.

Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations:

Tablet  strength
( telmisartan amlodipine  besylate  equivalent  to  amlodipine mg
Package  Configuration
NDC #
40 mg/5 mg
Bottles of 30
Bottles of 90
A box containing 100 Tablets (10 X 10 unit-dose)
68180-196-06
68180-196-09
68180-196-13
40 mg/10 mg
Bottles of 30
Bottles of 90
A box containing 100 Tablets (10 X 10 unit-dose)
68180-197-06
68180-197-09
68180-197-13
80 mg/5 mg
Bottles of 30
Bottles of 90
A box containing 100 Tablets (10 X 10 unit-dose)
68180-198-06
68180-198-09
68180-198-13
80 mg/10 mg
Bottles of 30
Bottles of 90
A box containing 100 Tablets (10 X 10 unit-dose)
68180-199-06
68180-199-09
68180-199-13

Storage

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Do not remove from blisters until immediately before administration. Protect from moisture and light.

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