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The procedure is already available in Europe and "...
Tekamlo is 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 amlodipine. There are no controlled trials demonstrating risk reduction with Tekamlo.
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.
Use Tekamlo as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
Base the choice of Tekamlo as initial therapy on an assessment of potential benefits and risks.
Switch a patient whose blood pressure is not adequately controlled with aliskiren alone or amlodipine besylate (or another dihydropyridine calcium channel blocker) to combination therapy with Tekamlo.
Tekamlo may be substituted for its titrated components.
Patients with moderate or severe hypertension are at a 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. Individualize the decision to use a combination as initial therapy by weighing factors such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk.
Data from the high-dose multifactorial study [see Clinical Studies] provide estimates of the probability of reaching a target blood pressure with Tekamlo compared to aliskiren or amlodipine monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Tekamlo 300 mg/10 mg, 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 because of a small number of subjects with high baseline blood pressures.
Figure 1: Probability of Achieving Systolic Blood
Pressure (SBP) < 140 mmHg
Figure 2: Probability of Achieving Diastolic Blood
Pressure (DBP) < 90 mmHg
Figure 3: Probability of
Achieving Systolic Blood Pressure (SBP) < 130 mmHg
Figure 4: Probability of
Achieving Diastolic Blood Pressure (DBP) < 80 mmHg
The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g. SBP < 140 mmHg or < 130 mmHg) for the high dose groups evaluated in the study. At all levels of baseline blood pressure, the probability of achieving any given diastolic or systolic goal is greater with the combination than for either monotherapy. For example, the mean baseline SBP/DBP for patients participating in this multifactorial study was 157/100 mmHg. A patient with a baseline blood pressure of 157/100 mmHg has about a 49% likelihood of achieving a goal of < 140 mmHg (systolic) and 50% likelihood of achieving < 90 mmHg (diastolic) on aliskiren alone, and the likelihood of achieving these goals on amlodipine alone is about 62% (systolic) and 69% (diastolic). The likelihood of achieving these goals on Tekamlo rises to about 74% (systolic) and 83% (diastolic). The likelihood of achieving these goals on placebo is about 25% (systolic) and 27% (diastolic) [see DOSAGE AND ADMINISTRATION and Clinical Studies].
DOSAGE AND ADMINISTRATION
The blood pressure lowering effects are largely attained within 1-2 weeks.
The recommended initial once-daily dose of Tekamlo is 150 mg/5 mg. Titrate as needed to a maximum of 300 mg/10 mg.
If blood pressure remains uncontrolled after 2 to 4 weeks of therapy, titrate the dose to a maximum of Tekamlo 300 mg/10 mg once daily.
The usual recommended starting dose of Tekamlo is 150 mg/5 mg once daily as needed to control blood pressure. Titrate the dose to a maximum of 300 mg/10 mg once daily.
Tekamlo is not recommended for use as initial therapy in patients with intravascular volume depletion [see WARNINGS AND PRECAUTIONS].
Use Tekamlo for patients not adequately controlled with aliskiren alone or amlodipine besylate (or another dihydropyridine calcium channel blocker) alone.
Switch a patient who experiences dose-limiting adverse reactions on either component alone to Tekamlo containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions.
Switch patients receiving aliskiren and amlodipine besylate from separate tablets to a single tablet of Tekamlo containing the same component doses. When substituting for individual components, increase the dose of one or both of the components if blood pressure control has not been satisfactory.
Use with Other Antihypertensive Drugs
Tekamlo may be administered with some other antihypertensive agents. In diabetics, do not use in combination with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme inhibitors (ACEIs) [see CONTRAINDICATIONS]. Concomitant use of aliskiren with an ARB or ACEI is not recommended in patients with GFR < 60 ml/min [see WARNINGS AND PRECAUTIONS]. It is not known whether Tekamlo decreases blood pressure further when added to maximum dosages of ACE inhibitors and beta blockers [see Clinical Studies].
Relationship to Meals
Advise patients to establish a routine pattern for taking Tekamlo with regard to meals. High-fat meals decrease absorption substantially [see CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
- 150 mg aliskiren/5 mg amlodipine tablets: Non-scored light yellow, ovaloid convex shaped film-coated tablet with a beveled edge with debossing “T2” on one side and “NVR” on the reverse side of the tablet.
- 150 mg aliskiren/10 mg amlodipine tablets: Non-scored yellow, ovaloid convex shaped film-coated tablet with a beveled edge with debossing “T7” on one side and “NVR” on the reverse side of the tablet.
- 300 mg aliskiren/5 mg amlodipine tablets: Non-scored dark yellow, ovaloid convex shaped film-coated tablet with a beveled edge with debossing “T11” on one side and “NVR” on the reverse side of the tablet.
- 300 mg aliskiren /10 mg amlodipine tablets: Non-scored brown yellow, ovaloid convex shaped film-coated tablet with a beveled edge with debossing “T12” on one side and “NVR” on the reverse side of the tablet.
Storage And Handling
Tekamlo (aliskiren and amlodipine) is supplied as follows:
150 mg aliskiren/5 mg amlodipine Tablets - Non-scored light yellow, ovaloid convex-shaped, film-coated tablet with a beveled edge with debossing “T2” on one side and “NVR” on the reverse side of the tablet. The tablet dimensions are approximately 16 x 6.3 mm.
150 mg aliskiren/10 mg amlodipine Tablets - Non-scored yellow, ovaloid convex shaped, film-coated tablet with a beveled edge with debossing “T7” on one side and “NVR” on the reverse side of the tablet. The tablet dimensions are approximately 16 x 6.3 mm.
300 mg aliskiren/5 mg amlodipine Tablets - Non-scored dark yellow, ovaloid convex-shaped, film-coated tablet with a beveled edge with debossing “T11” on one side and “NVR” on the reverse side of the tablet. The tablet dimensions are approximately 21 x 8.3 mm.
300 mg aliskiren/10 mg amlodipine Tablets - Non-scored brown yellow, ovaloid convex shaped, film-coated tablet with a beveled edge with debossing “T12” on one side and “NVR” on the reverse side of the tablet. The tablet dimensions are approximately 21 x 8.3 mm.
All strengths are packaged in bottles and unit-dose blister packages (10 strips of 10 tablets) as described below.
Table 2: Tekamlo Tablets Supply
|Aliskiren hemifumarate/ amlodipine besylate||Side 1||Side 2||Bottle of 30||Bottle of 90||Blister Packages of 100|
|150 mg/5 mg||Light yellow||T2||NVR||0603-15||0603-34||0603-35|
|150 mg/10 mg||Yellow||T7||NVR||0604-15||0604-34||0604-35|
|300 mg/5 mg||Dark yellow||T11||NVR||0605-15||0605-34||0605-35|
|300 mg/10 mg||Brown yellow||T12||NVR||0606-15||0606-34||0606-35|
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) in original container. Protect from heat and moisture. Dispense in original container.
Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. March 2012/March 2012
Last reviewed on RxList: 5/2/2012
This monograph has been modified to include the generic and brand name in many instances.
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