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Tekamlo (Aliskiren Hemifumarate / Amlodipine Besylate) - Summary

 
 



WARNING: AVOID USE IN PREG NANCY

When pregnancy is detected, discontinue Tekamlo as soon as possible. D rugs that act directly on the renin-angiotensin -aldosterone system can cause injury and even death to the developing fetus. [ See Warnings and Precautions (5.1 ) and Use in Specific Populations ( 8.1 ) ] .

 

TEKAMLO SUMMARY

Tekamlo is a single tablet of aliskirenhemifumarate (an orally active, nonpeptide, potent direct renin inhibitor) and amlodipine besylate (a dihydropyridine calcium channel blocker).

Tekamlo (ALISKIREN/AMLODIPINE) is indicated for the following:

Tekamlo is a combination of aliskiren, a renin inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, indicated for the treatment of hypertension:

  • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. (1)
  • In patients not adequately controlled with monotherapy.
  • As a substitute for its titrated components.

See all Tekamlo indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Tekamlo (Aliskiren / Amlodipine)

Treating Mild Hypertension With Drugs May Be Misdirected
Source: Medscape Medical Students Headlines [2014.09.23]
Experts have suggested that treating mild hypertension with drugs has unclear benefits and huge costs; priorities should shift to society-wide measures that promote lifestyle modification.
Medscape Medical News

Hypertension may be initiated by an autoimmune response
Source: Hypertension News From Medical News Today [2014.09.19]
High blood pressure is a major risk factor for heart attack, stroke, chronic heart failure, and kidney disease.

Dementia risk reduction through tobacco control and better prevention, detection and control of hypertension and diabetes
Source: Diabetes News From Medical News Today [2014.09.18]
The World Alzheimer Report 2014 'Dementia and Risk Reduction: An analysis of protective and modifiable factors', calls for dementia to be integrated into both global and national public health...

Men who improve their fitness levels can hold off development of hypertension
Source: Hypertension News From Medical News Today [2014.09.17]
A man's cardiorespiratory fitness can drastically delay the natural, age-associated increase of his blood pressure over his adult life span.

Experts raise concern over unnecessary treatment of mild hypertension in low risk people
Source: Hypertension News From Medical News Today [2014.09.15]
Lowering the drug threshold for high blood pressure (hypertension) has exposed millions of low-risk people around the world to drug treatment of uncertain benefit at huge cost to health systems...

more news >>

Published Studies Related to Tekamlo (Aliskiren / Amlodipine)

Effect of aliskiren addition to amlodipine on ankle edema in hypertensive patients: a three-way crossover study. [2011.06]
CONCLUSIONS: Direct renin inhibition by aliskiren partially counteracts the microcirculatory changes responsible for calcium-channel-induced edema formation, possibly through preferential vasodilation of venous capacitance vessels.

Efficacy and safety of aliskiren-based dual and triple combination therapies in US minority patients with stage 2 hypertension. [2011.03]
Minority patients with hypertension generally require combination therapy to reach blood pressure (BP) goals. We examined the BP-lowering efficacy and safety of combination aliskiren/amlodipine therapy in self-identified minority patients in the United States with stage 2 hypertension and the impact of adding hydrochlorothiazide (HCTZ) to this combination...

Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension and obesity or metabolic syndrome. [2011.11]
The renin-angiotensin system (RAS) is a common link between hypertension and comorbidities of obesity and metabolic syndrome (MetS). We evaluated the antihypertensive efficacy and safety of the combination direct renin inhibitor, aliskiren, with amlodipine versus amlodipine alone in self-identified African Americans with stage 2 hypertension in a subgroup of patients with obesity or MetS participating in the Aliskiren Amlodipine Combination in African AmEricans with Stage 2 HypertenSion (AACESS) trial.

Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension. [2011.08]
Initial multiple drug therapy for hypertension achieves greater and quicker reductions and higher blood pressure (BP) control rates than monotherapy. This 8-week, prospective, multicenter, randomized, double-blind study compared the efficacy and safety of the initial combination of aliskiren/amlodipine with amlodipine monotherapy in African Americans with stage 2 hypertension...

Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension. [2011]
Initial multiple drug therapy for hypertension achieves greater and quicker reductions and higher blood pressure (BP) control rates than monotherapy. This 8-week, prospective, multicenter, randomized, double-blind study compared the efficacy and safety of the initial combination of aliskiren/amlodipine with amlodipine monotherapy in African Americans with stage 2 hypertension...

more studies >>

Clinical Trials Related to Tekamlo (Aliskiren / Amlodipine)

Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension [Recruiting]
Part 1 investigated aliskiren, amlodipine and angiotensin II levels in interstitial fluid of fat and skeletal muscle; aliskiren concentration, angiotensin II levels, and renin activity and concentration in fat and skeletal muscle tissues; aliskiren and amlodipine concentrations, angiotensin II levels, and renin activity and concentrations in plasma.

Part 2 investigates the potential for aliskiren to modulate renin-angiotensin-aldosterone system (RAAS) activity, and lipid/carbohydrate metabolism in adipose and skeletal muscle tissue in obese patients with hypertension in comparison to amlodipine.

A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People [Recruiting]
This study will provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a CCB) in elderly individuals (≥ 65 years) with SBP 130 to 159 mmHg, in preventing major CV events and on global measures of physical, executive and cognitive function.

more trials >>

Reports of Suspected Tekamlo (Aliskiren / Amlodipine) Side Effects

Diabetes Mellitus (6)Osteoporosis (6)Poor Quality Sleep (6)Blood Uric Acid Increased (6)Vasodilatation (6)Breast Cancer (6)Hypoaesthesia (6)Alopecia (6)Hypothyroidism (6)Oedema Peripheral (3)more >>


Page last updated: 2014-09-23

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