WARNING: AVOID USE IN PREG NANCY
When pregnancy is detected, discontinue Tekturna HCT as soon as possible. D rugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. [ See Warnings and Precautions (5.1) ]
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TEKTURNA HCT SUMMARY
WARNING:
Tekturna HCT is a fixed combination of aliskiren, an orally active, nonpeptide, potent direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic.
Tekturna HCT is indicated for the treatment of hypertension.
Both aliskiren and hydrochlorothiazide are associated with dose-dependent and dose-independent adverse effects. Patients treated with Tekturna HCT may experience any or all of these adverse effects. For dose-dependent adverse effects, using a strength of Tekturna HCT with a lower dose of the component suspected of causing the adverse effect may produce better tolerability.
Add-On Therapy
A patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switched to combination therapy with Tekturna HCT.
A patient whose blood pressure is controlled with hydrochlorothiazide alone but who experiences hypokalemia may be switched to combination therapy with Tekturna HCT.
A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Tekturna HCT containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions.
Replacement Therapy
Tekturna HCT may be substituted for the titrated components.
Limitation of Use
This fixed dose combination is not indicated for initial therapy.
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NEWS HIGHLIGHTSMedia Articles Related to Tekturna HCT (Aliskiren / Hydrochlorothiazide)
New Consortium Paves The Way For Improved Treatment Of Hypertension And Associated Vascular Complications
Source: Hypertension News From Medical News Today [2009.11.18]
Top Institute Pharma (TI Pharma) has formed a consortium with Actelion Pharmaceuticals Ltd, Erasmus Medical Centre and Maastricht University to define new modalities for the treatment of hypertension (high blood pressure) and associated vascular complications such as heart and kidney failure, myocardial infarction and stroke.
Kids with CKD Often Have Masked Hypertension (CME/CE)
Source: MedPage Today Nephrology [2009.11.13]
Many children with chronic kidney disease may have undetected hypertension, placing them at risk for enlarged hearts and future cardiovascular disease, a cross-sectional study showed.
Key Player Identified In Cascade That Leads To Hypertension-Related Kidney Damage
Source: Hypertension News From Medical News Today [2009.11.06]
A key player in a cascade that likely begins with stress and leads to high blood pressure and kidney damage has been identified by researchers who say the finding may lead to better ways to control both. Medical College of Georgia researchers have found endothelin, a powerful blood vessel constrictor and inflammatory peptide, increases the number of T cells in the kidneys, which helps recruit other immune cells, causing inflammation and destruction.
A Recipe For Hypertension: High Fructose Corn Syrup
Source: Hypertension News From Medical News Today [2009.10.31]
A diet high in fructose increases the risk of developing high blood pressure (hypertension), according to a paper presented at the American Society of Nephrology's 42nd Annual Meeting and Scientific Exposition in San Diego, California. The findings suggest that cutting back on processed foods and beverages that contain high fructose corn syrup (HFCS) may help prevent hypertension.
Hypertension Guidelines Reappraised In Light Of New Research
Source: Hypertension News From Medical News Today [2009.10.30]
A Task Force of the European Society of Hypertension have released the official European guidelines on the management and treatment of hypertension. The guidelines are an update of those published in 2007, and will be published in the November issue of the Journal of Hypertension.
Published Studies Related to Tekturna HCT (Aliskiren / Hydrochlorothiazide)
Antihypertensive efficacy and tolerability of aliskiren/hydrochlorothiazide (HCT) single-pill combinations in patients who are non-responsive to HCT 25 mg alone. [2009.04]
OBJECTIVE: Thiazide diuretics such as hydrochlorothiazide (HCT) are a widely used first-line treatment for hypertension, but most patients will not achieve blood pressure (BP) control with HCT alone and so will require combination therapy. In this study the efficacy, safety and tolerability of a single-pill combination (SPC) of the direct renin inhibitor aliskiren with HCT were investigated in patients non-responsive to HCT 25 mg therapy... CONCLUSION: Aliskiren/HCT SPCs provide clinically significant BP reductions and improved BP control rates in patients who are non-responsive to HCT 25 mg monotherapy. Limitations of the study were the mainly Caucasian patient population and the non-responder design.
Efficacy of aliskiren/hydrochlorothiazide single-pill combinations in aliskiren non-responders. [2008.12]
OBJECTIVES: To evaluate the efficacy, safety and tolerability of a single-pill combination of the direct renin inhibitor aliskiren and hydrochlorothiazide (HCT) in patients with hypertension and an inadequate BP response to aliskiren monotherapy (mean sitting diastolic BP [msDBP] > 90 and < or = 110 mmHg following 4 weeks of aliskiren 300 mg)... CONCLUSIONS: Aliskiren/HCT single-pill combinations provide clinically significant additional BP reductions and improved BP control rates over aliskiren alone in patients who are non-responsive to aliskiren 300 mg monotherapy.
Comparative efficacy and safety of aliskiren, an oral direct renin inhibitor, and ramipril in hypertension: a 6-month, randomized, double-blind trial. [2008.03]
OBJECTIVES: This double-blind study compared long-term efficacy, safety and tolerability of the oral direct renin inhibitor aliskiren and the angiotensin-converting enzyme inhibitor ramipril alone and combined with hydrochlorothiazide in patients with hypertension... CONCLUSIONS: Aliskiren-based therapy was well tolerated and produced sustained blood pressure reductions in patients with hypertension over 6 months, greater than those with ramipril-based therapy.
A comparison of the tolerability of the direct renin inhibitor aliskiren and lisinopril in patients with severe hypertension. [2007.10]
Patients with severe hypertension (>180/110 mm Hg) require large blood pressure (BP) reductions to reach recommended treatment goals (<140/90 mm Hg) and usually require combination therapy to do so. This 8-week, multicenter, randomized, double-blind, parallel-group study compared the tolerability and antihypertensive efficacy of the novel direct renin inhibitor aliskiren with the angiotensin converting enzyme inhibitor lisinopril in patients with severe hypertension (mean sitting diastolic blood pressure (msDBP)>/=105 mm Hg and <120 mm Hg)...
Direct Renin inhibition with aliskiren in obese patients with arterial hypertension. [2007.05]
Current guidelines from the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure recommend first-line treatment with a thiazide diuretic but do not provide specific guidance for obese patients... In conclusion, combination treatment with aliskiren is a highly effective and well-tolerated therapeutic option for obese patients with hypertension who fail to achieve blood pressure control with first-line thiazide diuretic treatment.
Clinical Trials Related to Tekturna HCT (Aliskiren / Hydrochlorothiazide)
Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension [Recruiting]
This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy
to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients
with Stage II hypertension over a period of 12 weeks.
Efficacy and Safety of Once Daily Dosing of Aliskiren (300 mg qd) to Twice Daily Dosing of Aliskiren (150 mg Bid) in Patients With Moderate Hypertension [Recruiting]
This study will compare the safety and efficacy of once daily dosing of aliskiren to twice
daily dosing of aliskiren in patients with moderate hypertension
Efficacy and Safety of Aliskiren 75mg, 150mg and 300mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-Controlled Study [Recruiting]
This study will evaluate the efficacy and safety of aliskiren 75mg, 150mg and 300mg in
elderly patients with essential hypertension when given with a light meal.
A 54 Week, Randomized, Double-Blind, Parallel-Group, Multicenter Study Evaluating the Long-Term Gastrointestinal (GI) Safety and Tolerability of Aliskiren (300 mg) Compared to Ramipril (10 mg) in Patients With Essential Hypertension [Recruiting]
This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren
(300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone [Recruiting]
This study will assess the safety and efficacy of combination aliskiren/amlodipine in
patients not adequately controlled with aliskiren alone
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Tekturna HCT has an overall score of 1. The effectiveness score is 2 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
| | Tekturna HCT review by 75 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Ineffective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | high blood pressure |
| Dosage & duration: | | 300mg/12.5 mg taken 1 x daily for the period of 3 weeks |
| Other conditions: | | dermatomyositis,hypothyroidism |
| Other drugs taken: | | levothyroxine, prednisone | | |
Reported Results |
| Benefits: | | none,pressure never came down to acceptable range and had wide swings throughout the day |
| Side effects: | | pounding headache, nausea, dizziness while walking and arising from bed/chair, spots in eye, uncontrollable eye tearing. The latter two are still present after6 weeks on not taking meds. |
| Comments: | | they didn't work even after dossage was increased, Monitored at home and in doctor's office, results were the same. |
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Page last updated: 2009-11-18
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