Tekturna Hct
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Uses
Tekturna HCT is indicated for the treatment of hypertension.
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.
Initial Therapy
Tekturna HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
The choice of Tekturna HCT as initial therapy should be based on an assessment of potential benefits and risks.
Patients with Stage 2 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. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations 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 (14)] provides estimates of the probability of reaching a target blood pressure with Tekturna HCT compared to aliskiren or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Tekturna HCT 300/25 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 small numbers of subjects with high baseline blood pressures.
Figure 1: Probability of Achieving Systolic Blood Pressure (SBP) <140 mmHg
Figure 2: Probability of Achieving Systolic Blood Pressure (SBP) <130 mmHg
Figure 3: Probability of Achieving Diastolic Blood Pressure (DBP) <90 mmHg
Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP) <80 mmHg
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 msSBP/msDBP for patients participating in this multifactorial study was 154/99 mmHg. A patient with a baseline blood pressure of 154/99 mmHg has about a 62% chance of achieving a goal of <140 mmHg (systolic) and 61% chance of achieving <90 mmHg (diastolic) on aliskiren alone, and the chance of achieving these goals on hydrochlorothiazide alone is about 54% (systolic) and 49% (diastolic). The chance of achieving these goals on Tekturna HCT rises to about 77% (systolic) and 74% (diastolic). The chance of achieving these goals on placebo is about 34% (systolic) and 37% (diastolic). [See Dosage and Administration (2) and Clinical Studies (14).]
History
There is currently no drug history available for this drug.
Other Information
Tekturna HCT is a fixed combination of aliskiren, an orally active, nonpeptide, direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic.
Aliskiren
Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-Carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is
Molecular formula: C30H53N3O6 • 0.5 C4H4O4
Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-Octanol, and highly soluble in water.
Hydrochlorothiazide
Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.
Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is
Tekturna HCT tablets are formulated for oral administration to contain aliskiren and hydrochlorothiazide, USP 150/12.5 mg, 150/25 mg, 300/12.5 mg and 300/25 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide colorants, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide, and wheat starch.
Sources
Tekturna Hct Manufacturers
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Physicians Total Care, Inc.
![Tekturna Hct (Aliskiren Hemifumarate And Hydrochlorothiazide ) Tablet, Film Coated Tekturna Hct (Aliskiren Hemifumarate And Hydrochlorothiazide) Tablet, Film Coated [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tekturna Hct | Physicians Total Care, Inc.
2.1 Dose SelectionThe recommended once-daily doses of Tekturna HCT in order of increasing mean effect are 150/12.5 mg, 150/25 mg or 300/12.5 mg, and 300/25 mg.
2.2 Dose TitrationThe antihypertensive effect of Tekturna HCT is largely manifested within 1 week, with maximal effects generally seen at around 4 weeks. If blood pressure remains uncontrolled after 2 to 4 weeks of therapy, the dose may be titrated up to a maximum of aliskiren 300 mg/hydrochlorothiazide 25 mg.
2.3 Add-On TherapyA patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switched to combination therapy with Tekturna HCT. The usual recommended starting dose is 150/12.5 mg once daily as needed to control blood pressure. The dose may be titrated up to a maximum of aliskiren 300 mg/hydrochlorothiazide 25 mg once daily.
2.4 Replacement TherapyTekturna HCT may be substituted for the individually titrated components.
2.5 Initial TherapyThe usual recommended starting dose is 150/12.5 mg once daily as needed to control blood pressure. The dose may be titrated up to a maximum of aliskiren 300 mg/hydrochlorothiazide 25 mg once daily.
Tekturna HCT is not recommended for use as initial therapy in patients with intravascular volume depletion. [See Warnings and Precautions (5.3)]
2.6 Use with Other Antihypertensive DrugsTekturna HCT may be administered with other antihypertensive agents. There are no data available with use of Tekturna HCT with angiotensin-converting enzyme inhibitors or beta blockers [see Clinical Studies (14)].
2.7 Relationship to MealsPatients should establish a routine pattern for taking Tekturna HCT with regard to meals. High-fat meals decrease absorption substantially [see Clinical Pharmacology (12.3)].
2.8 Dosing in Specific PopulationsRenal Impairment
The usual regimens of Tekturna HCT may be followed as long as the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so Tekturna HCT is not recommended.
Hepatic Impairment
Adjustment of the starting dose is not necessary with hepatic impairment.
Elderly Patients
Adjustment of the starting dose is not required for elderly patients.
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Novartis Pharmaceuticals Corporation
Tekturna Hct | Novartis Pharmaceuticals Corporation
2.1 Dose SelectionThe recommended once-daily doses of Tekturna HCT in order of increasing mean effect are 150/12.5 mg, 150/25 mg or 300/12.5 mg, and 300/25 mg.
2.2 Dose TitrationThe antihypertensive effect of Tekturna HCT is largely manifested within 1 week, with maximal effects generally seen at around 4 weeks. If blood pressure remains uncontrolled after 2 to 4 weeks of therapy, the dose may be titrated up to a maximum of aliskiren 300 mg/HCTZ 25 mg.
2.3 Add-On TherapyA patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switched to combination therapy with Tekturna HCT. The usual recommended starting dose is 150/12.5 mg once daily as needed to control blood pressure. The dose may be titrated up to a maximum of aliskiren 300 mg/hydrochlorothiazide 25 mg once daily.
2.4 Replacement TherapyTekturna HCT may be substituted for the individually titrated components.
2.5 Initial TherapyThe usual recommended starting dose is 150/12.5 mg once daily as needed to control blood pressure. The dose may be titrated up to a maximum of aliskiren 300 mg/HCTZ 25 mg once daily.
Tekturna HCT is not recommended for use as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.4)].
2.6 Relationship to MealsPatients should establish a routine pattern for taking Tekturna HCT with regard to meals. High-fat meals decrease absorption substantially [see Clinical Pharmacology (12.3)].
![Tekturna Hct (Aliskiren Hemifumarate And Hydrochlorothiazide) Tablet, Film Coated [Novartis Pharmaceuticals Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2d545c2f-29a4-432f-bea9-2aeda6592a62&name=tekturna-hct-0A.jpg)
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