Tekturna Hct
NDC 54868-6041

The NDC code 54868-6041 is assigned by the FDA to the product Tekturna Hct. This pharmaceutical product is labeled by Physicians Total Care, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54868-6041-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

Tekturna HCT is indicated for the treatment of hypertension.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.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 TherapyTekturna HCT may be substituted for the titrated components.Initial TherapyTekturna 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 mmHgFigure 2: Probability of Achieving Systolic Blood Pressure (SBP) <130 mmHgFigure 3: Probability of Achieving Diastolic Blood Pressure (DBP) <90 mmHgFigure 4: Probability of Achieving Diastolic Blood Pressure (DBP) <80 mmHgAt 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).]

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

• RxCUI: 1011710 - aliskiren 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
• RxCUI: 1011710 - aliskiren 150 MG / hydrochlorothiazide 12.5 MG Oral Tablet
• RxCUI: 1011710 - aliskiren 150 MG / HCTZ 12.5 MG Oral Tablet
• RxCUI: 1011712 - Tekturna HCT 150 MG / 12.5 MG Oral Tablet
• RxCUI: 1011712 - aliskiren 150 MG / hydrochlorothiazide 12.5 MG Oral Tablet [Tekturna HCT]