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Tekturna HCT (Aliskiren / Hydrochlorothiazide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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 1: Probability of Achieving Systolic Blood Pressure (SBP) <140 mmHg

Figure 2: Probability of Achieving Systolic Blood Pressure (SBP) <130 mmHg

Figure 2: Probability of Achieving Systolic Blood Pressure (SBP) <130 mmHg

Figure 3: Probability of Achieving Diastolic Blood Pressure (DBP) <90 mmHg

Figure 3: Probability of Achieving Diastolic Blood Pressure (DBP) <90 mmHg

Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP) <80 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 and Clinical Studies . ]

DOSAGE AND ADMINISTRATION

Dose Selection

The 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.

Dose Titration

The 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.

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. 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.

Replacement Therapy

Tekturna HCT may be substituted for the individually titrated components.

Initial Therapy

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.

Tekturna HCT is not recommended for use as initial therapy in patients with intravascular volume depletion. [See Warnings and Precautions]

Use with Other Antihypertensive Drugs

Tekturna 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 [s ee Clinical Studies ].

Relationship to Meals

Patients should establish a routine pattern for taking Tekturna HCT with regard to meals. High-fat meals decrease absorption substantially [s ee Clinical Pharmacology (12.3)] .

Dosing in Specific Populations

Renal 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.

DOSAGE FORMS AND STRENGTHS

  • 150 mg/12.5 mg tablets: white, biconvex ovaloid, film-coated tablets imprinted with NVR/LCI
  • 150 mg/25 mg tablets: pale yellow, biconvex ovaloid, film-coated tablets imprinted with NVR/CLL
  • 300 mg/12.5 mg tablets: violet white, biconvex ovaloid, film-coated tablets imprinted with NVR/CVI
  • 300 mg/25 mg tablets: light yellow, biconvex ovaloid, film-coated tablets imprinted with NVR/CVV

HOW SUPPLIED/STORAGE AND HANDLING

Tekturna HCT is supplied as biconvex, ovaloid film-coated tablets.

All strengths are packaged in bottles as described below.

Table 4: Tekturna HCT Tablets Supply
Tablet Color Imprint Imprint NDC #
Aliskiren/HCTZ
Side 1 Side 2 Bottle of 30 Bottle of 90
150 mg/12.5 mg White NVR LCI 54868-6041-0 --
300 mg/12.5 mg Violet White NVR CVI -- 54868-6103-0
300 mg/25 mg
Light Yellow
NVR
CVV
--
54868-6194-0

Storage

Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].

Protect from moisture.

Dispense in tight container (USP).

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