Tekturna HCT (Aliskiren / Hydrochlorothiazide) - Indications and Dosage

      INDICATIONS AND USAGE

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.

      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.

Regardless of the dose of the single agent, patients switched from monotherapy to Tekturna HCT will experience greater blood pressure reductions with use of the combination product.

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.

Use with Other Antihypertensive Drugs

Tekturna HCT may be administered with other antihypertensive agents. It is not known whether additive effects are present when Tekturna HCT is used with angiotensin-converting enzyme inhibitors or beta blockers. [ See Clinical Studies (14) ] .

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 and unit-dose blister packages (10 strips of 10 tablets) as described below.

Table 4: Tekturna HCT Tablets Supply

Tablet	Color	Imprint	Imprint	NDC 0078- XXXX-XX
Aliskiren/HCTZ		Side 1	Side 2	Bottle of 30	Bottle of 90	Blister Packages of 100
150 mg/12.5 mg	White	NVR	LCI	0521-15	0521-34	0521-35
150 mg/25 mg	Pale Yellow	NVR	CLL	0522-15	0522-34	0522-35
300 mg/12.5 mg	Violet White	NVR	CVI	0523-15	0523-34	0523-35
300 mg/25 mg	Light Yellow	NVR	CVV	0524-15	0524-34	0524-35

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).