TEKTURNA HCT- aliskiren hemifumarate and hydrochlorothiazide tablet, film coated TEKTURNA HCT- aliskiren hemifumarate and hydr

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

ALISKIREN HEMIFUMARATE (UNII: C8A0P8G029) (ALISKIREN - UNII:502FWN4Q32), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Предлага се от:

Physicians Total Care, Inc.

INN (Международно Name):

ALISKIREN HEMIFUMARATE

Композиция:

ALISKIREN HEMIFUMARATE 150 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 a

Каталог на резюме:

Tekturna HCT is supplied as biconvex, ovaloid film-coated tablets. All strengths are packaged in bottles as described below. 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).

Статус Оторизация:

New Drug Application

Данни за продукта

TEKTURNA HCT - ALISKIREN HEMIFUMARATE AND HYDROCHLOROTHIAZIDE TABLET,
FILM COATED
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TEKTURNA HCT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TEKTURNA HCT.
TEKTURNA HCT (ALISKIREN AND HYDROCHLOROTHIAZIDE) TABLETS
INITIAL U.S. APPROVAL: 2008
WARNING: AVOID USE IN PREGNANCY
WHEN PREGNANCY IS DETECTED, DISCONTINUE TEKTURNA HCT AS SOON AS
POSSIBLE. DRUGS THAT ACT DIRECTLY ON
THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE
DEVELOPING FETUS. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1) 07/2009
Dosage and Administration
Add-On Therapy (2.3) 07/2009
Replacement Therapy (2.4) 07/2009
Initial Therapy (2.5) 07/2009
INDICATIONS AND USAGE
Tekturna HCT is a combination of aliskiren, a direct renin inhibitor,
and hydrochlorothiazide (HCTZ), a thiazide
diuretic, indicated for the treatment of hypertension: (1)
In patients not adequately controlled with monotherapy
As initial therapy in patients likely to need multiple drugs to
achieve their blood pressure goals (1)
DOSAGE AND ADMINISTRATION
The antihypertensive effect is largely manifested within 1 week, with
maximal effects seen at around 4 weeks. If blood
pressure remains uncontrolled after 2 to 4 weeks of therapy, titrate
up to a maximum of 300/25 mg. (2.2)
Order of increasing mean effect: 150/12.5 mg, 150/25 mg or 300/12.5
mg, and 300/25 mg (2.1)
One tablet daily, with a routine pattern with regard to meals. (2.7)
May be administered with other antihypertensive agents. (2.6)
Add-on or Initial therapy: Initiate with 150/12.5mg. Titrate as needed
up to a maximum of 300/25 mg. (2.3, 2.5)
Replacement therapy: May be substituted for titrated components (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets (mg aliskiren/mg HCTZ): 150/12.5, 150/25, 300/12.5, 300/25 (3)
(3)
CONTRAINDICATIONS
Anuria (4) (4)
Hypersensitivity to sulfonamide-derived drugs (4) (4)
WARNINGS AND PRECAUTIONS
Head and Neck Angioedema: Discontin