Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
ALISKIREN HEMIFUMARATE (UNII: C8A0P8G029) (ALISKIREN - UNII:502FWN4Q32), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Physicians Total Care, Inc.
ALISKIREN HEMIFUMARATE
ALISKIREN HEMIFUMARATE 150 mg
ORAL
PRESCRIPTION DRUG
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
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).
New Drug Application
TEKTURNA HCT - ALISKIREN HEMIFUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED PHYSICIANS TOTAL CARE, INC. ---------- 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 Leggi il documento completo