TEKTURNA HCT aliskiren hemifumarate and hydrochlorothiazide tablet film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

ALISKIREN HEMIFUMARATE (UNII: C8A0P8G029) (ALISKIREN - UNII:502FWN4Q32)

Disponible desde:

Novartis Pharmaceuticals Corporation

Designación común internacional (DCI):

ALISKIREN HEMIFUMARATE

Composición:

ALISKIREN 150 mg

tipo de receta:

PRESCRIPTION DRUG

Estado de Autorización:

New Drug Application

Ficha técnica

TEKTURNA HCT- ALISKIREN HEMIFUMARATE AND HYDROCHLOROTHIAZIDE TABLET,
FILM COATED
NOVARTIS PHARMACEUTICALS CORPORATION
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE TEKTURNA HCT AS SOON AS
POSSIBLE. (5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING
FETUS. (5.1)
RECENT MAJOR CHANGES
Contraindications (4) 3/2015
Warnings and Precautions (5.1, 5.2, 5.5, 5.8) 3/2015
INDICATIONS AND USAGE
Tekturna HCT is a combination of aliskiren, a renin inhibitor, and
hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated
for the treatment of hypertension, to lower blood pressure:
In patients not adequately controlled with monotherapy. (1)
As initial therapy in patients likely to need multiple drugs to
achieve their blood pressure goals. (1)
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial
infarction.
DOSAGE AND ADMINISTRATION
Initiate with 150/12.5mg daily. Titrate as needed 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)
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)
CONTRAINDICATIONS
Do not use with angiotensin receptor blockers (ARBs) or
angiotensin-converting enzyme inhibitors (ACEIs) in patients
with diabetes. (4)
Anuria (4)
Hypersensitivity to sulfonamide derived drugs or to any of the
components. (4)
WARNINGS AND PRECAUTIONS
Avoid concomitant use with ARBs or ACEIs particularly in patients with
renal impairment [creatinine c