TEKTURNA- aliskiren hemifumarate 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:

A-S Medication Solutions

Designación común internacional (DCI):

ALISKIREN HEMIFUMARATE

Composición:

ALISKIREN 300 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Tekturna is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating risk reduction with Tekturna. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety o

Resumen del producto:

Product: 50090-1250 NDC: 50090-1250-0 30 TABLET, FILM COATED in a BOTTLE

Estado de Autorización:

New Drug Application

Ficha técnica

TEKTURNA- ALISKIREN HEMIFUMARATE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TEKTURNA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TEKTURNA.
TEKTURNA (ALISKIREN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2007
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE TEKTURNA 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 (5.2, 5.5) 3/2015
INDICATIONS AND USAGE
Tekturna is a renin inhibitor (RI) indicated for:
The treatment of hypertension, to lower blood pressure (1.1)
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial
infarctions .
DOSAGE AND ADMINISTRATION
Starting dose: 150 mg once daily with a routine pattern with regard to
meals. If blood pressure remains uncontrolled
titrate up to 300 mg daily. (2.1, 2.2)
Majority of effect of given dose attained in 2 weeks (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 150 mg, 300 mg (3)
CONTRAINDICATIONS
Do not use with angiotensin receptor blockers (ARBs) or
angiotensin-converting enzyme inhibitors (ACEIs) in patients
with diabetes. (4)
Hypersensitivity to any of the components. (4)
WARNINGS AND PRECAUTIONS
Avoid concomitant use with ARBs or ACEIs particularly in patients with
renal impairment [creatinine clearance (CrCl)
<60 mL/min]. (5.2, 5.4)
Anaphylactic Reactions and Angioedema. (5.3)
Hypotension: Correct imbalances in volume and/or salt depleted
patients. (5.4)
Impaired Renal Function: Monitor serum creatinine periodically. (5.5)
Hyperkalemia: Monitor potassium levels periodically. (5.6)
ADVERSE REACTIONS
Most common adverse reaction: diarrhea (incidence 2.3%) (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NOVARTIS
PHARMACEUTICALS