TEKTURNA HCT- aliskiren hemifumarate and hydrochlorothiazide tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Noden Pharma USA, Inc.

INN (International namn):

ALISKIREN HEMIFUMARATE

Sammansättning:

ALISKIREN 150 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Tekturna HCT 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 including hydrochlorothiazide (HCTZ). There are no controlled trials demonstrating risk reduction with Tekturna HCT. 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). Nume

Produktsammanfattning:

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. Storage Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in original container.

Bemyndigande status:

New Drug Application

Produktens egenskaper

TEKTURNA HCT- ALISKIREN HEMIFUMARATE AND HYDROCHLOROTHIAZIDE TABLET,
FILM
COATED
NODEN PHARMA USA, 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, 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,
8.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH
TO THE DEVELOPING FETUS. ( 5.1, 8.1)
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 [cr