TEKTURNA- aliskiren hemifumarate tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Physicians Total Care, Inc.

INN (Nama Internasional):

ALISKIREN HEMIFUMARATE

Komposisi:

ALISKIREN HEMIFUMARATE 150 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 one 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 var

Ringkasan produk:

Tekturna is supplied as a light-pink, biconvex round tablet containing 150 mg of aliskiren, and as a light-red biconvex ovaloid tablet containing 300 mg of aliskiren. Tablets are imprinted with NVR on one side and IL, IU, on the other side of the 150, and 300 mg tablets, respectively. All strengths are packaged in bottles and unit-dose blister packages (10 strips or 10 tablets) as described below in Table 5. Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in original container.

Status otorisasi:

New Drug Application

Karakteristik produk

TEKTURNA - ALISKIREN HEMIFUMARATE 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 SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TEKTURNA .
T EKTURNA (ALISKIREN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2007
WARNING: AVOID USE IN PREGNANCY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
WHEN PREGNANCY IS DETECTED, DISCONTINUE TEKTURNA 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: Benefits of lowering blood pressure (1.1)
10/2011
Warnings and Precautions, Cyclosporine or Itraconazole (5.7) 02/2011
INDICATIONS AND USAGE
Tekturna is a renin inhibitor (RI) indicated for: (1)
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. (1)
DOSAGE AND ADMINISTRATION
Majority of effect of given dose substantially attained in 2 weeks
(2.1)
May be administered with other anti-hypertensive agents (2.2)
Additive effects with angiotensin-converting enzyme inihibitors (ACEI)
at maximal doses have not been studied (2.2)
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, 2.3)
No initial dosage adjustment required in the elderly, in patients with
mild to severe renal or hepatic impairment. (2.4,
12.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 150 mg, 300 mg (3) (3)
CONTRAINDICATIONS
None (4) (4)
WARNINGS AND PRECAUTIONS
Avoid neonatal/fetal exposure (5.1)
Head and neck angioedema. Discontinue use of Tekturna and monitor
until signs and symptoms resolve (5.2)
Hypotension in volume and/or salt depleted patients: Correct
imbalances before initiating therapy with Tekturna (5.3)
Patients with severe renal dysfunction: Consider pe