TEKTURNA aliskiren hemifumarate tablet film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Novartis Pharmaceuticals Corporation

INN (Tên quốc tế):

ALISKIREN HEMIFUMARATE

Thành phần:

ALISKIREN 150 mg

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

TEKTURNA- ALISKIREN HEMIFUMARATE 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 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
PHAR