ALISKIREN tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Par Pharmaceutical, Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Aliskiren tablets are indicated for the treatment of hypertension in adults 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 aliskiren tablets. 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 antihyperten

leaflet_short:

Aliskiren tablets are supplied as a pink colored, film-coated, biconvex round tablet containing 150 mg of aliskiren. Tablet is debossed with “E” on one side and “590” on the other side. Aliskiren tablets are supplied as a brown colored, film-coated, ovaloid shaped biconvex tablet containing 300 mg of aliskiren. Tablet is debossed with “E” on one side and “591” on the other side. All strengths are packaged in bottles as described below. 150 mg tablets: Bottles of 30 (NDC 49884-424-11) 300 mg tablets: Bottles of 30 (NDC 49884-425-11) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in original container.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

ALISKIREN- ALISKIREN TABLET, FILM COATED
PAR PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALISKIREN TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ALISKIREN TABLETS.
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 ALISKIREN TABLETS 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
None.
INDICATIONS AND USAGE
Aliskiren tablets are a renin inhibitor (RI) indicated for:
The treatment of hypertension in adults 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
Adult 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, 2.4)
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 Head and Neck 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 PAR PHARMACEUTICAL AT
1-800-828-9393 OR F