Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ALISKIREN HEMIFUMARATE (UNII: C8A0P8G029) (ALISKIREN - UNII:502FWN4Q32)
Par Pharmaceutical, Inc.
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
ALISKIREN- ALISKIREN TABLET, FILM COATED PAR PHARMACEUTICAL, INC. ---------- 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 Přečtěte si celý dokument