ALISKIREN- aliskiren hemifumarate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Prasco Laboratories

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Aliskiren is indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age and older 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. 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,

Product summary:

Aliskiren tablets are 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 mg and 300 mg tablets, respectively. All strengths are packaged in bottles as described below in Table 7. Store at 20°C to 25ºC (68°F to 77ºF); excursions permitted to 15ºC to 30ºC (59 ºF to 86ºF) [See USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

ALISKIREN- ALISKIREN HEMIFUMARATE TABLET, FILM COATED
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALISKIREN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALISKIREN.
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 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)
INDICATIONS AND USAGE
Aliskiren is a renin inhibitor (RI) indicated for the treatment of
hypertension in adults and in pediatric
patients weighing 50 kg or greater who are at least 6 years of age, to
lower blood pressure. Lowering blood
pressure reduces the risk of fatal and nonfatal cardiovascular events,
primarily strokes and myocardial
infarctions. (1.1)
DOSAGE AND ADMINISTRATION
Starting dose (adults and pediatric patients): 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)
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)
Aliskiren is contraindicated in pediatric patients less than 2 years
of age. (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