Aliskiren

ALISKIREN- aliskiren hemifumarate tablet, film coated
Prasco Laboratories

WARNING: FETAL TOXICITY

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)

1 INDICATIONS AND USAGE

1.1 Hypertension

Aliskiren is indicated for the treatment of hypertension in adults and children 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, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

2 DOSAGE AND ADMINISTRATION

2.1 Adult Hypertension

The usual recommended starting dose of Aliskiren is 150 mg once daily. In patients whose blood pressure is not adequately controlled, the daily dose may be increased to 300 mg. Doses above 300 mg did not give an increased blood pressure response but resulted in an increased rate of diarrhea. The antihypertensive effect of a given dose is substantially attained (85% to 90%) by 2 weeks.

2.2 Pediatric Hypertension 6 to 17 Years of Age

Aliskiren is contraindicated in children less than 2 years of age [see Contraindications (4)]. Aliskiren should not be used in children aged 2 to less than 6 years of age or in children who weigh less than 20 kg [see Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)]. See Table 1 for recommended dosage in pediatric patients 6 to 17 years of age.

Table 1: Recommended dosage in pediatric patients 6 to 17 years of age
Weight Recommended dosage
Less than 20 kg Aliskiren is not recommended
20 kg to 50 kg The recommended starting dose is 37.5 or 75 mg once daily. The maximum recommended dose is 150 mg
Greater than or equal to 50 kg The recommended dose is the same as in adults.

2.3 Administration of Aliskiren Oral Pellets

For patients unable to swallow tablets, Aliskiren oral pellets can be used.

Aliskiren Oral Pellets are provided in a dispensing capsule. Do not swallow the capsules containing Aliskiren Oral Pellets. Do not empty the contents of the capsule directly into the mouth. Do not chew or crush the contents of the capsule.

Aliskiren Oral Pellets may be taken by opening the dispensing capsule, emptying the contents into a spoon and then administering by mouth, follow with milk (dairy or soy-based) or water immediately without chewing or crushing. Make sure that no pellets remain in the dispensing capsule.

Alternatively, Aliskiren Oral Pellets may be taken by carefully open the dispensing capsule and take the contents orally immediately after mixing with 1 or more teaspoons of vanilla pudding (milk or soy-based), vanilla ice cream (milk or soy- based), milk (dairy or soy-based), or water as a dosing vehicle. Dosing vehicles are limited to those specified. It is recommended that the contents of one dispensing capsule be taken with one teaspoon of dosing vehicle; however, more or less dosing vehicle may be administered, if desired. Do not chew or crush the contents of the capsules.

2.4 Relationship to Meals

Patients should establish a routine pattern for taking Aliskiren with regard to meals. High-fat meals decrease absorption substantially [see Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

150 mg light pink biconvex round tablet, imprinted NVR/IL (Side 1/Side 2).

300 mg light red biconvex ovaloid round tablet, imprinted NVR/IU (Side 1/Side 2).

37.5 mg Aliskiren Oral Pellets in transparent, size-0 capsules.

Each size 0 capsule contains 12 white to yellowish round biconvex pellets. The capsule has red arrows pointing to the top and bottom of the capsule and is imprinted “NVR 12”.

4 CONTRAINDICATIONS

Do not use aliskiren with ARBs or ACEIs in patients with diabetes [see Warnings and Precautions (5.2) and Clinical Studies (14.3)].

Aliskiren is contraindicated in patients with known hypersensitivity to any of the components [see Warnings and Precautions (5.3)].

Aliskiren is contraindicated in pediatric patients less than 2 years of age [see Use in Specific Populations (8.4)] and Nonclinical Toxicology (13.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Fetal Toxicity

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Aliskiren as soon as possible [see Use in Specific Populations (8.1)].

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