Aliskiren: Difference between revisions

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Revision as of 19:37, 2 July 2014

Aliskiren
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

Disclaimer

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Black Box Warning

WARNING: FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
* When pregnancy is detected, discontinue Tekturna as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Overview

Aliskiren is a renin inhibitor that is FDA approved for the {{{indicationType}}} of hypertension. There is a Black Box Warning for this drug as shown here. Common adverse reactions include diarrhea, dizziness, headache, and elevated serum creatinine.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hypertension
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Aliskiren in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Aliskiren in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Aliskiren in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Aliskiren in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Aliskiren in pediatric patients.

Contraindications

  • Condition1

Warnings

WARNING: FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
* When pregnancy is detected, discontinue Tekturna as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Aliskiren in the drug label.

Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Aliskiren in the drug label.

Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Aliskiren in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Aliskiren during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Aliskiren with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Aliskiren with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Aliskiren with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Aliskiren with respect to specific gender populations.

Race

There is no FDA guidance on the use of Aliskiren with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Aliskiren in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Aliskiren in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Aliskiren in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Aliskiren in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Aliskiren in the drug label.

Condition1

Description

IV Compatibility

There is limited information regarding IV Compatibility of Aliskiren in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Aliskiren in the drug label.

Pharmacology

There is limited information regarding Aliskiren Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Aliskiren Mechanism of Action in the drug label.

Structure

There is limited information regarding Structure of Aliskiren in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Aliskiren in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Aliskiren in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Aliskiren in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Aliskiren in the drug label.

Condition1

Description

How Supplied

There is limited information regarding Aliskiren How Supplied in the drug label.

Storage

There is limited information regarding Aliskiren Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Aliskiren |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Aliskiren in the drug label.

Precautions with Alcohol

Alcohol-Aliskiren interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Tekturna®[1]

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "TEKTURNA (aliskiren hemifumarate) tablet, film coated [Novartis Pharmaceuticals Corporation]".
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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