Niacin (tablet): Difference between revisions

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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult===Indications==


* Dosing Information
* Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.


:* Dosage
* NIASPAN is indicated to reduce elevated [[TC]], [[LDL-C]], [[Apo B]] and [[TG]] levels, and to increase HDL-C in patients with primary [[hyperlipidemia]] and mixed [[dyslipidemia]].


=====Condition2=====
* NIASPAN in combination with simvastatin or lovastatin is indicated for the treatment of primary [[hyperlipidemia]] and mixed [[dyslipidemia]] when treatment with NIASPAN, simvastatin, or lovastatin monotherapy is considered inadequate.


* Dosing Information
* In patients with a history of [[myocardial infarction]] and [[hyperlipidemia]], niacin is indicated to reduce the risk of recurrent nonfatal [[myocardial infarction]].


:* Dosage
* In patients with a history of [[coronary artery disease]] ([[CAD]]) and [[hyperlipidemia]], niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of [[atherosclerotic disease]].


=====Condition3=====
* NIASPAN in combination with a bile acid binding resin is indicated to reduce elevated [[TC]] and LDL-C levels in adult patients with primary [[hyperlipidemia]].


* Dosing Information
* Niacin is also indicated as adjunctive therapy for treatment of adult patients with severe [[hypertriglyceridemia]] who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====


Revision as of 17:54, 4 May 2015

Niacin (tablet)
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: Kiran Singh, M.D. [2]

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Overview

Niacin (tablet) is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
  • NIASPAN in combination with simvastatin or lovastatin is indicated for the treatment of primary hyperlipidemia and mixed dyslipidemia when treatment with NIASPAN, simvastatin, or lovastatin monotherapy is considered inadequate.
  • NIASPAN in combination with a bile acid binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.
  • Niacin is also indicated as adjunctive therapy for treatment of adult patients with severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.

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 Niacin (tablet) in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Niacin (tablet) 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 Niacin (tablet) 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 Niacin (tablet) in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Niacin (tablet) in pediatric patients.

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Niacin (tablet) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Niacin (tablet) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
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 Niacin (tablet) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Niacin (tablet) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Niacin (tablet) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Niacin (tablet) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Niacin (tablet) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Niacin (tablet) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Niacin (tablet) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Niacin (tablet) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Niacin (tablet) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Niacin (tablet) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Niacin (tablet) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Niacin (tablet) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Niacin (tablet) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Niacin (tablet) in the drug label.

Pharmacology

There is limited information regarding Niacin (tablet) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Niacin (tablet)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Niacin (tablet) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Niacin (tablet) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Niacin (tablet) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Niacin (tablet) in the drug label.

How Supplied

Storage

There is limited information regarding Niacin (tablet) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Niacin (tablet) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Niacin (tablet) in the drug label.

Precautions with Alcohol

  • Alcohol-Niacin (tablet) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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