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{{DrugProjectFormSinglePage
|authorTag=


{{VP}}


{{drugbox
<!--Overview-->
| IUPAC_name = ''S''(+)2-ethoxy-4(2((3-methyl-1-(2-(1-piperidinyl) phenyl)-butyl) amino)-2-oxoethyl) benzoic acid
 
| image = Repaglinide.svg
|genericName=
| CAS_number = 135062-02-1
 
| ATC_prefix = A10
Repaglinide
| ATC_suffix = BX02
 
| PubChem = 65981
|aOrAn=
| DrugBank = APRD00439
 
| C = 27 | H = 36 | N = 2 | O = 4
a
| molecular_weight = 452.586 g/mol
 
| bioavailability = 56% (oral)
|drugClass=
| protein_bound = >98%
 
| metabolism = [[Liver|Hepatic]] oxidation and [[glucuronidation]] ([[CYP3A4]]-mediated)
 
| elimination_half-life = 1 hour
 
| excretion = Fecal (90%) and [[Kidney|renal]] (8%)
|indication=
| licence_EU = Novonorm
 
| licence_US = Prandin
 
| pregnancy_category = C <small> ([[Australia|AU]], [[United States|US]])</small>
 
| legal_UK = POM
|hasBlackBoxWarning=
| legal_US = Rx-only
 
| routes_of_administration = Oral
Yes
}}
 
{{SI}}
|adverseReactions=
For patient information, click [[Repaglinide (patient information)|here]]
 
 
 
<!--Black Box Warning-->
 
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Title
 
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* Content
 
<!--Adult Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Adult)-->
 
|fdaLIADAdult=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
 
|offLabelAdultGuideSupport=
 
=====Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
|fdaLIADPed=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
 
|offLabelPedGuideSupport=
 
=====Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
 
|offLabelPedNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
 
|contraindications=
 
* Condition1
 
<!--Warnings-->
 
|warnings=
 
* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
 
|clinicalTrials=
 
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=====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-->
 
|postmarketing=
 
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} 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=====
 
 
 
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* Drug
:* Description
 
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|useInPregnancyFDA=
* '''Pregnancy Category'''
 
|useInPregnancyAUS=
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
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|useInRace=
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There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
 
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
 
|administration=
 
* Oral
 
* Intravenous
 
|monitoring=
 
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
* Description
 
<!--IV Compatibility-->
 
|IVCompat=
 
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
 
|overdose=
 
===Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
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*
 
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|structure=
 
*
 
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Pharmacodynamics-->
 
|PD=
 
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<!--Pharmacokinetics-->
 
|PK=
 
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
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<!--Precautions with Alcohol-->
 
|alcohol=
 
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
<!--Brand Names-->


'''Repaglinide''' ('''Prandin®''' in the [[United States|U.S.]], '''GlucoNorm''' in [[Canada]], '''NovoNorm''' elsewhere) is a for the treatment of [[type II diabetes]]. It is supplied by [[Novo Nordisk]].
|brandNames=


Repaglinide belongs to the [[meglitinide]] class of blood glucose-lowering drugs.
* ®<ref>{{Cite web | title =  | url =  }}</ref>


==Pharmacology==
<!--Look-Alike Drug Names-->


Repaglinide lowers blood glucose by stimulating the release of [[insulin]] from the [[pancreas]]. It achieves this by closing [[Adenosine triphosphate|ATP]]-dependent [[potassium channels]] in the membrane of the [[beta cells]]. This depolarizes the beta cells, opening the cells' [[calcium channels]], and the resulting calcium influx induces insulin secretion.
|lookAlike=


==Dosage==
* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
Repaglinide is delivered in tablet form.


==History==
<!--Drug Shortage Status-->
Precursor drugs to repaglinide were invented in late 1983 by scientists at Dr Karl Thomae GmbH, a German drug manufacturer located at Biberach an der Riß in southern Germany which was acquired by [[Boehringer Ingelheim]] in 1990. The drug that became repaglinide was later licensed by Boehringer to Novo Nordisk, which filed an [[Investigational New Drug]] application for the compound with the [[Food and Drug Administration]] (FDA) in April 1992. Novo Nordisk filed its [[New Drug Application]] (NDA) for Prandin in July 1997 and it was quickly approved, gaining FDA approval in December 1997. The drug was the first of the meglitinide class. It was branded ''Prandin'' because its quick onset and short duration of action concentrates its effect around meal time (the ''prandium'' was the Roman meal which is comparable to the modern lunch).


==Intellectual property==
|drugShortage=
After several attempts to file for U.S. [[patent]] protection, a filing was made in March 1990 which eventually became U.S. Patents 5,216,167 (June 1993), 5,312,924 (May 1994) and 6,143,769 (November 2000). After filing its NDA for repaglinide in 1997, Novo Nordisk applied for patent extension under the Hatch-Waxman Act. This process, called ''patent term restoration'', allows drug patents to be extended based on the time that a drug spent in clinical trials and in the approval process. Previously it had been decided by the U.S. Patent and Trademark Office that the expiration date of U.S. Patents 5,216,167 and 5,312,924 would be 5 September 2006. In February 2001 Prandin's patent life was extended to 14 March 2009 in response to Novo Nordisk's patent term restoration application, with U.S. Patent 5,216,167 having been reissued as RE37035.
}}


==Generic status==
<!--Pill Image-->
As per the above paragraph, repaglinide will not become available as a [[generic drug]] in the United States before March 2009.


==Supply==
{{PillImage
Repaglinide is available in 0.5 mg, 1 mg and 2 mg tablets.
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
|drugName=
|NDC=
|drugAuthor=
|ingredients=
|pillImprint=
|dosageValue=
|dosageUnit=
|pillColor=
|pillShape=
|pillSize=
|pillScore=
}}


==Drug interactions==
<!--Label Display Image-->
Repaglinide should not be administered concomitantly with [[gemfibrozil]], [[clarithromycin]] or [[azole]] [[antifungal]]s such as [[itraconazole]] or [[ketoconazole]]. Administration of both repaglinide and one or more of these drugs results in an increase in plasma concentration of repaglinide and may lead to [[hypoglycemia]].


==External links==
{{LabelImage
*[http://www.prandin.com Prandin® Repaglinide Tablets (manufacturer's website)]
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
*[http://www.fda.gov/cder/foi/label/2005/20741s022lbl.pdf Prandin's label]
}}
*[http://patimg1.uspto.gov/.piw?Docid=RE037035&homeurl=http%3A%2F%2Fpatft.uspto.gov%2Fnetacgi%2Fnph-Parser%3FSect1%3DPTO2%2526Sect2%3DHITOFF%2526u%3D%2Fnetahtml%2Fsearch-adv.htm%2526r%3D1%2526p%3D1%2526f%3DG%2526l%3D50%2526d%3Dptxt%2526S1%3DRE37035.WKU.%2526OS%3Dpn%2FRE37035%2526RS%3DPN%2FRE37035&PageNum=&Rtype=&SectionNum=&idkey=D352419F1A91 RE37035, the reissued U.S. Patent 5,216,167]
*[http://patimg1.uspto.gov/.piw?Docid=05312924&homeurl=http%3A%2F%2Fpatft.uspto.gov%2Fnetacgi%2Fnph-Parser%3FSect1%3DPTO2%2526Sect2%3DHITOFF%2526u%3D%2Fnetahtml%2Fsearch-adv.htm%2526r%3D1%2526p%3D1%2526f%3DG%2526l%3D50%2526d%3Dptxt%2526S1%3D5,312,924.WKU.%2526OS%3Dpn%2F5,312,924%2526RS%3DPN%2F5,312,924&PageNum=&Rtype=&SectionNum=&idkey=78F2DB31DFC3 U.S. Patent 5,312,924]
*[http://patimg2.uspto.gov/.piw?Docid=06143769&homeurl=http%3A%2F%2Fpatft.uspto.gov%2Fnetacgi%2Fnph-Parser%3FSect1%3DPTO2%2526Sect2%3DHITOFF%2526u%3D%2Fnetahtml%2Fsearch-adv.htm%2526r%3D1%2526p%3D1%2526f%3DG%2526l%3D50%2526d%3Dptxt%2526S1%3D6,143,769.WKU.%2526OS%3Dpn%2F6,143,769%2526RS%3DPN%2F6,143,769&PageNum=&Rtype=&SectionNum=&idkey=70E08B986900 U.S. Patent 6,143,769]
*[http://patimg2.uspto.gov/.piw?Docid=06677358&homeurl=http%3A%2F%2Fpatft.uspto.gov%2Fnetacgi%2Fnph-Parser%3FSect1%3DPTO2%2526Sect2%3DHITOFF%2526u%3D%2Fnetahtml%2Fsearch-adv.htm%2526r%3D1%2526p%3D1%2526f%3DG%2526l%3D50%2526d%3Dptxt%2526S1%3D6,677,358.WKU.%2526OS%3Dpn%2F6,677,358%2526RS%3DPN%2F6,677,358&PageNum=&Rtype=&SectionNum=&idkey=FFC461309CD5 U.S. Patent 6,677,358]


{{Oral_hypoglycemics}}
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


[[Category:Pharmaceutical industry]]
<!--Category-->
[[Category:Meglitinides]]
[[Category:Endocrinology]]


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Revision as of 20:43, 11 November 2014

Repaglinide
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: Vignesh Ponnusamy, M.B.B.S. [2]

Disclaimer

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Repaglinide is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • 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 Repaglinide in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Repaglinide 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 Repaglinide 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 Repaglinide in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

{{#ask: Page Name::Repaglinide |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Repaglinide 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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