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{{drugbox
{{DrugProjectFormSinglePage
| IUPAC_name = 2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxy-ethyl]-acetamide
|authorTag=
| image = Midodrine.png
 
| width=205
Gerald Chi
| CAS_number = 133163-28-7
 
| ATC_prefix = C01
<!--Overview-->
| ATC_suffix = CA17
 
| ATC_supplemental =  
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| PubChem = 4195
 
| DrugBank = APRD01116
 
| C=12 | H=18 | N=2 | O=4
 
| molecular_weight = 254.282 g/mol
|aOrAn=
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| protein_bound =  
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* ®<ref>{{Cite web | title =  | url =  }}</ref>
 
<!--Look-Alike Drug Names-->


==Overview==
|lookAlike=
'''Midodrine''' (brand names '''Amatine''', '''ProAmatine''', '''Gutron''') is a [[vasopressor]]/[[antihypotensive]] agent.  Midodrine was approved in the United States by the [[Food and Drug Administration]] (FDA) in 1996 for the treatment of [[dysautonomia]] and [[orthostatic hypotension]].  In August 2010, the FDA proposed withdrawing this approval because the manufacturer, [[Shire plc]], has failed to complete required studies after the medicine reached the market.<ref>[http://uk.reuters.com/article/idUKTRE67F3SE20100816 U.S. proposes withdrawal of Shire hypotension drug], Aug 16, 2010.</ref><ref>{{cite web|last=O'Riordan|first=Michael|title=FDA recommends withdrawal of midodrine|url=http://www.theheart.org/article/1110411.do|work=Food and Drug Administration. FDA proposes withdrawal of low blood pressure drug [press release]. August 16, 2010.|publisher=TheHeart.org|accessdate=1 April 2011}}.</ref>


In September 2010, the FDA reversed its decision to remove Midodrine from the market and has allowed it to remain available to patients while Shire plc collects further data regarding the efficacy and safety of the drug.<ref>[http://healthcare.utah.edu/pharmacy/alerts/497.htm Midodrine (ProAmatine, generic) Proposed Market Withdrawal – Update] September 10, 2010.</ref> Shire plc announced on September 27, 2011 that it was continuing the process to work with the FDA towards a final approval of the drug.<ref>[http://www.sacbee.com/2011/09/22/3930671/shire-provides-update-on-proamatine.html Shire Announces Update on ProAmatime] September 27, 2011.</ref>
* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


==Chemical properties==
<!--Drug Shortage Status-->
Midodrine is an odorless, white, crystalline powder, soluble in water and sparingly soluble in [[methanol]].


==Mechanism of action==
|drugShortage=
Midodrine is a [[prodrug]] which forms an active [[metabolite]], desglymidodrine, which is an [[Alpha-1 adrenergic receptor|α<sub>1</sub>-receptor]] [[agonist]] and exerts its actions via activation of the [[alpha-adrenergic receptor]]s of the arteriolar and venous vasculature, producing an increase in vascular tone and elevation of blood pressure. Desglymidodrine does not stimulate cardiac [[beta-adrenergic receptor]]s. Desglymidodrine diffuses poorly across the [[blood–brain barrier]], and is therefore not associated with effects on the [[central nervous system]]. 
}}


==Metabolism==
<!--Pill Image-->
After oral administration, midodrine is rapidly absorbed. The plasma levels of the prodrug peak after about half an hour, and decline with a half-life of approximately 25 minutes, while the metabolite reaches peak blood concentrations about 1 to 2 hours after a dose of midodrine and has a half-life of about 3 to 4 hours. The absolute bioavailability of midodrine (measured as desglymidodrine) is 93%.


==Indications==
{{PillImage
Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension. In a critical care setting, it is widely used as an adjunctive therapy to weaning patients off of intravenous vasopressive medications. It has been suggested also as a treatment for [[chronic fatigue syndrome]]<ref name="pmid15082846">{{cite journal |author=Naschitz J, Dreyfuss D, Yeshurun D, Rosner I |title=Midodrine treatment for chronic fatigue syndrome |journal=Postgrad Med J |volume=80 |issue=942 |pages=230–2 |date=April 2004 |pmid=15082846 |doi= 10.1136/pgmj.2003.011429|url=http://pmj.bmj.com/cgi/pmidlookup?view=long&pmid=15082846 |pmc=1742969}}</ref> as well as for hepato-pulmonary syndrome. It is also used with [[octreotide]] for [[hepatorenal syndrome]]; the proposed mechanism is constriction of splanchnic vessels and dilation of renal vasculature.
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
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|drugAuthor=
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|dosageUnit=
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==Contraindications==
<!--Label Display Image-->
Midodrine is contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. Midodrine should not be used in patients with persistent and excessive supine hypertension.


==Side effects==
{{LabelImage
Headache; feeling of pressure/fullness in the head, vasodilation/flushing face, confusion/thinking abnormality, dry mouth; nervousness/anxiety and rash.
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


==References==
{{LabelImage
{{Reflist|2}}
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


==External links==
<!--Category-->
* [http://www.drugs.com/pro/midodrine.html Midodrine] at drugs.com


[[Category:Cardiovascular Drugs]]
[[Category:Cardiovascular Drugs]]
[[Category:Drug]]
[[Category:Drug]]

Revision as of 18:12, 24 July 2014

Midodrine
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

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

Overview

Midodrine 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 Midodrine in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Midodrine 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 Midodrine 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 Midodrine 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 Midodrine in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

Condition1
  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Midodrine 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 Midodrine in the drug label.

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Midodrine 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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