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{{Drugbox
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| IUPAC_name        = (''Z'')-7-[(1''R'',2''R'',3''R'',5''S'')-3,5-dihydroxy-2-(3-oxodecyl)<br>cyclopentyl]hept-5-enoic acid
|authorTag=
| image            = Unoprostone.svg
 
| CAS_number        = 120373-36-6
{{VP}}
| CAS_supplemental  = {{CAS|120373-24-2}} ([[isopropyl]])
 
| ATC_prefix        = S01
<!--Overview-->
| ATC_suffix        = EE02
 
| PubChem          = 5311236
|genericName=
| DrugBank          =  
 
| C=22|H=38|O=5
Unoprostone
| molecular_weight  = 382.534 g/mol
 
| bioavailability  =  
|aOrAn=
| protein_bound    =  
 
| metabolism        =  
a
| elimination_half-life =  
 
| excretion        =  
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| pregnancy_AU      = <!-- A / B1 / B2 / B3 / C / D / X -->
 
| pregnancy_US      = <!-- A / B            / C / D / X -->
 
| pregnancy_category=
 
| legal_AU          = <!-- Unscheduled / S2 / S3 / S4 / S5 / S6 / S7 / S8 / S9 -->
|indication=
| legal_CA          = <!--             / Schedule I, II, III, IV, V, VI, VII, VIII -->
 
| legal_UK          = <!-- GSL        / P      / POM / CD / Class A, B, C -->
open-angle [[glaucoma]] or [[ocular hypertension]]
| legal_US          =  <!-- OTC                  / Rx-only / Schedule I, II, III, IV, V -->
 
| legal_status      =
|hasBlackBoxWarning=
| routes_of_administration = Topical ([[eye drop]]s)
 
|adverseReactions=
 
burning/stinging, burning/stinging upon drug instillation, dry eyes, itching, increased length of eyelashes and injection
 
<!--Black Box Warning-->
 
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Title
 
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<i><span style="color:#FF0000;">ConditionName: </span></i>
 
* Content
 
<!--Adult Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Adult)-->
 
|fdaLIADAdult=
 
=====Open-Angle Glaucoma======
 
*Rescula (unoprostone isopropyl ophthalmic solution) 0.15% is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
 
*The recommended dosage is one drop in the affected eye(s) twice daily.
 
*Rescula may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If two drugs are used, they should be administered at least five (5) minutes apart.
 
<!--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.
 
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|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)-->
 
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=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
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<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
 
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=====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)-->
 
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=====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=
 
* Rescula is contraindicated in patients with [[hypersensitivity]] to unoprostone isopropyl or any other ingredient in this product.
 
<!--Warnings-->
 
|warnings=
 
* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
 
|clinicalTrials=
 
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=====Respiratory=====
 
 
 
 
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=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
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=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
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}}
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{{SI}}


<!--Pill Image-->


'''Unoprostone''' ([[International Nonproprietary Name|INN]]) is a [[prostaglandin analogue]]. Its [[isopropyl]] [[ester]], '''unoprostone isopropyl''', is marketed under the trade name '''Rescula''' for the management of [[glaucoma|open-angle glaucoma]] and [[ocular hypertension]].
{{PillImage
|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=
}}


{{Antiglaucoma preparations and miotics}}
<!--Label Display Image-->


[[Category:Prostaglandins]]
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


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


<!--Category-->


{{WikiDoc Help Menu}}
[[Category:Drug]]
{{WikiDoc Sources}}

Revision as of 20:38, 23 February 2015

Unoprostone
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

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Unoprostone is a that is FDA approved for the {{{indicationType}}} of open-angle glaucoma or ocular hypertension. Common adverse reactions include burning/stinging, burning/stinging upon drug instillation, dry eyes, itching, increased length of eyelashes and injection.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Open-Angle Glaucoma=
  • Rescula (unoprostone isopropyl ophthalmic solution) 0.15% is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
  • The recommended dosage is one drop in the affected eye(s) twice daily.
  • Rescula may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If two drugs are used, they should be administered at least five (5) minutes apart.

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 Unoprostone in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Rescula is contraindicated in patients with hypersensitivity to unoprostone isopropyl or any other ingredient in this product.

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Unoprostone01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Unoprostone 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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