Unoprostone: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{AJ}}
|authorTag=
|genericName=Unoprostone Isopropyl
 
|aOrAn=a
{{VP}}
|drugClass=[[antiglaucoma]], [[prostaglandin]] and [[ophthalmologic]] agent
 
|indicationType=treatment
<!--Overview-->
|indication=for lowering of [[intraocular pressure]] in patients with [[open-angle glaucoma]] or [[ocular hypertension]]
 
|adverseReactions=increased hair growth of eyelash, [[abnormal vision]], burning sensation in eye, [[Eyelid disease|disorder of eyelid]], [[Lacrimal apparatus disease|disorder of lacrimal system]], [[xerostomia|dry eyes]], [[hyperemia]] of surface of eye and itching of eye
|genericName=
|blackBoxWarningTitle=Title
 
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
Unoprostone
 
|aOrAn=
 
a
 
|drugClass=
 
 
 
|indication=
 
open-angle [[glaucoma]] or [[ocular hypertension]]
 
|hasBlackBoxWarning=
 
|adverseReactions=
 
burning/stinging, burning/stinging upon drug instillation, dry eyes, itching, increased length of eyelashes and injection
 
<!--Black Box Warning-->
 
|blackBoxWarningTitle=
Title
 
|blackBoxWarningBody=
<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
* Content
Line 15: Line 41:


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult=====Open-Angle Glaucoma=====


* Unoprostone Isopropyl [[ophthalmic]] solution 0.15% is indicated for the lowering of [[intraocular pressure]] in patients with [[open-angle glaucoma]] or [[ocular hypertension]].
|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.
*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.
*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.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--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)-->
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
|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-->
<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
|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)-->
<!--Off-Label Use and Dosage (Pediatric)-->


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
|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)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
|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-->
|contraindications=* Rescula is contraindicated in patients with [[hypersensitivity]] to unoprostone isopropyl or any other ingredient in this product.
 
|contraindications=
 
* Rescula is contraindicated in patients with [[hypersensitivity]] to unoprostone isopropyl or any other ingredient in this product.


<!--Warnings-->
<!--Warnings-->
|FDAPregCat=C
|drugBox={{Drugbox
| Verifiedfields = changed
| Watchedfields = changed
| verifiedrevid = 409092026
| IUPAC_name = (''Z'')-7-[(1''R'',2''R'',3''R'',5''S'')-3,5-dihydroxy-2-(3-oxodecyl)<br>cyclopentyl]hept-5-enoic acid
| image = Unoprostone.png


<!--Clinical data-->
|warnings=
| tradename =
 
| Drugs.com = {{drugs.com|CONS|unoprostone}}
* Description
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
 
| pregnancy_US = <!-- A / B            / C / D / X -->
====Precautions====
| pregnancy_category =
 
| legal_AU = <!-- Unscheduled / S2 / S3 / S4 / S5 / S6 / S7 / S8 / S9 -->
* Description
| legal_CA = <!--             / Schedule I, II, III, IV, V, VI, VII, VIII -->
 
| legal_UK = <!-- GSL        / P      / POM / CD / Class A, B, C -->
<!--Adverse Reactions-->
| legal_US = <!-- OTC                  / Rx-only  / Schedule I, II, III, IV, V -->
 
| legal_status =
<!--Clinical Trials Experience-->
| routes_of_administration = Topical ([[eye drop]]s)
 
|clinicalTrials=
 
There is limited information regarding <i>Clinical Trial 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=====
 
 
 
<!--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=====


<!--Pharmacokinetic data-->
| bioavailability = 
| protein_bound = 
| metabolism = 
| elimination_half-life = 
| excretion = 


<!--Identifiers-->
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 120373-36-6
| CAS_supplemental = {{CAS|120373-24-2}}
| ATC_prefix = S01
| ATC_suffix = EE02
| PubChem = 5311236
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = 
| UNII_Ref = {{fdacite|changed|FDA}}
| UNII = 6X4F561V3W
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D08661
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 1201407
|  ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = 4470755
|  smiles = O=C(O)CCC/C=C\C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1CCC(=O)CCCCCCC
|  InChI = 1/C22H38O5/c1-2-3-4-5-8-11-17(23)14-15-19-18(20(24)16-21(19)25)12-9-6-7-10-13-22(26)27/h6,9,18-21,24-25H,2-5,7-8,10-16H2,1H3,(H,26,27)/b9-6-/t18-,19-,20+,21-/m1/s1
|  InChIKey = TVHAZVBUYQMHBC-SNHXEXRGBX
|  StdInChI_Ref = {{stdinchicite|changed|chemspider}}
| StdInChI = 1S/C22H38O5/c1-2-3-4-5-8-11-17(23)14-15-19-18(20(24)16-21(19)25)12-9-6-7-10-13-22(26)27/h6,9,18-21,24-25H,2-5,7-8,10-16H2,1H3,(H,26,27)/b9-6-/t18-,19-,20+,21-/m1/s1
|  StdInChIKey_Ref = {{stdinchicite|changed|chemspider}}
| StdInChIKey = TVHAZVBUYQMHBC-SNHXEXRGSA-N


<!--Chemical data-->
=====Musculoskeletal=====
| C=22 | H=38 | O=5
 
| molecular_weight = 382.534 g/mol
 
 
=====Neurologic=====
 
 
 
=====Respiratory=====
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
=====Special Senses=====
 
 
 
=====Urogenital=====
 
 
 
=====Miscellaneous=====
 
 
 
<!--Drug Interactions-->
 
|drugInteractions=
 
* Drug
:* Description
 
<!--Use in Specific Populations-->
 
|useInPregnancyFDA=
* '''Pregnancy Category'''
 
|useInPregnancyAUS=
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
 
|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
 
|useInNursing=
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
 
|useInPed=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
 
|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
 
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
 
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
 
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
 
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
 
|useInReproPotential=
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-->
 
<!--Drug box 2-->
 
|drugBox=
 
 
 
<!--Mechanism of Action-->
 
|mechAction=
 
*
 
<!--Structure-->
 
|structure=
 
*
 
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Pharmacodynamics-->
 
|PD=
 
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
 
|PK=
 
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
<!--Nonclinical Toxicology-->
 
|nonClinToxic=
 
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
 
<!--Clinical Studies-->
 
|clinicalStudies=
 
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
<!--How Supplied-->
 
|howSupplied=
 
*
 
<!--Patient Counseling Information-->
 
|fdaPatientInfo=
 
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
 
<!--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-->
 
|brandNames=
 
* ®<ref>{{Cite web | title =  | url =  }}</ref>
 
<!--Look-Alike Drug Names-->
 
|lookAlike=
 
* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
 
<!--Drug Shortage Status-->
 
|drugShortage=
}}
}}
|alcohol=Alcohol-Unoprostone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
<!--Pill Image-->
 
{{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=
}}
}}
<!--Label Display Image-->
{{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-->
[[Category:Drug]]

Revision as of 16:09, 30 March 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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