Unoprostone

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: Adeel Jamil, M.D. [2]

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Overview

Unoprostone is a antiglaucoma, prostaglandin and ophthalmologic agent that is FDA approved for the treatment of for lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Common adverse reactions include increased hair growth of eyelash, abnormal vision, burning sensation in eye, disorder of eyelid, disorder of lacrimal system, dry eyes, hyperemia of surface of eye and itching of eye.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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.

• 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

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

Non–Guideline-Supported Use

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)

There is limited information regarding FDA-Labeled Use of Unoprostone in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

There is limited information regarding Unoprostone Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Unoprostone Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Unoprostone Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Unoprostone Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C There is no FDA guidance on usage of Unoprostone in women who are pregnant.
Pregnancy Category (AUS): 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 in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Unoprostone in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Unoprostone in geriatric settings.

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

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

Monitoring

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

IV Compatibility

There is limited information regarding the compatibility of Unoprostone and IV administrations.

Overdosage

There is limited information regarding Unoprostone overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Unoprostone

Clinical data
AHFS/Drugs.com	Micromedex Detailed Consumer Information
Routes of administration	Topical (eye drops)
ATC code	S01EE02 (WHO)
Identifiers
IUPAC name (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-(3-oxodecyl) cyclopentyl]hept-5-enoic acid
CAS Number	120373-36-6 Y 120373-24-2
PubChem CID	5311236
ChemSpider	4470755 N
UNII	6X4F561V3W
KEGG	D08661 Y
ChEMBL	ChEMBL1201407 N
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C22H38O5
Molar mass	382.534 g/mol
3D model (JSmol)	Interactive image
SMILES O=C(O)CCC/C=C\C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1CCC(=O)CCCCCCC
InChI InChI=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 N Key:TVHAZVBUYQMHBC-SNHXEXRGSA-N N
NY (what is this?)  (verify)

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Unoprostone How Supplied in the drug label.

Storage

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

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Unoprostone Patient Counseling Information 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

There is limited information regarding Unoprostone Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Unoprostone Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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