Unoprostone
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):
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
- Ophthalmic
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
There is limited information regarding Unoprostone Pharmacology in the drug label.
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.