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RHOPRESSA(netarsudil ophthalmic solution) 0.02%, for topical ophthalmic (一)
2018-06-21 08:19:51 来源: 作者: 【 】 浏览:3694次 评论:0
HIGHLIGHTS OF PRESCRIBING INFORMATION 
 
These highlights do not include all the information needed to use RHOPRESSA® safely and effectively. See full prescribing information for RHOPRESSA®. 
RHOPRESSA® (netarsudil ophthalmic solution) 0.02%, for topical ophthalmic use 
Initial U.S. Approval:  2017
 
INDICATIONS AND USAGE 
 
RHOPRESSA® (netarsudil ophthalmic solution) 0.02% is a Rho kinase inhibitor indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. (1) 
 
DOSAGE AND ADMINISTRATION 
 
One drop into the affected eye(s) once daily in the evening. (2) 
 
DOSAGE FORMS AND STRENGTHS 
 
Ophthalmic solution containing 0.2 mg/mL of netarsudil. (3) 
 
CONTRAINDICATIONS 
 
None. (4) 
 
ADVERSE REACTIONS 
 
The most common adverse reaction is conjunctival hyperemia (53%). Other common adverse reactions, approximately 20% include: corneal verticillata, instillation site pain, and conjunctival hemorrhage. (6.1) 
To report SUSPECTED ADVERSE REACTIONS, contact Aerie Pharmaceuticals, Inc. at 1‑855‑740-1924, or FDA at 
1-800-FDA-1088 or www.fda.gov/medwatch. 
 
See 17 for PATIENT COUNSELING INFORMATION.
 
Revised: 12/2017
 
FULL PRESCRIBING INFORMATION: CONTENTS* 
 
1 INDICATIONS AND USAGE  
 
2 DOSAGE AND ADMINISTRATION  
 
3 DOSAGE FORMS AND STRENGTHS  
 
4 CONTRAINDICATIONS  
 
5 WARNINGS AND PRECAUTIONS  
 
5.1 Bacterial Keratitis  
 
5.2 Use with Contact Lenses  
 
6 ADVERSE REACTIONS  
 
6.1 Clinical Trials Experience  
 
8 USE IN SPECIFIC POPULATIONS  
 
8.1 Pregnancy  
 
8.2 Lactation  
 
8.4 Pediatric Use  
 
8.5 Geriatric Use  
 
11 DESCRIPTION  
 
12 CLINICAL PHARMACOLOGY  
 
12.1 Mechanism of Action  
 
12.3 Pharmacokinetics  
 
13 NONCLINICAL TOXICOLOGY  
 
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility  
 
14 CLINICAL STUDIES  
 
16 HOW SUPPLIED/STORAGE AND HANDLING  
 
17 PATIENT COUNSELING INFORMATION  
* Sections or subsections omitted from the full prescribing information are not listed.  
1 INDICATIONS AND USAGE 
 
RHOPRESSA (netarsudil ophthalmic solution) 0.02% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
 
2 DOSAGE AND ADMINISTRATION 
 
The recommended dosage is one drop in the affected eye(s) once daily in the evening.
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