Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING RHOPRESSA ® (netarsudil ophthalmic solution) 0.02% (0.2 mg per mL) is supplied sterile in opaque white low density polyethylene bottles and tips with white polypropylene caps. 2.5 mL fill in a 4 mL container NDC # 70727-497-25 Storage: Store at 2°C to 8°C (36°F to 46°F) until opened. After opening, the product may be kept at 2°C to 25°C (36°F to 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C to 8°C (36°F to 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 70727-497-25 rhopressa ® (netarsudil ophthalmic solution) 0.02% For topical application in the eye Sterile Rx only 2.5 mL Alcon Usual dosage: One drop in the affected eye(s) once daily in the evening. Each mL Rhopressa ® ophthalmic solution contains: Active: netarsudil mesylate 0.285 mg Preservative: benzalkonium chloride 0.15 mg Inactives: mannitol, boric acid, sodium hydroxide to adjust pH and water for injection. Manufactured for: ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA U.S. Pat: www.alconpatents.com Store at 2°C - 8°C (36°F - 46°F) until opened. After opening, the product may be kept at 2°C - 25°C (36°F - 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C - 8°C (36°F - 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. 41079 NDC 70727-497-25 For topical application in the eye. rhopressa ® (netarsudil ophthalmic solution) 0.02% Rx only Sterile 2.5 mL Alcon 41077 See carton for storage conditions. Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134 LOT: EXP: NDC 70727-497-99 SAMPLE - Not for Resale rhopressa ® (netarsudil ophthalmic solution) 0.02% For topical application in the eye Sterile Rx only 2.5 mL Alcon Usual dosage: One drop in the affected eye(s) once daily in the evening. Each mL Rhopressa ® ophthalmic solution contains: Active: netarsudil mesylate 0.285 mg Preservative: benzalkonium chloride 0.15 mg Inactives: mannitol, boric acid, sodium hydroxide to adjust pH and water for injection. Manufactured for: ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA U.S. Pat: www.alconpatents.com Store at 2°C - 8°C (36°F - 46°F) until opened. After opening, the product may be kept at 2°C - 25°C (36°F - 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C - 8°C (36°F - 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. 41080 NDC 70727-497-99 SAMPLE - Not for Resale For topical application in the eye. rhopressa ® (netarsudil ophthalmic solution) 0.02% Rx only Sterile 2.5 mL Alcon 41078 See carton for storage conditions. Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134 LOT: EXP: NDC 70727-497-25 rhopressa ® (netarsudil ophthalmic solution) 0.02% For topical application in the eye Sterile Rx only 2.5 mL Alcon Usual dosage: One drop in the affected eye(s) once daily in the evening. Each mL Rhopressa ® ophthalmic solution contains: Active: netarsudil mesylate 0.285 mg Preservative: benzalkonium chloride 0.15 mg Inactives: mannitol, boric acid, sodium hydroxide toadjust pH and water for injection. ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA U.S. Pat: www.alconpatents.com Store at 2°C - 8°C (36°F - 46°F) until opened. After opening, the product may be kept at 2°C - 25°C (36°F - 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C - 8°C (36°F - 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. 300069021-1224 NDC 70727-497-25 For topical application in the eye. rhopressa ® (netarsudil ophthalmic solution) 0.02% Rx only Sterile 2.5 mL Alcon See carton for storage conditions. Alcon Laboratories, Inc. Fort Worth, TX 76134 LOT: EXP.: 300069075 1224 Carton Label; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 70727-497-99 SAMPLE - Not for Resale rhopressa ® (netarsudil ophthalmic solution) 0.02% For topical application in the eye Sterile Rx only 2.5 mL Alcon Usual dosage: One drop in the affected eye(s) once daily in the evening. Each mL Rhopressa ® ophthalmic solution contains: Active: netarsudil mesylate 0.285 mg Preservative: benzalkonium chloride 0.15 mg Inactives: mannitol, boric acid, sodium hydroxide to adjust pH and water for injection. ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA U.S. Pat: www.alconpatents.com Store at 2°C - 8°C (36°F - 46°F) until opened. After opening, the product may be kept at 2°C - 25°C (36°F - 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C - 8°C (36°F - 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. 300069020-1124 NDC 70727-497-99 SAMPLE - Not for Resale For topical application in the eye. rhopressa ® (netarsudil ophthalmic solution) 0.02% Rx only Sterile 2.5 mL Alcon See carton for storage conditions. Alcon Laboratories, Inc. Fort Worth, TX 76134 USA LOT: EXP.: 300069074 1124 Sample Carton Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING RHOPRESSA ® (netarsudil ophthalmic solution) 0.02% (0.2 mg per mL) is supplied sterile in opaque white low density polyethylene bottles and tips with white polypropylene caps. 2.5 mL fill in a 4 mL container NDC # 70727-497-25 Storage: Store at 2°C to 8°C (36°F to 46°F) until opened. After opening, the product may be kept at 2°C to 25°C (36°F to 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C to 8°C (36°F to 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 70727-497-25 rhopressa ® (netarsudil ophthalmic solution) 0.02% For topical application in the eye Sterile Rx only 2.5 mL Alcon Usual dosage: One drop in the affected eye(s) once daily in the evening. Each mL Rhopressa ® ophthalmic solution contains: Active: netarsudil mesylate 0.285 mg Preservative: benzalkonium chloride 0.15 mg Inactives: mannitol, boric acid, sodium hydroxide to adjust pH and water for injection. Manufactured for: ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA U.S. Pat: www.alconpatents.com Store at 2°C - 8°C (36°F - 46°F) until opened. After opening, the product may be kept at 2°C - 25°C (36°F - 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C - 8°C (36°F - 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. 41079 NDC 70727-497-25 For topical application in the eye. rhopressa ® (netarsudil ophthalmic solution) 0.02% Rx only Sterile 2.5 mL Alcon 41077 See carton for storage conditions. Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134 LOT: EXP: NDC 70727-497-99 SAMPLE - Not for Resale rhopressa ® (netarsudil ophthalmic solution) 0.02% For topical application in the eye Sterile Rx only 2.5 mL Alcon Usual dosage: One drop in the affected eye(s) once daily in the evening. Each mL Rhopressa ® ophthalmic solution contains: Active: netarsudil mesylate 0.285 mg Preservative: benzalkonium chloride 0.15 mg Inactives: mannitol, boric acid, sodium hydroxide to adjust pH and water for injection. Manufactured for: ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA U.S. Pat: www.alconpatents.com Store at 2°C - 8°C (36°F - 46°F) until opened. After opening, the product may be kept at 2°C - 25°C (36°F - 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C - 8°C (36°F - 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. 41080 NDC 70727-497-99 SAMPLE - Not for Resale For topical application in the eye. rhopressa ® (netarsudil ophthalmic solution) 0.02% Rx only Sterile 2.5 mL Alcon 41078 See carton for storage conditions. Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134 LOT: EXP: NDC 70727-497-25 rhopressa ® (netarsudil ophthalmic solution) 0.02% For topical application in the eye Sterile Rx only 2.5 mL Alcon Usual dosage: One drop in the affected eye(s) once daily in the evening. Each mL Rhopressa ® ophthalmic solution contains: Active: netarsudil mesylate 0.285 mg Preservative: benzalkonium chloride 0.15 mg Inactives: mannitol, boric acid, sodium hydroxide toadjust pH and water for injection. ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA U.S. Pat: www.alconpatents.com Store at 2°C - 8°C (36°F - 46°F) until opened. After opening, the product may be kept at 2°C - 25°C (36°F - 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C - 8°C (36°F - 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. 300069021-1224 NDC 70727-497-25 For topical application in the eye. rhopressa ® (netarsudil ophthalmic solution) 0.02% Rx only Sterile 2.5 mL Alcon See carton for storage conditions. Alcon Laboratories, Inc. Fort Worth, TX 76134 LOT: EXP.: 300069075 1224 Carton Label
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 70727-497-99 SAMPLE - Not for Resale rhopressa ® (netarsudil ophthalmic solution) 0.02% For topical application in the eye Sterile Rx only 2.5 mL Alcon Usual dosage: One drop in the affected eye(s) once daily in the evening. Each mL Rhopressa ® ophthalmic solution contains: Active: netarsudil mesylate 0.285 mg Preservative: benzalkonium chloride 0.15 mg Inactives: mannitol, boric acid, sodium hydroxide to adjust pH and water for injection. ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA U.S. Pat: www.alconpatents.com Store at 2°C - 8°C (36°F - 46°F) until opened. After opening, the product may be kept at 2°C - 25°C (36°F - 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C - 8°C (36°F - 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. 300069020-1124 NDC 70727-497-99 SAMPLE - Not for Resale For topical application in the eye. rhopressa ® (netarsudil ophthalmic solution) 0.02% Rx only Sterile 2.5 mL Alcon See carton for storage conditions. Alcon Laboratories, Inc. Fort Worth, TX 76134 USA LOT: EXP.: 300069074 1124 Sample Carton Label
Overview
Netarsudil is a Rho kinase inhibitor. Its chemical name is (S)-4-(3-amino-1-(isoquinolin-6-yl-amino)-1-oxopropan-2-yl) benzyl 2,4-dimethylbenzoate dimesylate. The molecular formula of the free base is C 28 H 27 N 3 O 3 and the molecular formula of the dimesylate is C 30 H 35 N 3 O 9 S 2 . The molecular weight of the free base is 453.54 and the molecular weight of the dimesylate is 645.74. The chemical structure is: Netarsudil dimesylate is a light yellow-to-white powder that is freely soluble in water, soluble in methanol, sparingly soluble in dimethyl formamide, and practically insoluble in dichloromethane and heptane. RHOPRESSA (netarsudil ophthalmic solution) 0.02% is supplied as a sterile, isotonic, buffered aqueous solution of netarsudil dimesylate with a pH of approximately 5 and an osmolality of approximately 295 mOsmol/kg. It is intended for topical application in the eye. Each mL of RHOPRESSA contains 0.2 mg of netarsudil (equivalent to 0.28 mg of netarsudil dimesylate). Benzalkonium chloride, 0.015%, is added as a preservative. The inactive ingredients are: boric acid, mannitol, sodium hydroxide to adjust pH, and water for injection. Netarsudil structural formula
Indications & Usage
RHOPRESSA is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. RHOPRESSA ® is a Rho kinase inhibitor indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )
Dosage & Administration
The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose in the evening. Twice a day dosing is not well tolerated and is not recommended. If RHOPRESSA is to be used concomitantly with other topical ophthalmic drug products to lower IOP, administer each drug product at least 5 minutes apart [see Patient Counseling Information ( 17 )]. One drop into the affected eye(s) once daily in the evening. ( 2 )
Warnings & Precautions
5.1 Epithelial Corneal Edema Epithelial corneal edema, described as honeycomb or bullous, has been reported in some patients with pre-existing corneal stromal edema or following ocular procedures that could affect corneal endothelial function. Epithelial corneal edema typically resolves upon discontinuation of RHOPRESSA. Advise patients to notify their physician if they experience eye pain or decreased vision while using RHOPRESSA [see Adverse Reactions ( 6.2 ) and Patient Counselling Information ( 17 )] . 5.2 Bacterial Keratitis There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface [see Patient Counseling Information ( 17 )]. 5.3 Use with Contact Lenses Contact lenses should be removed prior to instillation of RHOPRESSA and may be reinserted 15 minutes following its administration.
Contraindications
None. 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 Alcon Laboratories, Inc. at 1‑800-757-9195, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The most common ocular adverse reaction observed in controlled clinical studies with RHOPRESSA dosed once daily was conjunctival hyperemia which was reported in 53% of patients. Six percent of patients discontinued therapy due to conjunctival hyperemia. Other common (approximately 20%) ocular adverse reactions reported were: corneal verticillata, instillation site pain, and conjunctival hemorrhage. Instillation site erythema, corneal staining, blurred vision, increased lacrimation, erythema of eyelid, and reduced visual acuity were reported in 5-10% of patients. Corneal Verticillata Corneal verticillata occurred in approximately 20% of the patients in controlled clinical studies. The corneal verticillata seen in RHOPRESSA-treated patients were first noted at 4 weeks of daily dosing. This reaction did not result in any apparent visual functional changes in patients. Most corneal verticillata resolved upon discontinuation of treatment. 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of RHOPRESSA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Eye disorders : Epithelial corneal edema has been reported in some patients with pre-existing corneal stromal edema or following ocular procedures (that could affect corneal endothelial function) [see Warnings and Precautions ( 5.1 )] .
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