A 3-year open-label, prospective safety study with a 2-year extension phase was conducted to evaluate the progression of increased iris pigmentation with continuous use of Latanoprost Ophthalmic Solution once-daily as adjunctive therapy in 519 patients with open-angle glaucoma. The analysis was based on observed-cases population of the 380 patients who continued in the extension phase.
Results showed that the onset of noticeable increased iris pigmentation occurred within the first year of treatment for the majority of the patients who developed noticeable increased iris pigmentation. Patients continued to show signs of increasing iris pigmentation throughout the five years of the study. Observation of increased iris pigmentation did not affect the incidence, nature, or severity of adverse events (other than increased iris pigmentation) recorded in the study. IOP reduction was similar regardless of the development of increased iris pigmentation during the study.
It is supplied as a 2.5 mL solution filled in a 5 mL translucent low density polyethylene bottle with insert cap assembly comprising of a turquoise colored, high density polyethylene screw cap over a low density polyethylene nozzle with tamper evident Low density polyethylene dust cover sealing the bottle cap.
2.5 mL fill, 0.005% (50 mcg/mL) : Package of 1 bottle :NDC 64980-516-25
Storage: Protect from light. Store unopened bottle(s) under refrigeration at 2° to 8°C (36° to 46°F). During shipment to the patient, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 8 days. Once a bottle is opened for use, it may be stored at room temperature up to 25°C (77°F) for 6 weeks.
Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of Latanoprost Ophthalmic Solution [ see Warnings and Precautions (5.1)] .
Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment with Latanoprost Ophthalmic Solution. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment.
Instruct patients to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [ see Warnings and Precautions (5.6)].
Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection) or have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of the multiple-dose container.
Advise patients that Latanoprost Ophthalmic Solution contains benzalkonium chloride, which may be absorbed by contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of Latanoprost Ophthalmic Solution.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.
Made in India by:
Rising Pharmaceuticals, Inc.
Saddle Brook, NJ 07663
Latanoprost Ophthalmic Solution
Before using your latanoprost ophthalmic solution
Before using your latanoprost hydrochloride ophthalmic solution for the first time, be sure the dust cover seal is unbroken (See figure A)
Step 2. Snap off the dust cover by turning it clockwise to break the seal. See figure B
Giving your Latanoprost Ophthalmic Solution
Step 5. Tilt your head back and pull the lower eyelid down slightly to form pocket between your eyelid and your eye. Dispense drops with gentle pressure. Do not touch your eye or eyelid with the dropper tip. See figure E.
After using your Latanoprost Ophthalmic Solution
Step 7. Replace the cap after every use, tighten the cap on the nozzle. See figure F
Made in India By:
Distributed by :
Rising Pharmaceuticals, Inc
Saddle Brook, NJ 07663
|LATANOPROST latanoprost solution|
|Labeler — Rising Pharmaceuticals, Inc. (041241766)|
|Registrant — FDC Limited (650078413)|
|FDC Limited||862267994||manufacture (64980-516), analysis (64980-516)|
Revised: 06/2020 Rising Pharmaceuticals, Inc.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.