LATANOPROST (Page 3 of 3)

14.2 Progression of Increased Iris Pigmentation

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.

16 HOW SUPPLIED/STORAGE AND HANDLING

Latanoprost Sterile Ophthalmic Solution is a clear, isotonic, buffered, preserved colorless solution of latanoprost 0.005% (50 mcg/mL).

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.

17 PATIENT COUNSELING INFORMATION

Potential for Pigmentation

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)] .

Potential for Eyelash Changes

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.

Handling the Container

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)].

When to Seek Physician Advice

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.

Use with Contact Lenses

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.

Use with Other Ophthalmic Drugs

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:

FDC Limited

Distributed by:

Rising Pharmaceuticals, Inc.

Saddle Brook, NJ 07663

Revised: 03/2020

INSTRUCTIONS FOR USE

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)

Figure A

Step 1. Wash hands before each use.

Step 2. Snap off the dust cover by turning it clockwise to break the seal. See figure B

Figure B

Step 3. Pull off the dust cover see figure C

Figure C

Step 4.Unscrew the turquoise colored cap by turning in the counterclockwise direction. See figure D

Figure D

THE INSERT TIP IS DESIGNED TO DELIVER PREMEASURED DROP. THEREFORE, DO NOT ENLARGE THE HOLE OF THE INSERT TIP OR TAMPER WITH INSERT TIP.

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.

Figure E

Step 6. If your doctor has told you to us Latanoprost Ophthalmic Solution in both eyes, repeat step 4 and step 5.

After using your Latanoprost Ophthalmic Solution

Step 7. Replace the cap after every use, tighten the cap on the nozzle. See figure F

Figure F

This Instruction for Use has been approved by U.S. Food and Drug Administration.

Made in India By:

FDC Limited

Distributed by :

Rising Pharmaceuticals, Inc

Saddle Brook, NJ 07663

Revised: 03/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Latanoprost Ophthalmic Solution

Sterile

0.005%

Rx Only

2.5 ml

carton
(click image for full-size original)
LATANOPROST latanoprost solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-516
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LATANOPROST (LATANOPROST) LATANOPROST 50 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
SODIUM CHLORIDE
SODIUM PHOSPHATE, MONOBASIC
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64980-516-25 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 2.5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (64980-516-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202442 09/01/2016
Labeler — Rising Pharmaceuticals, Inc. (041241766)
Registrant — FDC Limited (650078413)
Establishment
Name Address ID/FEI Operations
FDC Limited 862267994 manufacture (64980-516), analysis (64980-516)

Revised: 06/2020 Rising Pharmaceuticals, Inc.

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