Latanoprost (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

Latanoprost 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 in a 4 mL clear low density polyethylene bottle with a low density polyethylene dropper tip, and a turquoise high density polypropylene screw cap, and a clear PVC film with a single perforation.

2.5 mL fill, 0.005% (50 mcg/mL): Package of 1 bottle:

NDC 71205-154-25

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

17.1 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) ].

17.2 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.

17.3 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) ].

17.4 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.

17.5 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.

17.6 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.

Bausch + Lomb, a division of

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

©Bausch & Lomb Incorporated

Relabeled by:

Proficient Rx, LP

Thousand Oaks, CA 91320

Revised: June 2016

9144707 (flat)

9144807 (folded)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 71205-154-25

Latanoprost

Ophthalmic

Solution 0.005%

125 mcg//2.5 mL

(Sterile)

FOR TOPICAL APPLICATION

IN THE EYE

Rx only

2.5 mL

71205-154-25
(click image for full-size original)
LATANOPROST
latanoprost solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-154(NDC:24208-463)
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
WATER
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-154-25 1 BOTTLE in 1 CARTON contains a BOTTLE
1 2.5 mL in 1 BOTTLE This package is contained within the CARTON (71205-154-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201006 03/22/2011
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-154), RELABEL (71205-154)

Revised: 05/2022 Proficient Rx LP

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