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
LATANOPROST latanoprost solution/ drops | |||||||||||||||||
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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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