Latanoprost Ophthalmic Solution

Sterile ophthalmic solution containing 50 mcg/mL latanoprost.

In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with Latanoprost Ophthalmic Solution. If such drugs are used, they should be administered at least five (5) minutes apart.

The combined use of two or more prostaglandins, or prostaglandin analogs including Latanoprost Ophthalmic Solution is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP.

Pregnancy

Teratogenic Effects: Pregnancy Category C.

Reproduction studies have been performed in rats and rabbits. In rabbits, an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose.

There are no adequate and well-controlled studies in pregnant women. Latanoprost Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Latanoprost Ophthalmic Solution is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Latanoprost Ophthalmic Solution, 0.005% 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 5 mL clear low density polyethylene bottle with a clear low density polyethylene dropper tip, and a turquoise polyethylene screw cap.

NDC 17478-625-12        2.5 mL fill, 0.005% (50 mcg/mL)

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.

• Darkening of your eyes and lashes: This drug can darken the color of your eye or change it from a light color to brown. It can also cause the skin around your eye to darken. It may cause your eyelashes to grow longer, thicker, and darker in color. These changes often occur slowly, but they can be permanent. If you only use this drug in one eye, your eyes may look different from each other. Call your doctor if you have these changes.
• Contact lenses: If you wear contact lenses, you should remove them from your eyes before using this drug. Wait at least 15 minutes after using your eye drops before you put your contacts in your eyes again.
• Contamination of dropper tip and solution: Be careful not to let the dropper tip of the eye drops touch your eye, eyelids, or surrounding areas when giving yourself the medication. This could contaminate the dropper tip and the solution and lead to infection.
• Eye problems: This drug may cause macular edema. In this condition, fluid builds up in your eye and causes it to swell. This can damage your vision. You’re at higher risk of this side effect if you have a history of macular edema or other eye problems. Talk to your doctor before using latanoprost if you have a history of eye problems.