Description
NDC: 70069-421-01
Latanoprost 0.005% Ophthalmic Solution, 2.5 mL — Somerset Therapeutics
| Active ingredients | Latanoprost 0.005% (50 mcg/mL) |
| Dosage form | Ophthalmic solution (eye drops) |
| Route | Topical ophthalmic |
| Size | 2.5 mL fill in a 5 mL bottle |
| Manufacturer | Somerset Therapeutics |
| NDC | 70069-421-01 |
Indications and Usage
Indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Dosage and Administration
Instill one drop in the affected eye(s) once daily in the evening. Dosing more frequently than once daily may decrease the intraocular pressure lowering effect. If more than one topical ophthalmic drug is used, administer each at least five minutes apart.
Warnings and Precautions
- May cause gradual and permanent increase in brown iris pigmentation and darkening of eyelid skin
- May increase eyelash length, thickness, and number, and cause other changes to eyelashes and periorbital tissue
- Use with caution in patients with intraocular inflammation, and in aphakic or pseudophakic patients with a torn posterior lens capsule due to risk of macular edema
- Remove contact lenses before use and reinsert 15 minutes after administration; avoid contaminating the dropper tip
Contraindications
Contraindicated in patients with known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredient in the product.
Adverse Reactions
The most common ocular adverse reactions include blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased iris pigmentation, and punctate keratitis.
Storage and Handling
Store unopened bottles refrigerated at 2°C to 8°C (36°F to 46°F). Once opened, may be stored at room temperature up to 25°C (77°F) for 6 weeks. Protect from light.
How Supplied
Supplied as 2.5 mL of solution filled in a 5 mL low-density polyethylene bottle with a dropper tip and a turquoise cap.
Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.
