XALATAN 50 ug/mL

Latanoprost · SOLUTION/ DROPS · Viatris Specialty LLC

No Recall History

Plain English

XALATAN is a solution/ drops containing latanoprost at 50 ug/mL, taken ophthalmic. Manufactured by Viatris Specialty LLC.

Key Facts

Brand Name: XALATAN
Generic Name: Latanoprost
NDC Code (Product): 58151-419
Manufacturer: Viatris Specialty LLC
Strength: 50 ug/mL
Dosage Form: SOLUTION/ DROPS
Route: OPHTHALMIC
Marketing Status
Application #: NDA020597
Drug Class: Prostaglandin Analog [EPC]
Marketing Start: 10/22/2024

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE XALATAN is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. XALATAN is a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. The dosage of XALATAN should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including XALATAN 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. Reduction of the IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours. XALATAN may be used concomitantly with other topical ophthalmic drug products to lower IOP. In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with XALATAN. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. Contact lenses should be removed prior to the administration of XALATAN, and may be reinserted 15 minutes after administration. One drop in the affected eye(s) once daily in the evening. ( 2 )

Contraindications

4 CONTRAINDICATIONS Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label: • Iris pigmentation changes [see Warnings and Precautions (5.1) ] • Eyelid skin darkening [see Warnings and Precautions (5.1) ] • Eyelash changes (increased length, thickness, pigmentation, and number of lashes) [see Warnings and Precautions (5.2) ] • Intraocular inflammation (iritis/uveitis) [see Warnings and Precautions (5.3) ] • Macular edema, including cystoid macular edema [see Warnings and Precautions (5.4) ] Most common adverse reactions (5-15%) from clinical trials are blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate keratitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and ma…

Frequently Asked Questions

What is XALATAN used for?

XALATAN contains Latanoprost. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is XALATAN a controlled substance?

XALATAN is not classified as a controlled substance by the DEA.

What is the generic name for XALATAN?

The generic name for XALATAN is Latanoprost. There are 12 other brand versions of Latanoprost.

What is the NDC code for XALATAN 50 ug/mL?

The NDC (National Drug Code) for XALATAN 50 ug/mL is 58151-419, listed by Viatris Specialty LLC.

Product NDC

58151-419

Package NDC

58151-419-35

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)