Medicine guide

Xalatan

50 ug/mL · Solution/ Drops

Prescription only

Active substance: Latanoprost
Made by: Viatris Specialty LLC
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2023-05-15

Used for

XALATAN is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

The label’s usual adult dose

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.

Full directions ↓

Do not take it if

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 )

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

16other products contain Latanoprost — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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 )

From the official label · 2023-05-15 · DailyMed

How it works

From this product’s own US prescribing label.

Latanoprost is a prostaglandin F 2α analogue that is believed to reduce the IOP by increasing the outflow of aqueous humor.
Studies in animals and man suggest that the main mechanism of action is increased uveoscleral outflow.

Peak level after2 h

How the body breaks it down

The active acid of latanoprost reaching the systemic circulation is primarily metabolized by the liver to the 1,2-dinor and 1,2,3,4-tetranor metabolites via fatty acid β-oxidation.

How it leaves the body

Following hepatic β-oxidation, the metabolites are mainly eliminated via the kidneys.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-05-15

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

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 )

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Pigmentation:
Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. ( 5.1 )
Eyelash Changes:
Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.2 ) 5.1 Pigmentation XALATAN has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as latanoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of latanoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. Beyond 5 years the effects of increased pigmentation are not known [see Clinical Studies (14.2) ] . Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with XALATAN can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. 5.2 Eyelash Changes XALATAN may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment. 5.3 Intraocular Inflammation XALATAN should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation because inflammation may be exacerbated. 5.4 Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with XALATAN. XALATAN should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. 5.5 Herpetic Keratitis Reactivation of herpes simplex keratitis has been reported during treatment with XALATAN. XALATAN should be used with caution in patients with a history of herpetic keratitis. XALATAN should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated. 5.6 Bacterial Keratitis There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. 5.7 Contact Lens Use XALATAN contains benzalkonium chloride, which may be absorbed by contact lenses. Contact lenses should be removed prior to the administration of XALATAN, and may be reinserted 15 minutes after administration.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary There are no adequate and well-controlled studies of XALATAN administration in pregnant women to inform drug-associated risks.
In animal reproduction studies, intravenous (IV) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see Data ] .
The background risk of major birth defects and miscarriage for the indicated population is unknown.
However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20% of clinically recognized pregnancies.
Data Animal Data Embryofetal studies were conducted in pregnant rabbits administered latanoprost daily by IV injection on gestation days 6 through 18, to target the period of organogenesis.
A no observed adverse effect level (NOAEL) was not established for rabbit developmental toxicity.
Post-implantation loss due to late resorption was shown as doses ≥0.2 mcg/kg/day (equivalent to 1.3 times the maximum recommended human ophthalmic dose [RHOD], on a mg/m 2 basis, assuming 100% absorption).
Spina bifida and abortion occurred at 5 mcg/kg/day (equivalent to 32 times the maximum RHOD).
Total litter loss due to early resorption was observed at doses ≥50 mcg/kg/day (324 times the maximum RHOD).
Transient signs of maternal toxicity were observed after IV dosing (increased breathing, muscle tremors, slight motor incoordination) at 300 mcg/kg/day (1946 times the maximum RHOD).
No maternal toxicity was observed at doses up to 50 mcg/kg/day.
Embryofetal studies were conducted in pregnant rats administered latanoprost daily by IV injection on gestation days 6 through 15, to target the period of organogenesis.
A NOAEL for rat developmental toxicity was not established.
Cleft palate was observed at 1 mcg/kg (equivalent to 3.2 times the maximum RHOD, on a mg/m 2 basis, assuming 100% absorption).
Brain porencephalic cyst(s) were observed ≥50 mcg/kg (162 times the maximum RHOD).
Skeletal anomalies were observed at 250 mcg/kg (811 times the maximum RHOD).
No maternal toxicity was detectable at 250 mcg/kg/day.
Prenatal and postnatal development was assessed in rats.
Pregnant rats were administered latanoprost daily by IV injection from gestation day 15, through delivery, until weaning (lactation day 21).
No adverse effects on rat offspring were observed at doses up to 10 mcg/kg/day (32 times the maximum RHOD, on a mg/m 2 basis, assuming 100% absorption).
At 100 mcg/kg/day (324 times the maximum RHOD), maternal deaths and pup mortality occurred.
IN SPECIFIC POPULATIONS
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of XALATAN administration in pregnant women to inform drug-associated risks.
In animal reproduction studies, intravenous (IV) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see Data ] .
The background risk of major birth defects and miscarriage for the indicated population is unknown.
However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20% of clinically recognized pregnancies.
Data Animal Data Embryofetal studies were conducted in pregnant rabbits administered latanoprost daily by IV injection on gestation days 6 through 18, to target the period of organogenesis.
A no observed adverse effect level (NOAEL) was not established for rabbit developmental toxicity.
Post-implantation loss due to late resorption was shown as doses ≥0.2 mcg/kg/day (equivalent to 1.3 times the maximum recommended human ophthalmic dose [RHOD], on a mg/m 2 basis, assuming 100% absorption).
Spina bifida and abortion occurred at 5 mcg/kg/day (equivalent to 32 times the maximum RHOD).
Total litter loss due to early resorption was observed at doses ≥50 mcg/kg/day (324 times the maximum RHOD).
Transient signs of maternal toxicity were observed after IV dosing (increased breathing, muscle tremors, slight motor incoordination) at 300 mcg/kg/day (1946 times the maximum RHOD).
No maternal toxicity was observed at doses up to 50 mcg/kg/day.
Embryofetal studies were conducted in pregnant rats administered latanoprost daily by IV injection on gestation days 6 through 15, to target the period of organogenesis.
A NOAEL for rat developmental toxicity was not established.
Cleft palate was observed at 1 mcg/kg (equivalent to 3.2 times the maximum RHOD, on a mg/m 2 basis, assuming 100% absorption).
Brain porencephalic cyst(s) were observed ≥50 mcg/kg (162 times the maximum RHOD).
Skeletal anomalies were observed at 250 mcg/kg (811 times the maximum RHOD).
No maternal toxicity was detectable at 250 mcg/kg/day.
Prenatal and postnatal development was assessed in rats.
Pregnant rats were administered latanoprost daily by IV injection from gestation day 15, through delivery, until weaning (lactation day 21).
No adverse effects on rat offspring were observed at doses up to 10 mcg/kg/day (32 times the maximum RHOD, on a mg/m 2 basis, assuming 100% absorption).
At 100 mcg/kg/day (324 times the maximum RHOD), maternal deaths and pup mortality occurred.
8.2 Lactation Risk Summary 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 XALATAN is administered to a nursing woman.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XALATAN and any potential adverse effects on the breastfed child from XALATAN.
8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

IV infusion of up to 3 mcg/kg of latanoprost in healthy volunteers produced mean plasma concentrations 200 times higher than during clinical treatment with XALATAN and no adverse reactions were observed.
IV dosages of 5.5 to 10 mcg/kg caused abdominal pain, dizziness, fatigue, hot flushes, nausea, and sweating.
If overdosage with XALATAN occurs, treatment should be symptomatic.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

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

Quoted from the official label, section “Geriatric Use”.

Side effects

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 may not reflect the rates observed in clinical practice. XALATAN was studied in three multicenter, randomized, controlled clinical trials. Patients received 50 mcg/mL XALATAN once daily or 5 mg/mL active-comparator (timolol) twice daily. The patient population studied had a mean age of 65±10 years. Seven percent of patients withdrew before the 6-month endpoint. Table 1:
Ocular Adverse Reactions and Ocular Signs/Symptoms Reported by 5-15% of Patients Receiving Latanoprost Symptom/Finding Adverse Reactions (Incidence (%)) Latanoprost (n=460) Timolol (n=369) Foreign body sensation 13 8 Punctate keratitis 10 9 Stinging 9 12 Conjunctival hyperemia 8 3 Blurred vision 8 8 Itching 8 8 Burning 7 8 Increased pigmentation of the iris 7 0 Less than 1% of the patients treated with XALATAN required discontinuation of therapy because of intolerance to conjunctival hyperemia. Table 2:
Adverse Reactions That Were Reported in 1-5% of Patients Receiving Latanoprost Adverse Reactions (Incidence (%)) Latanoprost (n=460) Timolol (n=369) Ocular Events/Signs and Symptoms Excessive tearing 4 6 Eyelid discomfort/pain 4 2 Dry eye 3 3 Eye pain 3 3 Eyelid margin crusting 3 3 Erythema of the eyelid 3 2 Photophobia 2 1 Eyelid edema 1 3 Blepharitis 1 3 Systemic Events Upper respiratory tract infection/nasopharyngitis/influenza 3 3 Myalgia/arthralgia/back pain 1 0.5 Rash/allergic skin reaction 1 0.3 6.2 Postmarketing Experience The following reactions have been identified during postmarketing use of XALATAN in clinical practice. Because they are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to XALATAN, or a combination of these factors, include:
Nervous System Disorders:
Dizziness; headache; toxic epidermal necrolysis Eye Disorders:
Eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation, and number of eyelashes); keratitis; corneal edema and erosions; intraocular inflammation (iritis/uveitis); macular edema, including cystoid macular edema; trichiasis; periorbital and lid changes resulting in deepening of the eyelid sulcus; iris cyst; eyelid skin darkening; localized skin reaction on the eyelids; conjunctivitis; pseudopemphigoid of the ocular conjunctiva. Respiratory, Thoracic and Mediastinal Disorders:
Asthma and exacerbation of asthma; dyspnea Gastrointestinal Disorders:
Nausea; vomiting Skin and Subcutaneous Tissue Disorders:
Pruritis Infections and Infestations:
Herpes keratitis Cardiac Disorders:
Angina; palpitations; angina unstable General Disorders and Administration Site Conditions:
Chest pain

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

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 XALATAN [see Warnings and Precautions (5.1) ] .
Potential for Eyelash Changes Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment with XALATAN.
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.
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) ] .
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.
Contact Lens Use Advise patients that XALATAN 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 XALATAN.
Use with Other Ophthalmic Drugs Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.
If a Dose is Missed Advise patients that if one dose is missed, treatment should continue with the next dose as normal.
Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A.
Made in Belgium © 2023 Viatris Inc.
XALATAN is a registered trademark of Pfizer PFE Holdings 4 LLC, a Viatris Company.
UPJ:XLTN:R1

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Ophthalmic solution containing latanoprost 50 mcg/mL (0.005%). Ophthalmic solution containing latanoprost 50 mcg/mL (0.005%). ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

XALATAN is a clear, isotonic, buffered, preserved colorless solution of latanoprost 50 mcg/mL (0.005%).
It is supplied as a 2.5 mL solution in a 5 mL clear low density polyethylene bottle with a clear polyethylene dropper tip, a turquoise high density polyethylene screw cap, and a tamper-evident clear low density polyethylene overcap. 2.5 mL fill, 50 mcg/mL (0.005%):
Package of 1 bottle:
NDC 58151-419-35 Storage:
Protect from light.
Store unopened bottle(s) under refrigeration at 2°C to 8°C (36°F 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.

Quoted from the official label, section “How Supplied”.

What is in it

Latanoprost is a prostaglandin F 2α analogue.
Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate.
Its molecular formula is C 26 H 40 O 5 and its chemical structure is:
Latanoprost is a colorless to slightly yellow oil that is very soluble in acetonitrile and freely soluble in acetone, ethanol, ethyl acetate, isopropanol, methanol, and octanol.
It is practically insoluble in water.
XALATAN (latanoprost ophthalmic solution) 0.005% is supplied as a sterile, isotonic, buffered aqueous solution of latanoprost with a pH of approximately 6.7 and an osmolality of approximately 267 mOsmol/kg.
Each mL of XALATAN contains 50 mcg of latanoprost.
Benzalkonium chloride, 0.02% is added as a preservative.
The inactive ingredients are disodium phosphate anhydrous, sodium chloride, sodium dihydrogen phosphate monohydrate, and water for injection.
One drop contains approximately 1.5 mcg of latanoprost.
Latanoprost Structural Formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

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Details

Made by	Viatris Specialty LLC
Active substance	Latanoprost
Strength	50 ug/mL
Form	Solution/ Drops
Route	Ophthalmic
Packs	1 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER
NDC	58151-419

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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