HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
Did you find an answer to your question?
Yes
No
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
XALATAN®(latanoprost)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
XALATAN® Quick Finder
Highlights
Indications and 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.
Did you find an answer to your question?
Yes
No
Dosage and 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...
Did you find an answer to your question?
Yes
No
Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing latanoprost 50 mcg/mL (0.005%).
Did you find an answer to your question?
Yes
No
Contraindications
4 CONTRAINDICATIONS
Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product.
Did you find an answer to your question?
Yes
No
Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Pigmentation
XALATAN has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no adequate...
Did you find an answer to your question?
Yes
No
Overdosage
10 OVERDOSAGE
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...
Did you find an answer to your question?
Yes
No
Description
11 DESCRIPTION
Latanoprost is a prostaglandin F2α analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-...
Did you find an answer to your question?
Yes
No
Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Latanoprost is a prostaglandin F2α analogue that is believed to reduce the IOP by...
Did you find an answer to your question?
Yes
No
Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
Did you find an answer to your question?
Yes
No
Clinical Studies
14 CLINICAL STUDIES
14.1 Elevated Baseline IOP
Patients with mean baseline IOP of 24 – 25 mmHg who were treated for 6 months in multi-center, randomized, controlled...
Did you find an answer to your question?
Yes
No
How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
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...
Did you find an answer to your question?
Yes
No
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
Potential for Pigmentation
Advise patients about the potential for increased brown pigmentation of the...
Did you find an answer to your question?
Yes
No
Did you find an answer to your question?
Yes
No
Resources
Report Adverse Event
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at https://vaers.hhs.gov or call (800) 822-7967.