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XALATAN®(latanoprost)
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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.
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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...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing latanoprost 50 mcg/mL (0.005%).
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Contraindications
4 CONTRAINDICATIONS
Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product.
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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...
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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...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no adequate...
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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...
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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-...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Latanoprost is a prostaglandin F2α analogue that is believed to reduce the IOP by...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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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...
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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...
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Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
Potential for Pigmentation
Advise patients about the potential for increased brown pigmentation of the...
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