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LATANOPROST Ophthalmic Solution (GREENSTONE LLC)

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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.

LATANOPROST Ophthalmic Solution (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

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

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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 latanoprost...

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3 DOSAGE FORMS AND STRENGTHS

Ophthalmic solution containing latanoprost 50 mcg/mL (0.005%).

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4 CONTRAINDICATIONS

Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product.

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5 WARNINGS AND PRECAUTIONS

5.1 Pigmentation

Latanoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported...

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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no adequate...

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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 latanoprost and no adverse reactions were observed. IV...

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11 DESCRIPTION

Latanoprost is a prostaglandin F 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...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Latanoprost is a prostaglandin F analogue that is believed to reduce the IOP by...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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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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16 HOW SUPPLIED/STORAGE AND HANDLING

Latanoprost ophthalmic solution 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...

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17 PATIENT COUNSELING INFORMATION

Potential for Pigmentation

Advise patients about the potential for increased brown pigmentation of the...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.

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