XALATAN Ophthalmic solution (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Pharmacia and Upjohn Company LLC
Λέξεις κλειδιά
0013-8303
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1. Indications and Usage
XALATAN is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
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 ...
3. Dosage Forms and Strengths
Ophthalmic solution containing latanoprost 50 mcg/mL (0.005%).
4. Contraindications
Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product.
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 pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. ...
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 <em>[see Warnings and Precautions ...
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 ...
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 ...
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 ...
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 ...
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.
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. ...
11. Description
Latanoprost is a prostaglandin F<sub>2</sub><sub>α</sub> 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 ...
12.1. Mechanism of Action
Latanoprost is a prostaglandin F<sub>2α</sub> 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 ...
12.2. Pharmacodynamics
Reduction of the IOP in man starts about 3–4 hours after administration and maximum effect is reached after 8–12 hours. IOP reduction is present for at least 24 hours.
12.3. Pharmacokinetics
Absorption Latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active. Distribution The distribution volume in humans is 0.16 ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis Latanoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 170 mcg/kg/day (approximately 2800 times the recommended maximum human dose) for ...
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 trials demonstrated 6–8 mmHg reductions in IOP. This IOP reduction ...
16.1. How Supplied
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 ...
16.2. Storage and Handling
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 ...
17. Patient Counseling Information
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 ...