Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Συνδρομές Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Ενδείξεις και αγωγές Βρείτε θεραπευτικές ενδείξεις και αγωγές για νόσους, συμπτώματα και ιατρικές πράξεις
Γνωρίζατε ότι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα

XALATAN Ophthalmic solution (2020)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

Pharmacia and Upjohn Company LLC

Λέξεις κλειδιά

0013-8303

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

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 ...
Μπορείτε να υποστηρίξετε τον Γαληνό στην αποστολή του να παρέχει δωρεάν έγκυρη πληροφόρηση για κάθε φάρμακο απενεργοποιώντας το Ad Blocker για αυτόν τον ιστότοπο.