XALATAN- latanoprost solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

LATANOPROST (UNII: 6Z5B6HVF6O) (LATANOPROST - UNII:6Z5B6HVF6O)

Disponibil de la:

PFIZER LABORATORIES DIV PFIZER INC

INN (nume internaţional):

LATANOPROST

Compoziție:

LATANOPROST 50 ug in 1 mL

Calea de administrare:

OPHTHALMIC

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

XALATAN is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. 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 of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see Data] . The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20% of clinically recognized pregnancies. Embryofetal studies were conducted in pregnant rabbits administered latanoprost daily by IV injection on gestation days 6 through

Rezumat produs:

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 polyethylene dropper tip, a turquoise high density polyethylene screw cap, and a tamper-evident clear low density polyethylene overcap. 2.5 mL fill, 50 mcg/mL (0.005%): Package of 1 bottle: NDC 0013-8303-04 Storage: 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 not exceeding 8 days. Once a bottle is opened for use, it may be stored at room temperature up to 25°C (77°F) for 6 weeks.

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

XALATAN- LATANOPROST SOLUTION
PFIZER LABORATORIES DIV PFIZER INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XALATAN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XALATAN.
XALATAN (LATANOPROST OPHTHALMIC SOLUTION) 0.005%, FOR TOPICAL
OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
XALATAN is a prostaglandin F
analogue indicated for the reduction of elevated intraocular pressure
in
patients with open-angle glaucoma or ocular hypertension. (1)
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s) once daily in the evening. (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing latanoprost 50 mcg/mL (0.005%). (3)
CONTRAINDICATIONS
Known hypersensitivity to latanoprost, benzalkonium chloride, or any
other ingredients in this product. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Most common adverse reactions (5-15%) from clinical trials are blurred
vision, burning and stinging,
conjunctival hyperemia, foreign body sensation, itching, increased
pigmentation of the iris, and punctate
keratitis. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PFIZER AT
1-800-438-1985 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Pigmentation
5.2 Eyelash Changes
5.3 Intraocular Inflammation
5.4 Macular Edema
5.5 Herpetic Keratitis
5.6 Bacterial Keratitis
5.7 Contact Lens Use
6 ADVERSE REACTIONS
®
2α
Pigmentation: Pigmentation of the iris, periorbital tissue (eyelid)
and eyelashes can occur. Iris
pigmentation likely to be permanent. (5.1)
Eyelash Changes: Gradual change to eyelashes including increased
length, thickness and number of
lashes. Usually reversible. (5.2)
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactati