LATANOPROST- latanoprost solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

American Regent, Inc.

INN (nemzetközi neve):

LATANOPROST

Összetétel:

LATANOPROST 50 ug in 1 mL

Az alkalmazás módja:

OPHTHALMIC

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. Teratogenic Effects Reproduction studies have been performed in rats and rabbits. In rabbits, an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose. There are no adequate and well-controlled studies in pregnant women. Latanoprost ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 latanoprost ophthalmic solution is administered to a nursing woman. Safety and effectiv

Termék összefoglaló:

Latanoprost ophthalmic solution is a sterile, clear, isotonic, buffered, preserved, colorless solution of latanoprost 0.005% (50 mcg/mL). It is supplied as a 2.5 mL solution in a 6 mL natural low density polyethylene bottle with a natural low density polyethylene dropper tip and a turquoise polyethylene screw cap. 2.5 mL fill, 0.005% (50 mcg/mL): Package of 1 bottle: NDC 0517-0830-01 2.5 mL fill, 0.005% (50 mcg/mL): Multi-pack of 3 bottles: NDC 0517-0830-03 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.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

LATANOPROST- LATANOPROST SOLUTION
AMERICAN REGENT, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LATANOPROST OPHTHALMIC SOLUTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LATANOPROST OPHTHALMIC
SOLUTION.LATANOPROST OPHTHALMIC SOLUTION 0.005% INITIAL U.S. APPROVAL:
1996
INDICATIONS AND USAGE
Latanoprost ophthalmic solution is a prostaglandin F
analogue indicated for the reduction of elevated intraocular pressure
in patients with open-angle glaucoma or ocular hypertension. (1) (1)
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s) once daily in the evening. (2) (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing 50 mcg/mL latanoprost (0.005%). (3) (3)
CONTRAINDICATIONS
Known hypersensitivity to latanoprost, benzalkonium chloride, or any
other ingredients in this product. (4) (4)
WARNINGS AND PRECAUTIONS
Pigmentation: pigmentation of the iris, periorbital tissue (eyelid)
and eyelashes can occur. Iris pigmentation likely to be
permanent. (5.1) (5)
Eyelash Changes: gradual change to eyelashes including increased
length, thickness and number of lashes. Usually
reversible. (5.2) (5)
ADVERSE REACTIONS
Most common adverse reactions (≥ 4%) from clinical trials are
blurred vision, burning and stinging, conjunctival hyperemia,
foreign body sensation, itching, increased pigmentation of the iris,
punctate epithelial keratopathy, and upper respiratory
tract infection/cold/flu. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AMERICAN REGENT, INC.
AT 1-800-734-9236 OR FDA AT 1-
800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
_In vitro _studies have shown that precipitation occurs when eye drops
containing thimerosal are mixed with latanoprost. If
such drugs are used, they should be administered at least 5 minutes
apart. (7) (7)
SEE 17 FOR PATIENT COUNSELING INFORMATION. (7)
Revised: 04/2016 (7)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS A