LATANOPROST solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

FDC Limited

Manustamisviis:

OPHTHALMIC

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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: Pregnancy Category C. 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 wom

Toote kokkuvõte:

Latanoprost Sterile Ophthalmic Solution is a clear, isotonic, buffered, preserved colorless solution of latanoprost 0.005% (50 mcg/mL). It is supplied as a 2.5 mL solution filled in a 5 mL translucent low density polyethylene bottle with insert cap assembly comprising of a turquoise coloured, high density polyethylene screw cap over a low density polyethylene nozzle with tamper evident Low density polyethylene dust cover sealing the bottle cap. 2.5 mL fill, 0.005% (50 mcg/mL) : Package of 1 bottle : NDC: 55545-1010-1 Storage: Protect from light. Store unopened bottle(s) under refrigeration at 2° to 8°C (36° 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.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

LATANOPROST- LATANOPROST SOLUTION
FDC LIMITED
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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)
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s) once daily in the evening. (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing 50 mcg/mL latanoprost (0.005%). (3)
CONTRAINDICATIONS
Known hypersensitivity to latanoprost, benzalkonium chloride, or any
other ingredients in this product. (4)
WARNINGS AND PRECAUTIONS
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 )
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 keratitis, and upper respiratory tract
infection/nasopharyngitis/influenza. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FDA AT 1-800-FDA-1088
OR _WWW.FDA.GOV/MEDWATCH._ (6)
DRUG INTERACTIONS
_In vitro_ studies have shown that precipitation occurs when eye drops
containing thimerosal are mixed with Latanoprost
Ophthalmic Solution. If such drugs are used, they should be
administered at least 5 minutes apart. (7)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2019
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 Pigm