IYUZEH- latanoprost ophthalmic solution 0.005% solution/ drops

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Thea Pharma Inc.

Vía de administración:

OPHTHALMIC

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

IYUZEH ™ (latanoprost ophthalmic solution) 0.005% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Known hypersensitivity to latanoprost or any other ingredients in this product. Risk Summary There are no adequate and well-controlled studies of IYUZEH 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 (equivalent to 1.3 – 324 times the maximum recommended human ophthalmic dose, on a mg/m 2 basis, assuming 100% absorption) (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 ma

Resumen del producto:

IYUZEH (latanoprost ophthalmic solution) is an opalescent, isotonic, white to slightly yellow solution of latanoprost 50 mcg/mL (0.005%) practically free from foreign particles. It is supplied as a sterile solution in translucent low-density polyethylene single-dose container packaged in foil pouches (5 single-dose containers per pouch). NDC 82584-003-30; Unit-of-Use Carton of 30 Storage: Store at 15°C to 25°C (59°F to 77°F). Store in the original pouch. After the pouch is opened, the single-dose containers may be stored in the opened foil pouch for up to 30 days at room temperature 15°C to 25°C (59°F to 77°F). Patient should be advised to write down the date the foil pouch is opened in the space provided on the pouch. Discard any unused containers 30 days after first opening the pouch.

Estat d'Autorització:

New Drug Application

Fitxa tècnica

IYUZEH- LATANOPROST OPHTHALMIC SOLUTION 0.005% SOLUTION/ DROPS
THEA PHARMA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IYUZEH SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IYUZEH.
IYUZEH (LATANOPROST OPHTHALMIC SOLUTION) 0.005%, FOR TOPICAL
OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
IYUZEH is a prostaglandin F2α 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 0.005% (50 mcg/mL). ( 3)
CONTRAINDICATIONS
Known hypersensitivity to latanoprost 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 (5% to 35%) for IYUZEH are: conjunctival
hyperemia, eye irritation, eye
pruritus, abnormal sensation in eye, foreign body sensation in eyes,
vision blurred and lacrimation
increased. ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT THEA PHARMA INC. AT
1-833-838-4028 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
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 Contact Lens Use
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pr