INDICATIONS AND USAGE

IYUZEH™ (latanoprost ophthalmic solution) 0.005% is a prostaglandin F2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Known hypersensitivity to latanoprost or any other ingredients in this product.

WARNINGS AND PRECAUTIONS

IYUZEH may cause changes to pigmented tissues. Most frequently reported changes are increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as IYUZEH is administered. Iris pigmentation is likely to be permanent. Eyelid skin darkening and eyelash changes may be reversible.

IYUZEH may cause gradual change to eyelashes including increased length, thickness, and number of lashes. These changes are usually reversible upon discontinuation of treatment.

IYUZEH should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.

IYUZEH should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Reactivation of herpes simplex keratitis has been reported during treatment with latanoprost. IYUZEH should be used with caution in patients with a history of herpetic keratitis.

Contact lenses should be removed prior to the administration of IYUZEH and may be reinserted 15 minutes after administration.

ADVERSE REACTIONS

The 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.

DRUG INTERACTIONS

The combined use of two or more prostaglandins or prostaglandin analogs including IYUZEH is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP.

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