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Sucampo Announces FDA Approval Of An SNDA For RESCULA® (unoprostone Isopropyl)

Important Safety Information

Contraindications

RESCULA is contraindicated in patients with hypersensitivity to unoprostone isopropyl or any other ingredient in this product.

Warnings and precautions

Unoprostone isopropyl ophthalmic solution may gradually increase the pigmentation of the iris. The pigmentation change is believed to be due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. The long term effects of increased pigmentation are not known. Iris color changes seen with administration of unoprostone isopropyl ophthalmic solution may not be noticeable for several months to years. Treatment with RESCULA solution can be continued in patients who develop noticeably increased iris pigmentation. Patients who receive treatment with RESCULA should be informed of the possibility of increased pigmentation which is likely to be permanent.

Unoprostone isopropyl has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as unoprostone isopropyl is administered, but has been reported to be reversible upon discontinuation of unoprostone isopropyl ophthalmic solution in most patients.

RESCULA should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.

Macular edema, including cystoid macular edema, has been reported. RESCULA should be used with caution in aphakic patients, in pseudoaphakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip. Keep bottle tightly closed when not in use. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.

RESCULA contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.

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