ZIOPTAN is indicated for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Select Important Safety Information

ZIOPTAN has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as ZIOPTAN is administered. After discontinuation of ZIOPTAN, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. While treatment with ZIOPTAN can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.

ZIOPTAN may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, color, thickness, shape, and number of lashes. Eyelash changes are usually reversible on discontinuation of treatment.

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

Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin F2α analogs. ZIOPTAN 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.

In clinical trials of patients receiving either preservative-containing or preservative-free ZIOPTAN, the most common pooled adverse reaction observed was conjunctival hyperemia, which was reported in a range of 4% to 20% of patients.

There are no adequate and well-controlled studies in pregnant women. ZIOPTAN should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.

It is not known whether ZIOPTAN or the metabolites of ZIOPTAN are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ZIOPTAN is administered to a nursing woman.

Use in pediatric patients is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.

Dosage and Administration

The recommended dose is 1 drop of ZIOPTAN in the conjunctival sac of the affected eye(s) once daily in the evening.

The dose of ZIOPTAN should not exceed once daily since it has been shown that more frequent administration of prostaglandin analogs may lessen the IOP-lowering effect.

ZIOPTAN may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than 1 topical ophthalmic product is being used, each one should be administered at least 5 minutes apart.

The solution from 1 individual unit of ZIOPTAN is to be used immediately after opening for administration to 1 or both eyes. Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration.

Before prescribing ZIOPTAN, please read the Prescribing Information.