TRAVATAN Z

The recommended dosage is one drop in the affected eye(s) once daily in the evening. TRAVATAN Z should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the IOP-lowering effect.

Reduction of the IOP starts approximately 2 hours after the first administration with maximum effect reached after 12 hours.

TRAVATAN Z may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.

Ophthalmic solution containing travoprost 0.04 mg/mL.

None.

Travoprost is a synthetic prostaglandin F analog. Its chemical name is [1

Travoprost is a clear, colorless to slightly yellow oil that is very soluble in acetonitrile, methanol, octanol, and chloroform. It is practically insoluble in water.

TRAVATAN Z is supplied as sterile, buffered aqueous solution of travoprost with a pH of approximately 5.7 and an osmolality of approximately 290 mOsmol/kg.

TRAVATAN Z contains Active: travoprost 0.04 mg/mL; Inactives: polyoxyl 40 hydrogenated castor oil, purified water, USP,

In clinical studies, patients with open-angle glaucoma or ocular hypertension and baseline pressure of 25 to 27 mmHg, who were treated with TRAVATAN or TRAVATAN Z dosed once daily in the evening, demonstrated 7 to 8 mmHg reductions in IOP. In sub-group analyses of these studies, mean IOP reduction in black patients was up to 1.8 mmHg greater than in non-black patients. It is not known at this time whether this difference is attributed to race or to heavily pigmented irides.

In a multi-center, randomized, controlled trial, patients with mean baseline IOP of 24 to 26 mmHg on TIMOPTIC** 0.5% twice daily who were treated with TRAVATAN dosed daily adjunctively to TIMOPTIC** 0.5% twice daily demonstrated 6 to 7 mmHg reductions in IOP.

TRAVATAN Z is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost (0.04 mg/mL).

TRAVATAN Z is supplied as a 2.5 mL solution in a 4 mL and a 5 mL solution in a 7.5 mL oval natural polypropylene dispenser bottle with a natural polypropylene dropper tip and a turquoise polypropylene or high-density polyethylene overcap.

2.5 mL fill…………………NDC 66758-095-56

5 mL fill……………………NDC 66758-095-75

After opening, TRAVATAN Z can be used until the expiration date on the bottle.

Advise the patient about the potential for increased brown pigmentation of the iris, which may be permanent. Inform the patient about the possibility of eyelid skin darkening, which may be reversible after discontinuation of TRAVATAN Z

Inform the patient about the possibility of eyelash and vellus hair changes in the treated eye during treatment with TRAVATAN Z. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment

Instruct the patient to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions

Advise the patient that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician's advice concerning the continued use of TRAVATAN Z

Contact lenses should be removed prior to instillation of TRAVATAN Z and may be reinserted 15 minutes following its administration

If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes between applications.

**TIMOPTIC is a registered trademark of Merck & Co., Inc.

Manufactured by

Novartis Manufacturing NV

Puurs-Sint-Amands, Belgium for

Sandoz Inc., Princeton, NJ 08540

9107971 US

NDC 66758-095-75 Rx Only

TRAVATAN Z

(travoprost ophthalmic

solution) 0.004%

FOR EYE USE ONLY

5 mL

SANDOZ