Travoprost Ophthalmic Solution

Travoprost is a synthetic prostaglandin F2α analog. Its chemical name is [1R-[1 (Z),2 (1E,3R*),3α,5 α]]-7-[3,5-Dihydroxy-2-[3-hydroxy-4-[3-(trifluoromethyl) phenoxy]-1­-butenyl]cyclopentyl]-5-heptenoic acid, 1-methylethylester. It has a molecular formula of C26H35F3O6 and a molecular weight of 500.55. The chemical structure of travoprost is:

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.

IZBA (travoprost ophthalmic solution) 0.003% is supplied as sterile, isotonic, buffered aqueous solution of travoprost with a pH of approximately 6.8 and an osmolality of approximately 290 mOsmol/kg.

IZBA contains Active: travoprost 0.03 mg/mL; Preservative: POLYQUAD® (polyquaternium-1) 0.01mg/mL; Inactives: boric acid, mannitol, polyoxyethylene 40 hydrogenated castor oil, propylene glycol, sodium chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH) and purified water, USP.

IZBA (travoprost ophthalmic solution) 0.003% is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Dosage Forms And Strengths

Ophthalmic solution containing travoprost 0.03 mg/mL.

Storage And Handling

IZBA (travoprost ophthalmic solution) 0.003% is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost (0.03 mg/mL) supplied in Alcon's oval DROP-TAINER® package system.

IZBA is supplied as a 2.5 mL solution in a 4 mL bottle and a 5 mL solution in a 7.5 mL bottle. The dispenser bottles are made of polypropylene and fitted with a natural color polypropylene dropper tip and a turquoise polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

2.5 mL fill NDC 0065-0000-00
5 mL fill NDC 0065-0000-00

Store at 2° -25°C (36° -77°F).

Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA. Revised: May 2014

Included as part of the PRECAUTIONS section.

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

Travoprost Ophthalmic Solution USP, 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

None

In clinical studies, patients with open-angle glaucoma or ocular hypertension and baseline pressure of 25 to 27 mm Hg who were treated with Travoprost Ophthalmic Solution 0.004% dosed once-daily in the evening demonstrated 7 to 8 mm Hg reductions in intraocular pressure. In subgroup analyses of these studies, mean IOP reduction in black patients was up to 1.8 mm Hg 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 intraocular pressure of 24 to 26 mm Hg on TIMOPTIC* 0.5% BID who were treated with Travoprost Ophthalmic Solution 0.004% dosed QD adjunctively to TIMOPTIC* 0.5% BID demonstrated 6 to 7 mm Hg reductions in intraocular pressure.

Travoprost is used to treat open-angle glaucoma or ocular hypertension (high blood pressure in the eye). Both of these conditions are caused by an increase of pressure in the eye. This can cause eye pain or vision changes, such as vision loss, blind spots, or blurry vision.

Travoprost comes in the form of an ophthalmic solution, or eye drop.

Travoprost is available as a brand-name drug called Travatan Z. It’s also available as a generic drug.

The more common side effects of this drug include eye pain or irritation, blurry vision, dry eyes, tears coming from the eye, or headache.

In some cases, travoprost can cause serious side effects. These can include blurry vision, pink eye, or redness or swelling of the eyelid. This drug can also make your eyes more sensitive to light.

• Darkening of eyes and lashes See Details

• Contact lenses See Details

• Eye infection See Details

• Eye problems See Details

What is travoprost?

Travoprost is a prescription drug. It comes in the form of an ophthalmic solution, or eye drop.

Travoprost is available as a brand-name drug called Travatan Z. It’s also available as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version. Talk to your doctor to see if the generic version will work for you.

Travoprost may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it's used

Travoprost is used to treat open-angle glaucoma or ocular hypertension (high blood pressure in the eye). Both of these conditions are caused by an increase in pressure in the eye. This can cause eye pain or vision changes such as vision loss, blind spots, or blurry vision.

How it works

More Details

More Common Side Effects

The more common side effects of travoprost can include:

• eye pain or irritation

• blurry vision

• dry eyes

• headache

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious Side Effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Eye sensitivity to light

• Blurry vision

• Pink eye (an infection of the eye and inner eyelid). Symptoms can include:

  • eye itching or redness
  • tearing or crusting in the eye

• Redness or swelling of the eyes