Pronunciation:

TA-floo-prost

Brand Names:

• Zioptan

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antiglaucoma

Pharmacologic—

Prostaglandin

Uses of This Medicine:

Tafluprost eye drops is used alone or together with other medicines to treat increased pressure in the eye caused by open-angle glaucoma or a condition called hypertension of the eye. Both conditions are caused by high pressure in the eye which can lead to pain or vision changes. This medicine is a prostaglandin.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Because of tafluprost's toxicity, use in children is not recommended.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tafluprost eye drops in the elderly.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Eye lens is missing (aphakia) or
• Eyes lens is torn—Use with caution. May cause more side effects.

• Eye pigmentation (extra color in the eye) or
• Iritis (eye inflammation) or
• Macular edema (swelling in the back of the eye) or
• Uveitis (eye inflammation)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Zioptan™ is a sterile eye solution that does not contain a preservative. After opening the single-use container, use the solution right away and throw away any unused medicine.

Your doctor may order 2 or more eye drops to be used together. You should wait at least 5 minutes before putting another eye drop in the same eye.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops):
  • For glaucoma or hypertension of the eye:
    • Adults—Use one drop in the affected eye once a day in the evening.
    • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Refrigerate the cartons and unopened foil pouches, but do not freeze. After the pouch is opened, keep the single-use containers in the opened foil pouch at room temperature for up to 28 days. Protect the medicine from moisture. Write the date you open the foil pouch in the space provided on the pouch. Throw away any unused medicine 28 days after the pouch is opened for the first time.

Precautions While Using This Medicine:

Your eye doctor will want to examine your eyes at regular visits to make sure that the medicine is working properly and is not causing unwanted effects.

This medicine may cause a brown color in the iris (colored part), eyelid, or eyelashes of your treated eye. Your eyelashes may also become longer, thicker, and darker. Some of these changes may be permanent even if you stop using tafluprost. Check with your doctor if you have any questions about this.

Check with your doctor right away if you have an eye injury, eye infection, or plan to have eye surgery.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Blurred vision

burning, dry, or itching eyes

decreased vision

eye discharge or excessive tearing

eye pain

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Headache

stinging or irritation of the eye

Less common

Cough

darker color of the eyelashes

dry eyes

increased growth of the eyelashes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.