Travoprost Ophthalmic

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Pregnancy Category: C

Lactation: distributed in milk in animals; caution if used in nursing women

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Avoid using too much of this medication, which can actually make it less effective in lowering the pressure inside the eye.

Avoid using any eyedrop medicine that has not been prescribed by your doctor.

There may be other drugs that can affect travoprost ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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 travoprost, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to travoprost 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.

Pediatric

Because of travoprost's side effects, use in children younger than 16 years of age is not recommended.

Geriatric

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

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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 travoprost. Make sure you tell your doctor if you have any other medical problems, especially:

• Eye infection (bacterial keratitis) or
• Eye lens problems or
• Macular edema (swelling in the back part of the eye) or
• Uveitis (eye inflammation)—Use with caution. May make these conditions worse.

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:

• Eye pain
• itching eye
• redness of the eye
• redness, swelling, or itching of eyelid

• Blurred or decreased vision
• burning, dry, or itching eyes
• eye color changes
• 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:

• Eye discomfort
• feeling of having something in the eye

• Acid or sour stomach (heartburn or indigestion)
• blood in the urine
• chest pain or tightness
• dry eyes
• eye discharge or excessive tearing
• faintness or lightheadedness when getting up from a lying or sitting position
• loss of bladder control
• lower back pain
• muscle pain or stiffness
• pain, swelling, or redness in the joints
• pain or burning while urinating
• pelvic pain
• slow or irregular heartbeat (less than 50 beats per minute)

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.

Travoprost is used to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases (e.g., ocular hypertension). Lowering high pressure inside the eye can help prevent blindness. This medication works by regulating the flow of fluid within the eye to maintain a normal pressure.

How to use Travoprost 0.004 % Eye Drops

Read the Patient Information Leaflet if available from your pharmacist before you start using travoprost and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Apply this medication in the affected eye(s)as directed by your doctor, usually once a day in the evening. Do not use travoprost more often because it will not work as well.

To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

Remove contact lenses before using this medication if your brand contains the preservative benzalkonium chloride. This preservative can be absorbed by contact lenses. Wait at least 15 minutes after using this medication before putting your lenses back in.

Tilt your head back, look upward and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed.

Do not rinse the dropper. Replace the dropper cap after each use.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. It is important to continue using travoprost even if you feel well. Most people with glaucoma or high pressure in the eye do not have symptoms.

Before using travoprost, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (e.g., bimatoprost, latanoprost); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (e.g., macular edema, iritis, uveitis, lens extraction/aphakia).

If you develop an eye infection or injury, or have eye surgery, check with your doctor about the continued use of your current bottle of travoprost. You may be advised to start using a new bottle.

This drug may cause temporary blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.