Latanoprost Ophthalmic

• Xalatan^®

Do not use this medication if you are allergic to latanoprost.

To make sure you can safely use latanoprost ophthalmic, tell your doctor if you have swelling or infection of your eye.

Latanoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

FDA pregnancy category C. It is not known whether latanoprost ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether latanoprost passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label:

• Iris pigmentation changes [see WARNINGS AND PRECAUTIONS]
• Eyelid skin darkening [see WARNINGS AND PRECAUTIONS]
• Eyelash changes (increased length, thickness, pigmentation, and number of lashes) [see WARNINGS AND PRECAUTIONS]
• Intraocular inflammation (iritis/uveitis) [see WARNINGS AND PRECAUTIONS]
• Macular edema, including cystoid macular edema [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

XALATAN was studied in three multicenter, randomized, controlled clinical trials. Patients received 50 mcg/mL XALATAN once daily or 5 mg/mL active-comparator (timolol) twice daily. The patient population studied had a mean age of 65±10 years. Seven percent of patients withdrew before the 6-month endpoint.

Table 1: Ocular Adverse Reactions and Ocular Signs/Symptoms Reported by 5-15% of Patients Receiving Latanoprost

Less than 1% of the patients treated with XALATAN required discontinuation of therapy because of intolerance to conjunctival hyperemia.

Table 2: Adverse Reactions That Were Reported in 1-5% of Patients Receiving Latanoprost

The ocular event/signs and symptoms of blepharitis have been identified as “commonly observed” through analysis of clinical trial data.

Postmarketing Experience

The following reactions have been identified during postmarketing use of XALATAN in clinical practice. Because they are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to XALATAN, or a combination of these factors, include:

Nervous System disorders: Dizziness; headache; toxic epidermal necrolysis

Eye Disorders: Eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation, and number of eyelashes); keratitis; corneal edema and erosions; intraocular inflammation (iritis/uveitis); macular edema, including cystoid macular edema; trichiasis; periorbital and lid changes resulting in deepening of the eyelid sulcus; iris cyst; eyelid skin darkening; localised skin reaction on the eyelids; conjunctivitis; pseudopemphigoid of the ocular conjunctiva

Respiratory, Thoracic and Mediastinal Disorders: Asthma and exacerbation of asthma; dyspnea

Skin and Subcutaneous Tissue Disorders: Pruritus

Infections and Infestations: Herpes keratitis

Cardiac Disorders: Angina; palpitations; angina unstable

General Disorders and Administration Site Conditions: Chest pain

Read the entire FDA prescribing information for Xalatan (Latanoprost Ophthalmic)

• Glaucoma

Latanoprost is used to treat certain kinds of glaucoma. It is also used to treat a condition called hypertension of the eye. Latanoprost appears to work by increasing the outflow of fluid from the eye. This lowers the pressure in the eye.

latanoprost is available only with your doctor's prescription.

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 latanoprost, the following should be considered:

Allergies

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

Studies on latanoprost have been done only in adult patients, and there is no specific information comparing use of latanoprost in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of latanoprost in the elderly with use in other age groups, latanoprost has been used mostly in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults.

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

• Eye disease, such as iritis or uveitis—Use of latanoprost may make the condition worse

• Eye problems, such as loss of the lens of the eye or
• Intraocular lens (IOL) replacement—May be more prone to an adverse reaction called macular edema

• Kidney disease or
• Liver disease—Higher blood levels of latanoprost may result, which may lead to increased side effects

Do not use this medication while wearing contact lenses. Latanoprost ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using latanoprost ophthalmic before putting your contact lenses in.

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before using the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

• Use only the number of drops your doctor has prescribed.

• Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.

• If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

• Wait at least 10 minutes before using any other eye drops that your doctor has prescribed.

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Tell your doctor right away if you have any eye injury or infection, or if you need to have any type of surgery, especially eye surgery.

Do not use the eye drops if the liquid changes colors or has particles in it.

Store an unopened bottle of latanoprost eye drops in a refrigerator.

Once you have opened and begun using the drops, you may store them at room temperature, away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Do not use the eye drops if it has been longer than 6 weeks since you first opened the bottle. If you still need to use the medication, call your doctor for a new prescription.

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

Do not use other eye medications unless your doctor tells you to.

Usual Adult Dose for Intraocular Hypertension:

One eye drop in the affected eye(s) once a day in the evening

Comments:
-If one dose is missed, treatment should continue with the next dose as normal.
-The dose should not exceed one drop in the affected eye(s) daily as more frequent administration may lessen the intraocular pressure lowering effect.
-Reduction of the intraocular pressure starts approximately 2 to 4 hours after the first administration with the maximum effect reached after 12 hours.
-This drug may be used concomitantly with other topical ophthalmic drugs to lower intraocular pressure.
-If more than one topical ophthalmic drug is being used, each one should be administered at least 5 minutes apart.

Use:
-Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

Usual Adult Dose for Glaucoma (Open Angle):

One eye drop in the affected eye(s) once a day in the evening

Comments:
-If one dose is missed, treatment should continue with the next dose as normal.
-The dose should not exceed one drop in the affected eye(s) daily as more frequent administration may lessen the intraocular pressure lowering effect.
-Reduction of the intraocular pressure starts approximately 2 to 4 hours after the first administration with the maximum effect reached after 12 hours.
-This drug may be used concomitantly with other topical ophthalmic drugs to lower intraocular pressure.
-If more than one topical ophthalmic drug is being used, each one should be administered at least 5 minutes apart.

Use:
-Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

Blurred vision, burning/stinging/itching/redness of the eye, feeling as if something is in the eye, changes in eyelash number/color/length/thickness, eyelid changes/skin darkening, dry eye, lid crusting/discomfort, or increased sensitivity to light may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may slowly (over months to years) cause brown discoloration of the colored portion of the eye (iris). If you are using latanoprost in only one eye, only that iris may change color. This color change may be permanent but the long-term effects are uncertain. Notify your doctor if this occurs and schedule regular eye exams to monitor it.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: eye pain, suspected eye infection (unusual redness or swelling of eyes), rapid vision changes (e.g., loss of vision).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, severe itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.