Pazeo

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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 and squeeze out a drop.
• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.
• Use only the number of drops your doctor has prescribed.
• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

An overdose of olopatadine ophthalmic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use olopatadine ophthalmic if you are allergic to it.

To make sure olopatadine ophthalmic is safe for you, tell your doctor if you have any type of infection in your eye.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether olopatadine ophthalmic passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice.

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of olopatadine eye drops in children. However, safety and efficacy of olopatadine ophthalmic solution and Patanol® have not been established in children younger than 3 years of age, and of Pataday™ and Pazeo™ have not been established in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olopatadine 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Donepezil

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.

• It is used to treat eye irritation due to allergies.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the eye only.
• Wash your hands before and after use.
• Take out contact lenses before using Pazeo. Talk with your doctor to see when lenses may be put back in after this medicine is given. Do not put contacts back in if your eyes are irritated or infected.
• Tilt your head back and drop drug into the eye.
• Do not touch the container tip to the eye, lid, or other skin.
• After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

• Store at room temperature.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

CONTAMINATION OF TIP AND SOLUTION

As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle to prevent contaminating the tip and solution. Keep bottle tightly closed when not in use.

CONTACT LENS USE

Patients should not wear a contact lens if their eye is red. The preservative in Pazeo solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least five minutes after instilling Pazeo before they insert their contact lenses.

PREGNANCY

Risk Summary
There are no adequate or well-controlled studies with Pazeo in pregnant women. Olopatadine caused maternal toxicity and embryofetal toxicity in rats at levels 1,080 to 14,400 times the maximum recommended human ophthalmic dose (MRHOD).  There was no toxicity in rat offspring at exposures estimated to be 45 to 150 times that at MRHOD.  Olopatadine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.


Animal Data
In a rabbit embryofetal study, rabbits treated orally at 400 mg/kg/day during organogenesis showed a decrease in live fetuses. This dose is 14,400 times the MRHOD, on a mg/m2 basis. 


An oral dose of 600 mg/kg/day olopatadine (10,800 times the MRHOD) was shown to be maternally toxic in rats, producing death and reduced maternal body weight gain.  When administered to rats throughout organogenesis, olopatadine produced cleft palate at 60 mg/kg/day (1080 times the MRHOD) and decreased embryofetal viability and reduced fetal weight in rats at 600 mg/kg/day. When administered to rats during late gestation and throughout the lactation period, olopatadine produced decreased neonatal survival at 60 mg/kg/day and reduced body weight gain in offspring at 4 mg/kg/day.  A dose of 2 mg/kg/day olopatadine produced no toxicity in rat offspring.  An oral dose of 1 mg/kg olopatadine in rats resulted in a range of systemic plasma area under the curve (AUC) levels that were 45 to 150 times higher than the observed human exposure [9.7 ng∙hr/mL] following administration of the recommended human ophthalmic dose.

NURSING MOTHERS

Olopatadine has been identified in the milk of nursing rats following oral administration. Oral administration of olopatadine doses at or above 4 mg/kg/day throughout the lactation period produced decreased body weight gain in rat offspring; a dose of 2 mg/kg/day olopatadine produced no toxicity.  An oral dose of 1 mg/kg olopatadine in rats resulted in a range of systemic plasma area under the curve (AUC) levels that were 45 to 150 times higher than the observed human exposure [9.7 ng∙hr/mL] following administration of the recommended human ophthalmic dose. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when Pazeo is administered to a nursing mother.

PEDIATRIC USE

The safety and effectiveness of Pazeo have been established in pediatric patients two years of age and older.  Use of Pazeo in these pediatric patients is supported by evidence from adequate and well-controlled studies of Pazeo in adults and an adequate and well controlled study evaluating the safety of Pazeo in pediatric and adult patients.

GERIATRIC USE

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Carcinogenicity
Olopatadine administered orally was not carcinogenic in mice and rats in doses up to 500 mg/kg/day and 200 mg/kg/day, respectively.  Based on a 35 μL drop size and a 60 kg person, these doses are approximately 4,500 and 3,600 times the MRHOD, on a mg/m2 basis.

Mutagenesis
No mutagenic potential was observed when olopatadine was tested in an in vitro bacterial reverse mutation (Ames) test, an in vitro mammalian chromosome aberration assay or an in vivo mouse micronucleus test.

Impairment of fertility
Olopatadine administered at an oral dose of 400 mg/kg/day (approximately 7,200 times the MRHOD) produced toxicity in male and female rats, and resulted in a decrease in the fertility index and reduced implantation rate.  No effects on reproductive function were observed at 50 mg/kg/day (approximately 900 times the MRHOD).

More Common Side Effects

The more common side effects that can occur with use of Pazeo include:

• blurred vision

• burning or stinging in the eye(s)

• dry eye(s)

• abnormal sensation in the eye(s)

• headache

• changes in the way food tastes

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 pain or itching

• severe irritation in the eye

• change in eyesight