Olopatadine Ophthalmic Solution

Do not share this medication with others.

Store the US product between 39-77 degrees F (4-25 degrees C) away from light and moisture. Do not store in the bathroom.Store the Canadian product between 39-86 degrees F (4-30 degrees C) away from light and moisture. Do not store in the bathroom.Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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Reviewed on 4/16/2014 References

Olopatadine hydrochloride ophthalmic solution, 0.1% is for topical use only and not for injection or oral use.

Information for Patients

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

Patients should be advised not to wear a contact lens if their eye is red. Olopatadine hydrochloride ophthalmic solution, 0.1% should not be used to treat contact lens related irritation. The preservative in olopatadine hydrochloride ophthalmic solution, 0.1%, 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 ten minutes after instilling olopatadine hydrochloride ophthalmic solution, 0.1% before they insert their contact lenses.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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 40 µL drop size, these doses were 78,125 and 31,250 times higher than the maximum recommended ocular human dose (MROHD). 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. Olopatadine administered to male and female rats at oral doses of 62,500 times MROHD level resulted in a slight decrease in the fertility index and reduced implantation rate; no effects on reproductive function were observed at doses of 7,800 times the maximum recommended ocular human use level.

Pregnancy

Pregnancy Category C. Olopatadine was found not to be teratogenic in rats and rabbits. However, rats treated at 600 mg/kg/day, or 93,750 times the MROHD and rabbits treated at 400 mg/kg/day, or 62,500 times the MROHD, during organogenesis showed a decrease in live fetuses. There are, however, no adequate and well controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.

Nursing Mothers

Olopatadine has been identified in the milk of nursing rats following oral administration. 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 olopatadine hydrochloride ophthalmic solution, 0.1% is administered to a nursing mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

Geriatric Use

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

The recommended dose is one drop in each affected eye two times per day at an interval of 6 to 8 hours.

An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well. To help prevent interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking.

To find out how olopatadine might interact with something else you’re taking, talk to your doctor or pharmacist.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking. Drug warnings

Pregnant women

This drug is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should only be used if the potential benefit justifies the potential risk to the fetus.

Women who are breast-feeding

This drug may pass into breast milk and may cause side effects in a child who is breast-fed.

Talk to your doctor if you breast-feed your child. You may need to decide whether to stop breast-feeding or stop taking this medication.

When to call the doctor

Call your doctor if:

• Your allergy symptoms are not controlled after using this drug.
• You become pregnant while using this drug.

Allergies

This drug can cause a severe allergic reaction. Symptoms can include:

• trouble breathing
• swelling of your throat or tongue

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).