Olopatadine Nasal Spray

Olopatadine nasal spray may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

1. bitter taste

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

1. sores inside the nose
2. a hole in the nasal septum (the wall between the two nostrils)

Olopatadine nasal spray may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 light, 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

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Olopatadine Hydrochloride Nasal Solution (Nasal Spray) is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older.

Administer olopatadine hydrochloride nasal solution (nasal spray) by the intranasal route only.

Adults and Adolescents 12 years of age and older

The recommended dosage is two sprays per nostril twice daily.

Children 6 to 11 years of age

The recommended dosage is one spray per nostril twice daily.

Administration Information

Priming: Before initial use, prime olopatadine hydrochloride nasal solution (nasal spray) by releasing 5 sprays or until a fine mist appears. When olopatadine hydrochloride nasal solution (nasal spray) has not been used for more than 7 days, re-prime by releasing 2 sprays. Avoid spraying olopatadine hydrochloride nasal solution (nasal spray) into the eyes.

Olopatadine Hydrochloride Nasal Solution (Nasal Spray) is a nasal spray solution supplied in a white plastic bottle with a metered-dose manual spray pump, a white nasal applicator, safety clip and a translucent overcap. Each spray (100 microliters) delivers 665 mcg of olopatadine hydrochloride.

None.

Pregnancy

Pregnancy Category C
No adequate and well-controlled studies in pregnant women have been conducted. Animal reproductive studies in rats and rabbits revealed treatment-related effects on fetuses or pups. Because animal studies are not always predictive of human responses, olopatadine hydrochloride nasal solution (nasal spray) should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.

A decrease in the number of live fetuses was observed in rabbits and rats at the oral olopatadine doses approximately 88 times and 100 times the maximum recommended human dose (MRHD) and above, respectively, for adults on a mg/m2 basis. In rats, viability and body weights of pups were reduced on day 4 post partum at the oral dose approximately 100 times the MRHD for adults on a mg/m2 basis, but no effect on viability was observed at the dose approximately 35 times the MRHD for adults on a mg/m2 basis.

Nursing Mothers

Olopatadine has been identified in the milk of nursing rats following oral administration. It is not known whether topical nasal administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk. Olopatadine hydrochloride nasal solution (nasal spray) should be used by nursing mothers only if the potential benefit to the patient outweighs the potential risks to the infant.

Pediatric Use

The safety and effectiveness of olopatadine hydrochloride nasal solution (nasal spray) has not been established for patients under 6 years of age. The safety of Olopatadine Nasal Spray was evaluated in 3 vehicle-controlled 2-week studies in 870 patients 6 to 11 years of age [see Adverse Reactions (6.1)]. Doses studied included 1 and 2 sprays per nostril twice daily. One of these studies evaluated the safety of olopatadine hydrochloride nasal solution (nasal spray) at doses of 1 and 2 sprays per nostril twice daily in 1188 patients, of which, 298 patients were exposed to olopatadine hydrochloride nasal solution (nasal spray) 1 spray and 297 patients were exposed to vehicle 1 spray. In this study, the incidence of epistaxis with olopatadine hydrochloride nasal solution (nasal spray) treatment was 5.7%, compared to 3.2% seen in adult and adolescent studies. This study also evaluated the effectiveness of olopatadine hydrochloride nasal solution (nasal spray) in patients 6 through 11 years of age with seasonal allergic rhinitis [see Clinical Studies (14)].

The safety of olopatadine hydrochloride nasal solution (nasal spray) at a dose of 1 spray per nostril twice daily was evaluated in one 2-week vehicle-controlled study in 132 children ages 2 to 5 years of age with allergic rhinitis. In this trial, 66 patients (28 females and 38 males) were exposed to olopatadine hydrochloride nasal solution (nasal spray). The racial distribution of patients receiving olopatadine hydrochloride nasal solution (nasal spray) was 66.7% white, 27.3% black, and 6.4% other. Two patients exposed to vehicle nasal spray discontinued due to an adverse reaction (1 patient with pneumonia and 1 patient with rhinitis) compared to no patients exposed to olopatadine hydrochloride nasal solution (nasal spray). The most common (greater than 1.0%) adverse events reported were diarrhea (9.1%), epistaxis (6.1%), rhinorrhea (4.5%), bitter taste (3.0%) and wheezing (3.0%). Diarrhea was reported less frequently (< 1%) in the 6 to 11 year old age group.

The incidence of epistaxis was higher in the pediatric population (5.7% in 6 to 11 year old patients and 6.1% in 2 to 5 year old patients) compared to the adult and adolescent population (3.2%).

Geriatric Use

Clinical studies of olopatadine hydrochloride nasal solution (nasal spray) did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.