United States - English - NLM (National Library of Medicine)

cipla usa inc. - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride ophthalmic solution usp, 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. olopatadine hydrochloride ophthalmic solution usp, 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution usp, 0.1%.

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride ophthalmic solution, 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. olopatadine hydrochloride ophthalmic solution, 0.1 % is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution, 0.1%.

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride ophthalmic solution usp 0.1 % is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. olopatadine hydrochloride ophthalmic solution 0.1 % is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution.

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride ophthalmic solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis. none. teratogenic effects: pregnancy category c olopatadine was found not to be teratogenic in rats and rabbits. however, rats treated at 600 mg/kg/day, or 150,000 times the mrohd and rabbits treated at 400 mg/kg/day, or approximately 100,000 times the mrohd, during organogenesis showed a decrease in live fetuses. in addition, rats treated with 600 mg/kg/day of olopatadine during organogenesis showed a decrease in fetal weight. further, rats treated with 600 mg/kg/day of olopatadine during late gestation through the lactation period showed a decrease in neonatal survival and body weight. 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

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride ophthalmic solution usp, 0.2 % is indicated for the treatment of ocular itching associated with allergic conjunctivitis. none. teratogenic effects: pregnancy category c olopatadine was found not to be teratogenic in rats and rabbits. however, rats treated at 600 mg/kg/day, or 150,000 times the mrohd and rabbits treated at 400 mg/kg/day, or approximately 100,000 times the mrohd, during organogenesis showed a decrease in live fetuses. in addition, rats treated with 600 mg/kg/day of olopatadine during organogenesis showed a decrease in fetal weight. further, rats treated with 600 mg/kg/day of olopatadine during late gestation through the lactation period showed a decrease in neonatal survival and body weight. 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

United States - English - NLM (National Library of Medicine)

eci pharmaceuticals, llc - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride ophthalmic solution, usp 0.1 % is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. olopatadine hydrochloride ophthalmic solution, usp 0.1 % is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution, usp 0.1 %.

United States - English - NLM (National Library of Medicine)

westminster pharmaceuticals, llc - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride ophthalmic solution, usp 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. olopatadine hydrochloride ophthalmic solution, usp 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution, usp 0.1%.

United States - English - NLM (National Library of Medicine)

direct rx - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride ophthalmic solution usp 0.1 % is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. olopatadine hydrochloride ophthalmic solution 0.1 % is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution.

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride ophthalmic solution, usp 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. olopatadine hydrochloride ophthalmic solution, usp 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution, usp 0.1%.

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals llc - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride (hcl) nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older. none. risk summary published data from postmarketing experience with antihistamines, with similar mechanism of action to olopatadine hcl, have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, there are no published human data specific to olopatadine hcl. in animal reproductive studies, oral administration of olopatadine hydrochloride to pregnant rats and rabbits caused a decrease in the number of live fetuses at maternal doses approximately 110 and 1,460 times the maximum recommended human daily intranasal dose (mrhdid) on a mg/m2 basis, respectively (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. animal data in an oral embryo-fetal development study, pregnant rabbits were dosed throughout the period of organogenesis at doses up to 400 mg/kg/day. a decrease in the number of live fetuses was observed at 400 mg/kg/day (1,460 times the mrhdid, on a mg/m2  basis). in an oral embryo-fetal development study, pregnant rats were dosed throughout the period of organogenesis at doses up to 600 mg/kg/day. maternal toxicity, producing death and reduced maternal body weight gain was observed at 600 mg/kg/day (approximately 1,100 times the mrhdid on a mg/m2  basis). olopatadine produced cleft palate at 60 mg/kg/day (approximately 110 times the mrhdid on a mg/m2  basis) and decreased embryo-fetal viability and reduced fetal weight in rats at 600 mg/kg/day (approximately 1,100 times the mrhdid on a mg/m2  basis). in peri-/postnatal toxicity studies, pregnant rats received oral doses of olopatadine up to 600 mg/kg/day during late gestation and throughout the lactation period. olopatadine produced decreased neonatal survival at 60 mg/kg/day (approximately 110 times the mrhdid on a mg/m2  basis) and reduced body weight gain in pups at 4 mg/kg/day (approximately 7 times the mrhdid on a mg/m2  basis). these effects appeared attributable to exposure of pups via the milk as demonstrated in a cross-fostered study in which pups of untreated dams cross-fostered to dams treated with 60 mg/kg/day olopatadine orally during the lactation period exhibited decreased body weight gain. risk summary there are no data on the presence of olopatadine in human milk, the effects on the breastfed infant, or the effects on milk production. although orally administered olopatadine is present in rat milk, there is no information about nasally administered olopatadine. it is not known whether topical nasal administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for olopatadine hcl and any potential adverse effects on the breast fed infant from olopatadine hcl or from the underlying maternal condition. the safety and effectiveness of olopatadine hcl for the relief of symptoms of seasonal allergic rhinitis have been established in pediatric patients aged 6 years and older. the safety and effectiveness of olopatadine hcl in pediatric patients 6 to 11 years of age are supported by 3 vehicle-controlled 2-week studies in 870 patients [see adverse reactions (6.1)] . doses studied included one and two sprays per nostril twice daily. one of these studies evaluated the safety of olopatadine hcl at doses of one and two sprays per nostril twice daily in 1,188 patients, of which 298 patients were exposed to olopatadine hcl 1 spray, and 297 patients were exposed to vehicle 1 spray. in this study, the incidence of epistaxis with olopatadine hcl use was 5.7% [see adverse reactions (6.1), clinical studies (14)] . the safety and effectiveness of olopatadine hcl in pediatric patients aged 12 years and older are supported by 3 randomized, double blind, parallel group, multicenter, placebo-controlled clinical trials of 2 weeks duration in adult and adolescent patients [see clinical studies (14)] . in these studies, the incidence of epistaxis with olopatadine hcl use in 587 patients was 3.2% [see adverse reactions (6.1)] . the safety and effectiveness of olopatadine hcl have not been established in pediatric patients under 6 years of age. the safety of olopatadine hcl at a dose of one spray per nostril twice daily was evaluated in one 2-week vehicle-controlled study in 132 pediatric patients 2 to 5 years of age with allergic rhinitis. in this trial, 66 patients were exposed to olopatadine hcl. the most common (greater than 1.0%) adverse reactions reported were diarrhea (9.1%), epistaxis (6.1%), rhinorrhea (4.5%), bitter taste (3.0%), and wheezing (3.0%). diarrhea was reported more frequently (9.1%) in patients 2 to 5 years of age than 6 to 11 year old age group (< 1%). clinical studies of olopatadine hcl 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. olopatadine hydrochloride (oh” loe pat’ a deen hye” droe klor’ ide) nasal spray, for intranasal use this instructions for use contains information on how to use olopatadine hcl nasal spray. read this instructions for use that comes with olopatadine hcl nasal spray before you start using it and each time you get a refill. there may be new information. this information does not take the place of talking with your healthcare provider about your medical condition or treatment. olopatadine hcl nasal spray is for use in your nose only. do not spray olopatadine hcl nasal spray in your eyes or mouth. important information you need to know before using olopatadine hcl nasal spray - use olopatadine hcl nasal spray exactly how your healthcare provider tells you to use it. - your olopatadine hcl nasal spray bottle must be shaken and primed before you use it for the first time and when you have not used it for more than 7 days. - throw away olopatadine hcl nasal spray after 240 sprays after the first priming. even though the bottle may not be completely empty, you may not get the correct dose of medicine if you continue to use it. using olopatadine hcl nasal spray step 1. remove the white plastic overcap and the white safety clip just under the “shoulders” of the pump (see figure a ). figure a step 2. hold the bottle and press down on the shoulders of the nasal applicator with your forefinger and middle finger. - support the bottom of the bottle with your thumb (see figure b ). prime the bottle by pressing and releasing the shoulders of the bottle down firmly 5 times or until you see a fine mist come out of the nasal applicator. - now your pump is primed and ready to use. - if you do not use olopatadine hcl nasal spray for more than 7 days, you will need to prime the bottle again by pressing and releasing the shoulders of the bottle down firmly 2 times or until you see a fine mist come out of the nasal applicator. figure b step 3. gently blow your nose to clear your nostrils. hold 1 nostril closed with a finger. tilt your head down (chin toward chest) and insert the nasal applicator into a nostril. hold the bottle upright with the nasal applicator tip pointing away from the center of the nose (see figure c ). step 4. breathe in gently through your nose. while breathing in, press firmly and quickly on the nasal applicator shoulders to release the spray into your nostril (see figure c ). figure c step 5. breathe out through your mouth. do not tilt your head back or blow your nose right after using olopatadine hcl nasal spray. this may cause you to get a bitter taste in your mouth. step 6. repeat steps 3 through 5 above to deliver a spray in your other nostril. step 7. if your healthcare provider tells you to use 2 sprays in each nostril, repeat steps 3 through 5 for the second spray in each nostril. step 8. wipe the nasal applicator with a clean tissue and replace the plastic cap (see figure d ). figure d cleaning the olopatadine hcl nasal spray nasal applicator step 9. to clean the nasal applicator, remove the plastic cap (see figure e ). if the nasal applicator becomes clogged, do not try to clear it using a pointed object. figure e step 10. gently pull the nasal applicator up to remove it from the bottle (see figure f ). figure f step 11. with the nasal applicator pointing downwards, wash it by running warm tap water into the nasal applicator for about 1 minute (see figure g ). step 12. shake the nasal applicator to remove any water and put the nasal applicator back on the bottle. step 13. prime the bottle again by pressing the shoulders of the bottle down firmly and releasing the shoulders 2 times or until you see a fine mist come out of the white nasal applicator. repeat steps 11 and 12 above if the nasal applicator is still clogged. figure g how should i store olopatadine hcl nasal spray? - store olopatadine hcl nasal spray at room temperature between 39°f to 77°f (4°c to 25°c). - do not use olopatadine hcl nasal spray after the expiration date on the label or box. keep olopatadine hcl nasal spray and all medicines out of the reach of children. for more information about olopatadine hcl nasal spray, call 1-877-835-5472. distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 rev. 04-2021-01 this instructions for use has been approved by the u.s. food and drug administration.