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

sandoz inc - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine 665 ug in 100 ul - olopatadine hydrochloride nasal spray is an h receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older. none. 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 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 ba

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

somerset therapeutics, llc - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine 1.11 mg in 1 ml - 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, 0.1%. olopatadine hydrochloride ophthalmic solution, 0.1% is for topical use only and not for injection or oral use.

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

wockhardt usa llc. - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine 1 mg in 1 ml - 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 0.1 %.

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

padagis israel pharmaceuticals ltd - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine 665 ug - olopatadine hydrochloride 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 hydrochloride nasal spray, 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 hydrochloride nasal spray. 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 1460 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. data 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 (1460 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 1100 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 1100 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 hydrochloride nasal spray and any potential adverse effects on the breast fed infant from olopatadine hydrochloride nasal spray or from the underlying maternal condition. the safety and effectiveness of olopatadine hydrochloride nasal spray 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 hydrochloride nasal spray 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 hydrochloride nasal spray at doses of one and two sprays per nostril twice daily in 1,188 patients, of which 298 patients were exposed to olopatadine hydrochloride nasal spray 1 spray and 297 patients were exposed to vehicle 1 spray. in this study, the incidence of epistaxis with olopatadine hydrochloride nasal spray use was 5.7% [see adverse reactions (6.1), clinical studies (14)]. the safety and effectiveness of olopatadine hydrochloride nasal spray 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 hydrochloride nasal spray use in 587 patients was 3.2% [see adverse reactions (6.1)] . the safety and effectiveness of olopatadine hydrochloride nasal spray have not been established in pediatric patients under 6 years of age. the safety of olopatadine hydrochloride nasal spray 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 hydrochloride nasal spray. 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 hydrochloride 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. instructions for use olopatadine hydrochloride (oh-loe-pa-ta-deen hye-droe-klor-ide) nasal spray, 665mcg/spray for intranasal use this instructions for use contains information on how to use olopatadine hydrochloride nasal spray. read this instructions for use that comes with olopatadine hydrochloride 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 hydrochloride nasal spray is for use in your nose only. do not spray olopatadine hydrochloride nasal spray in your eyes or mouth. important information you need to know before using olopatadine hydrochloride nasal spray your olopatadine hydrochloride 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 hydrochloride 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 hydrochloride nasal spray step 1. remove the blue plastic cap and the blue clip (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. now your pump is primed and ready to use. if you do not use olopatadine hydrochloride 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 ). step 5. breathe out through your mouth. do not tilt your head back or blow your nose right after using olopatadine hydrochloride 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. figure c step 8. wipe the nasal applicator with a clean tissue and replace the plastic cap and clip (see figure d ). figure d cleaning the olopatadine hydrochloride nasal spray nasal applicator step 9. to clean the nasal applicator, remove the plastic cap and clip (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 hydrochloride nasal spray? do not use olopatadine hydrochloride nasal spray after the expiration date on the label or box. keep olopatadine hydrochloride nasal spray and all medicines out of the reach of children. manufactured by padagis® yeruham, israel 4s000 rc ph6

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

apotex corp. - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine 665 ug - olopatadine hydrochloride nasal solution 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 hydrochloride nasal solution, 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 hydrochloride nasal solution. 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 1460 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.   data 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 (1460 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 1100 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 1100 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 hydrochloride nasal solution and any potential adverse effects on the breast fed infant from olopatadine hydrochloride nasal solution or from the underlying maternal condition. the safety and effectiveness of olopatadine hydrochloride nasal solution 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 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 hydrochloride nasal solution at doses of one and two sprays per nostril twice daily in 1,188 patients, of which 298 patients were exposed to olopatadine hydrochloride nasal solution 1 spray, and 297 patients were exposed to vehicle 1 spray. in this study, the incidence of epistaxis with olopatadine hydrochloride nasal solution use was 5.7% [see adverse reactions (6.1), clinical studies (14)]. the safety and effectiveness of olopatadine hydrochloride nasal solution 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 hydrochloride nasal solution use in 587 patients was 3.2% [see adverse reactions (6.1)].   the safety and effectiveness of olopatadine hydrochloride nasal solution have not been established in pediatric patients under 6 years of age.   the safety of olopatadine hydrochloride nasal solution 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 hydrochloride nasal solution. the most common (greater than 1%) adverse events reported were diarrhea (9.1%), epistaxis (6.1%), rhinorrhea (4.5%), bitter taste (3%) and wheezing (3%). 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 hydrochloride nasal solution 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.

Kenya - English - Pharmacy and Poisons Board

ajanta pharma limited ajanta house, charkop, kandivli (west), mumbai - olopatadine hydrochloride - eye drops - olopatadine hydrochloride usp equivalent to… - olopatadine

Kenya - English - Pharmacy and Poisons Board

ajanta pharma limited ajanta house, charkop, kandivli (west), mumbai - olopatadine hydrochloride ophthalmic solution usp - eye drops - olopatadine hydrochloride usp equivalent to… - olopatadine

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

takata pharmaceutical co., ltd. - olopatadine hydrochloride - yellow tablet, diameter: approximately 8.1 mm, thickness: 3.1 mm

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

me pharma co., ltd. - olopatadine hydrochloride - very light yellow tablet, diameter: 6.1 mm, thickness: 2.7 mm

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

sawai pharmaceutical co.,ltd. - olopatadine hydrochloride - very light red tablet, diameter: 7.0 mm, thickness: 2.3 mm