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albertsons companies - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - antihistamine temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander - if solution changes color or becomes cloudy   - if you are sensitive to any ingredient in this product - to treat contact lens related irritation you experience:   - eye pain - changes in vision - increased redness of the eye - itching worsens or lasts for more than 72 hours

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gland pharma limited - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) -

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a-s medication solutions - 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%.

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a-s medication solutions - 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 fe

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hikma specialty usa inc. - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm), mometasone furoate monohydrate (unii: mtw0weg809) (mometasone - unii:8hr4qj6dw8) - ryaltris is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older. ryaltris is contraindicated in patients with known hypersensitivity to any ingredients of ryaltris. hypersensitivity reactions, including wheezing, has occurred after nasal administration of mometasone furoate [see warnings and precautions (5.4)]. risk summary there are no available data on ryaltris or mometasone furoate use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. postmarketing experience with antihistamines, with similar mechanism of action to olopatadine, 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. animal reproduction studies have not been conducted with ryaltris. however, animal reproduction studies are available for olopatadine hydrochloride and mometasone furoate. oral administration of olopatadine hydrochloride to pregnant rats and rabbits caused a decrease in the number of live fetuses at maternal doses approximately 120 and 1600 times the maximum recommended human daily intranasal dose (mrhdid) on a mg/m2 basis, respectively (see data) . in animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1 to 16 times the mrhdid on a mcg/m2 or auc basis (see data) . however, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans. 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 estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data no reproductive toxicology studies were conducted with ryaltris; however, studies are available for olopatadine hydrochloride and mometasone furoate, as described below. olopatadine hydrochloride 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 1200 times the mrhdid on a mg/m2 basis). olopatadine produced cleft palate at 60 mg/kg/day (approximately 120 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 1200 times the mrhdid on a mg/m2 basis). 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 (approximately 1600 times the mrhdid on a mg/m2 basis). in peri-/post-natal 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 120 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. mometasone furoate in an embryo-fetal development study with pregnant mice dosed throughout the period of organogenesis, mometasone furoate produced cleft palate at a dose approximately equivalent to the mrhdid (on a mcg/m2 basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at approximately 4 times the mrhdid (on a mcg/m2 basis with a maternal subcutaneous dose of 180 mcg/kg). no toxicity was observed with a dose that produced an exposure approximately one-half of the mrhdid (on a mcg/m2 basis with maternal topical dermal doses of 20 mcg/kg and above). in an embryo-fetal development study with pregnant rats dosed throughout the period of organogenesis, mometasone furoate produced fetal umbilical hernia at exposures approximately 20 times the mrhdid (on a mcg/m2 basis with maternal topical dermal doses of 600 mcg/kg and above) and delays in fetal ossification at a dose approximately 12 times the mrhdid (on a mcg/m2 basis with maternal topical dermal doses of 300 mcg/kg and above). in another reproductive toxicity study, pregnant rats were dosed with mometasone furoate throughout pregnancy or late in gestation. treated animals had prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at a dose that was approximately equivalent to the mrhdid (on a mcg/m2 basis with a maternal subcutaneous dose of 15 mcg/kg). there were no findings at a dose approximately equivalent to or less than the mrhdid (on a mcg/m2 basis with a maternal subcutaneous dose of 7.5 mcg/kg). embryo-fetal development studies were conducted with pregnant rabbits dosed with mometasone furoate by either the topical dermal route or oral route throughout the period of organogenesis. in the study using the topical dermal route, mometasone furoate caused multiple malformations in fetuses (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at doses approximately 12 times the mrhdid (on a mcg/m2 basis with maternal topical dermal doses of 150 mcg/kg and above). in the study using the oral route, mometasone furoate caused increased fetal resorptions and cleft palate and/or head malformations (hydrocephaly and domed head) at a dose approximately 60 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 700 mcg/kg). at approximately 220 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 2800 mcg/kg), most litters were aborted or resorbed. no effects were observed at a dose approximately 12 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 140 mcg/kg). risk summary there are no available data on the presence of olopatadine or mometasone furoate or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. other corticosteroids similar to mometasone furoate, are excreted in human milk. however, mometasone furoate concentrations in plasma after nasal therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low. 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. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ryaltris and any potential adverse effects on the breast fed infant from ryaltris or from the underlying maternal condition. the safety and effectiveness of ryaltris for the treatment of symptoms associated with seasonal allergic rhinitis have been established in pediatric patients 12 years and older. use of ryaltris for this indication is supported by evidence from adequate and well-controlled studies in adult and pediatric patients 12 years and older [see clinical studies (14)] . the safety and effectiveness of ryaltris in pediatric patients below the age of 12 years have not been established. effect on growth controlled clinical studies have shown that nasal corticosteroids may cause a reduction in growth velocity in pediatric patients. this effect has been observed in the absence of laboratory evidence of hpa axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of hpa axis function. the long-term effects of this reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height, are unknown. the potential for “catch up” growth following discontinuation of treatment with nasal corticosteroids has not been adequately studied. the growth of pediatric patients receiving nasal corticosteroids, including ryaltris, should be monitored routinely (e.g., via stadiometry). the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the risk/benefits of non-corticosteroid treatment alternatives. the potential of mometasone furoate nasal spray 50 mcg to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out. there were 20 patients 65 years of age and older treated with ryaltris in the clinical studies for seasonal allergic rhinitis [see clinical studies (14)] . of the ryaltris-treated patients in these studies, 16 (2.7%) were between 65 to 75 years of age, while 4 (0.7%) were 75 years of age and older. clinical studies of ryaltris did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. no studies have been conducted with ryaltris in patients with hepatic impairment. however, there have been reports of concentrations of mometasone furoate appearing to increase with severity of hepatic impairment [see clinical pharmacology (12.3)]. instructions for use ryaltris (rye - al’ - tris) (olopatadine hydrochloride and mometasone furoate monohydrate nasal spray) important: for use in your nose only. do not spray ryaltris into your eyes or mouth. read the instructions for use before you start to use ryaltris and each time you get a refill.  there may be new information. this instructions for use does not take the place of talking with your healthcare provider about your medical condition or treatment. before you use ryaltris, make sure your healthcare provider shows you the right way to use it. shake the bottle for at least 10 seconds before each use. when ryaltris is not in use, the purple dust cap should always be kept tightly placed on the white nozzle tip. your ryaltris nasal spray bottle (see figure a) figure a preparing the nasal spray bottle before you prime the bottle, shake the bottle for at least 10 seconds. before first use, spray the product 6 times or until a fine mist appears. spray away from your eyes and face. step 1. remove the purple dust cap from the spray nozzle tip of the bottle. (see figure b ) figure b preparing the nasal spray bottle step 2. hold the nasal spray bottle firmly and upright with your index and middle finger on either side of the spray nozzle unit (on finger rests) while supporting the grooved base of the bottle with your thumb. step 3 . before first use, push down on the pump quickly and firmly 6 times, releasing the spray into the air, away from the eyes and face until a fine mist appears. (see figure c) figure c if you do not use ryaltris for 14 or more days, you will need to shake the bottle for at least 10 seconds, and prime the pump with 2 sprays or until a fine mist appears. your ryaltris is now ready for use. using your ryaltris step 4. gently blow your nose to clear your nostrils. (see figure d) figure d step 5. shake the bottle for at least 10 seconds before each use (morning and evening). step 6. hold the bottle firmly with your index and middle finger on either side of the spray nozzle unit (on finger rests) while supporting the grooved base of the bottle with your thumb. (see figure e) figure e step 7. hold 1 nostril closed with a finger. insert the end of the spray nozzle tip into the other nostril, pointing it slightly toward the outside of the nose, away from the nasal septum (the wall between the 2 nostrils). (see figure f) figure f step 8. tilt your head forward slightly. keep the bottle upright and press down one time quickly and firmly on the finger rests to activate the pump. (see figure g) breathe in (inhale) gently through your nose as you spray. then breathe out through your mouth. figure g step 9. repeat steps 6 through 8 and deliver a second spray in the same nostril. step 10. repeat steps 6 through 8 with 2 sprays in the other nostril. step 11 . to prevent any blockage, wipe the white spray nozzle tip with a clean dry tissue or cloth after each use. wipe the white spray nozzletip with a cleandry tissue or cloth. (see figure h) figure h step 12. hold the nozzle unit and push the purple dust cap back on the nozzle until you hear a click. (see figure i) figure i each bottle of ryaltris contains enough medicine for you to spray from the bottle 240 times after the first (initial) priming. you should keep track of the number of sprays used from each bottle of ryaltris. do not count any sprays used for initial priming of the bottle. how to clear the ryaltris nozzle tip if it gets blocked do not try to unblock the spray nozzle tip by inserting a pin or other sharp object. (see figure j ) this will damage the spray nozzle tip, and you may not get the correct dose of medicine. figure j step 13 . remove the spray nozzle unit by gently pulling upward (see figure k ). remove the purple dust cap and place only the spray nozzle unit in warm water to soak. (see figure l ) figure k figure l step 14 . after soaking the spray nozzle tip for 15 minutes, rinse the spray nozzle unit and purple dust cap with warm water and allow them to dry completely. (see figure m) figure m step 15 . place the purple dust cap back on the spray nozzle unit and put spray nozzle unit back on the bottle. (see figure n) figure n step 16 . after following the steps to clear your blocked spray nozzle tip see “priming your ryaltris pump before use” section above and re-prime using 2 sprays. replace the purple dust cap, and your ryaltris is ready for use. repeat the unblocking steps if needed. how should i store ryaltris? store ryaltris at room temperature between 68°f to 77°f (20°c to 25°c). do not freeze or refrigerate. do not use ryaltris after the expiration date on the label or the box. throw away your ryaltris bottle after using 240 sprays after 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. keep ryaltris and all medicines out of the reach of children. distributed by: hikma specialty usa inc. columbus, oh 43228 ryaltris and the ryaltris logo are registered trademarks of glenmark specialty sa

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alcon laboratories, inc. - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - patanol® (olopatadine hydrochloride ophthalmic solution) 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. patanol® (olopatadine hydrochloride ophthalmic solution) 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of patanol. warnings patanol® (olopatadine hydrochloride ophthalmic solution) 0.1% is for topical use only and not for injection or oral use.

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novartis pharmaceuticals corporation - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - patanase is indicated for the relief of the symptoms of seasonal allergic rhinitis (sar) 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 patanase, 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 patanase. 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 r

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micro labs limited - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - antihistamine temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander - if solution changes color or becomes cloudy - if you are sensitive to any ingredient in this product - to treat contact lens related irritation - eye pain - changes in vision - increased redness of the eye - itching worsens or lasts for more than 72 hours

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dolgencorp, llc - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - antihistamine and redness reliever temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander • if solution changes color or becomes cloudy  • if you are sensitive to any ingredient in this product • to treat contact lens related irritation you experience:   - eye pain - changes in vision - increased redness of the eye - itching worsens or lasts for more than 72 hours

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

dolgencorp, llc - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - antihistamine temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander - if solution changes color or becomes cloudy   - if you are sensitive to any ingredient in this product - to treat contact lens related irritation you experience:   - eye pain - changes in vision - increased redness of the eye - itching worsens or lasts for more than 72 hours