الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

akorn - pilocarpine hydrochloride (unii: 0ww6d218xj) (pilocarpine - unii:01mi4q9di3) - pilocarpine hydrochloride ophthalmic solution is indicated for the: none. pregnancy. category c. animal reproduction studies have not been conducted with pilocarpine hydrochloride. it is also not known whether pilocarpine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. pilocarpine hydrochloride ophthalmic solution should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when pilocarpine hydrochloride ophthalmic solution is administered to a nursing woman. safety and effectiveness of pilocarpine hydrochloride ophthalmic solution in pediatric patients have been established. no overall differences in safety or effectiveness have been observed between elderly and younger patients.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

leading pharma, llc - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.1) ]. teratogenic effects. developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥ 2.5 mg/kg/day revealed malformations of the vertebral bodies. these malformations occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased fetal weights. no treatment-related malformations were seen at 1 mg/kg/day. these doses represent estimated plasma cmax levels in rabbits, 37 and 15 times higher than the lower limit of detection in human plasma following ocular administration, respectively. there are no adequate and well-controlled studies in pregnant women. dorzolamide hydrochloride ophthalmic solution should b

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.1) ]. teratogenic effects . pregnancy category c. developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥ 2.5 mg/kg/day revealed malformations of the vertebral bodies. these malformations occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased fetal weights. no treatment-related malformations were seen at 1 mg/kg/day. these doses represent estimated plasma cmax levels in rabbits, 37 and 15 times higher than the lower limit of detection in human plasma following ocular administration, respectively. there are no adequate and well-controlled studies in pregnant women. dorzolamide hydrochloride o

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

micro labs limited - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.1)]. risk summary   there are no adequate and well-controlled studies in pregnant women with dorzolamide hydrochloride ophthalmic solution. dorzolamide caused fetal vertebral malformations when administered orally to rabbits at 2.5 mg/kg/day (37 times the clinical exposure). dorzolamide administered during the period of organogenesis was not teratogenic in rabbits dosed up to 1 mg/kg/day (15 times the clinical exposure). dorzolamide hydrochloride administered orally to rats during late gestation and lactation caused growth delays in offspring at 7.5 mg/kg/day (52 times the clinical exposure). growth was not delayed at 1 mg/kg/day (8.0 times the clinic

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - pilocarpine hydrochloride (unii: 0ww6d218xj) (pilocarpine - unii:01mi4q9di3) - pilocarpine hydrochloride ophthalmic solution is indicated for the: none. pregnancy category c. animal reproduction studies have not been conducted with pilocarpine hydrochloride. it is also not known whether pilocarpine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. pilocarpine hydrochloride ophthalmic solution should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when pilocarpine hydrochloride ophthalmic solution is administered to a nursing woman. safety and effectiveness of pilocarpine hydrochloride ophthalmic solution in pediatric patients have been established.   no overall differences in safety or effectiveness have been observed between elderly and younger patients.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - pilocarpine hydrochloride (unii: 0ww6d218xj) (pilocarpine - unii:01mi4q9di3) - pilocarpine hydrochloride ophthalmic solution is indicated for the: none. pregnancy category c. animal reproduction studies have not been conducted with pilocarpine hydrochloride. it is also not known whether pilocarpine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. pilocarpine hydrochloride ophthalmic solution should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when pilocarpine hydrochloride ophthalmic solution is administered to a nursing woman. safety and effectiveness of pilocarpine hydrochloride ophthalmic solution in pediatric patients have been established.   no overall differences in safety or effectiveness have been observed between elderly and younger patients.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

indoco remedies limited - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide hydrochloride ophthalmic solution, usp is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.1)]. risk summary there are no adequate and well-controlled studies in pregnant women with dorzolamide hydrochloride ophthalmic solution. dorzolamide caused fetal vertebral malformations when administered orally to rabbits at 2.5 mg/kg/day (37 times the clinical exposure). dorzolamide administered during the period of organogenesis was not teratogenic in rabbits dosed up to 1 mg/kg/day (15 times the clinical exposure). dorzolamide hydrochloride administered orally to rats during late gestation and lactation caused growth delays in offspring at 7.5 mg/kg/day (52 times the clinical exposure). growth was not delayed at 1 mg/kg/day (8.0 times the clinical exposure). the backgrou

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

biocon pharma inc. - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide hydrochloride ophthalmic solution, usp is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.1)]. risk summary there are no adequate and well-controlled studies in pregnant women with dorzolamide hydrochloride ophthalmic solution. dorzolamide caused fetal vertebral malformations when administered orally to rabbits at 2.5 mg/kg/day (37 times the clinical exposure). dorzolamide administered during the period of organogenesis was not teratogenic in rabbits dosed up to 1 mg/kg/day (15 times the clinical exposure). dorzolamide hydrochloride administered orally to rats during late gestation and lactation caused growth delays in offspring at 7.5 mg/kg/day (52 times the clinical exposure). growth was not delayed at 1 mg/kg/day (8.0 times the clinical exposure). the backgrou

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

gland pharma limited - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.1)]. risk summary there are no adequate and well-controlled studies in pregnant women with dorzolamide hydrochloride ophthalmic solution. dorzolamide caused fetal vertebral malformations when administered orally to rabbits at 2.5 mg/kg/day (37 times the clinical exposure). dorzolamide administered during the period of organogenesis was not teratogenic in rabbits dosed up to 1 mg/kg/day (15 times the clinical exposure). dorzolamide hydrochloride administered orally to rats during late gestation and lactation caused growth delays in offspring at 7.5 mg/kg/day (52 times the clinical exposure). growth was not delayed at 1 mg/kg/day (8.0 times the clinical exposure). the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data developmental toxicity studies were conducted in pregnant rabbits administered dorzolamide hydrochloride orally during the period of organogenesis from gestation days 6 through 18 at doses of 0.2, 1, 2.5, 5, and 10 mg/kg/day. the developmental lowest observed adverse effect level (loael) was 2.5 mg/kg/day, based on vertebral malformations and decreased fetal body weight. the maternal loael was 2.5 mg/kg/day, based on metabolic acidosis and reduced weight gain. the maternal and developmental no adverse effect levels (noaels) were 1 mg/kg/day. the rabbit doses of 1 and 2.5 mg/kg/day represent estimated plasma cmax levels in rabbits 15 and 37 times higher than the lower limit of detection in human plasma following ocular administration, respectively. dorzolamide hydrochloride was administered orally to rats during late gestation and lactation (gestation day 17 through postpartum day 20) at doses of 0.1, 1, or 7.5 mg/kg/day. the developmental loael was 7.5 mg/kg/day, based on reduced birth weight, reduced weight gain, and a slight delay in postnatal development (incisor eruption, vaginal canalization and eye openings) secondary to lower offspring body weight. this 7.5 mg/kg/day dose represents an estimated plasma cmax level in rats 52 times higher than the lower limit of detection in human plasma following ocular administration. the developmental noael was 1 mg/kg/day. the maternal loael was 1 mg/kg/day, based on reduced body weight gain. the maternal noael was 0.1 mg/kg/day. the rat doses of 1 and 0.1 mg/kg/day represent estimated plasma cmax levels in rats approximately 8.0 times and approximately equal (1x), respectively to the lower limit of detection in human plasma following ocular administration. risk summary there are no data on the presence of dorzolamide hydrochloride ophthalmic solution in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for dorzolamide hydrochloride ophthalmic solution and any potential adverse effects on the breast-fed child from dorzolamide hydrochloride ophthalmic solution. dorzolamide is present in the milk of lactating rats (see data) . data   animal data lactating rats were dosed orally with 7.5 mg/kg/day of dorzolamide hydrochloride; dorzolamide and the n-desethyl metabolite were detected in the milk. safety and effectiveness of dorzolamide hydrochloride ophthalmic solution have been demonstrated in pediatric patients in a 3-month, multicenter, double-masked, active-treatment-controlled trial. no overall differences in safety or effectiveness have been observed between elderly and younger patients. dorzolamide has not been studied in patients with severe renal impairment (crcl < 30 ml/min). because dorzolamide and its metabolite are excreted predominantly by the kidney, dorzolamide hydrochloride ophthalmic solution is not recommended in such patients.  dorzolamide has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

fosun pharma usa inc - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide hydrochloride ophthalmic solution, usp is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions ( 5.1)]. risk summary there are no adequate and well-controlled studies in pregnant women with dorzolamide hydrochloride ophthalmic solution. dorzolamide caused fetal vertebral malformations when administered orally to rabbits at 2.5 mg/kg/day (37 times the clinical exposure). dorzolamide administered during the period of organogenesis was not teratogenic in rabbits dosed up to 1 mg/kg/day (15 times the clinical exposure). dorzolamide hydrochloride administered orally to rats during late gestation and lactation caused growth delays in offspring at 7.5 mg/kg/day (52 times the clinical exposure). growth was not delayed at 1 mg/kg/day (8.0 times the