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

sandoz inc - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost 0.3 mg in 1 ml - bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. bimatoprost ophthalmic solution is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see adverse reactions (6.2)]. risk summary there are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. there is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. in embryofetal development studies, administration of bimatoprost to pregnant mice and rats during organogenesis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on the area under the curve (auc). these adverse effects were not observed at 2.6 time

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

lupin pharmaceuticals, inc. - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost 0.3 mg in 1 ml - bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. bimatoprost ophthalmic solution, 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see adverse reactions (6.2)] . risk summary there are no adequate and well-controlled studies of bimatoprost ophthalmic solution, 0.03% administration in pregnant women. there is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. in embryofetal developmental studies, administration of bimatoprost in pregnant mice and rats during organogensis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure at the recommended clinical dose (based on blood area under the curve [auc] levels). these adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure at the recommended

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

lupin limited - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost 0.3 mg in 1 ml - bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. none teratogenic effects:   in embryo/fetal developmental studies in pregnant mice and rats, abortion was observed at oral doses of bimatoprost which achieved at least 33 or 97 times, respectively, the maximum intended human exposure based on blood auc levels. at doses at least 41 times the maximum intended human exposure based on blood auc levels, the gestation length was reduced in the dams, the incidence of dead fetuses, late resorptions, peri- and postnatal pup mortality was increased, and pup body weights were reduced. there are no adequate and well-controlled studies of bimatoprost ophthalmic solution, 0.03% administration in pregnant women. because animal reproductive studies are not always predictive of human response. bimatoprost ophthalmic solution, 0.03% should be administered during pregnancy only if the potential benefit justifies the

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

micro labs limited - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. bimatoprost ophthalmic solution 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients  [see adverse reactions ( 6.2)] . risk summary there are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. there is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. in embryofetal developmental studies, administration of bimatoprost in pregnant mice and rats during organogenesis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure at the recommended clinical dose (based on blood area under the curve [auc] levels). these adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure at the recommended clinical dose. in pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis to the end of lactation resulted in reduced gestation length and fetal body weight, and increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure at the recommended clinical dose (based on blood auc levels).  no adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure at the recommended clinical dose (based on blood auc levels). because animal reproductive studies are not always predictive of human response bimatoprost ophthalmic solution 0.03% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. data animal data in an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure at the recommended human ophthalmic dose [rhod], based on auc). the no observed adverse effect level (noael) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure at the rhod, based on auc). no abnormalities were observed in rat fetuses at doses up to 0.6 mg/kg/day. in an embryofetal development mouse study, abortion and early delivery were observed in pregnant mice administered bimatoprost orally during organogenesis at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure at the rhod, based on auc). the noael for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure at the rhod, based on auc). no abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure at the rhod, based on auc). in a pre/postnatal development study, treatment of pregnant rats with bimatoprost orally from gestation day 7 to lactation day 20 resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at doses greater than or equal to 0.3 mg/kg/day. these effects were observed at exposures at least 41 times the human systemic exposure at the rhod, based on auc. the noael for postnatal development and mating performance of the offspring was 0.1 mg/kg/day (estimated at 14 times the human systemic exposure at the rhod, based on auc). risk summary it is not known whether topical ocular treatment with bimatoprost ophthalmic solution 0.03% could result in sufficient systemic absorption to produce detectable quantities in human milk. in animal studies, bimatoprost has been shown to be present in breast milk of lactating rats at an intravenous dose (i.e., 1 mg/kg) 324 times the rhod (on a m 2 g/m basis), however no animal data is available at clinically relevant doses. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bimatoprost ophthalmic solution, 0.03% and any potential adverse effects on the breastfed child from bimatoprost ophthalmic solution, 0.03%. use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. bimatoprost ophthalmic solution 0.03% before you use bimatoprost ophthalmic solution 0.03% for the first time: 1. check to make sure that the tamper evident ring between the bottle and the cap is not broken (see figure a). if the tamper evident ring is broken or missing, contact your pharmacist. 2. tear off the tamper evident ring (see figure b). 3. to open the bottle, remove the cap by turning it in the counterclockwise direction (see figure c). this instructions for use has been approved by the u.s. food and drug administration. manufactured by: micro labs limited bangalore-560099, india. manufactured for: micro labs usa, inc. somerset, nj 08873 rev.01/2024

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - bimatoprost, quantity: 0.3 mg/ml - eye drops - excipient ingredients: sodium hydroxide; benzalkonium chloride; citric acid monohydrate; hydrochloric acid; dibasic sodium phosphate heptahydrate; purified water; sodium chloride - bimatoprost eye drops are indicated for the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.

Australia - English - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - bimatoprost -

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - bimatoprost 0.1 mg/ml;   - eye drops, solution - 0.1 mg/ml - active: bimatoprost 0.1 mg/ml   excipient: benzalkonium chloride citric acid monohydrate dibasic sodium phosphate heptahydrate hydrochloric acid sodium chloride sodium hydroxide water for injection - bimatoprost actavis is indicated as monotherapy for the reduction of elevated intraocular pressure (iop) in patients with chronic glaucoma or ocular hypertension; or as adjunctive therapy in patients not adequately controlled on other agents.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - bimatoprost 0.3 mg/ml;   - eye drops, solution - 0.3 mg/ml - active: bimatoprost 0.3 mg/ml   excipient: benzalkonium chloride citric acid monohydrate dibasic sodium phosphate heptahydrate hydrochloric acid sodium chloride sodium hydroxide water for injection - bimatoprost actavis is indicated as monotherapy for the reduction of elevated intraocular pressure (iop) in patients with chronic glaucoma or ocular hypertension; or as adjunctive therapy in patients not adequately controlled on other agents.

Australia - English - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - bimatoprost, quantity: 300 microgram/ml - eye drops, solution - excipient ingredients: sodium chloride; citric acid monohydrate; hydrochloric acid; water for injections; dibasic sodium phosphate heptahydrate; sodium hydroxide - for the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers

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

alembic pharmaceuticals inc. - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. bimatoprost ophthalmic solution, 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see adverse reactions 6.2) ]. risk summary there are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. there is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. in embryofetal development studies, administration of bimatoprost to pregnant mice and rats during organogenesis resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on the area under the curve (auc). these adverse effects were not observ