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

abbvie pty ltd - ketorolac trometamol, quantity: 5 mg/ml - eye drops, solution - excipient ingredients: sodium chloride; disodium edetate; benzalkonium chloride; octoxinol 40; sodium hydroxide; hydrochloric acid; purified water - acular eye drops are indicated for the short term (2-4 weeks) relief of symptoms of seasonal allergic conjunctivitis. acular eye drops are also indicated for the short term (2-4 weeks) prophylaxis and reduction in inflammation in patients undergoing cataract extraction.

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

allergan, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 4 mg in 1 ml - acular ls  ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery.  acular ls ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation [see adverse reactions ( 6.1 )] . risk summary there are no adequate or well-controlled studies with acular ls in pregnant women. no evidence of teratogenicity has been observed in rats or rabbits with acular ls at clinically relevant doses. risk summary it is not known whether ketorolac when given topically is present in human milk. because many drugs are excreted in human milk, caution should be exercised when acular ls is administered to a nursing woman. safety and effectiveness of ketorolac tromethamine in pediatric patients below the age of 3 have not been established. no overall differences in safety or effectiveness have been observed between elderly and other adult patients.

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

allergan, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - acular ® ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. acular ® ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. acular ® solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation. teratogenic effects.   pregnancy category c ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. these doses are approximately 100 times and 250 times higher respectively than the maximum recommended human topical ophthalmic daily dose of 2 mg (5 mg/ml x 0.05 ml/drop, x 4 drops x 2 eyes) to affected eyes on a mg/kg basis. additionally, when administered to rats after day 17 of gestation at oral doses up to 1.5 mg/kg/day (approximately 40 times the typical human topical ophthalmic daily dos

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

allergan australia pty ltd - ketorolac trometamol -

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

stat rx usa llc - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 5 mg in 1 ml - acular ® ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. acular ® ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. acular ® ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

abbvie sdn bhd - ketorolac tromethamine -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

allergan malaysia sdn bhd - ketorolac tromethamine -

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

newton laboratories, inc. - micrurus corallinus venom (unii: v0s6h36980) (micrurus corallinus venom - unii:v0s6h36980), aconitum napellus (unii: u0nq8555jd) (aconitum napellus - unii:u0nq8555jd), gold (unii: 79y1949pyo) (gold - unii:79y1949pyo), barium carbonate (unii: 6p669d8hq8) (barium cation - unii:v645272hln), atropa belladonna (unii: wqz3g9pf0h) (atropa belladonna - unii:wqz3g9pf0h), crotalus horridus horridus venom (unii: yha2xlj956) (crotalus horridus horridus venom - unii:yha2xlj956), gelsemium sempervirens root (unii: - micrurus corallinus venom 30 [hp_x] in 1 g - macular degeneration  formulated for symptoms of atrophic and neovascular forms of macular degeneration as well as symptoms associated with the macula and retina. formulated for symptoms of atrophic and neovascular forms of macular degeneration as well as symptoms associated with the macula and retina.

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

newton laboratories, inc. - micrurus corallinus venom (unii: v0s6h36980) (micrurus corallinus venom - unii:v0s6h36980), aconitum napellus (unii: u0nq8555jd) (aconitum napellus - unii:u0nq8555jd), gold (unii: 79y1949pyo) (gold - unii:79y1949pyo), barium carbonate (unii: 6p669d8hq8) (barium cation - unii:v645272hln), atropa belladonna (unii: wqz3g9pf0h) (atropa belladonna - unii:wqz3g9pf0h), crotalus horridus horridus venom (unii: yha2xlj956) (crotalus horridus horridus venom - unii:yha2xlj956), gelsemium sempervirens root (unii: - micrurus corallinus venom 30 [hp_x] in 1 ml - macular degeneration  formulated for symptoms of atrophic and neovascular forms of macular degeneration as well as symptoms associated with the macula and retina. formulated for symptoms of atrophic and neovascular forms of macular degeneration as well as symptoms associated with the macula and retina.

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

rebel distributors corp. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 5 mg in 1 ml - indications and usage acular® ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. acular® ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. contraindications acular® ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.