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

akorn - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride 25 mg in 1 ml - phenylephrine hydrochloride ophthalmic solution, usp 2.5% and 10%, is indicated to dilate the pupil. phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients. phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients [see dosage and administration (2.2)] . animal reproduction studies have not been conducted with topical phenylephrine. it is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human breast milk. because many drugs are excreted in human milk, caution should be exercised when phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is administered to a nursing woman. phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age [see contraindications (4.2) ]. no overall differences in safety and effectiveness have been observed between elderly and younger adult patients.

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

omeros corporation - phenylephrine (unii: 1ws297w6mv) (phenylephrine - unii:1ws297w6mv), ketorolac (unii: yzi5105v0l) (ketorolac - unii:yzi5105v0l) - phenylephrine 10.16 mg in 1 ml - omidria ® is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. omidria is contraindicated in patients with a known hypersensitivity to any of its ingredients. risk summary there are no available data on omidria use in pregnant women or animals to inform any drug-associated risks. oral administration of ketorolac to rats during late gestation produced dystocia and increased pup mortality at a dose 740-times the plasma exposure at the recommended human ophthalmic dose (rhod). since human systemic exposure to omidria following a lens replacement procedure is low [ see clinical pharmacology ( 12.3) ], the applicability of animal findings to the risk of omidria in humans during pregnancy is unclear. omidria should be used during pregnancy only if the potential benefit justifies the p

European Union - English - EMA (European Medicines Agency)

rayner surgical (ireland) limited - ketorolac, phenylephrine - lens implantation, intraocular; pain, postoperative - ophthalmologicals - omidria is indicated in adults for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.

Canada - English - Health Canada

aa pharma inc - ketorolac tromethamine - solution - 0.5% - ketorolac tromethamine 0.5% - nonsteroidal anti-inflammatory agents

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

boucher & muir pty ltd - phenylephrine hydrochloride, quantity: 0.1 mg/ml - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; water for injections - phenylephrine hydrochloride is intended for the maintenance of an adequate level of blood pressure during spinal and inhalation anaesthesia. it is also employed to overcome paroxysmal supraventricular tachycardia.

Canada - English - Health Canada

waymade plc - ketorolac tromethamine - tablet - 10mg - ketorolac tromethamine 10mg - other nonsteroidal antiimflammatory agents

Canada - English - Health Canada

novopharm limited - ketorolac tromethamine - tablet - 10mg - ketorolac tromethamine 10mg - other nonsteroidal antiimflammatory agents

Canada - English - Health Canada

ratiopharm inc division of teva canada limited - ketorolac tromethamine - solution - 0.5% - ketorolac tromethamine 0.5% - nonsteroidal anti-inflammatory agents

Canada - English - Health Canada

nu-pharm inc - ketorolac tromethamine - solution - 0.5% - ketorolac tromethamine 0.5% - nonsteroidal anti-inflammatory agents

Canada - English - Health Canada

auro pharma inc - ketorolac tromethamine - solution - 30mg - ketorolac tromethamine 30mg - other nonsteroidal antiimflammatory agents