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ACULAR
Overview
What is ACULAR?
What does ACULAR look like?
What are the available doses of ACULAR?
Sorry No records found.
What should I talk to my health care provider before I take ACULAR?
Sorry No records found
How should I use ACULAR?
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.
DOSAGE AND ADMINISTRATION
The recommended dose of ACULAR ophthalmic solution is one drop (0.25 mg) four times a day for relief of ocular itching due to seasonal allergic conjunctivitis.
For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of ACULAR ophthalmic solution should be applied to the affected eye(s) four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.
ACULAR ophthalmic solution has been safely administered in conjunction with other ophthalmic medications such as antibiotics, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.
What interacts with ACULAR?
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What are the warnings of ACULAR?
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What are the precautions of ACULAR?
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What are the side effects of ACULAR?
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What should I look out for while using ACULAR?
CONTRAINDICATIONS
ACULAR ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.
What might happen if I take too much ACULAR?
Sorry No Records found
How should I store and handle ACULAR?
HOW SUPPLIEDACULAR (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light.Rx Only© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.ACULAR (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.® Marks owned by Allergan, Inc.U.S. Pat. 5,110,4938344X71590US11PRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320HOW SUPPLIEDACULAR (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light.Rx Only© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.ACULAR (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.® Marks owned by Allergan, Inc.U.S. Pat. 5,110,4938344X71590US11PRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320HOW SUPPLIEDACULAR (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light.Rx Only© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.ACULAR (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.® Marks owned by Allergan, Inc.U.S. Pat. 5,110,4938344X71590US11PRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320HOW SUPPLIEDACULAR (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light.Rx Only© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.ACULAR (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.® Marks owned by Allergan, Inc.U.S. Pat. 5,110,4938344X71590US11PRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320HOW SUPPLIEDACULAR (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light.Rx Only© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.ACULAR (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.® Marks owned by Allergan, Inc.U.S. Pat. 5,110,4938344X71590US11PRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320HOW SUPPLIEDACULAR (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light.Rx Only© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.ACULAR (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.® Marks owned by Allergan, Inc.U.S. Pat. 5,110,4938344X71590US11PRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320HOW SUPPLIEDACULAR (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light.Rx Only© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.ACULAR (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.® Marks owned by Allergan, Inc.U.S. Pat. 5,110,4938344X71590US11PRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320HOW SUPPLIEDACULAR (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light.Rx Only© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.ACULAR (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.® Marks owned by Allergan, Inc.U.S. Pat. 5,110,4938344X71590US11PRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320HOW SUPPLIEDACULAR (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light.Rx Only© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.ACULAR (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.® Marks owned by Allergan, Inc.U.S. Pat. 5,110,4938344X71590US11PRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320HOW SUPPLIEDACULAR (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light.Rx Only© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.ACULAR (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.® Marks owned by Allergan, Inc.U.S. Pat. 5,110,4938344X71590US11PRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320HOW SUPPLIEDACULAR (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light.Rx Only© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.ACULAR (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.® Marks owned by Allergan, Inc.U.S. Pat. 5,110,4938344X71590US11PRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320HOW SUPPLIEDACULAR (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light.Rx Only© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.ACULAR (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.® Marks owned by Allergan, Inc.U.S. Pat. 5,110,4938344X71590US11PRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320HOW SUPPLIEDACULAR (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light.Rx Only© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.ACULAR (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.® Marks owned by Allergan, Inc.U.S. Pat. 5,110,4938344X71590US11PRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320HOW SUPPLIEDACULAR (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light.Rx Only© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.ACULAR (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.® Marks owned by Allergan, Inc.U.S. Pat. 5,110,4938344X71590US11PRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CLINICAL PHARMACOLOGY
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis. Ketorolac tromethamine given systemically does not cause pupil constriction.
Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure. Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms.
Two drops (0.1 mL) of 0.5% ACULAR ophthalmic solution instilled into the eyes of patients 12 hours and 1 hour prior to cataract extraction achieved measurable levels in 8 of 9 patients' eyes (mean ketorolac concentration 95 ng/mL aqueous humor, range 40 to 170 ng/mL). Ocular administration of ketorolac tromethamine reduces prostaglandin E (PGE) levels in aqueous humor. The mean concentration of PGE was 80 pg/mL in the aqueous humor of eyes receiving vehicle and 28 pg/mL in the eyes receiving ACULAR 0.5% ophthalmic solution.
One drop (0.05 mL) of 0.5% ACULAR ophthalmic solution was instilled into one eye and one drop of vehicle into the other eye TID in 26 normal subjects. Only 5 of 26 subjects had a detectable amount of ketorolac in their plasma (range 10.7 to 22.5 ng/mL) at Day 10 during topical ocular treatment. When ketorolac tromethamine 10 mg is administered systemically every 6 hours, peak plasma levels at steady state are around 960 ng/mL.
Two controlled clinical studies showed that ACULAR ophthalmic solution was significantly more effective than its vehicle in relieving ocular itching caused by seasonal allergic conjunctivitis.
Two controlled clinical studies showed that patients treated for two weeks with ACULAR ophthalmic solution were less likely to have measurable signs of inflammation (cell and flare) than patients treated with its vehicle.
Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.
Non-Clinical Toxicology
CONTRAINDICATIONSACULAR ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.
WARNINGS
There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.
PRECAUTIONS
General:
All topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDS and topical steroids may increase the potential for healing problems.
Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.
Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients.
Postmarketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.
It is recommended that ACULAR ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
ADVERSE REACTIONS
The most frequent adverse events reported with the use of ketorolac tromethamine ophthalmic solutions have been transient stinging and burning on instillation. These events were reported by up to 40% of patients participating in clinical trials.
Other adverse events occurring approximately 1% - 10% of the time during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, superficial keratitis, and superficial ocular infections.
Other adverse events reported rarely with the use of ketorolac tromethamine ophthalmic solutions included: corneal infiltrates, corneal ulcer, eye dryness, headaches, and visual disturbance (blurry vision).
Clinical Practice:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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