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Acular (Ketorolac Tromethamine Ophthalmic) - Summary

 
 



ACULAR SUMMARY

ACULAR®
(ketorolac tromethamine ophthalmic solution) 0.5%
sterile

ACULAR® (ketorolac tromethamine ophthalmic solution) is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)

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.


See all Acular indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Acular (Ketorolac Ophthalmic)

Regular VEGF Inhibitor Dosing Better in Macular Degeneration
Source: Medscape Ophthalmology Headlines [2014.04.18]
Patients treated with a reactive as-needed approach, rather than a proactive approach, could lose visual acuity that cannot be regained, a new analysis suggests.
Medscape Medical News

Scientists have discovered a potentially novel form of therapy for Age-Related Macular Degeneration that uses a component of our immune system
Source: Eye Health / Blindness News From Medical News Today [2014.04.04]
Scientists at Trinity College Dublin have made a major breakthrough with important implications for sufferers of the eye disease Age-Related Macular Degeneration (AMD), which can cause central...

Macular Degeneration
Source: MedicineNet Cataracts Specialty [2014.01.23]
Title: Macular Degeneration
Category: Diseases and Conditions
Created: 7/23/1999 6:05:00 PM
Last Editorial Review: 1/23/2014 12:00:00 AM

Jetrea Gets FDA Nod for Macular Adhesion
Source: MedPage Today Product Alert [2012.10.19]
WASHINGTON -- The FDA has approved ocriplasmin (Jetrea) as the first nonsurgical treatment for symptomatic vitreomacular adhesion.

'Miniature Telescope' for Eye Approved for Macular Degeneration
Source: MedicineNet Macular Degeneration (Age-Related Type) Specialty [2010.07.07]
Title: 'Miniature Telescope' for Eye Approved for Macular Degeneration
Category: Health News
Created: 7/6/2010 2:10:00 PM
Last Editorial Review: 7/7/2010

more news >>

Published Studies Related to Acular (Ketorolac Ophthalmic)

Prophylactic nepafenac and ketorolac versus placebo in preventing postoperative macular edema after uneventful phacoemulsification. [2012]
randomized clinical trial... CONCLUSIONS: One month after uneventful phacoemulsification, there was no

Comparative evaluation of local infiltration of articaine, articaine plus ketorolac, and dexamethasone on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis. [2011.04]
INTRODUCTION: The inferior alveolar nerve block (IANB) has a poor success rate in patients with irreversible pulpitis. The purpose of this study was to evaluate the effect of ketorolac and dexamethasone infiltration along with standard IANB on the success rate... CONCLUSIONS: Articaine and ketorolac infiltration can increase the success rate of IANB in patients with irreversible pulpitis. None of the tested techniques gave 100% success rate. Copyright (c) 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Ketorolac tromethamine: stereo-specific pharmacokinetics and single-dose use in postoperative infants aged 2-6 months. [2011.03]
OBJECTIVE: We determined the postoperative pharmacokinetics (PK), safety, and analgesic effects of ketorolac in 14 infants (aged <6 months) receiving a single intravenous (IV) administration of racemic ketorolac or placebo. BACKGROUND: Information on the PK of ketorolac in infants is limited. Unblinded studies suggest ketorolac may be useful in infants... CONCLUSION: Stereo-isomer-specific clearance of ketorolac in infants (aged 2-6 months) shows rapid elimination of the analgesic S (-) isomer as reported in infants aged 6-18 months. No adverse effects were seen after a single IV ketorolac dose. (c) 2010 Blackwell Publishing Ltd.

Twice-daily, preservative-free ketorolac 0.45% for treatment of inflammation and pain after cataract surgery. [2011.03]
PURPOSE: To evaluate the efficacy and safety of twice-daily, preservative-free ketorolac 0.45% (Acuvail; Allergan, Inc, Irvine, California, USA) administration for treatment of inflammation and pain after cataract surgery. DESIGN: Prospective, randomized trial... CONCLUSIONS: Twice-daily ketorolac 0.45% was well tolerated and effectively treated inflammation and pain following cataract surgery. Copyright (c) 2011 Elsevier Inc. All rights reserved.

Ketorolac plus tobramycin/dexamethasone versus tobramycin/dexamethasone after uneventful phacoemulsification surgery: a randomized controlled trial. [2011]
BACKGROUND/AIMS: To evaluate the benefit of adding a nonsteroid agent to an antibiotic/steroid combination after uneventful phacoemulsification, adopting a weekly follow-up, to gain insight into the optimal duration of postoperative treatment and to examine whether risk factors for inflammation exist... CONCLUSION: The addition of ketorolac did not seem to offer any additional benefit in terms of inflammation-related signs. Four weeks appeared as an adequate treatment interval. Special attention should be paid to patients with pseudoexfoliation. Copyright (c) 2010 S. Karger AG, Basel.

more studies >>

Clinical Trials Related to Acular (Ketorolac Ophthalmic)

Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity [Enrolling by invitation]
The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or decrease its severity. In this study ACULAR will be compared to a placebo (artificial tear).

The hypothesis would be that ACULAR treatment will decrease the incidence of moderate to severe ROP (grade II and above)by 50%.

An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain [Not yet recruiting]
The purpose of this study is to determine the effectiveness, the safety, and the tolerability of intranasal ketorolac (Sprix) in relieving acute pain in adults ages 18-64 who come to the ED seeking care. Considering all ED visits, pain is the most common chief complaint. Giving intranasal ketorolac (Sprix) after stomach and dental surgeries has been shown to be safe and effective, but no studies have investigated the use of intranasal ketorolac (Sprix) for the treatment of acute pain in the ED.

Ketorolac (Sprix) has several advantages over other drugs commonly given for pain, including opioids. Ketorolac (Sprix) is non-addicting and has fewer side effects than opioids. The administration of ketorolac (Sprix) by other methods, such as IV, intramuscular shot, and oral pill form, has been shown to be safe and effective in treating acute pain.

This study is being done to find out if giving ketorolac (Sprix) as a single dose nasal spray will have the same benefit in decreasing patient's pain.

Disposition of Intravenous Ketorolac [Not yet recruiting]
The purpose of this study is:

- to document ketorolac disposition (concentration/time profile, protein binding,

metabolism) and its covariates following intravenous (iv) administration of ketorolac right after caesarean section and to compare those observations (n=32) with non-pregnant state (n=8) (intra-subject PK comparison)

- to document biochemical tolerance of ketorolac

- to evaluate if optimalisation of ketorolac dose regimen during pregnancy and labor are

appropriated and needed

- to quantify the neonatal exposure to ketorolac through excretion in the breast milk

Pain Control for Intrauterine Device Placement: A Trial of Ketorolac Prior to Intrauterine Device Placement [Recruiting]
Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs (Mirena IUD and Paragard IUD). Ketorolac has not been studied in regards to decreasing pain during and after IUD insertion although it is used by some providers for this purpose. It is a strong NSAID that is indicated for the treatment of moderate acute pain. In the intramuscular form it has an analgesia onset of action at 30min, thus may be a plausible option for pain management in the office setting compared to oral NSAIDs, which have a longer time to onset of analgesia and have not been proven to be effective in reducing pain associated with IUD placement. The primary aim of this study is to determine whether ketorolac (Toradol) decreases pain associated with intrauterine device placement compared to placebo. We hypothesize that administration of ketorolac 30mg intramuscularly at least 30 minutes prior to IUD insertion will decrease pain scores by at least 20mm on a visual analog scale at various time points during IUD insertion when compared to placebo of normal saline injection.

Study of Whether 15 mg Dose of Ketorolac IV is as Effective as a 30 mg Dose. [Recruiting]
The primary aim of this study is to show the non-inferiority of 15 mg intraoperative dose of ketorolac as compared to the standard 30 mg ketorolac by looking at the VAS scores 4 hours after an adult spine surgery.

more trials >>


Page last updated: 2014-04-18

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