ACULAR ® Ketorolac

ACULAR ® is a drug based on Ketorolac trometamol

THERAPEUTIC GROUP: Non-steroidal anti-inflammatory drugs

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications ACULAR ® Ketorolac

ACULAR ® is used in the prevention and treatment of ocular phlogistic states related to ophthalmic surgery.

Action mechanism ACULAR ® Ketorolac

ACULAR ® is a drug based on ketorolac, an active ingredient belonging to the category of non-selective non-steroidal anti-inflammatory drugs, as it is active both on cyclooxygenase 1 and on 2.

These are enzymes involved in the genesis of the inflammatory process, especially cyclooxygenase 2, from the moment in which, overexpressed in harmful conditions, they mediate the transformation of membrane phospholipids such as arachidonic acid into chemical mediators, known as prostaglandins with oedemic activity, vasopermeability and chemotactic, fundamental in supporting the phlogistic event.

However, topical ophthalmic use of this active ingredient does not end exclusively in the anti-inflammatory action but also has a significant analgesic action, modulating the activity of peripheral pain receptors.

Different studies also show how the reduction of prostaglandin concentrations in the aqueous humor, induced by the local use of Ketorolac, can also contribute to the maintenance of pupillary dilation, reducing the contraction intensity of the pupil constricting muscles, and to the control of the endocular pressure.

From a pharmacokinetic point of view, the ocular instillation of ketorolac trometamol appears to be safe, given the low level of systemic absorption, which allows to minimize the potential side effects commonly associated with systemic therapy with non-steroidal anti-inflammatory drugs.

Studies carried out and clinical efficacy

1.KETOROLAC AND CATARATTA

Sultan Qaboos Univ Med J. 2010 Apr; 10 (1): 57-63. Epub 2010 Apr 17.

Interesting work that demonstrates how topical administration of keterolac through ophthalmic treatment may reduce ocular inflammation while reducing miosis during cataract surgery.

2. THE KETEROLOAC IN THE ALTERNATIVE THERAPY OF THE DIABETIC MACULAR EDEMA

Curr Eye Res. 2011 Aug; 36 (8): 768-73.

Pilot study demonstrating how the intravitreal injection of ketorolac can guarantee an improvement in acuity visit approximately in 30% of patients suffering from diabetic macular edema refractory to laser photocoagulation.

3. KETOROLAC IN LASER THERAPY

Clin Ophthalmol. 2011; 5: 1451-7. Epub 2011 Oct 7.

Work demonstrating the marketing of alternative products to ketorolac in the treatment of ophthalmic pain following laser epithelial keratomileusis interventions. Despite this, ketorolac remains a drug still widely used in these episodes, given the considerable literature on this subject.

Method of use and dosage

ACULAR ®

Eye drops of 0.03 gr of Ketorolac trometamol per 100 ml of solution.

The dosing schedule should be defined by the doctor, based on the pre-set therapeutic goal.

Warnings ACULAR ® Ketorolac

Topical ophthalmic intake of ketorolac should be reserved for cases of real need, limiting its use exclusively in the pre and immediately post-operative phases.

Particular caution should be reserved for patients suffering from coagulative diathesis due to the increased risk of ocular bleeding, sustained by the antiplatelet action of ketorolac.

The use of ACULAR ® could also delay the healing of possible corneal ulcers.

The presence of benzalkonium chloride in ACULAR ® could cause a softening of the soft contact lenses, suggesting therefore to postpone their application at least 15 minutes after the instillation of the eye drops.

Given the lack of studies concerning the efficacy and safety of topical ophthalmic ketorolac in pediatric patients, the use of ACULAR ® is not recommended in children.

PREGNANCY AND BREASTFEEDING

The absence of studies capable of characterizing the safety profile of Ketorolac on the health of the fetus, when taken during pregnancy, and the potential side effects of non-steroidal anti-inflammatory drugs on correct embryonic and fetal development, does not allow the free use of ACULAR ® during the entire pregnancy and the subsequent breastfeeding period.

Interactions

The simultaneous intake of ACULAR ® and other active ingredients, both systemically and ophthalmic, was on the whole safe and free of pharmacologically relevant interactions.

However, it is advisable to space up topical medication for at least 5 minutes.

Contraindications ACULAR ® Ketorolac

ACULAR ® is contraindicated in patients who are hypersensitive to Ketorolac or associated active substances as well as its excipients.

Undesirable effects - Side effects

The use of Ketorolac by topical ophthalmology is decidedly safer than the systemic intake of the active ingredient, reducing the severity and incidence of side effects generally attributed to NSAID therapy.

More precisely eye irritations, burning at the time of instillation, superficial keratitis, localized edema and allergic reactions are the most frequently documented adverse reactions following the intake of ACULAR ®, for which in some cases it was necessary to provide for the suspension of therapy .