Ketorolac

Registered South African indications:

• Ocular inflammation

Contraindications 

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs

Cautions

• Pregnancy
• Breastfeeding  
• Fertility
• Renal impairment
• Hepatic impairment
• Elderly
• Known bleeding tendencies
• May mask the signs of infection
• Patients requiring wound care therapy
• Susceptibility to corneal epithelial breakdown (when used with topical corticosteroids)
• Complicated ocular surgeries
• Corneal denervation
• Corneal epithelial defects
• Diabetes mellitus
• Ocular surface diseases
• Rheumatoid arthritis
• Repeat ocular surgeries within a short period of time
• Prolonged use (beyond 14 days)  
• Use more than 24 hours prior to surgery
• History of nonsteroidal anti-inflammatory-induced asthma
• Concomitant use of contact lens
• Dry eyes
• Patients in which the cornea may be compromised
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: opd

Ocular inflammation
- Reduction of ocular pain following corneal refractive surgery

0.4%

• Ophthalmic (opd): 1 drop, 6hrly; Treatment duration: 4 days

- Prophylaxis and reduction of inflammation following ocular surgery, including cataract surgery

0.5%

• Ophthalmic (opd): 1 drop, 8hrly; Started pre-operatively within 24hrs; Treatment duration: 3 weeks

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid injury and contamination of eye drops

Not established for use in children

Pregnancy 

• Caution
• There are no adequate data from the use of eye drops containing ketorolac in pregnant women. Studies in animals have shown reproductive toxicity. Inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/ foetal development and/or postnatal development. Although very low systemic exposure is expected, the use of ketorolac eye drops is not recommended during pregnancy

Breastfeeding 

• Caution; not recommended
• Ketorolac eye drops should not be used during breastfeeding. Ketorolac is excreted in human milk after systemic administration

Fertility

• There are no adequate data from the use of ketorolac on fertility in humans

Renal Impairment 

• Caution; no information available

Hepatic Impairment 

• Caution; no information available

Elderly 

• Caution; no information available

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache

Respiratory Disorders

• Bronchospasm or exacerbation of asthma

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
  - Localised allergic reactions

Sensory Disorders

• Eye irritation, including burning
• Eye pain, including stinging
• Superficial punctate keratitis
• Eye and/or eyelid oedema
• Ocular pruritus
• Conjunctival hyperaemia
• Eye infection
• Eye inflammation
• Iritis
• Keratic precipitates
• Retinal haemorrhage
• Cystoid macular oedema
• Eye trauma
• Increased intraocular pressure
• Blurred vision
• Diminished vision
• Corneal ulcer
• Corneal infiltrates
• Eye dryness
• Epiphora
• Corneal damage
  - Thinning
  - Erosion
  - Epithelial breakdown
  - Perforation
• Ulcerative keratitis
• Eye swelling
• Ocular hyperaemia

• Topical corticosteroids
• Other topical nonsteroidal anti-inflammatory drugs 
• Other topical eye preparations

None routine. Specific cases may require

• Corneal examination

Benzalkonium chloride and the use of contact lenses

• The preservative in ketorolac eye drops, benzalkonium chloride, may cause eye irritation
• Contact lenses must be removed prior to application, with at least a 15 minute wait before reinsertion
• Benzalkonium chloride is known to discolour soft contact lenses, thus contact must be avoided
• Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Ketorolac should be used with caution in dry eye patients and in patients where the cornea may be compromised

Coadministration with other topical eye medications

• If ketorolac eye drops are used concomitantly with other topical eye medications there must be an interval of at least 5 minutes between the two medications

Ketorolac is a non-steroidal anti-inflammatory agent demonstrating analgesic and anti-inflammatory activity. Ketorolac inhibits the cyclo-oxygenase enzyme essential for biosynthesis of prostaglandins.

After topical ophthalmic administration, ketorolac has been shown to reduce prostaglandin levels in the aqueous humour without constriction of the pupil or any significant effects on intraocular pressure.

Eye drops (per ml) 4mg

• Acular 0.4% (Allergan) originator

Eye drops (per ml) 5mg

• Acular 0.5% (Allergan) originator
• Kelopt (Actor)

Also available in the following forms: Tablet and injection