Nepafenac ocular
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Eye drops containing nepafenac.
Drugs List
Therapeutic Indications
Uses
Risk reduction of macular oedema after cataract surgery in diabetics
Topical prophylaxis and treatment of inflammation after cataract surgery
Dosage
Adults
For the prevention and treatment of postoperative pain and inflammation
1mg/ml
Instil 1 drop into the conjunctival sac of the affected eye(s) 3 times daily, beginning one day prior to cataract surgery, continuing on the day of surgery and up to 21 days postoperatively. Administer an additional drop 30 to 120 minutes prior to surgery.
3mg/ml
Instil 1 drop into the conjunctival sac of the affected eye(s) once daily, beginning one day prior to cataract surgery, continuing on the day of surgery and up to 21 days postoperatively. Administer an additional drop 30 to 120 minutes prior to surgery.
For the reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients
1mg/ml
Instil 1 drop into the conjunctival sac of the affected eye(s) 3 times daily, beginning one day prior to cataract surgery, continuing on the day of surgery and up to 60 days postoperatively. Administer an additional drop 30 to 120 minutes prior to surgery.
3mg/ml
Instil 1 drop into the conjunctival sac of the affected eye(s) once daily, beginning one day prior to cataract surgery, continuing on the day of surgery and up to 60 days postoperatively. Administer an additional drop 30 to 120 minutes prior to surgery.
Missed dose
A double dose should not be used to make up for a missed dose, instead instil 1 drop as soon as possible after the missed dose before returning to the regular routine.
Contraindications
Children under 18 years
Soft contact lenses
Asthma, urticaria or acute rhinitis associated with NSAIDS
Third trimester of pregnancy
Precautions and Warnings
Corneal epithelial breakdown
Predisposition to haemorrhage
Corneal damage
Corneal disorder
First trimester of pregnancy
Keratitis
Ocular infection
Rheumatoid arthritis
Second trimester of pregnancy
May mask symptoms or signs of infections
Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride - may cause keratopathy
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Monitor for, and discontinue in, corneal epithelial breakdown
Corneal damage may follow prolonged application
Prolonged treatment may delay healing
Female: Ensure adequate contraception during treatment
Advise patient to avoid exposure to direct sunlight
Advise patient to avoid touching the eye/other surfaces with container tip
Soft contact lenses should not be worn during treatment
Caution should be taken when giving topical NSAIDs in patients with complicated ocular surgeries or repeat ocular surgeries within a short period of time, due to the increased risk of potentially sight threatening corneal adverse reactions.
Pregnancy and Lactation
Pregnancy
Nepafenac is contraindicated during the third trimester of pregnancy and caution is advised during the first and second trimesters.
Briggs(2015) suggests that although no reports of the use of nepafenac have been located, use in late pregnancy should be avoided due to potential fetal cardiovascular toxicity.
The manufacturer states that nepafenac eye drops are not recommended in pregnancy due to the potential effects of prostaglandin inhibition.
Animal studies have shown reproductive toxicity.
Lactation
Nepafenac is considered safe to use in breastfeeding.
It is unknown whether nepafenac is excreted in human milk. Animal studies note the excretion of nepafenac in the milk of rats.
As the systemic exposure of nepafenac to the breastfeeding woman is negligible, no effects on the breastfed child are anticipated.
Side Effects
Allergic conjunctivitis
Allergic dermatitis
Blepharitis
Blurred vision
Choroidal effusion
Conjunctival hyperaemia
Corneal deposits
Corneal epithelium defect
Corneal erosion
Corneal opacities
Corneal perforation
Corneal scar
Corneal thinning
Corneal ulcer
Dermatochalasis
Dizziness
Dry eyes
Eye disorder
Eye irritation
Eye pain
Eye pruritus
Eye swelling
Headache
Hypersensitivity reactions
Hypertension
Hyphaema
Impaired healing
Increased bleeding tendency
Increased blood pressure
Increased lacrimation
Iritis
Keratitis
Lid margin crusting
Nausea
Ocular discharge
Ocular discomfort
Punctate keratitis
Reduced visual acuity
Sensation of foreign body in eye
Ulcerative keratitis
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: August 2021.
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Nevanac 1mg/ml eye drops suspension. Novartis Europharm Limited. Revised August 2018.
Summary of Product Characteristics: Nevanac 3mg/ml eye drops suspension. Novartis Europharm Limited. Revised August 2018.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.