Diclofenac Sodium

Registered South African indications:

• Alleviation of post-operative inflammation of the anterior segment in cataract surgery
• Short term use for ocular surface pain from corneal origin
• Short term use for inflammation following argon laser trabeculoplasty

 

Contraindications

South African recommendations

• Hypersensitivity to diclofenac sodium or to any of the excipients
• Wearing soft contact lenses
• Hypersensitivity to aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) or other prostaglandin synthetase inhibitors
• Where attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or by other medicines with prostaglandin synthetase inhibiting activity
• In young children
• Intraocular use during surgical procedures
• Heart failure
• Established ischaemic heart disease
• Cerebrovascular disease (stroke)
• Peripheral arterial disease
• History of gastrointestinal perforation, ulceration or bleeding (PUBs) related to previous NSAIDs
• Active or a history of recurrent ulcer/ haemorrhage/ perforations
• Lactation
• Pregnant women from around 20 weeks of gestation or later in pregnancy

Recommendations in other jurisdictions

• Hypersensitivity to any of the ingredients
• Where attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibiting activity
• Intraocular use during surgical procedure

Cautions

• Pregnancy (<20 weeks) (South African recommendations)
• Pregnancy (Recommendations in other jurisdictions)
• Breastfeeding (Recommendations in other jurisdictions)
• Renal impairment 
• Hepatic impairment 
• Elderly 
• May mask the onset and/or progression of ocular infections
• Risk of ocular infections
• Pre-existing corneal inflammation
• May impair ability to drive and operate machinery

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

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Alleviation of post-operative inflammation of the anterior segment in cataract surgery
Short term use for ocular surface pain from corneal origin
Short term use for inflammation following argon laser trabeculoplasty

Pre-operatively

• Ophthalmic (opd): Up to 5 drops into the conjunctival sac, during the 3hrs before surgery

Post-operatively

• Ophthalmic (opd): 3 drops into the conjunctival sac, after surgery; Then: 1 drop into the conjunctival sac, 4-5 times dly

Other indications

• Ophthalmic (opd): 1 drop into the conjunctival sac, 4-5 times daily

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The dose is governed by the severity of the condition

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Safety and efficacy of treatment for inflammation following argon laser trabeculoplasty for more than 4 days have not been established

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Indications and dosages registered in other jurisdictions

Inhibition of peroperative miosis during cataract surgery

• Ophthalmic (opd): 1 drop into the conjunctival sac, 4 times during the 2hrs before surgery

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Ophthalmic diclofenac sodium has no intrinsic mydriatic properties and does not replace standard mydriatic agents

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Control of post-operative inflammation in cataract surgery

• Ophthalmic (opd): 1 drop into the conjunctival sac, 6hrly; Treatment duration: Up to 28 days

Control of ocular pain and discomfort associated with corneal epithelial defects after excimer PRK surgery

• Ophthalmic (opd): 1 drop into the conjunctival sac, 2 times in the 60min before surgery;  Then: 1 drop into the conjunctival sac, 2 times 5min apart immediately after PRK surgery; Then post-operatively: 1 drop, every 2-5hrs while awake; Treatment duration: Up to 24hrs

Control of ocular pain associated with corneal epithelial defects after accidental non-penetrating trauma

• Ophthalmic (opd): 1 drop into the conjunctival sac, 6hrly; Treatment duration: Up to 2 days

Control of inflammation after argon laser trabeculoplasty (ALT)

• Ophthalmic (opd): 1 drop into the conjunctival sac, 4 times during the 2hrs before ALT; Then: 1 drop into the conjunctival sac, 6hrly; Treatment duration: Up to 7 days

Relief of the ocular signs and symptoms of seasonal allergic conjunctivitis (SAC)

• Ophthalmic (opd): 1 drop into the conjunctival sac, 6hrly; Treatment duration: As long as required

Inflammation and discomfort after strabismus surgery

• Ophthalmic (opd): Week 1: 1 drop into the conjunctival sac, 6hrly; Week 2: 1 drop into the conjunctival sac, 8hrly; Week 3: 1 drop into the conjunctival sac, 12hrly; Week 4: As required

Ocular pain and discomfort after radial keratotomy

• Ophthalmic (opd): Pre-operatively: 1 drop before surgery; Post-operatively: 1 drop immediately after surgery; Then: 1 drop, 6hrly; Treatment duration: Up to 2 days

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All indications: Following instillation of the eye drops, nasolacrimal occlusion or closing the eyes for 5 minutes may reduce the systemic absorption. This may result in a decrease in systemic side effects and an increase in local activity

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All indications: Diclofenac sodium eye drop solution is for instillation into the conjunctival sac only. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye

Not established for use in children

Pregnancy

South African recommendations

• <20 weeks: Caution; no information available
• ≥20 weeks: Contraindicated
• It is recommended that diclofenac sodium eye drops are avoided in pregnant women at 20 weeks or later in pregnancy
• The use of non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac sodium, as in diclofenac sodium eye drops, around 20 weeks gestation or later in pregnancy may cause foetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment
• These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation
• Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation
• In some post marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. Healthcare professionals should consider ultrasound monitoring of amniotic fluid if diclofenac sodium eye drops treatment extends beyond 48 hours
• Discontinue diclofenac sodium eye drops if oligohydramnios occurs and follow up according to clinical practice

Recommendations in other jurisdictions

• First and second trimester: Caution
• Third trimester: Caution; not recommended
• There are no data on the use of diclofenac sodium eye drops in pregnancy
• During the 1^st and 2^nd trimesters, animal studies have so far shown no risk to the foetus but no controlled studies in pregnant women are available
• In the 3^rd trimester, diclofenac sodium eye drops should not be used, due to a possible risk of premature closure of the ductus arteriosus and possible inhibition of contractions
• Studies in animals with diclofenac have shown reproductive toxicity
• Preclinical data of systemically applied diclofenac from acute and repeated dose toxicity studies, as well as from genotoxicity and carcinogenicity studies revealed no specific hazard for humans at the intended therapeutic doses
• In reproductive and developmental toxicity studies systemic diclofenac has been shown to cross the placental barrier in mice and rats. Whilst no teratogenic effects have been demonstrated, maternally toxic doses were associated with dystocia, prolonged gestation, decreased foetal survival, and intrauterine growth retardation. The effects of diclofenac on fertility and delivery as well as the constriction of the ductus arteriosus in utero are pharmacological consequences of this class of prostaglandin synthesis inhibitors

Breastfeeding

South African recommendations

• Contraindicated
• Diclofenac, as in diclofenac sodium eye drops, is excreted in breast milk. However, at therapeutic doses of diclofenac sodium eye drops no effects on the suckling child are anticipated
• Use of diclofenac sodium eye drops is not recommended during breastfeeding

Recommendations in other jurisdictions

• Caution; not recommended
• Diclofenac is excreted in breast milk
• However, at therapeutic doses of diclofenac sodium eye drops no effects on the suckling child are anticipated
• Use of ocular diclofenac is not recommended during breastfeeding unless the expected benefits outweigh the possible risks

Renal Impairment

•  Caution; no information available

Hepatic Impairment

• Caution, no information available

Elderly

• Caution; no information available

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

•  Permitted - No warnings

Respiratory Disorders

• Dyspnoea
• Asthma
• Cough

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Rash
• Eczema
• Erythema
• Pruritus

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Pruritus
• Rhinitis

Sensory Disorders

• Eye pain
• Mild to moderate eye irritation
• Eye pruritus
• Ocular hyperaemia
• Conjunctival hyperaemia
• Allergic conjunctivitis
• Eyelid erythema
• Blurred vision
• Corneal disorders
• Ulcerative keratitis
• Corneal thinning
• Punctuate keratitis
• Corneal epithelium defect
• Corneal oedema

• Topical corticosteroids
• Agents that may prolong bleeding time

Ophthalmic examination

Concomitant administration with more than one opthalmic medication

• An interval of at least 5 minutes between the application of the different medicinal products must be allowed

Diclofenac sodium is a non-steroidal compound with pronounced anti-inflammatory and analgesic properties. Inhibition of prostaglandin biosynthesis, which has been demonstrated experimentally, is regarded as having an important bearing on its mechanism of action. Prostaglandins play a major role in the causation of inflammation and pain. 

Eye drops (per ml) 1mg

• Panamor (Pharmacare)
• Voltaren Optha (Adcock) originator
• Voltaren Optha SDU (Adcock) originator

Also available in the following forms: Sachet, tablet, capsule, drop, injection, suppository, gel, patch and lotion.