Diclofenac Eye Drops
(Diclofenac Sodium 0.1%W/V)
Each ml of Diclofenac Eye Drops contains 1mg of Diclofenac Sodium.
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. Prostaglandin plays a major role in the causation of inflammation and pain.
In clinical trials, Diclofenac Sodium has been found to inhibit miosis during cataract surgery, to reduce inflammation following surgical interventions and to reduce ocular pain and discomfort associated with corneal epithelial defects after photoreactive keratectomy (Laser Eye surgery) or accidental trauma.
In rabbits, peak concentrations of Diclofenac could be demonstrated in the cornea and conjunctiva 30 minutes after application. The highest amounts are found in these two tissues and in the choroid and retina. Elimination was fast and almost complete after 6 hours.
(i) Inhibition of preoperative miosis during cataract surgery (Diclofenac has no intrinsic mydriatic properties and does not replace standard mydriatic agents).
(ii) Treatment of post-operative inflammation in cataract surgery.
(iii) Control of ocular pain and discomfort associated with corneal epithelial defects after photoreactive keratectomy (Laser Eye surgery) or accidental trauma.
(iv) Control of inflammation after Argon Laser Trabeculoplasty (ALT)
(v) The relief of the ocular signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).
Patients with known hypersensitivity to any of the ingredients. Like other non-steroidal anti-inflammatory agents, Diclofenac Eye Drops is also contraindicated in patients in whom 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 is also contraindicated.
There is a theoretical possibility that patients receiving other medications which may prolong bleeding time, or with known haemostatic defects may experience exacerbation with Diclofenac Eye Drops. Clinical findings have shown that Diclofenac Eye Drops can, if necessary, be combined with steroid-containing eye drops. To prevent the active substances from being washed out when additional ophthalmic medication is used, an interval of at least 5 minutes between each application should be adhered to.
WARNINGS & PRECAUTIONS
In the presence of infection, or if there is a risk of infection, appropriate therapy (e.g. antibiotics) should be given concurrently with Diclofenac Eye Drops. Patients with blurred vision should be refrain from driving a vehicle or operating machine.
PREGNANCY AND LACTATION
There is no experience concerning the safety of Diclofenac Eye Drops in human pregnancy. Administration during pregnancy and lactation is therefore not recommended except for compelling reasons.
KEEP OUT OF THE REACH OF CHILDREN!
ADVERSE REACTIONS/SIDE EFFECTS
A mild to moderate burning sensation, blurred vision immediately after instillation of the eye drops, hypersensitivity reactions with itching and reddening, photosensitivity, keratitis punctata, corneal epithelial discontinuity rarely occur.
SYMPTOMS OF OVERDOSAGE AND ANTI DOTE
There is practically no risk of adverse effects due to accidental oral ingestion, since the 5ml eye drop solution contains 5mg of Diclofenac Sodium corresponding to about 10% of recommended adult dose (by oral administration). By way of comparison, the maximum oral daily dose for Diclofenac Sodium recommended in children is 2mg/kg body weight.
DOSAGE AND ADMINISTRATION
– Prophylaxis of preoperative miosis: Apply 1 drop four times during the 2 hours before surgery.
– Control of post-operative inflammation: Apply 1 drop 4 times daily for up to 28days.
– Control of Post photoreactive keratectomy (Laser eye surgery) Pain and discomfort: Apply 1 drop 2 times in the hour prior to surgery, one drop 2 times five minutes apart immediately after photoreactive keratectomy (Laser Eye surgery) and then post operatively 1 drop every 2-5 hours while awake for up to 24 hours.
– Control of ocular pain associated with corneal epithelial defects after accidental trauma: Apply one drop 4 times daily for up to 2 days
– Control of post-Argon Laser Trabeculoplasty (ALT) inflammation: Apply one drop 4 times during the 2 hours before Argon Laser Trabeculoplasty (ALT), and then one drop 4 times daily for up to 7days.
– The relief of the ocular signs and symptoms of Seasonal Allergic Conjunctivitis: Apply one drop 4 times daily for as long as required.
No specific studies with Diclofenac Eye Drops have been performed in children.
Diclofenac Eye Drops is a clear colourless 0.1%W/V sterile solution available in a transparent bottle containing 5ml of the drops.
Store below 300C. Protect from light. Replace cap immediately after usage. Discard after 28 days of opening the bottle.