Erdon Eye Drop (Diclofenac)

Therapeutic Group : NSAID & Analgesic

Presentation:

Erdon Sterile Eye Drops: Each ml contains Diclofenac Sodium BP 1.0 mg.

Indications:

Inhibition of miosis during cataract surgery.

Postoperative inflammation after cataract surgery and other surgical procedures. Preoperative and postoperative prevention of cystoid macular oedema associated with lens extraction and intraocular lens implantation. Non-infectious inflammatory conditions affecting the anterior region of the eye (e.g. chronic non-infectious conjunctivitis).

Post-traumatic inflammation in penetrating and non- penetrating wounds (as an adjuvant to local anti-infective therapy).

Dosage & Administration:

Adults:
Preoperative : 1 drop up to 5 times over the 3 hours preceding surgery.

Postoperative : 1 drop 3 times immediately after surgery, thereafter 1 drop 3-5 times daily for as long as required.

Other indications: 1 drop 4-5 times daily, depending on the severity of the condition.

Long- term treatment should be considered only after careful assessment of the indication and ophthalmological examination.

Children: No specific investigations have been carried out on the use of Diclofenac Eye Drops in children.

Contrainidications:

Known hypersensitivity to diclofenac or thiomersal. Like other non-steroidal anti-inflammatory agents, Erdon is contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis have been observed following application of acetyl salicylic acid or other cyclo-oxygenase inhibitors.

Warning & Precautions:

Topical NSAID used in ophthalmological surgery can retard the bleeding time. Therefore patients tending toward uncontrolled bleeding or under therapy with anticoagulants should use Erdon with caution. If infection is present or there is a risk of infection, appropriate treatment (e.g. with antibiotics) should be given concomitantly. If the response to treatment is inadequate, the diagnosis should be re-evaluated (infection, hypersensitivity to the preparation).
Patients experiencing blurred vision after application of Erdon eye drops should refrain from driving vehicles or use machinery until their vision has cleared.
Note for patients wearing contact lenses: Contact lenses must be removed before the application and should only be inserted 15 min after application.

Side effects:

Occasional: Nausea, vomiting.
Rare: Systemic hypersensitivity reactions like asthma, urticaria, itching, acute rhinitis. The following unwanted effects have been observed during clinical studies with Diclofenac Eye Drops. Occasional mild or moderate, transient stinging and/or blurred vision directly after application of eye drops.

Drug interaction:

Erdon can be combined with eye drops containing steroids, if necessary. To prevent the active substance being washed out by further doses, an interval of at least 5 minutes should be allowed to elapse between each application.

Use in special groups:

Pregnancy & Lactation: 1st and 2nd trimester: Pregnancy category B: Reproduction toxicity studies carried out in animals have not revealed evidence of an increased risk to the fetus, but no controlled studies have been conducted in pregnant women.

3rd timester: Pregnancy category D: Erdon should not be prescribed because of the risk of a premature closure of the Ductus arteriosus Botalli and a possible inhibition of labour pains. After oral doses of 50 mg (content of 10 bottles), no adverse reactions for the infant are expected as only small amounts of the active subtance pass into the mother\’s milk.

Packing:

Erdon Sterile Eye Drops: Each LDPE dropper bottle contains 5 ml drops