ERDON
Sterile
Eye Drops
Composition:
Each ml contains
Diclofenac Sodium BP 1.0 mg.
Preservative:
Thiomersal 0.004%
Properties and actions:
Erdon contains diclofenac
sodium, a non-steroidal substance with anti-inflammatory and
analgesic effects.
Inhibition of
prostaglandin synthesis, which has been demonstrated in experiments,
is considered to be fundamental to the mechanism of action
of diclofenac. Prostaglandin plays a major role in the pathogenesis
of inflammation and pain. Erdon
has an anti-inflammatory effect when given after surgery
or trauma to the eye, and in other non-infectious inflammatory
conditions. It has been shown that prophylactic administration
of Erdon in patients undergoing
cataract removal and intraocular lens implantation reduces
the frequency and severity of cystoid macular oedema, if it
occurs. Effective daily doses of about 0.25-0.5 mg diclofenac
sodium administered in the form of eye drops 91 drops 3-5
times daily) are equivalent to less than 1% of the daily oral
dosage recommended for diclofenac sodium in rheumatic indication.
Pharmacokinetics:
It has been confirmed
that diclofenac penetrates the anterior chamber in humans.
Diclofenac was not detectable in human plasma after topical
application of 0.1% diclofenac sodium eye drops.
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.
Contraindications:
-
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.
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.
Pregnancy and 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
trimester: 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
substance pass into the mother’s milk.
Adverse reaction:
Retardation of
wound healing.
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.
Rare: hypersensitivity
reaction in the form of itching, reddening and photosensitivity;
keratitis punctata; postoperative mydriasis.
Interactions/Incompatibilities:
None know so
far.
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.
Overdose:
Accidental ingestion
of Erdon presents
virtually no risk of unwanted effects, since one of 5 ml bottle
of eye drop solution contains only 5 mg of diclofenac sodium,
which is equivalent to about 3% of the recommended maximum
oral dose for adults.
Shelf-life: If the pack is
unopened, Erdon
eye drops can be used until the expiry date indicated with
“EXP” on the pack.
Additional Information:
Close the bottle
immediately after use. Do not use for more than one month
after first opening. Store at room temperature. Keep all medicines
out of the reach of children.
To be dispensed
only by or on the prescription of a registered physician.
Supply:
Erdon
Sterile Eye Drop is supplied in 5 ml plastic dropper bottle.
