Indocollyre 0.1% Teva

/ Salomon, Levin & Elstein Ltd

Topical route.
BY OCULAR INSTILLATION.
Dosage in adults:
Inhibition of myosis during surgery: 4 drops the day before surgery and 4 drops in the 3 hours preceding surgery.
Prevention of inflammation subsequent to cataract surgery or surgery of the anterior chamber of the eye: 1 drop 4 to 6 times daily until complete disappearance of symptoms, starting the treatment 24 hours before surgery.
Treatment of ocular pain following photorefractive keratectomy: 1 drop 4 times daily for the first few days after surgery.
To administer the treatment, gently pull down the lower lid of the eye and apply one drop of solution while looking upwards.

Inhibition of myosis during surgery. Prevention of inflammation subsequent to cataract surgery or surgery of the anterior chamber of the eye. Treatment of ocular pain following photorefractive keratectomy for the first few days after surgery.

This product is contra-indicated in the following situations:
– from the 6th month of pregnancy onwards,
– documented allergy to diclofenac or to drugs with similar activity e.g. other nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin,
– previous asthma attacks caused by aspirin or other NSAIDs,
– active peptic ulcer,
– severe hepatocellular failure,
– severe renal insufficiency.
In general, this medication should not be taken in combination with:
– oral anticoagulants,
– others NSAIDs (including high doses of salicylates, i.e. from 3 g/day in adults),
– heparin,
– lithium,
– high doses of methotrexate,
– ticlopidine.

Children: no specific studies have been conducted in children.
If hypersensitivity is noted, stop the treatment.
– Prescribe appropriate treatment in cases presenting a risk of eye infection.
– A NSAID may retard corneal healing.
– A NSAID may increase the bleeding of ocular tissues during surgery, notably in patients with a known tendency to bleed or in those receiving other treatments liable to prolong bleeding.
– It is inadvisable to wear contact lenses during treatment with INDOCOLLYRE 0.1%.
– If at the same time the patient is receiving treatment with another eye-drop preparation containing a different active substance, administer the two solutions at least 15 minutes apart.
– Do not touch the eye with the tip of the bottle.

Occasional effects: A slight transient burning or stinging, and/or vision disorders may occur after instillation.
Rare effects:
– hypersensitivity reaction with pruritus and redness.
– possible photosensitivity.
– punctate keratitis.

To avoid diluting the active ingredients, instil products at least 15 minutes apart.
If necessary, indomethacin administered by ocular route can be combined with eyedrops containing corticosteroids.
Although only small amounts of indomethacin pass into the systemic bloodstream after ocular instillation, drug interactions are nevertheless possible. It is therefore advisable to take account of the interactions observed with NSAIDs administered by general route.
See prescribing information for full details.

Pregnancy: No particular malformations have been reported in humans. However, supplementary epidemiological studies are required to confirm that there is no possible risk.
In the 3rd trimester of pregnancy, all inhibitors of prostaglandin synthesis may expose:
– the foetus:
– to cardiopulmonary toxicity (pulmonary hypertension with premature closure of the arterial canal);
– to renal malfunction which may reach renal insufficiency with oligohydramnios.
– the mother and the child at the end of pregnancy to possible increased bleeding time.
In consequence, indomethacin should only be given if absolutely necessary over the first 5 months of pregnancy.
Indomethacin is contra-indicated from the 6th month of pregnancy onwards.
Lactation: In view of the fact that NSAIDs pass into mother’s milk, their administration in women who are breast-feeding should be avoided as a precautionary measure.

Not applicable.