Generic drug of the therapeutic class: Ophthalmology
active ingredients: Atropine sulfate
Box of 100 Single-dose containers of 0.4 mL
Indications are limited to:
· In diagnosis: dilatation for examination in the ophthalmologist's office,
· In therapy: keratitis, uveitis, iridocyclitis.
Dosage ATROPINE FAURE 1% Eye drops Box of 100 Single-dose containers of 0.4 mL
1 drop of eye drops contains 500 μg of active ingredient (atropine).
1 to 2 drops, 2 to 4 times a day.
The maximum dose for the child from 30 months to 15 years corresponds to the instillation of 3 times 2 drops of atropine at 0.3% per 24 hours.
As for all eye drops, carry out, in order, the following operations:
· Wash hands thoroughly.
· Avoid touching the eye or eyelids with the tip of the single-dose container.
· To instil this eye drop, look upward and gently pull the lower eyelid down.
· With the eye closed, cleanly wipe the excess, especially on the cheek.
· To avoid ingestion especially in children see section Warnings and precautions for use .
· In order to avoid systemic effects induced by the passage of atropine into the general circulation through the lacrimal ducts and by oral ingestion, it is recommended, especially in children and the elderly, to compress the internal angle of the eye for 1 minute after each instillation and wipe the excess on the cheek.
· Discard single dose after use. Do not reuse an open-dose unit for later administration.
· If concomitant treatment with another eye drops, allow 15 minutes for instillation.
· In case of hypersensitivity to atropine or any of the excipients of eye drops.
· In patients at risk for angle closure glaucoma.
· In case of breastfeeding.
Side effects Atropine Faure
Ocular adverse effects
· Risk of acute glaucoma by closing the angle (see section 4.3 ).
· Annoying mydriasis, prolonged accommodation disturbances.
· Local irritation, tingling, possible allergic reaction.
Systemic side effects
Atropine eye drops enter the systemic circulation and may cause systemic effects especially in children and the elderly (see sections Dosage and method of administration "method of administration" and Warnings and precautions for use ) .
The undesirable effects are mainly neurological and psychiatric:
· In particular: agitation, hyperexcitability or sudden drowsiness, confusion,
· More rarely at therapeutic doses: convulsions and hallucinations,
· The child and the elderly have variable responses to atropine eye drops.
Other signs of atropine impregnation are common:
· Redness of the face, tachycardia, dry mouth.
· Fever in children, rarely severe except in case of overdose.
· Digestive disorders :
o constipation especially in the elderly,
o in the premature newborn: Abdominal distention, ileus, occlusion.
Great caution in administration is essential in this population of premature newborns.