Anti-allergic eye drops
Presentation and Composition:
Dropper bottle of 5 ml
Each ml contains:
Active ingredient: Ketotifen fumarate O.345mg corresponding to 0.25 mg ofketotifen.
Excipients: Glycerol 21.25rng • sodium hydroxide I N q.s., water for injections to l ml.
Preservative: Benzalkonium chloride 0.1 mg
Properties and actions:
Ketotifen is a histamine HI – receptor antagonist. Ketotifcn also inhibits the release of mediators (e.g.histamine,leukotrienes, prostaglandins, PAF) from cells involved in type I, or immediate allergic reactions (mast cells, eosinophils, basophile and neutrophils).Ketotifen also reduces the chemotaxis, activatica and degranulation of eosinophils .cAMP levels increased by phosphodiesterase inhibition can contribute to the cell-stabilising action of kerotifen.
The antihistaminic effect ofORCHAZID eye drops has a rapid onset following instillation into the eye and persists for 8-12 hours.
ORCHAZID eye drops alleviate the symptoms of allergic conjunctivitis, such as pruritus and hyperaemia.
The extent of’ketotifen absorption from these eye drops is not known. ketotifen is almost completely absorbed following oral administration, with a “first pass effect” in the liver of nearly 50010 Maximum plasma concentrations are achieved within 2-4 hours. ketcrifen shows 75% protein binding.
Elimination: ketotifen undergoes bipbasic elimination, with a short half-life of3-5 hours and a longeroneof21 hours. Within 48 hours approximately 1% of the active substance is excreted unchanged in the urine, with 60-70% excreted in the form ofmetabolites. The principal metabolite in urine is the virtually inactive ketotifen-N-glucuronide. Following ocular instillation (daily dose <25).1g), the blood level is below the detection limit.
Treatment of signs and symptoms of allergic conjunctivitis
Dose and Method of administration :
Adults, elderly and children (age 12 and older): instill I drop twice a day into the conjunctival sac of each eye. For children below 12 years the efficacy has not been tested but the drug has been shown to be safe in children As young as 3 years of age.The maximum treatment duration is 6 weeks.
Hypersensitivity to ketotifeo or to any of the excipients .
Precautions Ior’use :
Contact lenses should not be worn iftbe eyes are red and! or inflamed.
ORCHAZlD eye drops in bottles of 5 ml contain bezalkonium chloride as a preservative, which can permeate into soft hydrophilic contact lenses. For this reason, soft hydrophilic contact lenses must be taken out before applying ORCHAZID eye drops and not replaced for at least 15 minutes.
ORCHAZID shouldn’t be used to treat irritation caused by contact lenses.
Pregnancy and lactation:
For ORCHAZID eye drops no clinical data on use during pregnancy are available. Animal studies using oral, toxic doses showed increased pre and postnatal mortality, but no teratogenicity, Systemic levels of ketotifen after ocular use are generally below the limit of quanrization. Caution should be exercised when prescribing to
pregnant women. Although animal-data following oral administration show excretion into breast milk, topical administration to human is unlikely 10 produce detectable quantities in breast milk. Nursing mothers receiving
ORCHAZID eye drops can breast feed.
If several medicines are to be administered into the eye, there should be an interval of at least 5 minutes between
To date, there have been no reports of overdoses with ORCHAZID eye drops.
One 5ml bottle contain 1.25mg ketotifen (i!I.725mg ketotifen fumarate). Drinking one whole bottle would result est:ionofro-Io otltie recommended dally dose”f0nr3·years-old child. Doses of up to 2O”mg-ketotifen orally have not been found to produce any severe intoxication symptoms.
Occasionally (<2% ) :changes in visual acuity, dry eyes, headaches, fatigue, skin rash.
Isolated cases : burning! stinging, conjunctivitis, subconjunctival haemorrhage, ophthalmalgia, sensitivity to light, allergic reaction, dry mouth, eczema.
Orchazid can impair the patient reaction .Cautiou is therefore recommended while driving, operating machinery,etc,
Shelf life :
B~ttle of Sml:
May be used up to I month after first opening (taking into account the expiry date).
Store at temperature not exceeding 30°C
Manufactured by :
Orchi<lia Pharmaceutical Industries