Product Information
Registration Status: ActiveSIN12209P
ZADITEN EYE DROPS 0.25mg/ML is approved to be sold in Singapore with effective from 2003-02-25. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN12209P.
This product contains Ketotifen 0.25mg/ml in the form of SOLUTION. It is approved for OPHTHALMIC use.
This product is manufactured by Excelvision in FRANCE.
It is a has been granted the exemption for supply without a presciption if it met certain criteria.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
A cycloheptathiophene blocker of histamine H1 receptors and release of inflammatory mediators. It has been proposed for the treatment of asthma, rhinitis, skin allergies, and anaphylaxis.
Indication
Indicated as an add-on or prophylactic oral medication in the chronic treatment of mild atopic asthmatic children. Also used as self-medication for the temporary relief of itching of the eye due to allergic conjunctivitis (ophthalmic).
Mechanism of Action
Ketotifen is a relatively selective, non-competitive histamine antagonist (H1-receptor) and mast cell stabilizer. Ketotifen inhibits the release of mediators from mast cells involved in hypersensitivity reactions. Decreased chemotaxis and activation of eosinophils have also been demonstrated. Ketotifen also inhibits cAMP phosphodiesterase. Properties of ketotifen which may contribute to its antiallergic activity and its ability to affect the underlying pathology of asthma include inhibition of the development of airway hyper-reactivity associated with activation of platelets by PAF (Platelet Activating Factor), inhibition of PAF-induced accumulation of eosinophils and platelets in the airways, suppression of the priming of eosinophils by human recombinant cytokines and antagonism of bronchoconstriction due to leukotrienes. Ketotifen inhibits of the release of allergic mediators such as histamine, leukotrienes C4 and D4(SRS-A) and PAF.
Pharmacokinetics
- Absorption
- Following oral administration absorption is at least 60%
- Distribution
- Metabolism
- Primarily hepatic. The main metabolite found in both plasma and urine is the inactive ketotifen-N-glucuronide. Nor-ketotifen, the N-demethylated metabolite, and the 10-alpha-hydroxyl derivative are the only other metabolites detectable in human urine.
- Elimination
Toxicity
Adverse reactions include headaches, conjunctival injection and rhinitis.
Active Ingredient/Synonyms
Ketotifene | Ketotifeno | Ketotifenum | Ketotifen |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.