KETOTIFEN OPHTHALMIC SOLUTION 0.25 MG
KETOTIFEN (KETOTIFEN FUMARATE) : 0.25 MG · DIN 02400871 · STERIMAX INC
Health Canada status: DORMANT
What is KETOTIFEN OPHTHALMIC SOLUTION?
KETOTIFEN OPHTHALMIC SOLUTION 0.25 MG contains KETOTIFEN (KETOTIFEN FUMARATE) : 0.25 MG. It is listed in the Health Canada Drug Product Database under DIN 02400871, held by STERIMAX INC, supplied as SOLUTION for OPHTHALMIC administration. Health Canada currently lists it as dormant, status dated 19-Aug-2021. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is KETOTIFEN OPHTHALMIC SOLUTION used for?
Ketotifen Ophthalmic Solution is indicated for treatment of allergic conjunctivitis. It is used in adults and children older than 3 years of age, to treat itchy, watery, red or swollen eyes and/or eyelids, caused by seasonal allergies.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02400871 |
|---|---|
| Brand name | KETOTIFEN OPHTHALMIC SOLUTION |
| Generic / active ingredient | KETOTIFEN (KETOTIFEN FUMARATE) : 0.25 MG |
| Manufacturer | STERIMAX INC |
| Strength | 0.25 MG |
| Dosage form | SOLUTION |
| Route of administration | OPHTHALMIC |
| Schedule | Prescription |
| ATC code | S01GX08 KETOTIFEN |
| AHFS class | 52:02.00 |
| Biosimilar | No |
| Health Canada status | DORMANT |
| Status date | 19-Aug-2021 |
| Original market date | 2013-03-07 00:00:00 |
How is it administered?
One drop in the affected eye(s) every 8 to 12 hours. Use nasolacrimal occlusion for 1-2 minutes after administration to reduce systemic absorption.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store between 4°C and 25°C. After opening the bottle, the eye drops can only be stored for 4 weeks.
How is it supplied?
multi-dose white plastic bottles with controlled dropper tips containing 5 mL
Contraindications
Hypersensitivity to ketotifen or any ingredient in the formulation or component of the container.
Warnings and precautions
For topical use only. Not for injection/oral use. Contains benzalkonium chloride; remove soft contact lenses before use. May cause blurred vision or somnolence; caution when driving.
What can be used instead?
Other Canadian products sharing ATC code S01GX08 KETOTIFEN. 2 of 5 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| JAMP KETOTIFEN OPHTHALMIC | 0.25 MG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02542722 |
| ZADITOR | 0.25 MG | SOLUTION | LABORATOIRES THEA | MARKETED | DIN 02242324 |
| JAMP KETOTIFEN | 0.025 % W/V | SOLUTION | JAMP PHARMA CORPORATION | APPROVED | DIN 02489651 |
| ZADITOR | 0.25 MG | SOLUTION | NOVARTIS PHARMACEUTICALS CANADA INC | CANCELLED POST MARKET | DIN 02279223 |
Who else supplies KETOTIFEN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. KETOTIFEN appears in 2031 registered pack listings across 10 markets, published on 8 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.