ZADITEN 1 MG / 5 ML
KETOTIFEN (KETOTIFEN FUMARATE) : 1 MG / 5 ML · DIN 00600784 · TEVA CANADA LIMITED
Health Canada status: CANCELLED POST MARKET
What is ZADITEN?
ZADITEN 1 MG / 5 ML contains KETOTIFEN (KETOTIFEN FUMARATE) : 1 MG / 5 ML. It is listed in the Health Canada Drug Product Database under DIN 00600784, held by TEVA CANADA LIMITED, supplied as SYRUP for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 30-Jul-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 ZADITEN used for?
Add-on medication in the chronic treatment of mild atopic asthmatic children. Prophylactic agent; not for acute asthma attacks.
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 | 00600784 |
|---|---|
| Brand name | ZADITEN |
| Generic / active ingredient | KETOTIFEN (KETOTIFEN FUMARATE) : 1 MG / 5 ML |
| Manufacturer | TEVA CANADA LIMITED |
| Strength | 1 MG / 5 ML |
| Dosage form | SYRUP |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | R06AX17 KETOTIFEN |
| AHFS class | 04:92.00 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 30-Jul-2021 |
| Original market date | 1990-12-31 00:00:00 |
How is it administered?
Children >3 years: 1 mg twice daily. Children 6 months to 3 years: 0.05 mg/kg twice daily. Slow increase recommended during first week to minimize sedation. Administer orally.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at temperatures not exceeding 25°C. Tablets should be stored in a dry place.
How is it supplied?
Tablets: Packs of 56 (4 blister strips of 14 tablets). Syrup: 250 mL bottles.
Contraindications
Known hypersensitivity to ketotifen or any components. Patients sensitive to benzoate compounds should not take Zaditen syrup.
Warnings and precautions
Not for acute attacks. Do not stop other anti-asthmatic drugs abruptly. May lower seizure threshold (caution in epilepsy). May cause drowsiness; caution with activities requiring alertness.
What can be used instead?
Other Canadian products sharing ATC code R06AX17 KETOTIFEN. 1 of 9 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 |
|---|---|---|---|---|---|
| ZADITEN | 1 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 00577308 |
| APO-KETOTIFEN - SYR 1MG/5ML | 1 MG / 5 ML | SYRUP | APOTEX INC | CANCELLED POST MARKET | DIN 02221330 |
| NOVO-KETOTIFEN - SYR 1MG/5ML | 1 MG / 5 ML | SYRUP | NOVOPHARM LIMITED | CANCELLED POST MARKET | DIN 02176084 |
| NOVO-KETOTIFEN TAB 1MG | 1 MG | TABLET | NOVOPHARM LIMITED | CANCELLED POST MARKET | DIN 02230730 |
| NU-KETOTIFEN SYRUP - 1MG/5ML | 1 MG / 5 ML | SYRUP | NU-PHARM INC | CANCELLED POST MARKET | DIN 02218305 |
| PMS-KETOTIFEN | 1 MG | TABLET | PHARMASCIENCE INC | CANCELLED POST MARKET | DIN 02231680 |
| PMS-KETOTIFEN | 1 MG / 5 ML | SYRUP | PHARMASCIENCE INC | CANCELLED POST MARKET | DIN 02231679 |
| ZADITEN - DPS 1MG/ML | 1 MG | DROPS | NOVARTIS PHARMACEUTICALS CANADA INC | APPROVED | DIN 02172585 |
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.