CETIRIZINE 5 MG
CETIRIZINE HYDROCHLORIDE : 5 MG · DIN 02375087 · APOTEX INC
Health Canada status: APPROVED
What is CETIRIZINE?
CETIRIZINE 5 MG contains CETIRIZINE HYDROCHLORIDE : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02375087, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as approved, status dated 14-Oct-2011. 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 CETIRIZINE used for?
Relief of nasal/non-nasal symptoms of seasonal and perennial allergic rhinitis (sneezing, rhinorrhea, congestion, itchy eyes/nose/throat) and chronic idiopathic urticaria (pruritus and hives).
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 | 02375087 |
|---|---|
| Brand name | CETIRIZINE |
| Generic / active ingredient | CETIRIZINE HYDROCHLORIDE : 5 MG |
| Manufacturer | APOTEX INC |
| Strength | 5 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | NON-PRESCRIPTION DRUGS |
| ATC code | R06AE07 CETIRIZINE |
| AHFS class | 04:08.00 |
| Biosimilar | No |
| Health Canada status | APPROVED |
| Status date | 14-Oct-2011 |
How is it administered?
Adults/Children 12+: 5-10 mg once daily (max 20 mg). Children 6-12: 10 mg once daily or 5 mg twice daily. Seniors/Renal/Hepatic impairment: 5 mg/day starting dose.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at room temperature 15-30°C. Protect from moisture.
How is it supplied?
Bottles of 100 and 500; unit dose packages of 6, 10, 12, 18, 20, 24, 30, 36, 48 and 72 tablets.
Contraindications
Known hypersensitivity to cetirizine, hydroxyzine, or any ingredient; severe renal impairment (creatinine clearance < 10 mL/min).
Warnings and precautions
May cause somnolence; caution when driving or operating machinery. Use with caution in patients with preexisting liver disease due to potential transaminase elevations.
What can be used instead?
Other Canadian products sharing ATC code R06AE07 CETIRIZINE. 27 of 65 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 |
|---|---|---|---|---|---|
| ALLERGY RELIEF | 10 MG | TABLET | APOTEX INC | MARKETED | DIN 02240266 |
| ALLERGY RELIEF LIQUID GELS | 10 MG | CAPSULE | JUNO OTC INC | MARKETED | DIN 02528738 |
| APO-CETIRIZINE | 10 MG | TABLET | APOTEX INC | MARKETED | DIN 02231603 |
| APO-CETIRIZINE | 20 MG | TABLET | APOTEX INC | MARKETED | DIN 02453363 |
| BIO-CETIRIZINE | 20 MG | TABLET | BIOMED PHARMA | MARKETED | DIN 02510030 |
| CETIRIZINE | 20 MG | TABLET | SIVEM PHARMACEUTICALS ULC | MARKETED | DIN 02534126 |
| CETIRIZINE | 20 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02515695 |
| EXTRA STRENGTH ALLERGY RELIEF | 10 MG | TABLET | VITA HEALTH PRODUCTS INC | MARKETED | DIN 02540495 |
| EXTRA STRENGTH ALLERGY RELIEF | 10 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02315955 |
| JAMP-CETIRIZINE | 10 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02451778 |
Who else supplies CETIRIZINE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. CETIRIZINE appears in 177 registered pack listings across 9 markets, published on 7 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.