APO-OXYBUTYNIN 5 MG
OXYBUTYNIN CHLORIDE : 5 MG · DIN 02163543 · APOTEX INC
Health Canada status: MARKETED
What is APO-OXYBUTYNIN?
APO-OXYBUTYNIN 5 MG contains OXYBUTYNIN CHLORIDE : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02163543, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 25-Jan-2022. 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 APO-OXYBUTYNIN used for?
Relief of symptoms associated with voiding in patients with uninhibited neurogenic bladder and reflex neurogenic bladder (urgency, frequency, urinary leakage, urge incontinence, dysuria).
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 | 02163543 |
|---|---|
| Brand name | APO-OXYBUTYNIN |
| Generic / active ingredient | OXYBUTYNIN CHLORIDE : 5 MG |
| Manufacturer | APOTEX INC |
| Strength | 5 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | G04BD04 OXYBUTYNIN |
| AHFS class | 86:12.04 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 25-Jan-2022 |
| Original market date | 1995-12-31 00:00:00 |
How is it administered?
Adults: 5 mg 2-3 times/day (max 5 mg 4 times/day). Children >5: 5 mg 2 times/day (max 5 mg 3 times/day). Elderly/debilitated: Start at lowest dose and increase carefully.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at room temperature 15°C to 30°C in tight, light-resistant containers.
How is it supplied?
Tablets: Bottles of 100 and 500. Syrup: Bottles of 473 mL.
Contraindications
Urinary retention, gastric retention, severe decreased GI motility, uncontrolled narrow-angle glaucoma, and hypersensitivity to the drug or any component.
Warnings and precautions
May cause heat prostration in high temperatures. May produce drowsiness or blurred vision; caution with motor vehicles/machinery. May aggravate CHD, CHF, arrhythmias, and hypertension.
Is OXYBUTYNIN in shortage in Canada?
A Canadian shortage report is on file for this molecule: Discontinued — reported by SANIS HEALTH INC, last seen 04 Jun 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
What can be used instead?
Other Canadian products sharing ATC code G04BD04 OXYBUTYNIN. 5 of 35 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 |
|---|---|---|---|---|---|
| PMS-OXYBUTYNIN | 2.5 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02240549 |
| PMS-OXYBUTYNIN | 5 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02240550 |
| PMS-OXYBUTYNIN | 5 MG / 5 ML | SYRUP | PHARMASCIENCE INC | MARKETED | DIN 02223376 |
| TEVA-OXYBUTYNIN | 5 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02230394 |
| ALBERT OXYBUTYNIN | 5 MG | TABLET | AVENTIS PHARMA INC | CANCELLED POST MARKET | DIN 02220067 |
| APO-OXYBUTYNIN | 1 MG | SYRUP | APOTEX INC | DORMANT | DIN 02231089 |
| AVA-OXYBUTYNIN | 5 MG | TABLET | AVANSTRA INC | CANCELLED POST MARKET | DIN 02363917 |
| DITROPAN SYRUP 1MG/ML | 1 MG | SYRUP | JANSSEN INC | CANCELLED POST MARKET | DIN 01924753 |
| DITROPAN TABLETS 5MG | 5 MG | TABLET | JANSSEN INC | CANCELLED POST MARKET | DIN 01924761 |
| DITROPAN XL | 10 MG | TABLET (EXTENDED-RELEASE) | JANSSEN INC | CANCELLED POST MARKET | DIN 02243961 |
Who else supplies OXYBUTYNIN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. OXYBUTYNIN appears in 39 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.