PRO-RISPERIDONE 0.5 MG
RISPERIDONE : 0.5 MG · DIN 02312719 · PRO DOC LIMITEE
Health Canada status: MARKETED
What is PRO-RISPERIDONE?
PRO-RISPERIDONE 0.5 MG contains RISPERIDONE : 0.5 MG. It is listed in the Health Canada Drug Product Database under DIN 02312719, held by PRO DOC LIMITEE, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 09-Jul-2008. 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 PRO-RISPERIDONE used for?
Acute and maintenance treatment of schizophrenia; short-term management of aggression/psychotic symptoms in severe Alzheimer’s dementia; monotherapy for acute manic episodes in Bipolar I disorder.
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 | 02312719 |
|---|---|
| Brand name | PRO-RISPERIDONE |
| Generic / active ingredient | RISPERIDONE : 0.5 MG |
| Manufacturer | PRO DOC LIMITEE |
| Strength | 0.5 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | N05AX08 RISPERIDONE |
| AHFS class | 28:16.08.04 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 09-Jul-2008 |
| Original market date | 2008-07-09 00:00:00 |
How is it administered?
Schizophrenia: 1-2 mg/day initially, target 4-6 mg/day. Dementia: 0.25 mg b.i.d. initially, target 0.5 mg b.i.d. Bipolar: 2-3 mg once daily. Adjustments at intervals ≥24h or 1 week depending on condition.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text snippet (standard reference is 15-30°C, but not in text).
How is it supplied?
Bottles of 100 (all strengths); bottles of 500 (0.25, 0.5, 1, 2, 3 mg); blister packs of 60 (1, 2, 3 mg).
Contraindications
Hypersensitivity to risperidone, paliperidone, or any ingredients in the formulation.
Warnings and precautions
Increased mortality in elderly patients with dementia. Risk of cerebrovascular adverse events (stroke), Neuroleptic Malignant Syndrome, Tardive Dyskinesia, and orthostatic hypotension.
Is RISPERIDONE in shortage in Canada?
A Canadian shortage report is on file for this molecule: Active — reported by SIVEM PHARMACEUTICALS ULC, last seen 04 Sep 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 N05AX08 RISPERIDONE. 71 of 217 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 |
|---|---|---|---|---|---|
| APO-RISPERIDONE | 0.25 MG | TABLET | APOTEX INC | MARKETED | DIN 02282119 |
| APO-RISPERIDONE | 0.50 MG | TABLET | APOTEX INC | MARKETED | DIN 02282127 |
| APO-RISPERIDONE | 1.0 MG | TABLET | APOTEX INC | MARKETED | DIN 02282135 |
| APO-RISPERIDONE | 2.0 MG | TABLET | APOTEX INC | MARKETED | DIN 02282143 |
| APO-RISPERIDONE | 3.0 MG | TABLET | APOTEX INC | MARKETED | DIN 02282151 |
| APO-RISPERIDONE | 4.0 MG | TABLET | APOTEX INC | MARKETED | DIN 02282178 |
| JAMP-RISPERIDONE | 0.25 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02359529 |
| JAMP-RISPERIDONE | 0.50 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02359537 |
| JAMP-RISPERIDONE | 1.0 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02359545 |
| JAMP-RISPERIDONE | 2.0 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02359553 |
Who else supplies RISPERIDONE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. RISPERIDONE appears in 12168 registered pack listings across 13 markets, published on 12 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.