APO-PRAMIPEXOLE 1.0 MG
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE : 1.0 MG · DIN 02292394 · APOTEX INC
Health Canada status: MARKETED
What is APO-PRAMIPEXOLE?
APO-PRAMIPEXOLE 1.0 MG contains PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE : 1.0 MG. It is listed in the Health Canada Drug Product Database under DIN 02292394, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 26-Feb-2007. 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-PRAMIPEXOLE used for?
Treatment of signs and symptoms of idiopathic Parkinson’s disease (early or adjunct to levodopa) and symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS).
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 | 02292394 |
|---|---|
| Brand name | APO-PRAMIPEXOLE |
| Generic / active ingredient | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE : 1.0 MG |
| Manufacturer | APOTEX INC |
| Strength | 1.0 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | N04BC05 PRAMIPEXOLE |
| AHFS class | 28:36.20.08 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 26-Feb-2007 |
| Original market date | 2007-02-26 00:00:00 |
How is it administered?
Parkinson’s: Start 0.375 mg/day in 3 divided doses; titrate every 5-7 days to max 4.5 mg/day. RLS: Start 0.125 mg once daily 2-3 hours before bedtime; max 0.75 mg/day. Tapering required for cessation.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at 15-30°C. (Note: Standard pharmaceutical storage based on monograph context, though specific section 11 text was truncated).
How is it supplied?
Bottles of 100 tablets.
Contraindications
Hypersensitivity to pramipexole or any of the excipients.
Warnings and precautions
Sudden onset of sleep/somnolence; orthostatic hypotension; hallucinations; impulse control disorders; dopamine agonist withdrawal syndrome; augmentation in RLS; fibrotic complications.
What can be used instead?
Other Canadian products sharing ATC code N04BC05 PRAMIPEXOLE. 29 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 |
|---|---|---|---|---|---|
| ACT PRAMIPEXOLE | 0.25 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02297302 |
| ACT PRAMIPEXOLE | 0.5 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02297310 |
| ACT PRAMIPEXOLE | 1 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02297329 |
| ACT PRAMIPEXOLE | 1.5 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02297337 |
| APO-PRAMIPEXOLE | 0.25 MG | TABLET | APOTEX INC | MARKETED | DIN 02292378 |
| APO-PRAMIPEXOLE | 0.5 MG | TABLET | APOTEX INC | MARKETED | DIN 02292386 |
| APO-PRAMIPEXOLE | 1.5 MG | TABLET | APOTEX INC | MARKETED | DIN 02292408 |
| AURO-PRAMIPEXOLE | 0.25 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02424061 |
| AURO-PRAMIPEXOLE | 0.5 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02424088 |
| AURO-PRAMIPEXOLE | 1 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02424096 |
Who else supplies PRAMIPEXOLE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. PRAMIPEXOLE appears in 2459 registered pack listings across 11 markets, published on 10 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.