ACTONEL DR 35 MG
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) : 35 MG · DIN 02370417 · ABBVIE CORPORATION
Health Canada status: MARKETED
What is ACTONEL DR?
ACTONEL DR 35 MG contains RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) : 35 MG. It is listed in the Health Canada Drug Product Database under DIN 02370417, held by ABBVIE CORPORATION, supplied as TABLET (DELAYED-RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 22-May-2025. 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 ACTONEL DR used for?
Treatment/prevention of postmenopausal osteoporosis; osteoporosis in men; glucocorticoid-induced osteoporosis; Paget’s disease of bone. ACTONEL DR is for postmenopausal osteoporosis only.
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 | 02370417 |
|---|---|
| Brand name | ACTONEL DR |
| Generic / active ingredient | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) : 35 MG |
| Manufacturer | ABBVIE CORPORATION |
| Strength | 35 MG |
| Dosage form | TABLET (DELAYED-RELEASE) |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | M05BA07 RISEDRONIC ACID |
| AHFS class | 92:24.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 22-May-2025 |
| Original market date | 2011-08-10 00:00:00 |
How is it administered?
ACTONEL: Take on empty stomach 30 min before food/drink with 120mL water; stay upright for 30 min. ACTONEL DR: Take with breakfast with 120mL water; stay upright for 30 min. Do not chew/crush.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (standard reference to section 11 which is not fully transcribed).
How is it supplied?
35 mg: Cartons of 4 blister-packaged tablets. 150 mg: Cartons of 1 blister-packaged tablet.
Contraindications
Hypersensitivity to risedronate sodium or any ingredient in the formulation; Hypocalcemia.
Warnings and precautions
Upper GI disorders (esophagitis, ulcers); Osteonecrosis of the jaw (ONJ); Atypical femur fractures; Severe musculoskeletal pain; Ocular disturbances (uveitis, scleritis).
What can be used instead?
Other Canadian products sharing ATC code M05BA07 RISEDRONIC ACID. 20 of 40 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 |
|---|---|---|---|---|---|
| AA-RISEDRONATE DR | 35 MG | TABLET (DELAYED-RELEASE) | AA PHARMA INC | MARKETED | DIN 02493268 |
| ACTONEL | 150 MG | TABLET | ABBVIE CORPORATION | MARKETED | DIN 02316838 |
| ACTONEL | 35 MG | TABLET | ABBVIE CORPORATION | MARKETED | DIN 02246896 |
| APO-RISEDRONATE | 150 MG | TABLET | APOTEX INC | MARKETED | DIN 02377721 |
| APO-RISEDRONATE | 35 MG | TABLET | APOTEX INC | MARKETED | DIN 02353687 |
| AURO-RISEDRONATE | 35 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02406306 |
| NB-RISEDRONATE | Strength | Tablet | NB PHARMA INC. 208 2700 Rue Jean-Perrin Québec Quebec Canada G2C 1S9 | MARKETED | DIN 02561859 |
| PMS-RISEDRONATE | 150 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02424177 |
| PMS-RISEDRONATE | 35 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02302209 |
| RISEDRONATE | 150 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02528460 |
Who else supplies RISEDRONIC ACID worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. RISEDRONIC ACID appears in 16 registered pack listings across 2 markets, published on 1 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.