SAMSCA 30 MG
TOLVAPTAN : 30 MG · DIN 02370476 · OTSUKA PHARMACEUTICAL CO LTD
Health Canada status: MARKETED
What is SAMSCA?
SAMSCA 30 MG contains TOLVAPTAN : 30 MG. It is listed in the Health Canada Drug Product Database under DIN 02370476, held by OTSUKA PHARMACEUTICAL CO LTD, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 22-Sep-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 SAMSCA used for?
Treatment of clinically important, non-hypovolemic hyponatremia (serum sodium < 130 mEq/L or symptomatic). Not for urgent correction of serious neurological symptoms.
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 | 02370476 |
|---|---|
| Brand name | SAMSCA |
| Generic / active ingredient | TOLVAPTAN : 30 MG |
| Manufacturer | OTSUKA PHARMACEUTICAL CO LTD |
| Strength | 30 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | C03XA01 TOLVAPTAN |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 22-Sep-2011 |
How is it administered?
Initiate/re-initiate in hospital. Start 15 mg once daily; titrate to 30 mg and 60 mg at 24-hour intervals to achieve desired serum sodium. Avoid fluid restriction in first 24 hours.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (refer to Part I Summary Product Information or Part II).
How is it supplied?
Not explicitly detailed in provided text (mentions 15 mg, 30 mg, 60 mg strengths).
Contraindications
Hypersensitivity to tolvaptan/benzazepines; anuria; hypovolemic hyponatremia; hypernatremia; urgent need to raise sodium; inability to sense thirst; strong CYP3A inhibitors; pregnancy/nursing; ADPKD.
Warnings and precautions
Risk of Osmotic Demyelination Syndrome if sodium correction is >12 mEq/L/24h. Potential for irreversible/fatal liver injury; monitor transaminases. Risk of dehydration and hypersensitivity.
What can be used instead?
Other Canadian products sharing ATC code C03XA01 TOLVAPTAN. 10 of 11 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 |
|---|---|---|---|---|---|
| JINARC | 15 MG | TABLET | OTSUKA PHARMACEUTICAL CO LTD | MARKETED | DIN 02437503 |
| JINARC | 15 MG | TABLET | OTSUKA PHARMACEUTICAL CO LTD | MARKETED | DIN 02491575 |
| JINARC | 60 MG | TABLET | OTSUKA PHARMACEUTICAL CO LTD | MARKETED | DIN 02437511 |
| JINARC | 90 MG | TABLET | OTSUKA PHARMACEUTICAL CO LTD | MARKETED | DIN 02437538 |
| JINARC | Strength | Tablet | OTSUKA PHARMACEUTICAL CO LTD 2-9 Kanda-Tsukasamachi Chiyoda-Ku Tokyo -- Japan 101-8535 | MARKETED | DIN 02491583 |
| LUPIN-TOLVAPTAN | 15 MG | TABLET | LUPIN PHARMA CANADA LIMITED | MARKETED | DIN 02557177 |
| LUPIN-TOLVAPTAN | 30 MG | TABLET | LUPIN PHARMA CANADA LIMITED | MARKETED | DIN 02557185 |
| LUPIN-TOLVAPTAN | 90 MG | TABLET | LUPIN PHARMA CANADA LIMITED | MARKETED | DIN 02557215 |
| SAMSCA | 15 MG | Tablet | OTSUKA PHARMACEUTICAL CO LTD | MARKETED | DIN 02370468 |
| SAMSCA | 60 MG | TABLET | OTSUKA PHARMACEUTICAL CO LTD | APPROVED | DIN 02370484 |
Who else supplies TOLVAPTAN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. TOLVAPTAN appears in 113 registered pack listings across 11 markets, published on 9 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.