VALPROIC ACID 250 MG
VALPROIC ACID : 250 MG · DIN 02237830 · APOTEX INC
Health Canada status: APPROVED
What is VALPROIC ACID?
VALPROIC ACID 250 MG contains VALPROIC ACID : 250 MG. It is listed in the Health Canada Drug Product Database under DIN 02237830, held by APOTEX INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as approved, status dated 20-Nov-2020. 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 VALPROIC ACID used for?
Sole or adjunctive therapy for simple/complex absence seizures (petit mal) and primary generalized seizures with tonic-clonic manifestations. Adjunctive for multiple seizure types.
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 | 02237830 |
|---|---|
| Brand name | VALPROIC ACID |
| Generic / active ingredient | VALPROIC ACID : 250 MG |
| Manufacturer | APOTEX INC |
| Strength | 250 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | N03AG01 VALPROIC ACID |
| AHFS class | 28:12.92 |
| Biosimilar | No |
| Health Canada status | APPROVED |
| Status date | 20-Nov-2020 |
How is it administered?
Initial: 15 mg/kg/day, increasing by 5-10 mg/kg/day weekly. Max: 60 mg/kg/day. Doses >250 mg should be divided. Swallow capsules whole. Oral solution available.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text snippet (Section 11 not fully visible), but standard pharmaceutical storage usually applies.
How is it supplied?
Capsules: Bottles of 100, 250, and 500. Oral Solution: Bottles of 450 mL.
Contraindications
Pregnancy (unless no alternative), women of childbearing potential (unless program fulfilled), hepatic disease, mitochondrial disorders (POLG mutations), urea cycle disorders, carnitine deficiency.
Warnings and precautions
Serious hepatotoxicity (fatalities), life-threatening pancreatitis, fetal harm (teratogenicity), and risk of neurodevelopmental disorders in children of treated males.
What can be used instead?
Other Canadian products sharing ATC code N03AG01 VALPROIC ACID. 17 of 70 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-DIVALPROEX | 125 MG | TABLET (DELAYED-RELEASE) | APOTEX INC | MARKETED | DIN 02239698 |
| APO-DIVALPROEX | 250 MG | TABLET (DELAYED-RELEASE) | APOTEX INC | MARKETED | DIN 02239699 |
| APO-DIVALPROEX | 500 MG | TABLET (DELAYED-RELEASE) | APOTEX INC | MARKETED | DIN 02239700 |
| APO-VALPROIC ACID | 250 MG | CAPSULE | APOTEX INC | MARKETED | DIN 02238048 |
| DEPAKENE | 250 MG / 5 ML | SOLUTION | BGP PHARMA ULC | MARKETED | DIN 00443832 |
| EPIVAL | 125 MG | TABLET (DELAYED-RELEASE) | BGP PHARMA ULC | MARKETED | DIN 00596418 |
| EPIVAL | 250 MG | TABLET (DELAYED-RELEASE) | BGP PHARMA ULC | MARKETED | DIN 00596426 |
| EPIVAL | 500 MG | TABLET (DELAYED-RELEASE) | BGP PHARMA ULC | MARKETED | DIN 00596434 |
| JAMP DIVALPROEX | 250 MG | TABLET (DELAYED-RELEASE) | JAMP PHARMA CORPORATION | MARKETED | DIN 02551152 |
| JAMP DIVALPROEX | 500 MG | TABLET (DELAYED-RELEASE) | JAMP PHARMA CORPORATION | MARKETED | DIN 02551160 |
How can I get it?
This product is approved by Health Canada but not yet marketed in Canada, so there is no Canadian supply to draw on today. Nexara can tell you whether it has been launched, and can look at supply from other markets where a Canadian pack is not required or where importation is 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.