SPORANOX 10 MG
ITRACONAZOLE : 10 MG · DIN 02231347 · JANSSEN INC
Health Canada status: CANCELLED POST MARKET
What is SPORANOX?
SPORANOX 10 MG contains ITRACONAZOLE : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02231347, held by JANSSEN INC, supplied as SOLUTION for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 29-Sep-2023. 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 SPORANOX used for?
Treatment of oral and/or esophageal candidiasis in adult HIV-positive or other immunocompromised patients. Not for initiation in patients at immediate risk of systemic candidiasis.
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 | 02231347 |
|---|---|
| Brand name | SPORANOX |
| Generic / active ingredient | ITRACONAZOLE : 10 MG |
| Manufacturer | JANSSEN INC |
| Strength | 10 MG |
| Dosage form | SOLUTION |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | J02AC02 ITRACONAZOLE |
| AHFS class | 08:14.08 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 29-Sep-2023 |
| Original market date | 1997-07-28 00:00:00 |
How is it administered?
Oral solution should be swished and swallowed without food. Oral Candidiasis: 200 mg daily for 1-2 weeks. Esophageal Candidiasis: 100-200 mg daily for minimum 3 weeks.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly specified in provided text (refer to section 11).
How is it supplied?
150 mL in amber glass bottles with a supplied dosing cup (2.5 mL, 5 mL, and 10 mL graduations).
Contraindications
Ventricular dysfunction (CHF); Coadministration with CYP3A4 substrates (e.g., methadone, simvastatin, ticagrelor); Hypersensitivity to itraconazole.
Warnings and precautions
Serious hepatotoxicity; Congestive Heart Failure (negative inotropic effects); Cardiac dysrhythmias with certain drug interactions; Hearing loss; Neuropathy.
What can be used instead?
Other Canadian products sharing ATC code J02AC02 ITRACONAZOLE. 3 of 5 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 |
|---|---|---|---|---|---|
| JAMP ITRACONAZOLE ORAL SOLUTION | 10 MG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02484315 |
| MINT-ITRACONAZOLE | 100 MG | CAPSULE | MINT PHARMACEUTICALS INC | MARKETED | DIN 02462559 |
| ODAN ITRACONAZOLE | 10 MG | SOLUTION | ODAN LABORATORIES LTD | MARKETED | DIN 02495988 |
| SPORANOX | 100 MG | CAPSULE | JANSSEN INC | CANCELLED POST MARKET | DIN 02047454 |
Who else supplies ITRACONAZOLE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. ITRACONAZOLE appears in 779 registered pack listings across 14 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.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.