SPORANOX 100 MG
ITRACONAZOLE : 100 MG · DIN 02047454 · JANSSEN INC
Health Canada status: CANCELLED POST MARKET
What is SPORANOX?
SPORANOX 100 MG contains ITRACONAZOLE : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02047454, held by JANSSEN INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 01-Apr-2026. 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?
SPORANOX (itraconazole) is indicated for the treatment of systemic fungal infections such as invasive and non-invasive pulmonary aspergillosis, oral and/or esophageal candidiasis, chronic pulmonary histoplasmosis, cutaneous and lymphatic sporotrichosis, paracoccidioidomycosis, chromoblastomycosis, and blastomycosis. It is also indicated for topical fungal infections like dermatomycoses (tinea corporis, tinea cruris, tinea pedis, pityriasis versicolor) and onychomycosis, where oral therapy is deemed appropriate.
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 | 02047454 |
|---|---|
| Brand name | SPORANOX |
| Generic / active ingredient | ITRACONAZOLE : 100 MG |
| Manufacturer | JANSSEN INC |
| Strength | 100 MG |
| Dosage form | CAPSULE |
| 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 | 01-Apr-2026 |
| Original market date | 1993-12-31 00:00:00 |
How is it administered?
100-400 mg/day depending on infection. Administer immediately after a full meal. Capsules must be swallowed whole. Pulse dosing used for onychomycosis.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
null
How is it supplied?
HDPE bottles of 30 capsules
Contraindications
Ventricular dysfunction (CHF); Coadministration with CYP3A4 substrates (e.g., methadone, quinidine, simvastatin); Hypersensitivity to itraconazole; Pregnancy for onychomycosis/dermatomycoses.
Warnings and precautions
Serious hepatotoxicity (liver failure/death); Congestive Heart Failure (negative inotropic effect); Cardiac dysrhythmias with certain drug interactions; Transient/permanent hearing loss.
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 | 10 MG | SOLUTION | JANSSEN INC | CANCELLED POST MARKET | DIN 02231347 |
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.
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.