TEVA-PROCTOSONE 1 %
FRAMYCETIN SULFATE : 1 % DIBUCAINE HYDROCHLORIDE : 0.5 % ESCULIN : 1 % HYDROCORTISONE (HYDROCORTISONE ACETATE) : 0.5 % · DIN 02226383 · TEVA CANADA LIMITED
Health Canada status: MARKETED
What is TEVA-PROCTOSONE?
TEVA-PROCTOSONE 1 % contains FRAMYCETIN SULFATE : 1 % DIBUCAINE HYDROCHLORIDE : 0.5 % ESCULIN : 1 % HYDROCORTISONE (HYDROCORTISONE ACETATE) : 0.5 %. It is listed in the Health Canada Drug Product Database under DIN 02226383, held by TEVA CANADA LIMITED, supplied as OINTMENT for RECTAL administration. Health Canada currently lists it as marketed, status dated 22-Jan-2018. 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 TEVA-PROCTOSONE used for?
Reduction of swelling, pain and inflammation of hemorrhoids and rectal lesions; management of proctitis, cryptitis, fissures, fistulas, and pruritus ani; pre- and postoperative care.
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 | 02226383 |
|---|---|
| Brand name | TEVA-PROCTOSONE |
| Generic / active ingredient | FRAMYCETIN SULFATE : 1 % DIBUCAINE HYDROCHLORIDE : 0.5 % ESCULIN : 1 % HYDROCORTISONE (HYDROCORTISONE ACETATE) : 0.5 % |
| Manufacturer | TEVA CANADA LIMITED |
| Strength | 1 % |
| Dosage form | OINTMENT |
| Route of administration | RECTAL |
| Schedule | Prescription |
| ATC code | C05AA01 HYDROCORTISONE |
| AHFS class | 84:06.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 22-Jan-2018 |
| Original market date | 1997-02-03 00:00:00 |
How is it administered?
Ointment: Apply small quantity morning, evening, and after bowel movements. Suppositories: One suppository morning, evening, and after bowel movements.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store between 15°-30°C.
How is it supplied?
Ointment: 15 and 30 g tubes with rectal cannula. Suppositories: Boxes of 12.
Contraindications
Tuberculosis, fungal and viral infections. Sensitivity to any of the components.
Warnings and precautions
Discontinue if sensitization occurs. Complete proctologic examination before use. Prolonged use may produce systemic corticosteroid effects. Risk of drug-resistant bacteria with misuse.
What can be used instead?
Other Canadian products sharing ATC code C05AA01 HYDROCORTISONE. 10 of 32 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 |
|---|---|---|---|---|---|
| ANODAN-HC 10MG SUPPOSITORIES | 10 MG | SUPPOSITORY | ODAN LABORATORIES LTD | MARKETED | DIN 02236399 |
| ANODAN-HC OINTMENT | 0.5 % | OINTMENT | ODAN LABORATORIES LTD | MARKETED | DIN 02128446 |
| ANUSOL-HC OINTMENT | 0.5 % | OINTMENT | CHURCH & DWIGHT CANADA CORP | MARKETED | DIN 00505773 |
| ANUSOL-HC SUPPOSITORIES | 10 MG | SUPPOSITORY | CHURCH & DWIGHT CANADA CORP | MARKETED | DIN 00476285 |
| JAMPZINC-HC | 0.5 % | OINTMENT | JAMP PHARMA CORPORATION | MARKETED | DIN 02387239 |
| PROCTODAN-HC OINTMENT | 1 % | OINTMENT | ODAN LABORATORIES LTD | MARKETED | DIN 02234466 |
| PROCTODAN-HC SUPPOSITORIES | 10 MG | SUPPOSITORY | ODAN LABORATORIES LTD | MARKETED | DIN 02240851 |
| PROCTOL OINTMENT | 0.5 % | OINTMENT | ODAN LABORATORIES LTD | MARKETED | DIN 02247322 |
| PROCTOL SUPPOSITORIES | 10 MG | SUPPOSITORY | ODAN LABORATORIES LTD | MARKETED | DIN 02247882 |
| EGOZINC-HC | 0.5 % | OINTMENT | PHARMASCIENCE INC | CANCELLED POST MARKET | DIN 02209764 |
Who else supplies HYDROCORTISONE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. HYDROCORTISONE appears in 37 registered pack listings across 7 markets, published on 6 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.