OTIXAL 0.3 %
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) : 0.3 % FLUOCINOLONE ACETONIDE : 0.025 % · DIN 02459655 · MEDEXUS PHARMACEUTICALS INC.
Health Canada status: MARKETED
What is OTIXAL?
OTIXAL 0.3 % contains CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) : 0.3 % FLUOCINOLONE ACETONIDE : 0.025 %. It is listed in the Health Canada Drug Product Database under DIN 02459655, held by MEDEXUS PHARMACEUTICALS INC., supplied as SOLUTION for OTIC administration. Health Canada currently lists it as marketed, status dated 25-Jan-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 OTIXAL used for?
OTIXAL (0.3% w/v ciprofloxacin (as ciprofloxacin hydrochloride) and 0.025% w/v fluocinolone acetonide) otic solution is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (age 6 months and older) due to Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Moraxella catarrhalis and Pseudomonas aeruginosa. To reduce the development of drug-resistant bacteria and maintain the effectiveness of OTIXAL and other antibacterial drugs, OTIXAL should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
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 | 02459655 |
|---|---|
| Brand name | OTIXAL |
| Generic / active ingredient | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) : 0.3 % FLUOCINOLONE ACETONIDE : 0.025 % |
| Manufacturer | MEDEXUS PHARMACEUTICALS INC. |
| Strength | 0.3 % |
| Dosage form | SOLUTION |
| Route of administration | OTIC |
| Schedule | Prescription |
| ATC code | S02CA05 FLUOCINOLONE ACETONIDE AND ANTIINFECTIVES |
| AHFS class | 92:20.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 25-Jan-2023 |
How is it stored and handled?
Store at room temperature (15°C to 30°C). Protect from light; store unused vials in pouch and discard 7 days after opening the pouch. Do not open until ready to use.
How is it supplied?
Two vials are packed per pouch (sample). Fifteen vials, divided in three strips of five vials, are packed per pouch (commercial pack). Forty-eight vials divided into twenty-four pouches, strips of two vials per pouch (commercial pack).
What can be used instead?
Other Canadian products sharing ATC code S02CA05 FLUOCINOLONE ACETONIDE AND ANTIINFECTIVES. 1 of 2 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 |
|---|---|---|---|---|---|
| SYNALAR BI-OTIC SOLUTION | 3.5 MG | SOLUTION | MEDICIS CANADA LTD. | CANCELLED POST MARKET | DIN 00189499 |
Who else supplies FLUOCINOLONE ACETONIDE AND ANTIINFECTIVES worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. FLUOCINOLONE ACETONIDE AND ANTIINFECTIVES appears in 4 registered pack listings across 3 markets, published on 3 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.