SANDOZ FLUOROMETHOLONE 0.1 %
FLUOROMETHOLONE : 0.1 % · DIN 00432814 · SANDOZ CANADA INCORPORATED
Health Canada status: MARKETED
What is SANDOZ FLUOROMETHOLONE?
SANDOZ FLUOROMETHOLONE 0.1 % contains FLUOROMETHOLONE : 0.1 %. It is listed in the Health Canada Drug Product Database under DIN 00432814, held by SANDOZ CANADA INCORPORATED, supplied as SUSPENSION for OPHTHALMIC administration. Health Canada currently lists it as marketed, status dated 24-Jul-2012. 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 SANDOZ FLUOROMETHOLONE used for?
Steroid responsive inflammation of palpebral and bulbar conjunctiva, cornea and anterior segment of globe.
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 | 00432814 |
|---|---|
| Brand name | SANDOZ FLUOROMETHOLONE |
| Generic / active ingredient | FLUOROMETHOLONE : 0.1 % |
| Manufacturer | SANDOZ CANADA INCORPORATED |
| Strength | 0.1 % |
| Dosage form | SUSPENSION |
| Route of administration | OPHTHALMIC |
| Schedule | Prescription |
| ATC code | S01BA07 FLUOROMETHOLONE |
| AHFS class | 52:08.08 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 24-Jul-2012 |
| Original market date | 2012-07-24 00:00:00 |
How is it administered?
1-2 drops into conjunctival sac 2-4 times daily. May increase to 2 drops every hour during first 24-48 hours. Shake well before use.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at 15 – 25º C. Protect from freezing. Avoid excessive heat. Store in carton until fully used. Store upright.
How is it supplied?
5 mL natural low density polyethylene (LDPE) bottle with dispensing plug and white polypropylene cap.
Contraindications
Tuberculosis of the eye, fungal diseases, acute superficial herpes simplex keratitis, viral diseases of cornea/conjunctiva, untreated purulent infections, hypersensitivity.
Warnings and precautions
May increase intraocular pressure; check IOP frequently. Prolonged use may result in glaucoma, optic nerve damage, or cataracts. Risk of corneal perforation in thinning diseases.
What can be used instead?
Other Canadian products sharing ATC code S01BA07 FLUOROMETHOLONE. 2 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 |
|---|---|---|---|---|---|
| FML | 0.1 % | SUSPENSION | ABBVIE CORPORATION | MARKETED | DIN 00247855 |
| FLAREX | 0.1 % | SUSPENSION | NOVARTIS PHARMACEUTICALS CANADA INC | CANCELLED POST MARKET | DIN 00756784 |
| FML FORTE SUS 0.25% | 0.25 % | SUSPENSION | ALLERGAN INC | CANCELLED POST MARKET | DIN 00707511 |
| PMS-FLUOROMETHOLONE | 0.1 % | SUSPENSION | PHARMASCIENCE INC | CANCELLED POST MARKET | DIN 02238568 |
Who else supplies FLUOROMETHOLONE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. FLUOROMETHOLONE appears in 18 registered pack listings across 9 markets, published on 7 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.