FUCIDIN OINTMENT 2% 2 %
FUSIDATE SODIUM : 2 % · DIN 00586676 · LEO PHARMA INC
Health Canada status: MARKETED
What is FUCIDIN OINTMENT 2%?
FUCIDIN OINTMENT 2% 2 % contains FUSIDATE SODIUM : 2 %. It is listed in the Health Canada Drug Product Database under DIN 00586676, held by LEO PHARMA INC, supplied as OINTMENT for TOPICAL administration. Health Canada currently lists it as marketed, status dated 31-Dec-1984. 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 FUCIDIN OINTMENT 2% used for?
For use in the treatment of primary and secondary skin infections caused by sensitive strains of Staphylococcus aureus, Streptococcus spp and Corynebacterium minutissimum. Primary skin infections that may be expected to respond to treatment with FUCIDIN OINTMENT (sodium fusidate) and CREAM (fusidic acid) include: impetigo contagiosa, erythrasma and secondary skin infections such as infected wounds and infected burns. To reduce the development of drug-resistant bacteria and maintain the effectiveness of FUCIDIN OINTMENT and CREAM and other antibacterial drugs, FUCIDIN OINTMENT and CREAM should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. Appropriate culture and susceptibility studies should be performed. However, while waiting results of these studies and, if antibiotic therapy is considered to be necessary, FUCIDIN OINTMENT and CREAM may be administered to those patients in whom an infection caused by susceptible bacteria is suspected. This antibiotic treatment may subsequently require modification once these results become available. In addition, local concentrations of FUCIDIN OINTMENT and CREAM are active against other Corynebacteria spp. No cross-resistance has been observed to date between FUCIDIN and other antibiotics presently in clinical use. Resistance to FUCIDIN has readily been induced in vitro. The development of resistance has also been shown to occur in the clinical setting. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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 | 00586676 |
|---|---|
| Brand name | FUCIDIN OINTMENT 2% |
| Generic / active ingredient | FUSIDATE SODIUM : 2 % |
| Manufacturer | LEO PHARMA INC |
| Strength | 2 % |
| Dosage form | OINTMENT |
| Route of administration | TOPICAL |
| Schedule | Prescription |
| ATC code | D06AX01 FUSIDIC ACID |
| AHFS class | 84:04.04 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 31-Dec-1984 |
| Original market date | 1984-12-31 00:00:00 |
How is it administered?
A small amount of FUCIDIN OINTMENT or CREAM should be applied to the lesion two to three times daily for 7-14 days. Whenever the lesion is to be covered with a gauze dressing, less frequent applications (1 or 2 daily) may be used. In impetigo contagiosa, it has been shown to be unneccessary to remove the crusts before application of FUCIDIN OINTMENT or CREAM. When required, incision and drainage of infected skin lesions should be carried out before treatment with FUCIDIN OINTMENT or CREAM.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
FUCIDIN CREAM: Store below 30°C. FUCIDIN OINTMENT: Store below 30°C. Use within 3 months of first opening the tube. Keep out of reach and sight of children and pets.
How is it supplied?
FUCIDIN CREAM: Available in aluminium tubes of 15 g and 30 g covered with internal epoxyphenol lacquer. The tube has re-closable high density polyethylene screw cap. FUCIDIN OINTMENT: Available in aluminium tubes of 15 g and 30 g covered with internal epoxyphenol lacquer. The tube has re-closable high density polyethylene screw cap.
Contraindications
Fusidic acid 2% cream and Sodium fusidate 2% ointment are contraindicated in patients who are hypersensitive to these drugs or to any ingredient in the formulations, including non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
Warnings and precautions
Treatment of severe or refractory skin lesions should be supplemented with the administration of a systemic antibacterial agent. Use of topical antibiotics occasionally allows overgrowth of non-susceptible organisms. If this occurs, or irritation or sensitization develops, treatment with FUCIDIN OINTMENT or CREAM should be discontinued and appropriate therapy instituted. Prescribing FUCIDIN OINTMENT and CREAM in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of resistant organisms. Bacterial resistance among Staphylococcus aureus has been reported to occur with the use of topical FUCIDIN. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance. Limiting therapy with topical fusidic acid to no more than 14 days at a time will minimize the risk of developing resistance. FUCIDIN CREAM contains butyl hydroxyanisole, cetyl alcohol and potassium sorbate. These excipients may cause local skin reactions (e.g. contact dermatitis). Butyl hydroxyanisole may also cause irritation to the eyes and mucous membranes. FUCIDIN CREAM should therefore be used with care when applied in the proximity of the eyes. FUCIDIN OINTMENT contains cetyl alcohol and hydrous lanolin. These excipients may cause local skin reactions (e.g. contact dermatitis). FUCIDIN OINTMENT contains butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. When FUCIDIN OINTMENT is used on the face; care should be taken to avoid the eyes as the excipients in the ointment may cause conjunctival irritation.
What can be used instead?
Other Canadian products sharing ATC code D06AX01 FUSIDIC ACID. 3 of 3 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 |
|---|---|---|---|---|---|
| FUCIDIN CREAM 2% | 2 % | CREAM | LEO PHARMA INC | MARKETED | DIN 00586668 |
| TARO-FUSIDIC ACID | 2 % | CREAM | TARO PHARMACEUTICALS INC | MARKETED | DIN 02528096 |
Who else supplies FUSIDIC ACID worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. FUSIDIC ACID appears in 108 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.