DIFICID 200 MG
FIDAXOMICIN : 200 MG · DIN 02387174 · MERCK CANADA INC
Health Canada status: MARKETED
What is DIFICID?
DIFICID 200 MG contains FIDAXOMICIN : 200 MG. It is listed in the Health Canada Drug Product Database under DIN 02387174, held by MERCK CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 20-Sep-2016. 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 DIFICID used for?
DIFICID® (fidaxomicin) is indicated in adults (≥18 years of age) for the treatment of Clostridium difficile infection (CDI). To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID® and other antibacterial drugs, DIFICID® should be used only to treat infections that are proven or strongly suspected to be caused by Clostridium difficile.
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 | 02387174 |
|---|---|
| Brand name | DIFICID |
| Generic / active ingredient | FIDAXOMICIN : 200 MG |
| Manufacturer | MERCK CANADA INC |
| Strength | 200 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | A07AA12 FIDAXOMICIN |
| AHFS class | 08:12.12.08 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 20-Sep-2016 |
| Original market date | 2012-06-21 00:00:00 |
How is it administered?
The recommended dose for adults ≥18 years of age is one 200-mg DIFICID® tablet orally twice daily for 10 days with or without food. If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, no additional dose should be taken and the regular dosing schedule should be resumed. No more than two doses of DIFICID® (1 tablet twice a day) should be taken in a 24-hour period. No dose adjustment in adults is necessary based on age or gender, renal function or hepatic impairment.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store between 15°C and 30°C. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date. Store in a tightly closed container away from heat and direct light.
How is it supplied?
30 cc HDPE bottles capped with induction seal closure; 20 film-coated tablets per bottle. 60 cc HDPE bottles capped with induction seal closure; 60 film-coated tablets per bottle. 20 × 1 alu/alu perforated unit dose blisters (10 film-coated tablets per card; 2 cards per carton). 100 × 1 alu/alu perforated unit dose blisters (10 film-coated tablets per card; 10 cards per carton).
Contraindications
Hypersensitivity to this drug or to any ingredient in the formulation or component of the container.
Warnings and precautions
Not for Systemic Infections: Since there is minimal systemic absorption of fidaxomicin, DIFICID® should not be used for the treatment of systemic infections. Development of Drug Resistant Bacteria: Prescribing DIFICID® in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Hypersensitivity: Acute hypersensitivity reactions, such as dyspnea, rash, pruritus, and angioedema of the mouth, throat, and face have been reported with fidaxomicin. If a severe hypersensitivity reaction occurs, DIFICID® should be discontinued and appropriate therapy should be instituted. Some patients with hypersensitivity reactions also reported a history of allergy to macrolides. Physicians prescribing DIFICID® to patients with a known macrolide allergy should be aware of the possibility of hypersensitivity reactions.
Who else supplies FIDAXOMICIN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. FIDAXOMICIN appears in 8 registered pack listings across 8 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.