Dificid (fidaxomicin) is a new-generation macrolide antibacterial agent. It plays an important role in the treatment of Clostridioides difficile infections through a unique targeted mechanism of action.

What Kind of Drug Is Dificid (Fidaxomicin)?

Precision Antibacterial Properties

Fidaxomicin is an antibacterial agent specifically developed for Clostridioides difficile - associated diarrhea (CDAD), indicated for patients aged 6 months and older.

Its mechanism of action focuses on the local gastrointestinal tract. It directly targets the lesion by inhibiting RNA synthesis, achieving effective clearance of Clostridioides difficile.

The use of this drug must strictly follow the scope of indications, and it is only for cases of confirmed or highly suspected Clostridioides difficile infection.

Clinical Application Value

By targeting the treatment of CDAD, fidaxomicin reduces the risk of drug-resistant bacterial strains while maintaining the therapeutic advantages of itself and other antibacterial agents.

When bacterial culture and drug sensitivity data are available, the selection or adjustment of antibacterial treatment regimens should be based on this information.

Specifications and Properties of Dificid (Fidaxomicin)

Tablet Specifications

200 mg film-coated tablets.

Appearance: White to off-white oval shape.

One side of the tablet is engraved with "FDX", and the other side is marked with "200".

Oral Suspension

Concentration specification: 40 mg/mL (200 mg/5 mL after reconstitution).

Granules: White to yellowish-white.

Reconstituted suspension: White to yellowish-white homogeneous liquid.

Formulation Composition

The active ingredient of the tablets is fidaxomicin. The excipient system includes more than ten components such as butylated hydroxytoluene, hydroxypropyl cellulose, soybean lecithin, and magnesium stearate.

In addition to the active ingredient, the oral suspension contains specific excipients such as citric acid, microcrystalline cellulose, and mixed berry flavor.

Storage Conditions of Dificid (Fidaxomicin)

Storage Requirements for Original Packaging

Tablets: Store at 20°C - 25°C (68°F - 77°F); short-term storage within the range of 15°C - 30°C (59°F - 86°F) is allowed.

Storage of Oral Suspension Before Reconstitution

Maintain the integrity of the original packaging.

Store at 20°C - 25°C (68°F - 77°F).

Unopened aluminum foil packaging must be stored at the specified temperature.

Handling After Reconstitution

Refrigerate immediately after reconstitution (2°C - 8°C / 36°F - 46°F).

The shelf life is strictly limited to 12 days.

The discard date must be clearly marked on the vial.

The suspension must be discarded if it exceeds the specified storage time.

Specifications for Use Process

Take the suspension out of the refrigerator 15 minutes in advance before each administration.

Shake vigorously before use until a uniform consistency is achieved.

A dedicated oral dosing syringe must be used to accurately measure the dose.

Reseal immediately after administration and store it in the refrigerator.