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DIFFORAL CAPSULES 125MG [SIN16931P]

Active ingredients: DIFFORAL CAPSULES 125MG

Last updated 26 October 2025

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Product Info
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION

Product Info

DIFFORAL CAPSULES 125MG

[SIN16931P]

Product information

Active Ingredient and Strength

VANCOMYCIN HYDROCHLORIDE EQV VANCOMYCIN - 125 MG

Dosage Form

CAPSULE

Manufacturer and Country

KLEVA PHARMACEUTICALS S.A. - GREECE

Registration Number

SIN16931P

Licence Holder

GOLDPLUS UNIVERSAL PTE LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

A07AA09

INDICATIONS AND USAGE

Vancomycin Hydrochloride Capsule is indicated for the treatment of C. difficile-associated diarrhea. Vancomycin Hydrochloride Capsule is also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age.

Limitations of Use

  • Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsule must be given orally for these infections.

  • Orally administered Vancomycin Hydrochloride Capsule is not effective for other types of infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride Capsule and other antibacterial drugs, Vancomycin Hydrochloride Capsule should be used only to treat or to prevent infection that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION

Adults
Vancomycin Hydrochloride Capsule is used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.

  • C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days.

  • Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.

Pediatric Patients (less than 18 years of age)
For both C. difficile-associated diarrhea and staphylococcal enterocolitis, the usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

CONTRAINDICATIONS
Vancomycin Hydrochloride Capsule is contraindicated in patients with known hypersensitivity to vancomycin.