- Approval Id
- 022f716e971f1b8b
- Drug Name
- DIFFORAL CAPSULES 125MG
- Product Name
- DIFFORAL CAPSULES 125MG
- Approval Number
- SIN16931P
- Approval Date
- 2024-01-17
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>Adults</strong><br>
Vancomycin Hydrochloride Capsule is used in treating <em>C. difficile</em>-associated diarrhea and staphylococcal enterocolitis.</p>
<ul>
<li><em>C. difficile</em>-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days.</li>
<li>Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.</li>
</ul>
<p><strong>Pediatric Patients (less than 18 years of age)</strong><br>
For both <em>C. difficile</em>-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.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS AND USAGE</strong></p>
<p>Vancomycin Hydrochloride Capsule is indicated for the treatment of <em>C. difficile</em>-associated diarrhea. Vancomycin Hydrochloride Capsule is also used for the treatment of enterocolitis caused by <em>Staphylococcus aureus</em> (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age.</p>
<p><u>Limitations of Use</u></p>
<ul>
<li>Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsule must be given orally for these infections.</li>
<li>Orally administered Vancomycin Hydrochloride Capsule is not effective for other types of infections.</li>
</ul>
<p>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.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
Vancomycin Hydrochloride Capsule is contraindicated in patients with known hypersensitivity to vancomycin.</p>
- Atc Code
- A07AA09
- Atc Item Name
- vancomycin
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
