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Vancomycin (Vancomycin Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Vancomycin Hydrochloride Capsules, USP are indicated for the treatment of C.   difficile -associated diarrhea.  Vancomycin hydrochloride capsules, USP are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).  Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride, USP must be given orally for these infections.

Orally administered vancomycin hydrochloride is not effective for other types of infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride, USP and other antibacterial drugs, vancomycin hydrochloride, USP should be used only to treat infections 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 capsules are 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

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.

DOSAGE FORMS AND STRENGTHS

Vancomycin hydrochloride 125 mg* capsules have a grey cap and opaque light-grey body imprinted with “VANCO” on the cap and “125 mg” on the body in black ink.

Vancomycin hydrochloride 250 mg* capsules have a green cap and turquoise body imprinted with “VANCO” on the cap and “250 mg” on the body in white ink.

*Equivalent to vancomycin.

HOW SUPPLIED/STORAGE AND HANDLING

Vancomycin Hydrochloride Capsules, USP are available in a carton containing 2 blister cards of 10 capsules each, for a total of 20 capsules.

Product

No.

NDC

No.

Strength

Description

313820

63323-338-20

125 mg*

Capsules have a grey cap and opaque light-grey body imprinted with “VANCO” on the cap and “125 mg” on the body in black ink.

313920

63323-339-20

250 mg*

Capsules have a green cap and turquoise body imprinted with “VANCO” on the cap and “250 mg” on the body in white ink.

*Equivalent to vancomycin.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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