VANCOCIN- vancomycin hydrochloride capsule
ANI Pharmaceuticals, Inc.
VANCOCIN � (vancomycin hydrochloride USP) CAPSULES
1 INDICATIONS AND USAGE
VANCOCIN CAPSULES are indicated for the treatment of C. difficil e-associated diarrhea. VANCOCIN CAPSULES 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, VANCOCIN CAPSULES must be given orally for these infections.
Orally administered VANCOCIN is not effective for other types of infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of VANCOCIN CAPSULES and other antibacterial drugs, VANCOCIN CAPSULES 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.
2 DOSAGE AND ADMINISTRATION
2.1 Adults
VANCOCIN CAPSULES are used in treating C. difficile -associated diarrhea and staphylococcal enterocolitis.
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C. difficile- associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days.
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Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.
2.2 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.
3 DOSAGE FORMS AND STRENGTHS
VANCOCIN 125 mg* CAPSULES have an opaque blue cap and opaque brown body imprinted with "3125" on the cap and "VANCOCIN HCL 125 MG" on the body in white ink.
VANCOCIN 250 mg* CAPSULES have an opaque blue cap and opaque lavender body imprinted with "3126" on the cap and "VANCOCIN HCL 250 MG" on the body in white ink.
*Equivalent to vancomycin.
4 CONTRAINDICATIONS
VANCOCIN CAPSULES are contraindicated in patients with known hypersensitivity to vancomycin.
5 WARNINGS AND PRECAUTIONS
5.1 Oral Use Only
This preparation for the treatment of colitis is for oral use only and is not systemically absorbed. VANCOCIN CAPSULES must be given orally for treatment of staphylococcal enterocolitis and Clostridium difficile- associated diarrhea. Orally administered VANCOCIN CAPSULES are not effective for other types of infections.
Parenteral administration of vancomycin is not effective for treatment of staphylococcal enterocolitis and C. difficile -associated diarrhea. If parenteral vancomycin therapy is desired, use an intravenous preparation of vancomycin and consult the package insert accompanying that preparation.
DESCRIPTION
VANCOCIN CAPSULES for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66 H75 Cl2 N9 O24 �HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol.
The capsules contain vancomycin hydrochloride equivalent to 125 mg (0.08 mmol) or 250 mg (0.17 mmol) vancomycin. The capsules also contain F D & C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients.
Mechanism of Action
Vancomycin is an antibacterial drug (see CLINICAL PHARMACOLOGY
Microbiology
Mechanism of action
The bactericidal action of vancomycin against Staphylococcus aureus and the vegetative cells of Clostridium difficile results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis.
Mechanism of resistance
Staphylococcus aureus
S. aureus
isolates with vancomycin minimal inhibitory concentrations (MICs) as high as 1024 mcg/mL have been reported.
The exact mechanism of this resistance is not clear but is believed to be due to cell wall thickening and potentially the transfer of genetic material.
Clostridium difficile
Isolates of C. difficile generally have vancomycin MICs of <1 mcg/mL, however vancomycin MICs ranging from 4 mcg/mL to 16 mcg/mL have been reported. The mechanism which mediates C. difficile's decreased susceptibility to vancomycin has not been fully elucidated.
Vancomycin has been shown to be active against susceptible isolates of the following bacteria in clinical infections as described in the INDICATIONS AND USAGE section.
Gram-positive bacteria
Staphylococcus aureus
(including methicillin-resistant isolates) associated with enterocolitis.
Anaerobic gram-positive bacteria
Clostridium difficile
isolates associated with C. difficile associated diarrhea.