Drug Catalog - Product Detail
VANCOMYCIN HCL USP CP 125MG 2X10 UD
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 17478-0741-02 | AKORN | 20 | 125MG | CAPSULE |
PACKAGE FILES
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Description
11 DESCRIPTION Vancomycin Hydrochloride Capsule, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis ), which has the chemical formula C 66 H 75 Cl 2 N 9 O 24 •HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. The 125 mg capsules contain vancomycin hydrochloride equivalent to 125 mg (0.08 mmol) vancomycin. These capsules also contain FD&C Blue No. 2, gelatin, iron oxide yellow and red, polyethylene glycol, titanium dioxide. The 250 mg capsules contain vancomycin hydrochloride equivalent to 250 mg (0.17 mmol) vancomycin. These capsules also contain FD&C Blue No. 2, gelatin, iron oxide red and black, polyethylene glycol, titanium dioxide. Both 125 mg and 250 mg capsules are imprinted with white ink which may contain purified shellac, purified titanium dioxide and FD&C Blue No. 1 Lake. Vancomycin hydrochloride has the structural formula: Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Vancomycin Hydrochloride Capsules, USP are available in: The 125 mg* capsules have an opaque blue cap and opaque brown body imprinted with "741" on the cap and "125 mg" on the body in white ink. They are available in: NDC 17478-741-02 Vancomycin HCl 125 mg*; each carton contains 2 blister cards of 10 capsules each, for a total of 20 capsules. The 250 mg* capsules have an opaque blue cap and opaque lavender body imprinted with "742" on the cap and "250 mg" on the body in white ink. They are available in: NDC 17478-742-02 Vancomycin HCl 250 mg*; each carton contains 2 blister cards of 10 capsules each, for a total of 20 capsules. *Equivalent to vancomycin STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Vancomycin hydrochloride capsule is indicated for the treatment of Clostridioides 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. Vancomycin hydrochloride capsules is a glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: ( 1 ) Clostridioides difficile -associated diarrhea Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) Limitations of Use: ( 1 ) ( 5.1 ) Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin hydrochloride injection 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 prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 ) 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 prevent 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
2 DOSAGE AND ADMINISTRATION C. difficile -associated diarrhea: Adult Patients (18 years of age or greater): 125 mg orally 4 times daily for 10 days. ( 2.1 ) Pediatric Patients (less than 18 years of age): 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. ( 2.2 ) Staphylococcal enterocolitis: Adult Patients (18 years of age or greater): 500 mg to 2 g orally in 3 or 4 divided doses for 7 to 10 days. ( 2.1 ) Pediatric Patients (less than 18 years of age): 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. ( 2.2 ) 2.1 Adults Vancomycin hydrochloride capsule 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. 2.2 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.