vancomycin hydrochloride capsule
1 INDICATIONS AND USAGE Vancomycin hydrochloride capsule is a glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: ( 1 ) Clostridioide 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 capsule must be given orally for these infections. Orally administered vancomycin hydrochloride capsules are 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) Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficil e -associated diarrhea. Vancomycin hydrochloride capsules are 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 capsules must be given orally for these infections. Orally administered vancomycin hydrochloride capsules are not effective for other types of infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules 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.
lupin pharmaceuticals, inc.
CAPSULE BLUE LU S01
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16 HOW SUPPLIED/STORAGE AND HANDLING
VANCOMYCIN HYDROCHLORIDE capsules, USP are available in: The 125 mg (equivalent to vancomycin): Size 2, Hard gelatin capsules having an opaque blue cap imprinted with "LU" in white ink and opaque brown body imprinted with "S01" in white ink containing cream coloured hard mass. They are available in: Unit Dose Carton: 20 capsules (2 blister cards containing 10 capsules per card) NDC # 68180-166-13 The 250 mg (equivalent to vancomycin): Size 0, Hard gelatin capsules having an opaque blue cap imprinted with "LU" in white ink and opaque Lavender body imprinted with "S02" in white ink containing cream coloured hard mass. They are available in: Unit Dose Carton: 20 capsules (2 blister cards containing 10 capsules per card) NDC # 68180-167-13 Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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