반코트리신주500밀리그램(반코마이신염산염)

Vancomycin Hydrochloride Capsules are indicated for the treatment of C. difficile -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 is 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. Vancomycin hydrochloride capsules are glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: (1) C. difficile -associated diarrhea Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) Limitations of Use: (1) (5.1) …

Hypersensitivity to vancomycin (4) Vancomycin hydrochloride capsules are contraindicated in patients with known hypersensitivity to vancomycin.

Vancomycin hydrochloride capsules must be given orally for treatment of staphylococcal enterocolitis and C. difficile -associated diarrhea. Orally administered vancomycin hydrochloride capsules are not effective for other types of infections. (5.1) Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin hydrochloride capsules for active C. difficile -associated diarrhea. Monitoring of serum concentrations may be appropriate in some instances. (5.2) Nephrotoxicity has occurred following oral vancomycin hydrochloride capsule therapy and can occur either during or after completion of therapy. The risk is increased in geriatric patients. (5.3) Monitor renal function. Ototoxicity has occurred in patients receiving vancomycin hydrochloride capsules (5.4) Assessment of auditory function may be appropriate in some instances. Severe Dermatologic Reactions: Discontinue vancomycin hydrochloride capsules at the first appearance of skin rashes, mucosal lesions, or blisters. (5.5) Prescribing vancomycin hydrochloride capsules in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. (5.6) The 125 mg strength capsules contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. (5.7) 5.1 Oral Use Only Vancomycin …

8.1 Pregnancy Risk Summary Systemic absorption of vancomycin is low following oral administration of Vancomycin Hydrochloride Capsules; however, absorption may vary depending on various factors [see Clinical Pharmacology (12.3) ]. There are no available data on vancomycin use in pregnant women to assess a risk of major birth defects or miscarriage. Available published data on intravenous vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse maternal or fetal outcomes (see Data). Vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or …