VANCOMYCIN HYDROCHLORIDE capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

vancomycin hydrochloride (UNII: 71WO621TJD) (vancomycin - UNII:6Q205EH1VU)

可用日期:

Akorn

INN（国际名称）:

vancomycin hydrochloride

组成:

vancomycin 125 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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. 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 se

產品總結:

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].

授权状态:

Abbreviated New Drug Application

产品特点

VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE CAPSULE
AKORN
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VANCOMYCIN
HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
VANCOMYCIN HYDROCHLORIDE CAPSULES.
VANCOMYCIN HYDROCHLORIDE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1986
INDICATIONS AND USAGE
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)
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)
DOSAGE FORMS AND STRENGTHS
125 mg capsules and 250 mg capsules (3)
CONTRAINDICATIONS
Hypersensitivity to vancomycin (4)
WARNINGS AND PR