VANCOMYCIN HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VANCOMYCIN HYDROCHLORIDE (UNII: 71WO621TJD) (VANCOMYCIN - UNII:6Q205EH1VU)

Available from:

ANI Pharmaceuticals, Inc.

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Composition:

VANCOMYCIN 125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides 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 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 contraindicated in patients with known hypersensitivity

Product summary:

Vancomycin Hydrochloride Capsules USP are available in: The 125 mg (equivalent to vancomycin) 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. NDC 62559-390-20: Carton containing 2 blister packs. Each blister pack contains 10 capsules for a total of 20 capsules per carton. NDC 62559-390-50: Bottle of 50 capsules. The 250 mg (equivalent to vancomycin) 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. NDC 62559-391-20: Carton containing 2 blister packs. Each blister pack contains 10 capsules for a total of 20 capsules per carton. NDC 62559-391-50: Bottle of 50 capsules. 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].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE CAPSULE
ANI PHARMACEUTICALS, INC.
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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
RECENT MAJOR CHANGES
Warnings and Precautions, Severe Dermatologic Reactions (5.5) 12/2020
INDICATIONS AND USAGE
Vancomycin Hydrochloride Capsules are a glycopeptide antibacterial
indicated in adult and pediatric
patients (less than 18 years of age) for the treatment of: (1)
•
•
Limitations of Use: (1) (5.1)
•
•
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 bacteria. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
125 mg capsules and 250 mg capsules (3)
CONTRAINDICATIONS
Hypersensitivity to vancomycin (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
_Clostridioides difficile-associated diarrhea_
Enterocolitis caused by _Staphylococcus aureus_ (including
methicillin-resistant strains)
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.
_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