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:

Alvogen 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 lessthan 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 ofinfections. 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 considere

Product summary:

Vancomycin hydrochloride capsules, USP are available in: The 125 mg* capsules have a grey cap and pink body imprinted with "SAL" on the cap and "729" on the body in black ink. The 250 mg* capsules have a brown cap and brown body imprinted with "SAL" on the cap and "730" on the body in white ink. *Equivalent to vancomycin. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USPControlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE CAPSULE
ALVOGEN 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 glycopeptide antibacterial
indicated in adult and pediatric patients
(less than 18 years of age) for the treatment of: (1)
_Clostridioidesdifficile_-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 capsules must be given orally for these infections.
• Orally administered vancomycin hydrochloride capsules are not
effective forother 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 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 STRE