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:

PAI Holdings, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vancomycin Hydrochloride Capsules are indicated for the treatment of C. difficile -associated diarrhea. Vancomycin Hydrochloride Capsules is also used for the treatment of 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 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 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 antibact

Product summary:

Vancomycin Hydrochloride Capsules, USP are available in: The 125 mg* CAPSULES have a blue cap and yellow body imprinted with "OP64" on both cap and body in white ink. The 250 mg* CAPSULES have a blue cap and dark-yellow body imprinted with "OP65" on both cap and body in white ink. A carton contains 2 blister packs. Each blister pack contains 10 capsules for a total of 20 capsules per carton. A carton contains 2 blister packs. Each blister pack contains 10 capsules for a total of 20 capsules per carton. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] *Equivalent to vancomycin.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE CAPSULE
PAI HOLDINGS, LLC
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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 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
INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY
SUSCEPTIBLE BACTERIA.
INDICATIONS AND USAGE
Treatment of: ( 1 )
_C. difficile_ -associated diarrhea
Enterocolitis caused by _Staphylococcus aureus_ (including
methicillin- resistant strains)
Important Limitations: ( 1 ) ( 5.1 )
Orally administered vancomycin hydrochloride capsules is not effective
for other types of infections.
DOSAGE AND ADMINISTRATION
• _C. difficile-_ associated diarrhea:
Adult Patients (≥18 years of age): 125 mg orally 4 times daily for
10 days. ( 2.1 )
Pediatric Patients (<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): 500 mg to 2 g orally in 3 or 4
divided doses for 7 to 10 days. ( 2.1 )
Pediatric Patients (<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 ( 3 )
250 mg capsules ( 3 )
CONTRAINDICATIONS
Hypersensitivity to vancomycin ( 4 ) (4)
WARNINGS AND PRECAUTIONS
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