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Vancomycin Hydrochloride for Oral Solution

VANCOMYCIN HYDROCHLORIDE

Standard Dose

2 DOSAGE AND ADMINISTRATION C. difficile‑ associated diarrhea: Adult Patients (18 years of age and older): 125 mg orally 4 times daily for 10 days. ( 2.2 ) 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. ( 2.3 ) Staphylococcal enterocolitis: Adult Patients (18 years of age and older): 500 mg to 2 g orally in 3 or 4 divided doses for 7 to 10 days. ( 2.2 ) 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. ( 2.3 ) See Full Prescribing Information for preparation and important administration information. ( 2.1 ) 2.1 Important Administration Instructions Prior to oral administration, the supplied vancomycin hydrochloride powder must be reconstituted by the healthcare provider (i.e., a pharmacist) to produce the oral solution [ see Dosage and Administration ( 2.4 ) ]. 2.2 Adults C. difficile ‑associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days. 2.3 Pediatric Patients (less than 18 years of age) For both C. difficile ‑associated diarrhea and staphylococcal enterocolitis, the usual daily dosage of vancomycin hydrochloride is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. 2.4 Preparation and Storage of Solutions of Vancomycin Hydrochloride Each vancomycin hydrochloride for oral solution kit contains 1 bottle of vancomycin hydrochloride USP powder and 1 bottle of pre‑measured Grape‑Flavored Diluent to be added to the vancomycin bottle. A healthcare provider (i.e., a pharmacist) must reconstitute vancomycin hydrochloride USP powder with the Grape‑Flavored Diluent provided in the kit. Vancomycin hydrochloride for oral solution is available in various strengths and volumes in the kit as shown in Table 1 . Table 1: Vancomycin Concentration and Volume after Reconstitution Vancomycin Concentration after Reconstitution Final Volume of Vancomycin Hydrochloride after Reconstitution Vancomycin Strength per Bottle Diluent for Vancomycin Hydrochloride 25 mg/mL 150 mL 3.75 g 147 mL 300 mL 7.5 g 295 mL 50 mg/mL 150 mL 7.5 g 145 mL 300 mL 15.0 g 289 mL Steps for the Preparation of Solutions of Vancomycin Hydrochloride Hold the neck of the bottle containing the vancomycin hydrochloride USP powder for oral solution (see Table 1 ), and tap the bottom edges on a hard surface to loosen the powder. Remove the cap from the vancomycin hydrochloride USP powder for oral solution bottle (“Powder Bottle”). Tap the top of the induction seal liner to loosen any powder that may have adhered to the liner. Carefully and slowly peel back the inner foil seal liner from the Powder Bottle. Shake the Grape‑Flavored Diluent (see ) for a few seconds. Remove the cap from the diluent bottle. Carefully and slowly peel back the inner foil seal from the diluent bottle. Transfer approximately one-half the contents of Grape-Flavored Diluent into the Powder Bottle. Replace the Powder Bottle cap, tighten onto the Powder Bottle, and shake the Powder Bottle vertically for approximately 45 seconds. NOTE: DO NOT use the diluent cap on the Powder Bottle as it may cause the solution to leak from the bottle. Re-open the Powder Bottle and add the remaining Grape‑Flavored Diluent into the Powder Bottle. Replace the Powder Bottle cap, tighten onto the Powder Bottle, and shake the Powder Bottle for approximately 30 seconds. NOTE: DO NOT use the diluent cap on the Powder Bottle as it may cause the solution to leak from the bottle. Dispense the Powder Bottle containing reconstituted solution of vancomycin hydrochloride oral solution to the patient [ see Patient Counseling Information ( 17 ) ]. Instruct the patient to shake the reconstituted solution of vancomycin hydrochloride well before each use and to use an oral dosing device that measures the appropriate volume of the oral solution in milliliters. Store the reconstituted solution of vancomycin hydrochloride at refrigerated conditions, 2°C to 8°C (36°F to 46°F) when not in use. Discard the reconstituted solution of vancomycin hydrochloride after 14 days, or if it appears hazy or contains particulates.

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE Vancomycin hydrochloride is indicated for the treatment of Clostridium difficil e‑associated diarrhea in adults and pediatric patients less than 18 years of age.

Summary

Vancomycin hydrochloride is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Vancomycin hydrochloride is indicated for the treatment of Clostridium difficil e‑associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. To reduce the development of drug‑resistant bacteria and maintain the effectiveness of vancomycin hydrochloride and other antibacterial drugs, vancomycin hydrochloride 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 is a glycopeptide antibacterial indicated in adults and pediatric patients less than 18 years of age for the treatment of: ( 1 ) Clostridium difficile ‑associated diarrhea Enterocolitis caused by Staphylococcus aureus (including methicillin‑resistant strains) Important Limitations of Use: ( 1 ) ( 5.1 ) Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. To reduce the development of drug‑resistant bacteria and maintain the effectiveness of vancomycin hydrochloride and other antibacterial drugs, vancomycin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION C. difficile‑ associated diarrhea: Adult Patients (18 years of age and older): 125 mg orally 4 times daily for 10 days. ( 2.2 ) 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. ( 2.3 ) Staphylococcal enterocolitis: Adult Patients (18 years of age and older): 500 mg to 2 g orally in 3 or 4 divided doses for 7 to 10 days. ( 2.2 ) 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. ( 2.3 ) See Full Prescribing Information for preparation and important administration information. ( 2.1 ) 2.1 Important Administration Instructions Prior to oral administration, the supplied vancomycin hydrochloride powder must be reconstituted by the healthcare provider (i.e., a pharmacist) to produce the oral solution [ see Dosage and Administration ( 2.4 ) ]. 2.2 Adults C. difficile ‑associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days. 2.3 Pediatric Patients (less than 18 years of age) For both C. difficile ‑associated diarrhea and staphylococcal enterocolitis, the usual daily dosage of vancomycin hydrochloride is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. 2.4 Preparation and Storage of Solutions of Vancomycin Hydrochloride Each vancomycin hydrochloride for oral solution kit contains 1 bottle of vancomycin hydrochloride USP powder and 1 bottle of pre‑measured Grape‑Flavored Diluent to be added to the vancomycin bottle. A healthcare provider (i.e., a pharmacist) must reconstitute vancomycin hydrochloride USP powder with the Grape‑Flavored Diluent provided in the kit. Vancomycin hydrochloride for oral solution is available in various strengths and volumes in the kit as shown in Table 1 . Table 1: Vancomycin Concentration and Volume after Reconstitution Vancomycin Concentration after Reconstitution Final Volume of Vancomycin Hydrochloride after Reconstitution Vancomycin Strength per Bottle Diluent for Vancomycin Hydrochloride 25 mg/mL 150 mL 3.75 g 147 mL 300 mL 7.5 g 295 mL 50 mg/mL 150 mL 7.5 g 145 mL 300 mL 15.0 g 289 mL Steps for the Preparation of Solutions of Vancomycin Hydrochloride Hold the neck of the bottle containing the vancomycin hydrochloride USP powder for oral solution (see Table 1 ), and tap the bottom edges on a hard surface to loosen the powder. Remove the cap from the vancomycin hydrochloride USP powder for oral solution bottle (“Powder Bottle”). Tap the top of the induction seal liner to loosen any powder that may have adhered to the liner. Carefully and slowly peel back the inner foil seal liner from the Powder Bottle. Shake the Grape‑Flavored Diluent (see ) for a few seconds. Remove the cap from the d

Monitoring

• 5 WARNINGS AND PRECAUTIONS Vancomycin hydrochloride must be given orally for treatment of C.
• difficile ‑associated diarrhea and staphylococcal enterocolitis.
• Orally administered vancomycin hydrochloride is not effective for treatment of 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 for C.

Interaction Notes

• 7 DRUG INTERACTIONS No drug interaction studies have been conducted using orally administered vancomycin hydrochloride products.