Vancomycin Hydrochloride

Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by

(including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by . Parenteral administration of vancomycin is not effective for the above indications; therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other antibacterial drugs, Vancomycin Hydrochloride for Oral Solution 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 for Oral Solution is used in treating antibiotic-associated pseudomembranous colitis caused by

and staphylococcal enterocolitis. Vancomycin Hydrochloride for Oral Solution is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.

Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) occurred in 5% of subjects treated with vancomycin hydrochloride. Nephrotoxicity following vancomycin hydrochloride typically first occurred within one week after completion of treatment (median day of onset was Day 16). Nephrotoxicity following vancomycin hydrochloride occurred in 6% of subjects over 65 years of age and 3% of subjects 65 years of age and younger. Nephrotoxicity can also occur during oral vancomycin administration.

The incidences of hypokalemia, urinary tract infection, peripheral edema, insomnia, constipation, anemia, depression, vomiting, and hypotension were higher among subjects over 65 years of age than in subjects 65 years of age and younger.

Discontinuation of study drug due to adverse events occurred in 7% of subjects treated with vancomycin hydrochloride. The most common adverse events leading to discontinuation of vancomycin hydrochloride were

colitis (< 1%), nausea (< 1%), and vomiting (< 1%).

Vancomycin Hydrochloride for Oral Solution USP contains chromatographically purified vancomycin hydrochloride USP, a tricyclic glycopeptide antibiotic derived from

(formerly ), which has the chemical formula C₆₆H₇₅Cl₂N₉O₂₄•HCl. The molecular weight of vancomycin hydrochloride is 1,485.73; 500 mg of the base is equivalent to 0.34 mmol.

Vancomycin hydrochloride has the following structural formula:

Vancomycin Hydrochloride for Oral Solution USP is intended for reconstitution with water. Each 5 mL of reconstituted solution contains vancomycin hydrochloride equivalent to 250 mg (0.17 mmol) vancomycin.

Inactive ingredients: citric acid anhydrous, sodium benzoate, sucralose, and mixed berry flavor. Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).

Vancomycin is poorly absorbed after oral administration. During multiple dosing of 250 mg every 8 hours for 7 doses, fecal concentrations of vancomycin in volunteers exceeded 100 mg/kg in the majority of samples. No blood concentrations were detected and urinary recovery did not exceed 0.76%. In anephric patients with no inflammatory bowel disease, blood concentrations of vancomycin were barely measurable (0.66 mcg/mL) in 2 of 5 subjects who received 2 g of Vancomycin Hydrochloride for Oral Solution daily for 16 days. No measurable blood concentrations were attained in the other 3 subjects. With doses of 2 g daily, very high concentrations of drug can be found in the feces (>3,100 mg/kg) and very low concentrations (<1 mcg/mL) can be found in the serum of patients with normal renal function who have pseudomembranous colitis. Orally administered vancomycin does not usually enter the systemic circulation even when inflammatory lesions are present. After multiple-dose oral administration of vancomycin, measurable serum concentrations may infrequently occur in patients with active

-induced pseudomembranous colitis, and, in the presence of renal impairment, the possibility of accumulation exists.