Vancocin HCl capsules, usp

Vancocin HCl (Vancomycin Hydrochloride Capsules, USP) contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis ), which has the chemical formula C 66 H 75 Cl 2 N 9 O 24 ·HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol.

The Capsule contain vancomycin hydrochloride equivalent to 125 mg (0.08 mmol) or 250 mg (0.17 mmol) vancomycin. The Capsule also contain F D & C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients.

Vancomycin hydrochloride has the following structural formula:

Vancocin HCl Pulvules may be administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile . Parenteral administration of Vancocin HCl is not effective for the above indications; therefore, Vancocin HCl must be given orally for these indications. Orally administered Vancocin HCl is not effective for other types of infection.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancocin HCl and other antibacterial drugs, Vancocin HCl 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.

CONTRAINDICATION

Vancocin HCl is contraindicated in patients with known hypersensitivity to this antibiotic.

Nephrotoxicity --Rarely, renal failure, principally manifested by increased serum creatinine or BUN concentrations, especially in patients given large doses of intravenously administered Vancocin HCl has been reported. Rare cases of interstitial nephritis have been reported. Most of these have occurred in patients who were given aminoglycosides concomitantly or who had preexisting kidney dysfunction. When Vancocin HCl was discontinued, azotemia resolved in most patients.

Ototoxicity --A few dozen cases of hearing loss associated with intravenously administered Vancocin HCl have been reported. Most of these patients had kidney dysfunction or a preexisting hearing loss or were receiving concomitant treatment with an ototoxic drug. Vertigo, dizziness, and tinnitus have been reported rarely.

Hematopoietic --Reversible neutropenia, usually starting 1 week or more after onset of intravenous therapy with Vancocin HCl or after a total dose of more than 25 g, has been reported for several dozen patients. Neutropenia appears to be promptly reversible when Vancocin HCl is discontinued. Thrombocytopenia has rarely been reported.

Miscellaneous --Infrequently, patients have been reported to have had anaphylaxis, drug fever, chills, nausea, eosinophilia, rashes (including exfoliative dermatitis), Stevens-Johnson syndrome, toxic epidermal necrolysis, and rare cases of vasculitis in association with the administration of Vancocin HCl.

A condition has been reported that is similar to the IV-induced syndrome with symptoms consistent with anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, pruritus, flushing of the upper body ("Red Man Syndrome"), pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours.

Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance.

Treatment --To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

Vancocin HCl Capsules (or Vancomycin Hydrochloride Capsules, USP) are available in:

The 125 mg * Pulvules 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. They are available in:

The 250 mg * 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. They are available in:

Store at controlled room temperature, 59° to 86°F (15° to 30°C).

VANCOCIN is a registered U.S. trademark owned by ViroPharma Incorporated.

PULVULES is a registered U.S. trademark owned by Eli Lilly and Company under license to ViroPharma Incorporated.

Rx Only

© ViroPharma Incorporated 2005. All rights reserved.

Distributed by: ViroPharma Incorporated, Exton, PA 19341, USA

PV 5170 UCP

Rev. 1/2005