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Basic Drug Info
Drug Name:Vancomycin Hydrochloride
Manufacturer:Hospira, Inc.
Other Info:



Clinical Trials:


Indications and Usage

Vancomycin hydrochloride is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (?-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs.

Vancomycin hydrochloride is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.Vancomycin hydrochloride is effective in the treatment of staphylococcal endocarditis.

Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections.

When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.Vancomycin hydrochloride has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S.

bovis.

For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin hydrochloride has been reported to be effective only in combination with an aminoglycoside.Vancomycin hydrochloride has been reported to be effective for the treatment of diphtheroid endocarditis.

Vancomycin hydrochloride has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S.

epidermidis or diphtheroids.Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin hydrochloride.The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C.

difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications.

Vancomycin hydrochloride is not effective by the oral route for other types of infection.Although no controlled clinical efficacy studies have been conducted, intravenous vancomycin has been suggested by the American Heart Association and the American Dental Association as prophylaxis against bacterial endocarditis in penicillin-allergic patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when these patients undergo dental procedures or surgical procedures of the upper respiratory tract.

NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.3To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin 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.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Unspecified Staphylococcus infection in conditions classified elsewhere and of unspecified site --

Septicemia -- systemic disease associated with presence and persistance of pathogenic microorganisms or their toxins in the blood.

Osteomyelitis -- inflammation of the bone marrow and adjacent bone caused by a pyogenic organism; it may remain localized or may spread through the bone to involve the marrow, cortex, cancellous tissue, and periosteum.

Lower respiratory tract infection --

skin infection -- Skin diseases caused by bacteria, fungi, parasites, or viruses.

Staphylococcal Infections -- Infections with bacteria of the genus STAPHYLOCOCCUS.

Endocarditis -- Inflammation of the inner lining of the heart (ENDOCARDIUM), the continuous membrane lining the four chambers and HEART VALVES. It is often caused by microorganisms including bacteria, viruses, fungi, and rickettsiae. Left untreated, endocarditis can damage heart valves and become life-threatening.

ENTEROCOLITIS -- Inflammation of the MUCOSA of both the SMALL INTESTINE and the LARGE INTESTINE. Etiology includes ISCHEMIA, infections, allergic, and immune responses.

Communicable Diseases -- broad class of diseases whose causative agents may be passed between individuals in many different ways.

Bacterial Endocarditis -- Inflammation of the ENDOCARDIUM caused by BACTERIA that entered the bloodstream. The strains of bacteria vary with predisposing factors, such as CONGENITAL HEART DEFECTS; HEART VALVE DISEASES; HEART VALVE PROSTHESIS IMPLANTATION; or intravenous drug use.

Congenital heart disease -- imperfections or malformations of the heart, existing at, and usually before, birth regardless of their causation.

Rheumatism -- Disorders of connective tissue, especially the joints and related structures, characterized by inflammation, degeneration, or metabolic derangement.

Heart valve disease -- Pathological conditions involving any of the various HEART VALVES and the associated structures (PAPILLARY MUSCLES and CHORDAE TENDINEAE).

Contraindications
Sterile vancomycin hydrochloride, USP is contraindicated in patients with known hypersensitivity to this antibiotic.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension and, rarely, cardiac arrest.Vancomycin hydrochloride should be administered in a dilute solution over a period of not less than 60 minutes to avoid rapid-infusion-related reactions.

Stopping the infusion usually results in a prompt cessation of these reactions.

Ototoxicity has occurred in patients receiving vancomycin hydrochloride.

It may be transient or permanent.

It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Vancomycin should be used with caution in patients with renal insufficiency because the risk of toxicity is appreciably increased by high, prolonged blood concentrations.Dosage of vancomycin hydrochloride must be adjusted for patients with renal dysfunction (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).

Pseudomembranous colitis has been reported with nearly all antibacterial agents including vancomycin, and may range in severity from mild to life-threatening.

Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.

Studies indicate that a toxin produced by Clostridium difficile is one primary cause of antibiotic-associated colitis.

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated.

Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug effective against C.

difficile colitis.
Branded Drugs
The following US Branded drugs contain Vancomycin Hydrochloride


VANCOCIN HYDROCHLORIDE -- VIROPHARMA INC

VANCOLED -- LEDERLE PARENTERALS INC

VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

VANCOLED -- BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE

VANCOR -- PHARMACIA AND UPJOHN CO


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