Vancomycin Hydrochloride Capsules - Product Information
|Manufacture:||Fresenius Kabi USA, LLC|
|Condition:||Bacteremia, Bacterial Endocarditis Prevention (Bacterial Endocarditis Prophylaxis), Bacterial Infection, Bone infection (Osteomyelitis), Methicillin-Resistant Staphylococcus Aureus Infection, Pneumonia, Sepsis, Skin or Soft Tissue Infection, Surgical Prophylaxis|
Summary Product Information
|Route of Administration||Dosage Form / Strength||Clinically Relevant Nonmedicinal Ingredients|
|Oral||Capsule 125 mg and 250 mg||For a complete listing, see Composition section.|
In vitro studies indicate that the bactericidal action of vancomycin hydrochloride against many gram-positive bacteria results from the inhibition of cell-wall synthesis. There is also evidence that vancomycin alters the permeability of the cell membrane and selectively inhibits RNA synthesis.
Indications and Clinical Uses
Vancomycin Hydrochloride Capsules, USP may be used orally for the treatment of staphylococcal enterocolitis and antibiotic-associated pseudomembranous colitis produced by C.difficile. Parenteral administration of vancomycin hydrochloride is not effective for theseindications, therefore vancomycin hydrochloride must be given orally.
Vancomycin Hydrochloride Capsules, USP is not effective by the oral route for the treatment of other types of infection. Vancomycin is not effective in vitro against gram-negative bacilli, mycobacteria, or fungi.
Vancomycin Hydrochloride Capsules, USP is contraindicated in patients with known hypersensitivity to this antibiotic.
When given intravenously, toxic serum levels can occur. Vancomycin is excreted fairly rapidly by the kidney and blood levels increase markedly with decreased renal clearance. During parenteral therapy, the risk of toxicity appears appreciably increased by high blood concentrations or prolonged treatment. Vancomycin hydrochloride is poorly absorbed orally. Toxic serum levels are therefore not attained from oral dosage.
Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin for active C. difficile-induced pseudomembranous colitis; therefore, monitoring of serum concentrations may be appropriate in these patients.
Ototoxicity has occurred when serum levels exceeded 80 μg/mL. Deafness may be preceded by tinnitus. The elderly are more susceptible to auditory damage. Experience with other antibiotics suggests that deafness may be progressive despite cessation of treatment.
Concurrent and sequential use of other neurotoxic and/or nephrotoxic agents, particularly ethacrynic acid, neuromuscular blocking agents, aminoglycoside antibiotics, polymixin B, colistin, viomycin, and cisplatin, requires careful monitoring.
If parenteral and oral vancomycin are administered concomitantly, an additive effect can occur. This should be taken into consideration when calculating the total dose. In this situation, serum levels of the antibiotic should be monitored.
Because of its ototoxicity and nephrotoxicity, Vancomycin Hydrochloride Capsules, USP should be used with care in patients with renal insufficiency.
Vancomycin Hydrochloride Capsules, USP should be avoided (if possible) in patients with previous hearing loss. If it is used in such patients, the dose of Vancomycin Hydrochloride Capsules, USP should be regulated by periodic determination of drug levels in the blood.
Patients with renal insufficiency and individuals over the age of 60 should be given serial tests of auditory function and of vancomycin blood levels. All patients receiving the drug should have periodic hematologic studies, urinalyses, and liver and renal function tests.
The prolonged use of Vancomycin Hydrochloride Capsules, USP may result in overgrowth of non-susceptible organisms. If new infections due to bacteria or fungi appear during therapy with this product, appropriate measures should be taken, including withdrawal of Vancomycin Hydrochloride Capsules, USP.
Some patients with inflammatory disorders of the intestinal mucosa may have significant systemic absorption of oral vancomycin and, therefore, may be at risk for the development of adverse reactions associated with the parenteral administration of vancomycin. The risk is greater if renal impairment is present. It should be noted that the total systemic and renal clearances of vancomycin are reduced in the elderly.
When patients with underlying renal dysfunction or those receiving concomitant therapy with an aminoglycoside are being treated, serial monitoring of renal function should be performed.
In vitro resistance to vancomycin has been reported among some enterococcal and staphylococcal isolates.
Usage in Pregnancy
Vancomycin Hydrochloride Capsules, USP should be given to a pregnant woman only if clearly needed. In a controlled clinical study, Vancomycin hydrochloride was administered to 10 pregnant women for serious staphylococcal infections complicating intravenous drug abuse to evaluate potential ototoxic and nephrotoxic effects on the infant. Vancomycin hydrochloride levels of 13.2 and 16.6 μg/mL were measured in cord blood of two patients. No sensorineural hearing loss or nephrotoxicity attributable to vancomycin hydrochloride was noted. One infant whose mother received vancomycin hydrochloride in the third trimester experienced conductive hearing loss that was not attributed to the administration of vancomycin hydrochloride. Because the number of patients treated in this study was limited and vancomycin hydrochloride was administered only in the second and third trimesters, it is not known whether Vancomycin Hydrochloride Capsules causes fetal harm.
Vancomycin hydrochloride is excreted in human milk. Caution should be exercised if Vancomycin Hydrochloride Capsules, USP is administered to a nursing woman. Because of the potential for adverse events, a decision should be made whether to discontinue nursing or discontinue administration of the drug, taking into account the importance of the drug to the mother.
Usage in Pediatrics
In premature neonates and young infants, it may be appropriate to confirm desired vancomycin serum concentrations. Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing in children.
The natural decrease of glomerular filtration with increasing age may lead to elevated vancomycin serum concentrations if dosage is not adjusted. Vancomycin dosage schedules should be adjusted in elderly patients.
Rarely, renal failure, principally manifested by increased serum creatinine or BUN concentrations, especially in patients given large doses of vancomycin hydrochloride 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 pre-existing kidney dysfunction. When vancomycin hydrochloride was discontinued, azotemia resolved in most patients.
A few dozen cases of hearing loss associated with vancomycin hydrochloride have been reported. Most of these patients had kidney dysfunction, pre-existing hearing loss, or concomitant treatment with an ototoxic drug. Vertigo, dizziness, and tinnitus have been reported rarely.
Reversible neutropenia, usually starting one week or more after onset of therapy with vancomycin hydrochloride or after a total dose of more than 25 g, has been reported in several dozen patients. Neutropenia appears to be promptly reversible when vancomycin hydrochloride is discontinued. Thrombocytopenia has rarely been reported. Although a causal relationship has not been established, reversible agranulocytosis (granulocyte count less than 500/mm3) has been reported rarely.
Anaphylaxis, drug fever, nausea, chills, eosinophilia, hypotension, wheezing, dyspnea, urticaria, pruritus, flushing of the upper body (“red neck”), pain and muscle spasm of the chest and back, rashes, including exfoliative dermatitis, Stevens-Johnson syndrome, linear IgA bullous dermatosis and rare cases of vasculitis have been associated with the administration of vancomycin hydrochloride.
Treatment of Overdosage
Other than general supportive treatment, no specific antidote is known. Dialysis does not remove significant amounts of vancomycin. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance.
In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.
Dosage and Administration
The usual daily dosage for antibiotic-associated pseudomembranous colitis produced by C.difficile and staphylococcal enterocolitis is 125 to 500 mg administered orally every 6 to 8 hours for 7 to 10 days. Vancomycin is not effective by the oral route for other types of infections.
The usual daily dosage is approximately 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.
Note: Vancomycin Hydrochloride Capsules, USP capsules are formulated in a matrix gel that prevents administration by a nasogastric tube; if this route of administration is being considered, the i.v. dosage form should be used.