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VANCOCIN is a brand name for Vancomycin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VANCOCIN® (vancomycin hydrochloride capsules) is indicated for: • The treatment of infections caused by susceptible strains of the designated microorganisms in the following diseases and specific conditions: o staphylococcal enterocolitis, and o antibiotic associated pseudomembranous colitis produced by Clostridium…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • 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.
• VANCOCIN® capsules are formulated in a matrix gel that prevents administration by a nasogastric PrVANCOCIN® (vancomycin hydrochloride) Product Monograph Page 5 of 20 tube; if this route of administration is being considered, the IV dosage form should be used.
difficile and staphylococcal entercolitis is 125 to 500 mg administered orally every 6 to 8 hours for 7 to 10 days.
Pediatrics:
The usual daily dosage is approximately 40mg/kg in 3 or 4 divided doses for 7 to 10 days administered orally. The total daily dosage should not exceed 2 g. 4 Administration Oral administration. 5 Missed Dose If a dose of this medication has been missed, it should be taken as soon as possible.
However, if it is almost time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not double doses.
3 Less Common Clinical Trial Adverse Reactions Renal: Nephrotoxicity Rarely, renal failure, principally manifested by increased serum creatinine or blood urea nitrogen (BUN) concentrations, especially in patients given large doses of VANCOCIN®, 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 VANCOCIN® was discontinued, azotemia resolved in most patients.
Ear/Nose/Throat:
Ototoxicity A few dozen cases of hearing loss associated with VANCOCIN® 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.
Immune:
Hematopoietic Reversible neutropenia, usually starting one week or more after onset of therapy with VANCOCIN® or after a total dose of more than 25 g, has been reported in several dozen patients. Neutropenia appears to be promptly reversible when VANCOCIN® 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. Eosinophilia has been associated with the administration of VANCOCIN®.
PrVANCOCIN® (vancomycin hydrochloride) Product Monograph Page 9 of 20 Drug Reaction with Eosinophilia and Systemic Symptoms Syndrome (DRESS) Toxic Epidermal Necrolysis (TEN) Miscellaneous: Anaphylaxis, drug fever, nausea, chills, 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 VANCOCIN®.
General Vancomycin is poorly absorbed orally. Toxic serum levels are therefore not expected 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. When given intravenously, toxic serum levels can occur. During parenteral therapy, the risk of toxicity appears appreciably increased by high blood concentrations or prolonged treatment.
Driving and Operating Machinery Ringing in your ears and dizziness have been reported and this may affect your ability to drive and use machines. Ear/Nose/Throat Ototoxicity has occurred when serum levels exceeded 80μg/mL. Deafness may be preceded by tinnitus.
Deafness may be transient or permanent. The elderly are more susceptible to auditory damage. Deafness may be progressive despite cessation of treatment. VANCOCIN® should be avoided (if possible) in patients with previous hearing loss.
If it is used in such patients, the dose of VANCOCIN® 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.
Gastrointestinal 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. Hematologic Neutropenia can occur starting one week or more after onset of therapy with VANCOCIN® or after a total dose of more than 25 g. Neutropenia appears to be promptly reversible when treatment is discontinued.
• VANCOCIN® is contraindicated for patients who are hypersensitive to vancomycin hydrochloride or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Vancomycin in Canada.
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Monitoring and Laboratory Tests All patients receiving the drug should have periodic hematologic studies, urinalyses, and liver and renal function tests. PrVANCOCIN® (vancomycin hydrochloride) Product Monograph Page 7 of 20 Renal Because of its ototoxicity and nephrotoxicity, VANCOCIN® should be used with care in patients with renal insufficiency.
Vancomycin is excreted fairly rapidly by the kidney and blood levels increase markedly with decreased renal clearance. There is an increased risk of renal failure in patients receiving large doses of VANCOCIN®. In patients with underlying renal dysfunction or those receiving concomitant therapy with an aminoglycoside there is a risk of developing interstitial nephritis.
When these patients are being treated with VANCOCIN®, serial monitoring of renal function should be performed. Sensitivity/Resistance Development of Drug Resistant Bacteria The prolonged use of VANCOCIN® 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 VANCOCIN®. In vitro resistance to vancomycin has been reported among some entercoccal and staphylococcal isolates.
Vancomycin is not effective in vitro against gram-negative bacilli, mycobacteria, or fungi. 1 Pregnant Women VANCOCIN® should be given to pregnant woman only if clearly needed. In a controlled study, VANCOCIN® was administered to 10 pregnant women for serious staphylococcal infections complicating intravenous drug abuse to evaluate potential ototoxic and nephrotoxic effects on the infant.
6μg/mL were measured in core blood in two patients. No sensorineural hearing loss or nephrotoxicity attributable to VANCOCIN® was noted. One infant whose mother received VANCOCIN® in the third trimester experienced conductive hearing loss that was not attributed to the administration of VANCOCIN®.
Because the number of patients treated in this study was limited and VANCOCIN® was administered only in the second and third trimesters, it is not known whether VANCOCIN® causes fetal harm. 2 Breast-feeding Vancomycin is excreted in human milk.
Caution should be exercised if VANCOCIN® 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.
3 Pediatrics Pediatrics (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.
4 Geriatrics 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. It should be noted that the total systemic and renal clearances of vancomycin are reduced in the elderly.
The elderly are more susceptible to auditory damage.