Vancomycin (Vancocin)

1. Health Canada Product Monograph — Vancomycin

• Vancocin is indicated for the treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile.
• Vancocin is indicated for the treatment of staphylococcal enterocolitis.
• Oral Vancocin is not effective for treating other types of infection, since intravenous vancomycin is required for infections outside the intestine.

• Vancocin should be used during pregnancy only if clearly needed, as the effects of oral vancomycin on the fetus have not been fully established.
• Limited data from pregnant women treated with vancomycin for serious infection found no clear evidence of hearing or kidney harm to the infant, but the number of women studied was small.

• Vancomycin passes into breast milk, so caution is advised when Vancocin is used by a nursing mother.
• The decision to continue or stop breastfeeding, or to continue or stop Vancocin, should weigh the importance of the drug to the mother's health.

• Older adults (65 years and older) may have reduced systemic and kidney clearance of vancomycin, which can raise blood levels if the dose is not adjusted accordingly.
• Older adults are more susceptible to hearing damage from vancomycin and should have their dose regulated with periodic drug level and hearing testing.

• Vancocin's dosing in children is based on body weight, at approximately 40 mg per kg per day in 3 or 4 divided doses, up to a maximum of 2 g per day.
• Premature neonates and young infants may have differences in safety compared to older children, and monitoring of vancomycin blood levels may be appropriate in this group.
• Concomitant use of vancomycin with anesthetic agents in children has been linked to flushing and histamine-like skin reactions.

• For antibiotic-associated pseudomembranous colitis or staphylococcal enterocolitis in adults, the usual dose is 125 mg to 500 mg by mouth every 6 to 8 hours for 7 to 10 days.
• In children, the usual dose is approximately 40 mg/kg per day in 3 to 4 divided doses for 7 to 10 days, not to exceed 2 g per day.
• Vancocin capsules must be swallowed whole and should not be given through a nasogastric tube, since the capsule's gel matrix is designed to release the drug in the intestine; an intravenous formulation should be used if tube administration is required.
• If vancomycin is given by both the intravenous and oral routes at the same time, the combined effect should be considered and serum levels monitored.
• If a dose is missed, take it as soon as possible, but skip it if it is almost time for the next dose; do not double up doses.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• Activated charcoal may be given to help remove unabsorbed drug from the gastrointestinal tract.
• General supportive care is the mainstay of overdose management, as no specific antidote for vancomycin exists.
• Standard dialysis does not remove significant amounts of vancomycin from the blood.
• Hemofiltration or hemoperfusion using a polysulfone resin filter has been reported to increase vancomycin clearance in overdose.

• Drug-induced fever may occur.
• Nausea may occur.
• Chills may occur.
• Itching, hives, or skin rash may occur.
• Low blood pressure (hypotension), causing dizziness, fainting, or lightheadedness, may occur.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Vancocin may cause severe allergic reactions (anaphylaxis) with facial or throat swelling, wheezing, chest tightness, or difficulty breathing.
• "Red man syndrome," a flushing and redness of the skin on the face, neck, and upper body, may occur, especially with rapid or high-dose administration.
• Reversible neutropenia (low white blood cell count) can develop, typically after a week or more of therapy or after a cumulative dose above 25 g, raising the risk of infection.
• Thrombocytopenia (low platelet count) has rarely been reported, causing unusual bleeding, bruising, or nosebleeds.
• Eosinophilia has been associated with vancomycin, sometimes accompanied by rash, weight loss, wheezing, or abdominal pain.
• Agranulocytosis has rarely been reported.
• Kidney damage, including interstitial nephritis and renal failure, may occur, particularly with high doses, pre-existing kidney impairment, or concomitant aminoglycoside use.
• Ototoxicity, including tinnitus, vertigo, dizziness, and temporary or permanent hearing loss, may occur, particularly when blood levels exceed 80 mcg/mL, and can progress even after the drug is stopped.
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome, have been reported.
• Pain and muscle spasm of the chest and back may occur.
• Seek immediate medical attention for facial or throat swelling, severe skin reactions, signs of kidney problems such as reduced urination or swelling, or new hearing changes.

• Use with caution in patients with pre-existing hearing loss or ear problems, since Vancocin should be avoided if possible in this group and requires periodic auditory testing and drug level monitoring if used.
• Use with caution in patients with kidney impairment, since higher blood levels and inflamed intestinal mucosa increase the risk of systemic absorption.
• Use with caution in patients with inflammatory bowel disease, Crohn's disease, or ulcerative colitis, since more vancomycin than usual may be absorbed into the bloodstream from an inflamed intestine.
• Use with caution in patients over age 60, who are more susceptible to hearing damage and require serial auditory and kidney function testing.
• Use with caution in patients receiving concomitant aminoglycoside antibiotics, due to increased risk of kidney toxicity.
• Use with caution when driving or operating machinery, since dizziness and tinnitus may impair these activities.
• Periodic monitoring of blood counts, urinalysis, and liver and kidney function is recommended for all patients on therapy.
• Prolonged use may lead to overgrowth of non-susceptible organisms, including resistant bacteria or fungi; monitor for new infections during treatment.

• Contraindicated in patients with known hypersensitivity to vancomycin hydrochloride.
• Contraindicated in patients with hypersensitivity to any other ingredient in the capsule formulation or components of the container.

• Concomitant use with anesthetic agents has been associated with erythema and histamine-like flushing, particularly in children.
• Combining Vancocin with aminoglycoside antibiotics (such as amikacin, gentamicin, kanamycin, or tobramycin), polymyxin B, colistin, or viomycin increases the risk of kidney and hearing toxicity, and therapeutic drug monitoring is recommended.
• Concomitant use with cisplatin, a chemotherapy drug, requires caution and monitoring for added kidney toxicity.
• Combining Vancocin with other nephrotoxic drugs, particularly ethacrynic acid, increases the risk of kidney damage.
• Concomitant use with neuromuscular blocking agents used during surgery requires caution and monitoring.
• Combining Vancocin with other neurotoxic agents requires caution and monitoring.
• Concurrent parenteral (intravenous) and oral vancomycin administration can have an additive effect, so total dosage and serum levels should be monitored.

• Vancocin capsules can be taken with or without food; no clinically significant food interaction has been established for oral vancomycin, since it acts locally in the intestine and is minimally absorbed into the bloodstream.

• Vancocin doses should be spaced evenly, about every 6 to 8 hours, to maintain consistent drug levels in the intestine.
• It can be taken at any time of day, with or without food.

• Store Vancocin capsules at room temperature, between 15°C and 25°C, and protect from moisture.
• Keep out of reach and sight of children.

• Vancocin is an antibiotic taken by mouth to treat bacterial infections of the intestine, particularly C. difficile-associated colitis; it is not effective for other types of infections when taken orally.
• Complete the full course of therapy as prescribed, even if you feel better, to help prevent relapse and antibiotic resistance.
• Tell your healthcare professional about any hearing problems, kidney problems, or inflammatory bowel conditions before starting treatment.
• Report new or worsening hearing changes, ringing in the ears, reduced urination, or swelling promptly, since these may signal serious side effects.
• Seek immediate medical attention for signs of a severe allergic reaction, such as facial swelling, difficulty breathing, or a widespread blistering rash.