Vancocin

Mechanism of Action

Inhibits cell-wall biosynthesis; blocks glycopeptide polymerization by binding tightly to D-alanyl-D-alanine portion of cell wall precursor

Absorption

PO, poor; IM, erratic; intraperitoneal, ~38%

Peak serum time (IV): Immediately after completion of infusion

Distribution

Distributed widely in body tissues and fluid, except for cerebrospinal fluid (CSF)

Relative diffusion from blood into CSF: Good only with inflammation (exceeds usual minimal inhibitory concentrations); CSF level nil with normal meninges, 20-30% of blood level with inflamed meninges

Protein bound: ~50%

Elimination

Half-life; 5-11 hr (adults); 6-10 hr (newborns); 2-2.3 hr (children); 4 hr (infants and children 3 months to 4 years); 200-250 hr (renal impairment or end-stage renal disease)

Excretion: Urine (IV; 80-90% as unchanged drug); primarily feces (PO)

Type of medicine	An antibiotic
Used for	A bacterial infection called Clostridium difficile
Also called	Vancocin®
Available as	Capsules

Vancomycin is used to a treat a bacterial infection in your bowel caused by Clostridium difficile (C. difficile). Infection with C. difficile most commonly occurs in people who have recently had a course of antibiotics and are in hospital.

Some people have small numbers of C. difficile germs (bacteria) which live in their bowels, and they usually do no harm. This is because the number of C. difficile bacteria living in the gut of healthy people is kept in check by other harmless bacteria that also live in the gut. However, if the number of C. difficile bacteria increases, then it can cause problems. The most common reason why this occurs is due to taking antibiotics. As well as killing the bacteria that are causing an infection, antibiotics also kill many of the harmless bacteria that live in your gut. This allows the number of C. difficile bacteria to increase.

Symptoms of C. difficile infection can range from mild diarrhoea to a life-threatening inflammation of the bowel. No treatment may be needed in mild cases except drinking plenty of fluids. However, treatment with specific antibiotics like vancomycin is needed in more severe cases. Vancomycin works by stopping the growth of C. difficile bacteria.

This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.

This medication is usually given by injection into a vein, usually 1 or 2 times a day or as directed by your doctor. It should be injected slowly over 1 to 2 hours. The dosage is based on your medical condition, weight, kidney function, and response to treatment. (See also Side Effects.)If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.When taking this medication by mouth, mix each dose into at least 1 ounce (30 milliliters) of water before swallowing all of the mixture.Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, use this drug at evenly spaced intervals.Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.Tell your doctor if your condition persists or worsens.

Before using vancomycin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, hearing problems, stomach/intestinal problems (e.g., inflammatory disorders of the intestines).This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for hearing or kidney problems while using this drug.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Consult your doctor before breast-feeding.

• Cardinal Health, Inc.

• ViroPharma, Incorporated

• Advise patients that antibacterials (including vancomycin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).155 197

• Importance of completing full course of therapy, even if feeling better after a few days.155 197

• Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with vancomycin or other antibacterials in the future.155 197

• Importance of reporting possible manifestations of adverse effects to the clinician, including ototoxicity, nephrotoxicity, infusion site reactions, and hypersensitivity.266 267

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.266 267

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.266 267

• Importance of advising patients of other important precautionary information. (See Cautions.)

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Vancocin CAPSULES are indicated for the treatment of C. difficile-associated diarrhea. Vancocin CAPSULES are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains). Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancocin CAPSULES must be given orally for these infections.

Orally administered Vancocin is not effective for other types of infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancocin CAPSULES and other antibacterial drugs, Vancocin CAPSULES should be used only to treat 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.

Vancocin CAPSULES are contraindicated in patients with known hypersensitivity to vancomycin.

Applies to vancomycin: compounding powder, intravenous powder for injection, intravenous solution, oral capsule, oral powder for reconstitution, oral solution

General

The most commonly reported side effects include nausea, abdominal pain, and hypokalemia.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 17%), abdominal pain (up to 15%)
Common (1% to 10%): Vomiting, diarrhea, flatulence
Frequency not reported: Clostridium difficile colitis/pseudomembranous colitis, constipation, chemical peritonitis, indigestion, stomach ache, mild gastrointestinal tract disturbances[Ref]

Chemical peritonitis occurred with intraperitoneal administration.[Ref]

Metabolic

Very common (10% or more): Hypokalemia (up to 13%)[Ref]

Renal

Common (1% to 10%): Nephrotoxicity, renal impairment, increased blood creatinine
Frequency not reported: Renal failure, interstitial nephritis, azotemia, uremia, acute kidney injury, transient increased urea and granular urinary casts[Ref]

Renal failure was most commonly characterized by increased serum creatinine of blood urea nitrogen levels.

Azotemia usually resolved upon discontinuation of treatment.[Ref]

Other

Common (1% to 10%): Pyrexia, fatigue
Frequency not reported: Non-susceptible organism overgrowth, pain, superinfection
Postmarketing reports: Ototoxicity, hearing loss, tinnitus, drug fever, chills[Ref]

Cardiovascular

Hypotension, bradycardia, cardiogenic shock, and cardiac arrest have occurred with rapid bolus administration.[Ref]

Common (1% to 10%): Peripheral edema
Frequency not reported: Hypotension, bradycardia, cardiogenic shock, cardiac arrest, phlebitis, palpitations, substernal pressure, tachycardia, generalized flushing, thrombophlebitis
Postmarketing reports: Vasculitis, chest pain[Ref]

Musculoskeletal

Common (1% to 10%): Back pain
Frequency not reported: Rigor
Postmarketing reports: Neck pain, chest and back muscle spasm[Ref]

Nervous system

Common (1% to 10%): Headache
Postmarketing reports: Vertigo, dizziness[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Hematologic

Frequency not reported: Anemia, reversible neutropenia, thrombocytopenia, reversible agranulocytosis, leukopenia
Postmarketing reports: Eosinophilia[Ref]

Dermatologic

Frequency not reported: Linear IgA bullous dermatosis, bullous eruption disorders, erythematous macular rash with intense pruritus over face, neck, and upper body
Postmarketing reports: Rash, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, pruritus/itch, erythema, upper body flushing/red neck/Red Man Syndrome[Ref]

Local

Frequency not reported: Injection site inflammation, tissue irritation, necrosis[Ref]

Hypersensitivity

Frequency not reported: Anaphylactoid reaction, hypersensitivity reactions
Postmarketing reports: Anaphylaxis[Ref]

Psychiatric

Frequency not reported: Insomnia, depression[Ref]

Hepatic

Frequency not reported: Transaminase elevations[Ref]

Respiratory

Postmarketing reports: Wheezing, dyspnea[Ref]

Immunologic

Postmarketing reports: Drug rash with eosinophilia and systemic symptoms (DRESS)[Ref]

Some side effects of Vancocin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.