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Patients

VANCOCIN® (Vancomycin Hydrochloride Capsules, USP)

VANCOCIN capsules are the capsule form of vancomycin hydrochloride. Vancomycin hydrochloride is an antibacterial agent. It kills susceptible bacteria by weakening their cell wall structure. This causes the bacteria's cell wall to break open and the organism to die.

VANCOCIN capsules are used to treat two bacterial infections that affect part of the gastrointestinal tract called the colon.

Vancocin is indicated for the treatment of C. difficile-associated diarrhea (CDAD). Vancocin is also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains). Vancocin is contraindicated in patients who have experienced a hypersensitivity to vancomycin. Vancocin must be given orally for treatment of staphylococcal enterocolitis and CDAD. Orally administered Vancocin is not effective for other types of infections. Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of Vancocin for active CDAD. Monitoring of serum concentrations may be appropriate in some instances.

Nephrotoxicity has occurred following oral Vancocin therapy and can occur either during or after completion of therapy. The risk is increased in geriatric patients. Monitor renal function. Ototoxicity has occurred in patients receiving Vancocin. Assessment of auditory function may be appropriate in some instances. Prescribing Vancocin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. In clinical trials, the most common adverse reactions (greater than or equal to 10 percent) were nausea (17 percent), abdominal pain (15 percent), and hypokalemia (13 percent). Patients over 65 years of age may take longer to respond to therapy compared to patients less than 65 years of age. Clinicians should be aware of the importance of appropriate duration of Vancocin treatment in patients over 65 years of age and not discontinue or switch to alternative treatment prematurely.

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The following topics address questions you may have about your Vancocin® prescription:

WHAT ARE VANCOCIN CAPSULES?

VANCOCIN capsules are an antibiotic used to treat infections caused by certain germs caused bacteria. VANCOCIN capsules kills many of the bacteria that reside in the colon and has been shown to be safe and effective in a number of clinical trials.

Sometimes viruses rather than bacteria may infect the colon. VANCOCIN capsules like other antibiotics, do not kill viruses.

What do VANCOCIN capsules look like?
VANCOCIN capsules are available in a 125mg and 250mg presentation. The 125 mg capsules have an opaque blue cap and opaque brown body imprinted with “3125” on the cap and “VANCOCIN HCl 125 MG” on the body in white ink. The 250 mg capsules have an opaque blue cap and opaque lavender body imprinted with “3126” on the cap and “VANCOCIN HCl 250 MG” on the body in white ink.

What are VANCOCIN capsules indicated to treat?
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.

How do VANCOCIN capsules work?
VANCOCIN capsules work by preventing bacterial cell walls from forming, this in turn kills the bacteria. VANCOCIN capsules are poorly absorbed after being taken orally and little, if any, drug enters the blood stream. Vancocin capsules, therefore, works at the site of the infection within the colon.

VANCOCIN capsules are available in 2 different strengths (125 mg and 250 mg). Your prescriber will select the most appropriate strength and duration of therapy for your infection. Use only the antibiotic that your healthcare professional prescribed for your condition, and not one used by another person or for another illness. Take the prescribed amount of drug at the correct times and do not skip doses. Even if you start to feel better, continue taking your drug for the full course (prescribed number of days) to ensure that no infectious bacteria can survive.

ABOUT YOUR PRESCRIPTION

Why are VANCOCIN capsules prescribed for you?
VANCOCIN capsules is an antibiotic used to treat certain infections caused by germs known as bacteria. If you have one of these kinds of infections, your healthcare professional may have chosen VANCOCIN capsules to treat your infection.

What to expect with VANCOCIN capsules
The information provided below about use of VANCOCIN capsules do not take the place of discussions with your healthcare professional about your medical condition or your treatment. All the benefits and risks of VANCOCIN capsules are not included in the information below.

Who should not take VANCOCIN capsules?
You should not take VANCOCIN capsules if you have a known hypersensitivity to vancomycin.

If you are pregnant or are planning to become pregnant while taking VANCOCIN capsules, talk to your healthcare professional before taking this medication. VANCOCIN capsules are not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. VANCOCIN capsules should only be given to a pregnant woman if clearly needed.

What are the side effects of VANCOCIN capsules?
In clinical trials, the most common adverse reactions (greater than or equal to 10 percent) were nausea (17 percent), abdominal pain (15 percent), and hypokalemia (13 percent). Patients over 65 years of age may take longer to respond to therapy compared to patients less than 65 years of age.

How should I store VANCOCIN capsules?
Store VANCOCIN capsules at room temperature, 59° to 86°F (15° to 30°C)

TALKING WITH YOUR HEALTHCARE PROFESSIONAL

A bacterial infection can slow you down, keep you from work, and other activities. When speaking with your healthcare professional, he or she will ask you about your symptoms before diagnosing the condition and conducting any tests.

When you talk with your doctor or other healthcare professional, here a few things to keep in mind:
Tell your doctor and other healthcare professionals about any changes in your daily life.

You should also inform your healthcare professionals of the following:

  • If you are taking any other prescription or over-the-counter medications, herbal supplements or vitamins
  • Any allergies to medications, or if you suspect you have previously experienced an adverse or allergic reaction to a particular medicine
  • If you are currently pregnant, have plans to become pregnant, or if you are nursing a baby
  • Illnesses or problems for which another doctor or healthcare professional is currently treating or has recently treated you

Ask About Side Effects
A side effect or adverse reaction is an unwanted effect of a medication or therapy that occurs in addition to its intended effect. Some side effects are more predictable. Known and common side effects are listed in the printed information that comes with every drug.

Some adverse reactions occur unexpectedly, some may be serious and some cannot be predicted. Serious adverse reactions are generally rare. The causes of adverse reactions include medication errors, such as overdose, interactions between drugs, or interactions between drugs and certain foods. Call your doctor, pharmacist or other healthcare professional immediately if you think you have experienced an adverse reaction to a medication.

Your doctor, pharmacist or other healthcare professional can help you anticipate, understand and deal with side effects. Ask them any questions or discuss any concerns you have about your medications.

Follow Prescription Directions
Always take medications as instructed by your doctor, pharmacist or other healthcare professional, and do not change the way you take them unless instructed by them to do so.

If you are a caregiver for another adult, you may have to remind him or her to take a medication, or you may need to administer it yourself.

IMPORTANT SAFETY INFORMATION REGARDING VANCOCIN CAPSULES

Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of Vancocin for active CDAD. Monitoring of serum concentrations may be appropriate in some instances.

Nephrotoxicity has occurred following oral Vancocin therapy and can occur either during or after completion of therapy. The risk is increased in geriatric patients. Monitor renal function. Ototoxicity has occurred in patients receiving Vancocin. Assessment of auditory function may be appropriate in some instances. Prescribing Vancocin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. In clinical trials, the most common adverse reactions (greater than or equal to 10 percent) were nausea (17 percent), abdominal pain (15 percent), and hypokalemia (13 percent). Patients over 65 years of age may take longer to respond to therapy compared to patients less than 65 years of age. Clinicians should be aware of the importance of appropriate duration of Vancocin treatment in patients over 65 years of age and not discontinue or switch to alternative treatment prematurely.

ANTIBIOTIC INFORMATION

Antibiotics, also known as antibacterial or antimicrobial drugs, fight infections caused by bacteria. When these medications emerged in the 1930's and 1940's, they transformed medical care by dramatically reducing illness and death from infectious diseases.

Antibacterial drugs continue to bring relief to people recovering from a variety of bacterial illnesses and they keep bacterial infections from being the killer they were less than 100 years ago. But the use of antibiotics promotes the development of antibiotic-resistant bacteria. And over the last half century, common bacteria have developed resistance to certain antibiotics.

Antibiotic resistance is a serious area for concern. Many common bacteria causing infections are becoming resistant to certain antibiotics and common infections, once easily treatable with antibiotics, could again cause danger and suffering for those who contract these infections.

It is important to understand that there are many controllable factors that play into the potential for resistance. There are a variety of antibacterial drugs available. Your healthcare professional is your best advisor when and if an antibiotic is right for you, and they can help you understand the appropriate use of antibiotics.

There are many types of bacteria, which are tiny living organisms. Most are harmless and some are even helpful. A few bacteria can cause diseases in humans. An antibiotic is a drug that can slow or stop the growth of bacteria. The proper use of antibiotics is important to ensure that the drug works well against the bacteria.

Remember the 3 Ds of appropriate antibiotic use:

  • The right Drug. Use only the antibiotic that your healthcare professional prescribed for your condition, and not one used by another person or for another illness.
  • The right Dose. Take the prescribed amount of your drug at the correct times.
  • The right Duration. Even if you start to feel better, continue taking your drug for the full course (the prescribed number of days) to ensure that no bacteria can survive.