FIRST-Vancomycin 25

Vancomycin is an antibiotic. Oral (taken by mouth) vancomycin fights bacteria in the intestines.

Vancomycin is used to treat an infection of the intestines caused by Clostridium difficile, which can cause watery or bloody diarrhea. Vancomycin is also used to treat staph infections that can cause inflammation of the colon and small intestines.

Oral vancomycin works only in the intestines. This medicine is not normally absorbed into the body and will not treat other types of infection. An injection form of this medication is available to treat serious infections in other parts of the body.

Vancomycin may also be used for purposes not listed in this medication guide.

Oral vancomycin works only in the intestines and will not treat infections in other parts of the body. Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not take this medication if you are allergic to vancomycin.

To make sure vancomycin is safe for you, tell your doctor if you have:

• an intestinal disorder such as inflammatory bowel disease, Crohn's disease, or ulcerative colitis;
• kidney disease;
• hearing problems; or
• if you are receiving any IV antibiotics.

FDA pregnancy category C. It is not known whether vancomycin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Vancomycin can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Side effects on the kidneys may be more likely in older adults taking this medicine.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

• Tell all of your health care providers that you take First-Vancomycin 25. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may need to have hearing tests while you use this medicine. Talk with the doctor.
• Do not use longer than you have been told. A second infection may happen.
• If you are 65 or older, use First-Vancomycin 25 with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Flushing.
• Pain when passing urine.
• Very bad kidney problems may happen while you are taking this medicine or after you stop taking it. The risk may be greater in older adults. Tell your doctor right away if you are unable to pass urine or if there is a change in the amount of urine passed.
• This medicine may cause hearing loss that may not go away. The chance may be higher if you use First-Vancomycin 25 for a long time. Do not use this medicine longer than you have been told by your doctor. Tell your doctor right away if you have a change in hearing or hearing loss.
• Swelling in the arms or legs.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.

• Store in a refrigerator. Do not freeze.
• Protect from light.
• Throw away any unused portion after 30 days.
• 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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Clostridium difficile-associated diarrhea: 125 mg orally 4 times a day
-Duration of therapy: 10 days

Enterocolitis: 500 mg to 2 g orally in 3 to 4 divided doses
-Maximum dose: 2 g/day
-Duration of therapy: 7 to 10 days

Comment: Formulations administered parenterally will not treat colitis.

Uses:
-Treatment of C difficile-associated diarrhea
-Treatment of enterocolitis caused by S aureus (including MRSA)

Society of Healthcare Epidemiology of America (SHEA) and IDSA Recommendations:
Initial treatment of severe C difficile infection (CDI): 125 mg orally 4 times a day
-Duration of therapy: 10 to 14 days

Severe, complicated CDI: 500 mg orally 4 times a day AND 500 mg (in 100 mL normal saline) rectally every 6 hours with/without IV metronidazole

Comments:
-Rectal formulations should be administered as a retention enema.
-The first recurrence of CDI may be treated with the initial treatment regimen; a second recurrence of CDI may be treated with a tapered/pulsed regimen of this drug.

Uses:
-Initial treatment of patients with severe CDI
-Initial treatment of patients with complicated, severe CDI

500 mg IV every 6 hours OR 1 g IV every 12 hours

Comments:
-This drug should be administered at a rate up to 10 mg/min or over 1 hour, whichever is longer.
-Doses should be determined by patient-specific factors (e.g., obesity, age).

Use: Empirical treatment of bone infections caused by susceptible strains of methicillin-resistant staphylococci in patients who are allergic to penicillin, failed to respond/cannot receive other drugs (e.g., penicillins, cephalosporins), and/or to treat organisms that are resistant to other drugs

IDSA Recommendations:
15 to 20 mg/kg IV every 12 hours
-Duration of therapy: 4 to 6 weeks

Uses:
-First choice treatment for native vertebral osteomyelitis caused by oxacillin-resistant staphylococci, penicillin-resistant Enterococcus species
-Alternative treatment for native vertebral osteomyelitis caused by oxacillin-susceptible staphylococci
-Alternative treatment for native vertebral osteomyelitis caused by penicillin-susceptible Enterococcus species, Enterobacteriaceae, beta-hemolytic streptococci, or Propionibacterium acnes in patients allergic to penicillin

IDSA, American Academy of Neurology (AAN), American Association of Neurological Surgeons (AANS), and Neurocritical Care Society (NCS) Recommendations:
30 to 60 mg/kg IV per day, given in divided doses every 8 to 12 hours
-Some experts recommend: 15 mg/kg IV once, followed by 60 mg/kg per day continuous infusion
-Maximum dose: 2 g/dose
-Duration of treatment: At least 2 weeks

Comment: Surgical evaluation is recommended for patients with septic thromboses, empyema, and/or abscesses.

Uses:
-Treatment of patients with healthcare-associated ventriculitis and meningitis caused by methicillin-resistant staphylococci
-In combination with a third-generation cephalosporin, treatment of patients with healthcare-associated ventriculitis and meningitis caused by Streptococcus pneumoniae
-Alternative treatment of patients with healthcare-associated ventriculitis and meningitis caused by methicillin-sensitive staphylococci or P acnes
-Treatment of patients with brain abscess, subdural empyema, and/or spinal epidural abscess
-Treatment of patients with septic thrombosis of cavernous/Dural venous sinus

IDSA, AAN, AANS, and NCS Recommendations:
Patients with slit ventricles: 5 mg via intraventricular route (plus gentamicin)
Patients with normal-sized ventricles: 10 mg via intraventricular route (plus gentamicin)
Patients with enlarged ventricles: 15 to 20 mg via intraventricular route (plus gentamicin)

Frequency of dosing:
-External drain output less than 50 mL/day: every 3 days
-External drain output 50 to 100 mL/day: every 2 days
-External drain output 100 to 150 mL/day: once a day
-External drain output 150 to 200 mL/day: increase the dose by 5 mg (plus gentamicin) and give once a day
-External drain output 200 to 250 mL/day: increase the dose by 10 mg (plus gentamicin) and give once a day

Use: Treatment of healthcare-associated ventriculitis and meningitis in patients who respond poorly to systemic antibiotics

Neonates:
Initial dose: 15 mg/kg IV once

Maintenance dose:
-First week of life: 10 mg/kg IV every 12 hours
-After first week of life: 10 mg/kg IV every 8 hours

1 month or older: 10 mg/kg IV every 6 hours


Comments:
-This drug should be infused over 1 hour.
-Premature infants may require longer dosing intervals.
-Doses should be determined by patient-specific factors (e.g., obesity, age).

Uses:
-Empirical treatment of serious/severe staphylococcal infections caused by susceptible strains of methicillin-resistant staphylococci in patients who are allergic to penicillin, failed to respond/cannot receive other drugs (e.g., penicillins, cephalosporins), and/or to treat organisms that are resistant to other drugs
-Empirical treatment of septicemia caused by susceptible strains of methicillin-resistant staphylococci in patients who are allergic to penicillin, failed to respond/cannot receive other drugs (e.g., penicillins, cephalosporins), and/or to treat organisms that are resistant to other drugs
-Empirical treatment of bone infections caused by susceptible strains of methicillin-resistant staphylococci in patients who are allergic to penicillin, failed to respond/cannot receive other drugs (e.g., penicillins, cephalosporins), and/or to treat organisms that are resistant to other drugs

IDSA Recommendations:
Bacteremia:
15 mg/kg IV every 6 hours
-Duration of therapy: 2 to 6 weeks, depending on the severity of infection

Bacterial Infection:
7 days or less and less than 1200 g: 15 mg/kg IV every 24 hours
7 days or less than 1200 to 2000 g: 10 to 15 mg/kg IV every 12 to 18 hours
7 days or less than greater than 2000 g: 10 to 15 mg/kg IV every 8 to 12 hours

8 to 30 days and less than 1200 g: 15 mg/kg IV every 24 hours
8 to 30 days and 1200 to 2000 g: 10 to 15 mg/kg IV every 8 to 12 hours
8 to 30 days and greater than 2000 g: 15 to 20 mg/kg IV every 8 hours

1 month to 18 years: 10 to 13.33 mg/kg IV every 6 to 8 hours
-Maximum dose: 40 mg/kg/day

Uses:
-Preferred treatment for IV catheter-related bloodstream infections caused by MRSA/coagulase-negative staphylococci, ampicillin-resistant, vancomycin-sensitive E faecalis/E faecium, C jeikeium (group JK)
-Alternative treatment for IV catheter-related bloodstream infections caused by MSSA/coagulase-negative staphylococci, ampicillin susceptible E faecalis/E faecium
-Treatment of bacteremia

IDSA, AAN, AANS, and NCS Recommendations:
60 mg/kg IV per day, given in divided doses every 6 hours
-Duration of therapy: 2 weeks

Use: Treatment of patients with healthcare-associated ventriculitis and meningitis

Mild to moderate renal dysfunction:
-Initial dose: 15 mg/kg IV once
-Maintenance dose: 1.9 mg/kg IV every 24 hours

Severe renal dysfunction:
-Initial dose: 15 mg/kg IV once
-Maintenance dose: 1.9 mg/kg IV every 24 hours OR 250 to 1000 mg IV once every several days

Patients with anuria:
-Initial dose: 15 mg/kg IV once
-Maintenance dose: 1000 mg IV once every 7 to 10 days

Safety and efficacy of oral capsule formulations have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

• If you have been prescribed vancomycin capsules for the treatment of C. difficile-associated diarrhea or for enterocolitis, take it exactly as directed by your doctor and finish the course. Do not use vancomycin capsules to treat any other type of infection.
• Contact your doctor immediately if you experience hearing loss or a ringing in your ears, if you develop diarrhea that is very watery or bloody, or if you are concerned it may be affecting your kidneys (symptoms include swelling, weight gain, pain in the lower back or on your side, little or no urination).
• Also talk with your doctor if you think your potassium levels may be low (symptoms may include confusion, extreme thirst, muscle weakness, increased urination or an uneven heart rate).

• Orally administered vancomycin is not effective for the treatment of infections other than C. difficile-associated diarrhea and enterocolitis caused by S. aureus. In most people, oral vancomycin is poorly absorbed systemically (does not get absorbed through the gut into the blood stream). However, there have been reports of absorption of oral vancomycin particularly in those with inflammatory disorders of the intestine.
• Although symptoms may improve early on in the course of therapy, it is important to finish the course as prescribed to reduce the risk of resistant bacteria developing. the usual duration of therapy is seven to ten days.

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