BACiiM

Administration

Administer IM.100 104

Has been administered orally†,101 102 103 112 113 117 140 143 but oral preparations not commercially available in US.

IM Injection

Inject into upper outer quadrant of the buttocks.100 104 Alternate injection sites between right and left side.100 104 Avoid making multiple injections in same region because of transient pain following injection.100 104

Reconstitute lyophilized powder for injection by dissolving in 0.9% sodium chloride injection containing 2% procaine hydrochloride.100 104 If 9.8 mL of this diluent is used to reconstitute a vial containing 50,000 units of bacitracin, resultant solution contains 5000 units/mL.100 104

Do not use bacitracin solutions containing <5000 units/mL or >10,000 units/mL.100 104

Do not use diluents containing parabens;100 104 cloudy solutions and precipitate formation may occur.100 104

Dosage

Pediatric Patients

Infants <2.5 kg: Manufacturers recommend 900 units/kg daily given in 2 or 3 divided doses.100 104

Infants >2.5 kg: Manufacturers recommend 1000 units/kg daily in 2 or 3 divided doses.100 104

Prescribing Limits

Pediatric Patients

Do not exceed recommended dosage;100 104 duration >12 days not recommended.a

Special Populations

No special population dosage recommendations.100 104

Absorption

Bioavailability

Not appreciably absorbed from GI tract.14

Completely and rapidly absorbed following IM injection.100 104

Following IM dosage of 200–300 units/kg every 6 hours in individuals with normal renal function, serum concentrations are 0.2–2 mcg/mL.100 104

Following single IM dose of 10,000–20,000 units in adults with normal renal function, peak serum concentrations occur after 1–2 hours and the drug is detectable in serum for 6–8 hours after the dose.a

Distribution

Extent

Widely distributed into all body organs;100 104 readily diffuses into ascitic and pleural fluids following IM injection.100 104

Only low concentrations distributed into CSF.14

Plasma Protein Binding

Only slightly protein bound.a

Elimination

Elimination Route

IM: 10–40% of a dose excreted slowly by glomerular filtration and appears in urine within 24 hours.14

Oral: Excreted in feces.a

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Very upset stomach or throwing up.
• It is common to have diarrhea when taking BACiiM. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)–associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking this medicine or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Pain where the shot was given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• 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.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

This information should not be used to decide whether or not to take BACiiM or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to BACiiM. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

In accord with the statements in the “Warning Box” the use of intramuscular bacitracin is limited to the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug.

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

TO BE ADMINISTERED INTRAMUSCULARLY ONLY

Infant dose: For infants under 2500 grams – 900 units/kg/24 hours in 2 or 3 divided doses. For infants over 2500 grams – 1,000 units/kg/24 hours, in 2 or 3 divided doses. Intramuscular injections of the solution should be given in the upper outer quadrant of the buttocks, alternating right and left and avoiding multiple injections in the same region because of the transient pain following injection.

Preparation of Solutions – Should be dissolved in sodium chloride injection containing 2 percent procaine hydrochloride. The concentration of the antibiotic in the solution should not be less than 5,000 units per mL nor more than 10,000 units per mL.

Diluents containing parabens should not be used to reconstitute bacitracin; cloudy solutions and precipitate formation have occurred.

Reconstitution of the 50,000 unit vial with 9.8 mL of diluent will result in a concentration of 5,000 units per mL.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Bacitracin for Injection, USP is available in vials containing 50,000 units.

NDC 39822-0277-5. Boxes of ten vials use NDC 39822-0277-2.

Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F).

Solutions are stable for one week when stored in a refrigerator 2° to 8°C (36° to 46°F).

Manufactured for:

X-Gen Pharmaceuticals, Inc.

Big Flats, 14814

Revised June 2012

BIM-P04