Bacitracin injection

Bacitracin injection is an antibiotic that treats staph infection caused by a bacteria called staphylococcus (STAF-il-oh-KOK-us).

Bacitracin injection is used in infants to treat pneumonia. It is also used to treat an infection that causes pus to build up between the lungs and the membrane that covers them.

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

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If your baby has diarrhea that is watery or bloody, call your doctor. Do not give your baby anti-diarrhea medicine unless your doctor tells you to.

Get emergency medical help if your baby has any of these signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

While receiving bacitracin injection, your baby will be watched for the following side effects:

• diarrhea that is watery or bloody;

• urinating more than usual or more often;

• little or no urinating (fewer wet diapers);

• blood in the urine;

• lower back pain; or

• painful urination.

Common side effects include:

• nausea, vomiting;

• mild skin rash; or

• pain, burning, or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Bacitracin can harm your baby's kidneys. This effect is increased when the baby also receives certain other medicines. Tell your doctor about all medicines your baby uses, especially:

• antivirals;

• chemotherapy;

• injected antibiotics;

• medicine for bowel disorders;

• medicine to prevent organ transplant rejection; or some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

This list is not complete. Other drugs may interact with bacitracin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Bacitracin for Injection, USP is an antibiotic for intramuscular administration.  Bacitracin is derived from cultures of Bacillus licheniformis.  It is a white to pale buff, hygroscopic powder, odorless or having a slight odor.  It is freely soluble in water; insoluble in acetone, chloroform, and ether.  While soluble in alcohol, methanol, and glacial acetic acid, there is some insoluble residue.  It is precipitated from its solutions and inactivated by many of the heavy metals.

The structural formula is:

C66H103N17O16S                                M.W. 1422.71

Bacitracin is comprised of a polypeptide complex and Bacitracin A is the major component in this complex.

TO BE ADMINISTERED INTRAMUSCULARLY ONLY

Infant dose

For infants under 2,500 grams - 900 units/kg/24 hours, in 2 or 3 divided doses.  For infants over 2,500 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.

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