Bacitracin

Bacitracin belongs to the pharmacological class of Polypeptide Antibiotics.

Bacitracin has been approved to relieve symptoms and also for the treatment and maintenance of Topical and skin infections, Ophthalmic Treatments of eye infections, Prevention of infection.

Bacitracin exhibits varying characteristics in terms of absorption, distribution, protein binding, metabolism, and elimination. When applied topically, used ophthalmically, or taken orally, bacitracin shows limited systemic absorption. However, intramuscular administration leads to rapid and complete absorption. Unfortunately, there is a lack of readily available data on the volume of distribution and protein binding of bacitracin in humans. Similarly, information regarding its metabolism in humans is also not readily accessible. As a protein, bacitracin is expected to undergo metabolism into smaller polypeptides and amino acids, although its unique structure may provide some degree of protection against proteases. Regarding elimination, the primary route for bacitracin is renal excretion, with approximately 87% of an intramuscular dose being recovered in the urine within six hours.

The common side effects involved in using Bacitracin are Kidney toxicity, which may present as albuminuria, cylindruria, or azotemia, Nausea and vomiting, Itching, Blood dyscrasias, Sweating, Reactions at the injection site, such as pain, burning, or swelling, Skin rashes.

Bacitracin is available in the form of Topical ointment, Ophthalmic ointment, Oral capsules, Injectable solution.

Bacitracin is approved in Germany, Japan, Malaysia, India, the U.K., the U.S., and China.

Bacitracin belongs to the pharmacological class of Polypeptide Antibiotics.

Bacitracin forms complexes with divalent metal ions like Mn(II), Co(II), Ni(II), Cu(II), or Zn(II). These complexes then bind to C55-isoprenyl pyrophosphate, inhibiting the hydrolysis of lipid dolichol pyrophosphate and ultimately preventing cell wall synthesis. Additionally, bacitracin metal complexes have the ability to bind to and oxidatively cleave DNA.

Bacitracin has been approved to relieve symptoms and also for the treatment and maintenance of Topical and skin infections, Ophthalmic Treatments of eye infections, Prevention of infection.

It has a short duration of action as Bacitracin must be given every 3 to 4 hours topically.

Bacitracin is found to be available in the form of Topical ointment, Ophthalmic ointment, Oral capsules, Injectable solution.

Bacitracin can be used in the following treatment:

• Topical treatment of skin infections: Bacitracin is commonly used to prevent and treat bacterial infections on the skin, including minor cuts, wounds, and burns.
• Ophthalmic treatment of eye infections: Bacitracin ophthalmic ointment is used to treat certain eye infections, such as conjunctivitis (pink eye) and corneal ulcers caused by susceptible bacteria.
• Prevention of infection: Bacitracin can be applied to prevent infection in certain situations, such as after minor skin injuries or surgical procedures.

Bacitracin can help to relieve symptoms and also for the treatment and maintenance of Topical and skin infections, Ophthalmic Treatments of eye infections, Prevention of infection.

Bacitracin is approved for use in the following clinical indications:

• Topical treatment of skin infections: Bacitracin is commonly used to prevent and treat bacterial infections on the skin, including minor cuts, wounds, and burns.
• Ophthalmic treatment of eye infections: Bacitracin ophthalmic ointment is used to treat certain eye infections, such as conjunctivitis (pink eye) and corneal ulcers caused by susceptible bacteria.
• Prevention of infection: Bacitracin can be applied to prevent infection in certain situations, such as after minor skin injuries or surgical procedures.

• Blepharitis: Apply bacitracin ophthalmic medication twice daily, including before going to bed.
• Superficial infections of the conjunctiva and/or cornea: Apply the medication up to every 3 to 4 hours for a period of 10 days, depending on the severity of the infection.
• Infection prevention: Topical use: Apply the medication 1 to 3 times daily to prevent infection.

Powder for injection: 150mg/vial

Topical ointment, Ophthalmic ointment, Oral capsules, Injectable solution.

Dosage Adjustments in Kidney Patients:

• When the creatinine clearance (CrCl) is greater than 80 mL/min, no adjustment in dosage is necessary.
• For patients with a CrCl ranging from 50 to 79 mL/min, the recommended dosage is 2.5-3.8 mg/kg/day, given intravenously or intramuscularly, divided into two doses every 12 hours.
• If the CrCl is between 30 and 49 mL/min, the recommended dosage is 2.5 mg/kg/day administered intravenously or intramuscularly, either once daily or divided into two doses every 12 hours.

• In patients with a CrCl of 10-29 mL/min, the recommended dosage is 1.5 mg/kg administered intravenously or intramuscularly every 36 hours.

Dosage Adjustments in Pediatric Patients:

• Parenteral use: Bacitracin is rarely administered systemically. Prior to administration, it is advisable to confirm the intended use and route of administration with the prescribing healthcare professional. Bacitracin is intended for intramuscular (IM) administration only and should be administered to the upper outer quadrant of the buttocks. It is important to rotate the administration site. Intravenous (IV) administration should be avoided.

Use: Approved Indications

• Pneumonia and empyema: Bacitracin is indicated for the treatment of pneumonia and empyema in infants caused by staphylococci that are susceptible to the medication. Due to the potential risks of toxicity, systemic use of bacitracin should be limited to situations where other less toxic alternatives have been deemed ineffective.
• Infection prevention: Infants, children, and adolescents should use bacitracin topically. Apply a small amount 1 to 3 times daily. It is not recommended to continue treatment for more than 7 days .
• Infections of the eyes:

Ophthalmic use:

Blepharitis: Apply bacitracin ophthalmic ointment twice daily, including at bedtime.

• Superficial infections of the conjunctiva and/or cornea: Apply bacitracin ophthalmic ointment as frequently as every 3 to 4 hours for a duration of 10 days, adjusting the frequency based on the severity of the infection.
  

There are no specific dietary restrictions associated with the use of Bacitracin. However, it is always advisable to follow a balanced and healthy diet while taking any medication to support overall well-being and optimize the body's response to treatment.

Bacitracin may be contraindicated under the following conditions:

1. Patients with a known hypersensitivity to Colistimethate for Injection USP should not receive the medication due to contraindications.

• For Intramuscular Administration:
• Nephrotoxicity: The use of bacitracin in parenteral (intramuscular) therapy can lead to renal failure caused by damage to the kidney's tubules and glomeruli. It should be limited to infants with staphylococcal pneumonia and empyema caused by bacteria susceptible to bacitracin. The administration should only take place in settings with adequate laboratory facilities and constant patient supervision.
• Prior to treatment and on a daily basis during therapy, renal function should be carefully assessed. The recommended daily dosage should not be exceeded, and appropriate fluid intake and urinary output should be maintained to prevent kidney toxicity. If signs of renal toxicity appear, the drug should be discontinued. Concurrent use of other nephrotoxic drugs, particularly streptomycin, kanamycin, polymyxin B, polymyxin E (colistin), neomycin, and viomycin, should be avoided.
• Susceptibility/Resistance:
• Development of Drug-Resistant Bacteria: Prescribing bacitracin in the absence of a proven or strongly suspected bacterial infection is unlikely to benefit the patient and increases the risk of developing bacteria that are resistant to the drug.
• Precautions:
• Please refer to "WARNINGS" for precautions concerning the kidney toxicity associated with intramuscular use of bacitracin.
• Maintaining adequate fluid intake is important, either orally or through parenteral means if necessary.
• As with other antibiotics, the use of this medication may result in the overgrowth of non-susceptible organisms, including fungi. If a superinfection occurs, appropriate therapy should be initiated.

There is no specific warning against consuming alcohol while using Bacitracin. However, it is generally recommended to avoid alcohol when taking antibiotics as it can potentially interfere with the effectiveness of the medication and may also increase the risk of side effects. Alcohol consumption can strain the liver and impair its ability to metabolize drugs, which can affect how Bacitracin is processed in the body. Furthermore, both Bacitracin and alcohol can individually cause gastrointestinal side effects, and consuming alcohol may exacerbate these symptoms.

There is no specific food warning associated with the use of bacitracin. Bacitracin is an antibiotic medication typically used topically to treat skin infections. It is not intended for oral consumption or to be ingested through food.

The adverse reactions related to Bacitracin can be categorized as follows:

Common:

• Skin irritation or rash at the application site.
• Itching or pruritus.
• Nausea and vomiting.

Less common :

• Allergic reactions, including hives or swelling.
• Contact dermatitis.
• Redness or inflammation at the application site.
• Headache.
• Diarrhea or stomach upset.
• Pain or discomfort at the injection site (for intramuscular administration).

Rare adverse:

• Kidney toxicity, which may manifest as albuminuria (presence of albumin in the urine), cylindruria (presence of casts or cylindrical structures in the urine), or azotemia (abnormally high levels of nitrogenous waste products in the blood).
• Blood dyscrasias, such as abnormal changes in blood cell counts.
• Severe allergic reactions, including anaphylaxis (a life-threatening allergic response).
• Serious skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis.

The following are the side effects involving Bacitracin:

• Kidney toxicity, may present as albuminuria, cylindric, or azotemia.
• Nausea and vomiting.
• Itching.
• Blood dyscrasias.
• Sweating.
• Reactions at the injection site, such as pain, burning, or swelling.
• Skin rashes.

Physicians should be knowledgeable as well as vigilant about the treatment and identification of overdosage of Bacitracin.

Pharmacodynamics

Bacitracin consists of a combination of polypeptides that inhibit the formation of bacterial cell walls and enzymatically break down DNA through oxidation. This medication has a limited duration of effectiveness, necessitating topical administration every 3 to 4 hours. However, it is important to note that when administered intramuscularly, bacitracin can be nephrotoxic and potentially contribute to the development of renal failure.

Pharmacokinetics

Absorption:

● Bacitracin is poorly absorbed into the systemic circulation when administered topically, ophthalmically, or orally. However, intramuscular administration allows for rapid and complete absorption.

The volume of distribution:

● There is a lack of readily available data regarding the volume of distribution of bacitracin in humans.

Protein binding:

● Data on the protein binding of bacitracin in humans is not readily accessible.

Metabolism:

● Information regarding the metabolism of bacitracin in humans is not readily accessible. Due to its protein nature, bacitracin is expected to undergo metabolism into smaller polypeptides and amino acids. However, the structural characteristics of bacitracin may offer some protection against the action of proteases.

Route of elimination:

● The primary route of elimination for bacitracin is through renal excretion. Approximately 87% of an intramuscular dose is recovered in the urine within 6 hours.

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