Bacitracin eent

Name: Bacitracin eent

Cautions for Bacitracin

Contraindications

  • Known hypersensitivity to bacitracin or any ingredient in the formulation.101 104 a d e f

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Cutaneous sensitization possible (e.g., itching, reddening, conjunctival or eyelid edema).104 e

Hypersensitivity reactions (e.g., itching, rash, swelling of lips and face, sweating, tightness of the chest), including anaphylaxis, reported rarely.a

During long-term use of topical antibiotics, periodically examine patient for signs of sensitization; may manifest as a failure to heal.104 e f If signs or symptoms of sensitivity occur, discontinue the drug.101 104 a e f

Patients sensitive to neomycin may also be sensitive to bacitracin.a

General Precautions

Deep-seated Ocular Infections

Do not use for treatment of deep-seated ocular infections or infections likely to become systemic.101

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.101 104 d e f Discontinue drug and institute appropriate therapy if superinfection occurs.101 a d e

Infection Complications

Ophthalmic ointments may delay healing.104 d e f

Use of Fixed Combinations

Concomitant topical corticosteroids may mask clinical signs of bacterial, fungal, or viral infections, prevent recognition of ineffectiveness of the antibiotic, or may suppress hypersensitivity reactions to bacitracin or other ingredients in the formulation.f

When bacitracin is used in fixed combination with other agents (corticosteroids, other anti-infectives), consider the cautions, precautions, and contraindications associated with the concomitant agent(s).104 d e f

Specific Populations

Pregnancy

Category C.104 e f

Lactation

Experts consider topical bacitracin compatible with nursing.g

Use the fixed combination with neomycin and polymyxin B sulfates with caution in nursing women.e

Pediatric Use

Safety and efficacy not established in pediatric patients.104 e f

Geriatric Use

No substantial differences in safety or efficacy relative to younger patients.104 e

Bacitracin Pharmacokinetics

Absorption

Extent

Not substantially absorbed from intact or denuded skin, wounds, or mucous membranes.a

Distribution

Extent

Not known whether topical bacitracin is distributed into breast milk.e g

Actions and Spectrum

  • Bacitracin consists of 3 separate compounds, bacitracin A, B, and C; bacitracin A is the chief constituent.a d e

  • May be bactericidal or bacteriostatic in action, depending on concentration of the drug attained at the site of infection and the susceptibility of the infecting organism.a e

  • Inhibits bacterial cell wall synthesis by preventing incorporation of amino acids and nucleotides into the cell wall.a e

  • Spectrum of activity includes many gram-positive aerobic bacteria, some aerobic gram-negative bacteria, and some anaerobic bacteria.a 101 e Inactive against fungi.101

  • Gram-positive bacteria: Active against Staphylococcus aureus and some streptococci.a 101

  • An increasing number of staphylococci, including penicillin-resistant staphylococci, are resistant to bacitracin.a Cross-resistance does not usually occur between bacitracin and other anti-infectives.a

What are some side effects that I need to call my doctor about right away?

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.

What are some other side effects of this drug?

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 you have any side effects that bother you or do not go away.

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.

Some side effects of bacitracin ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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