Class: Antibacterials
VA Class: DE101
CAS Number: 1405-87-4
Brands: AK-Poly-Bac
Introduction
Antibacterial; polypeptide antibiotic produced by Bacillus subtilis.104 a d e f
Uses for Bacitracin Zinc
Bacterial Ophthalmic Infections
Treatment of superficial infections of the eye involving the conjunctiva and/or cornea caused by susceptible organisms.101 d e
Used alone or in fixed combination with other topical anti-infectives (e.g., neomycin, polymyxin B) with or without topical corticosteroids (e.g., hydrocortisone) when such combination therapy is indicated.104 a d e f (See Use of Fixed Combinations under Cautions.)
Not recommended for topical prophylaxis of neonatal ophthalmia.a
Not indicated for treatment of deep-seated ocular infections or infections likely to become systemic.101
Bacitracin Zinc Dosage and Administration
Administration
Ophthalmic Administration
Apply topically to conjunctival sac of the eye as an ointment.101
Not for injection into the eye; do not instill directly into the anterior chamber of the eye.104 e f
When treating blepharitis, carefully remove all scales and crusts prior to application of the ointment; spread ointment uniformly over lid margins.101
Avoid contaminating the tip of the ointment container.101 104 e f
Dosage
Available as bacitracin alone; as fixed combination containing bacitracin zinc and polymyxin B sulfate; and as fixed combinations containing bacitracin zinc, and neomycin and polymyxin B sulfates, with or without hydrocortisone or hydrocortisone acetate. Dosage of bacitracin or bacitracin zinc is expressed in terms of bacitracin.101 104 d e f
Adults
Bacterial Ophthalmic Infections
Bacitracin
Ophthalmic Ointment
Apply into the conjunctival sac of the affected eye(s) 1–3 times daily.101
Bacitracin Zinc and Neomycin and Polymyxin B Sulfates
Ophthalmic Ointment
Apply to affected eye(s) every 3 or 4 hours for 7–10 days, depending on the severity of the infection.e
Bacitracin Zinc, Neomycin and Polymyxin B Sulfates, and Hydrocortisone
Ophthalmic Ointment
Apply to affected eye(s) every 3 or 4 hours, depending on severity of the condition.104 f
Bacitracin Zinc and Polymyxin B Sulfate
Ophthalmic Ointment
Apply to affected eye(s) every 3 or 4 hours for 7–10 days, depending on the severity of the infection.d
Special Populations
No special population dosing recommendations at this time.101 104 a d e f
Cautions for Bacitracin Zinc
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 Zinc 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
Stability
Storage
Ophthalmic
Ointment
Bacitracin: 15–30°C.a
Bacitracin zinc and polymyxin B sulfate: 20–25°C.d
Neomycin and polymyxin B sulfates and bacitracin zinc: 20–25°C.e
Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone: 15–30°C.f
Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate: 15–25°C.104
Actions and SpectrumActions
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
Advice to Patients
Importance of not touching tip of container to the eye, eyelid, fingers, or any other surface to avoid contamination.101 104 e f Advise patient to keep container tightly closed when not in use.e f
Importance of discontinuing therapy and contacting clinician if the infection worsens or does not improve, or if any signs of sensitivity occur (e.g., rash, itching, swelling, redness, burning).101 104 a e f
Advise patient not to share the drug with any other person.104 e
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.104 d e
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.104 e
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | 500 units/g* | Bacitracin | Akorn, Fougera |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | Bacitracin Zinc 500 units (of bacitracin) per g and Polymyxin B Sulfate 10,000 units (of polymyxin B) per g | AK-Poly-Bac | Akorn |
Bacitracin Zinc and Polymyxin B Sulfate | Bausch & Lomb, Fougera |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Bacitracin Zinc 400 units (of bacitracin) per g* | Neomycin and Polymyxin B Sulfates and Bacitracin Zinc | Bausch & Lomb, Fougera |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone 1%* | Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone | Bausch & Lomb |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone Acetate 1% | Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Acetate | Fougera |
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
Only references cited for selected revisions after 1984 are available electronically.
101. E. Fougera & Co. Bacitracin ophthalmic ointment USP prescribing information. Melville, NY; 1998 Mar.
102. Akorn. Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment USP prescribing information. Buffalo Grove, IL; 2003 Dec.
103. Akorn. Bacitracin zinc and polymyxin B sulfate ophthalmic ointment USP prescribing information. Somerset, NJ; 1998 Jul.
104. E. Fougera & Co. Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment prescribing information. Melville, NY; 2004 Aug.
a. AHFS drug information 2008. McEvoy, GK, ed. Bacitracin. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2837-8.
d. Akorn, Inc. Bacitracin zinc and polymyxin B sulfate ophthalmic ointment USP prescribing information. Buffalo Grove, IL; 2007 Aug.
e. Akorn, Inc. Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment, USP prescribing information. Buffalo Grove, IL; 2007 Oct.
f. Bausch & Lomb Incorporated. Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment USP prescribing information. Tampa, FL; 2003 Nov.
g. Briggs CC, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation, 7th ed. Philadelphia, PA: Lippincott, Williams, & Wilkins; 2005: 144-5.
h. AHFS drug information 2008. McEvoy GK, ed. EENT corticosteroids general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2867-9.
More Bacitracin Zinc eent resources
- Bacitracin Zinc eent Use in Pregnancy & Breastfeeding
- Bacitracin Zinc eent Support Group
- 0 Reviews for Bacitracin Zinc eent - Add your own review/rating
Compare Bacitracin Zinc eent with other medications
- Conjunctivitis, Bacterial
No comments:
Post a Comment