Bacitracin (opthalmic)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]
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Overview
Bacitracin (opthalmic) is a antibiotic that is FDA approved for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.. Common adverse reactions include contact dermatitis.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.
Dosing Information
- The ointment should be applied directly into the conjunctival sac 1 to 3 times daily. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins. Patients should be instructed to take appropriate measures to avoid gross contamination of the ointment when applying the ointment directly to the infected eye.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Bacitracin (opthalmic) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Bacitracin (opthalmic) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Bacitracin (opthalmic) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Bacitracin (opthalmic) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Bacitracin (opthalmic) in pediatric patients.
Contraindications
- This product should not be used in patients with a history of hypersensitivity to Bacitracin.
Warnings
PRECAUTIONS:
- Bacitracin ophthalmic ointment should not be used in deep-seated ocular infections or in those that are likely to become systemic. The prolonged use of antibiotic containing preparations may result in overgrowth of nonsusceptible organisms particularly fungi. If new infections develop during treatment appropriate antibiotic or chemotherapy should be instituted.
Adverse Reactions
Clinical Trials Experience
- Contact dermatitis
Postmarketing Experience
There is limited information regarding Bacitracin (opthalmic) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Bacitracin (opthalmic) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Bacitracin (opthalmic) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bacitracin (opthalmic) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Bacitracin (opthalmic) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Bacitracin (opthalmic) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Bacitracin (opthalmic) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Bacitracin (opthalmic) in geriatric settings.
Gender
There is no FDA guidance on the use of Bacitracin (opthalmic) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Bacitracin (opthalmic) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Bacitracin (opthalmic) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Bacitracin (opthalmic) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Bacitracin (opthalmic) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Bacitracin (opthalmic) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Bacitracin (opthalmic) Administration in the drug label.
Monitoring
There is limited information regarding Bacitracin (opthalmic) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Bacitracin (opthalmic) and IV administrations.
Overdosage
There is limited information regarding Bacitracin (opthalmic) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Bacitracin (opthalmic) Pharmacology in the drug label.
Mechanism of Action
- The antibiotic, Bacitracin, exerts a profound action against many gram-positive pathogens, including the common Streptococci and Staphylococci. It is also destructive for certain gram-negative organisms. It is ineffective against fungi.
Structure
There is limited information regarding Bacitracin (opthalmic) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Bacitracin (opthalmic) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Bacitracin (opthalmic) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Bacitracin (opthalmic) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Bacitracin (opthalmic) Clinical Studies in the drug label.
How Supplied
NDC 48102-007-13 3 - 1 g sterile tamper evident tubes with ophthalmic tip.
NDC 48102-007-35 3.5 g (1/8 oz.) sterile tamper evident tubes with ophthalmic tip.
Storage
- Store at 20°-25° C (68°-77° F) (See USP Controlled room temperature).
Images
Drug Images
{{#ask: Page Name::Bacitracin (opthalmic) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
PRINCIPAL DISPLAY PANEL - 3X1 G TUBES, CARTON LABEL
NDC 48102-007-13
Rx only
BACITRACIN OPHTHALMIC OINTMENT USP, 500 units/g STERILE
3 x 1 g tubes
Sterile Ophthalmic Ointment
Weighing 1 gram each
USUAL DOSAGE: Apply 1 to 3 times daily. See package insert for full prescribing information.
EACH GRAM CONTAINS: 500 units of Bacitracin per gram, White Petrolatum, Mineral Oil.
Keep tightly closed.
Store at 20°-25° C (68°-77° F) (See USP
Controlled room temperature).
Keep out of reach of children.
PRINCIPAL DISPLAY PANEL - 1 G TUBE, IMMEDIATE CONTAINER LABEL
NDC 48102-007-11
STERILE
Rx only
BACITRACIN
OPHTHALMIC OINTMENT USP
500 units/g
NET WT 1 gm
PRINCIPAL DISPLAY PANEL - 3.5 G TUBE, CARTON LABEL
NDC 48102-007-35
Rx only
BACITRACIN OPHTHALMIC OINTMENT USP STERILE
CONTAINS: 500 units of Bacitracin per gram, White Petrolatum, Mineral Oil.
NET WT 3.5 g (1/8 Oz)
USUAL DOSAGE: 3 applications daily. See insert for complete information.
KEEP TIGHTLY CLOSED STORE AT ROOM TEMPERATURE KEEP OUT OF REACH OF CHILDREN
See crimp of tube for Lot No. & Exp. Date
PRINCIPAL DISPLAY PANEL - 3.5 G TUBE, IMMEDIATE CONTAINER LABEL
NDC 48102-007-35
BACITRACIN OPHTHALMIC OINTMENT USP STERILE
Rx only
USUAL DOSAGE: 3 applications daily. See insert for complete information.
WARNING: Keep out of reach of children.
See crimp for Lot No. and Exp. Date
CONTAINS: 500 units of Bacitracin per gram, White Petrolatum, Mineral Oil.
NET WT 3.5 g (1/8 Oz)
KEEP TIGHTLY CLOSED STORE AT ROOM TEMPERATURE {{#ask: Label Page::Bacitracin (opthalmic) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Bacitracin (opthalmic) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Bacitracin (opthalmic) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- Ocu-Tracin
Look-Alike Drug Names
There is limited information regarding Bacitracin (opthalmic) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.