Bacitracin (opthalmic)

Bacitracin (opthalmic)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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 {{{aOrAn}}} {{{drugClass}}} 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 {{{adverseReactions}}}.

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

There is limited information regarding Bacitracin (opthalmic) Clinical Trials Experience in the drug label.

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

There is limited information regarding Bacitracin (opthalmic) Brand Names in the drug label.

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.