Chloramphenicol (ophthalmic)

Chloramphenicol (ophthalmic)
Black Box Warning
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: Kiran Singh, M.D. [2]

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Black Box Warning

{{{blackBoxWarningTitle}}} See full prescribing information for complete Boxed Warning. * Bone marrow hypoplasia, including aplastic anemia and death has been reported following local application of chloramphenicol. Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.

Overview

Chloramphenicol (ophthalmic) is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Chloramphenicol should be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated. Bacteriological studies should be performed to determine the causative organisms and their sensitivity to chloramphenicol (See Box Warning). For treatment of ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms.

Chloramphenicol has a wide spectrum of antimicrobial activity and is effective against many gram negative and gram positive bacteria, including the following common eye pathogens:

Staphylococcus aureus

Streptococci, including Streptococcus pneumoniae

Escherichia coli

Haemophilus influenzae

Klebsiella/Enterobacter species

Neisseria species

Moraxella lacunata (Morax-Axenfeld bacillus)

The product does not provide adequate coverage against:

Pseudomonas aeruginosa

Serratia marcescens

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Chloramphenicol (ophthalmic) in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Chloramphenicol (ophthalmic) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Chloramphenicol (ophthalmic) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Chloramphenicol (ophthalmic) in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Chloramphenicol (ophthalmic) in pediatric patients.

Contraindications

• Condition1

Warnings

{{{blackBoxWarningTitle}}} See full prescribing information for complete Boxed Warning. * Bone marrow hypoplasia, including aplastic anemia and death has been reported following local application of chloramphenicol. Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Chloramphenicol (ophthalmic) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Chloramphenicol (ophthalmic) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Chloramphenicol (ophthalmic) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Chloramphenicol (ophthalmic) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Chloramphenicol (ophthalmic) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Chloramphenicol (ophthalmic) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Chloramphenicol (ophthalmic) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Chloramphenicol (ophthalmic) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Chloramphenicol (ophthalmic) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Chloramphenicol (ophthalmic) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Chloramphenicol (ophthalmic) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Chloramphenicol (ophthalmic) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Chloramphenicol (ophthalmic) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Chloramphenicol (ophthalmic) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Chloramphenicol (ophthalmic) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Chloramphenicol (ophthalmic) in the drug label.

Pharmacology

There is limited information regarding Chloramphenicol (ophthalmic) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Chloramphenicol (ophthalmic)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Chloramphenicol (ophthalmic) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Chloramphenicol (ophthalmic) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Chloramphenicol (ophthalmic) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Chloramphenicol (ophthalmic) in the drug label.

How Supplied

Storage

There is limited information regarding Chloramphenicol (ophthalmic) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Chloramphenicol (ophthalmic) in the drug label.

Precautions with Alcohol

• Alcohol-Chloramphenicol (ophthalmic) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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