Chloramphenicol (ophthalmic): Difference between revisions

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

VisualWikitext

Revision as of 12:19, 11 May 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Black Box Warning

Warning

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

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

Non–Guideline-Supported Use

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)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Warnings

Warning

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

{{#ask: Page Name::Chloramphenicol (ophthalmic) |?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

{{#ask: Label Page::Chloramphenicol (ophthalmic) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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

®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

Price

References

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

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[1] Empty citation (help)

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[1]

[2]

@@ Line 5: / Line 5: @@
 |hasBlackBoxWarning=Yes
 |adverseReactions=<!--Black Box Warning-->
+|blackBoxWarningTitle=Warning
 |blackBoxWarningBody=* 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.
 |fdaLIADAdult===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 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
+* 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:
-Streptococci, including Streptococcus pneumoniae
+:*Staphylococcus aureus
-Escherichia coli
+:*Streptococci, including Streptococcus pneumoniae
-Haemophilus influenzae
+:*Escherichia coli
-Klebsiella/Enterobacter species
+:*Haemophilus influenzae
-Neisseria species
+:*Klebsiella/Enterobacter species
-Moraxella lacunata (Morax-Axenfeld bacillus)
+:*Neisseria species
-The product does not provide adequate coverage against:
+:*Moraxella lacunata (Morax-Axenfeld bacillus)
-Pseudomonas aeruginosa
+* The product does not provide adequate coverage against:
-Serratia marcescens
+:*Pseudomonas aeruginosa
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