Chloramphenicol (ophthalmic)

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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

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 an antibiotic that is FDA approved for the treatment of ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include optic atrophy and blood dyscrasias.

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. 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:
  • Moraxella lacunata (Morax-Axenfeld bacillus)
  • The product does not provide adequate coverage against:

Dosage

  • Solution: In severe disease, instill two drops on the eye(s) hourly until improvement, following which treatment should be diminished prior to discontinuation. In mild disease, drops may be used four times daily. Ointment: Apply a small amount to the lower conjunctival sac(s) at bedtime as a supplement to the drops.

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

  • This product is contraindicated in those persons who have shown hypersensitivity to any of its components.

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.
  • Ophthalmic ointment may retard corneal wound healing.

Adverse Reactions

Clinical Trials Experience

  • Blood dyscrasias may be associated with the systemic use of chloramphenicol. One case of bone-marrow hypoplasia following the prolonged (23 month) topical use of chloramphenicol ophthalmic solution has been reported.

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS): 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

  • Ophthalmic

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

Template:Px
Template:Px
Chloramphenicol (ophthalmic)
Systematic (IUPAC) name
2,2-dichloro-N-[1,3-dihydroxy-1-(4-nitrophenyl)propan-2-yl]acetamide
Identifiers
CAS number 56-75-7
ATC code D06AX02 D10AF03 (WHO) G01AA05 (WHO) J01BA01 (WHO) S01AA01 (WHO) S02AA01 (WHO) S03AA08 (WHO) Template:ATCvet
PubChem 298
DrugBank DB00446
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 323.1320 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability 75–90%
Protein binding 60%
Metabolism Hepatic
Half life 1.6-3.3 hours
Excretion Renal (5-15%), faeces (4%)
Therapeutic considerations
Licence data

US

Pregnancy cat.

A(AU) C(US)

Legal status

Prescription Only (S4)(AU) ?(CA) POM(UK) [[Prescription drug|Template:Unicode-only]](US)

Routes Topical (ocular), oral, IV, IM

Mechanism of Action

It is primarily bacteriostatic and acts by inhibition of protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.

Structure

  • ECONOCHLOR® (Chloramphenicol) is a sterile topical ophthalmic antibacterial prepared in solution and ointment forms. The active ingredient is represented by the chemical structure:
This image is provided by the National Library of Medicine.
  • Established name:
  • Chloramphenicol
  • Chemical name:
  • Acetamide, 2,2-dichloro-N-[2-hydroxy-1-(hydroxymethyl)-2- (4-nitrophenyl) ethyl]-, [R-(R*,R)]-
  • Each ml of solution contains: Active: Chloramphenicol 0.5% (5mg/ml). Preservative: Thimerosal 0.01%. Vehicle: Hydroxypropyl Methylcellulose: Inactive: Boric Acid, Sodium Borate (to adjust pH), Purified Water.
  • DM-00
  • Each gram of ointment contains: Active: Chloramphenicol 1.0% (10 mg/g). Inactive: Mineral Oil, Anhydrous Liquid Lanolin, White Petrolatum.
  • DM-00

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

  • Solution in 5ml (2.5ml fill) and 15ml plastic Drop-Tainer® dispensers. Ointment in 3.5 gram ophthalmic tube. Rx only.
  • 2.5ml NDC 0065-0642-25
  • 15ml NDC 0065-0642-15
  • 3.5 g NDC 0065-0641-35

Storage

  • Solution: Refrigerate until dispensed. Ointment: Store between 46° and 80°F.

Images

Drug Images

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Drug Label Author:

This pill image is provided by the National Library of Medicine's PillBox.

Package and Label Display Panel

This image is provided by the National Library of Medicine.
This image of the FDA label is provided by the National Library of Medicine.

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

  • ECONOCHLOR ®[1]

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. "chloramphenicol ointment".
  2. "http://www.ismp.org". External link in |title= (help)