Chloramphenicol (Ophthalmic)


VA CLASSIFICATION
Primary: OP201

Commonly used brand name(s): Ak-Chlor Ophthalmic Ointment; Ak-Chlor Ophthalmic Solution; Chloracol Ophthalmic Solution; Chlorofair Ophthalmic Ointment; Chlorofair Ophthalmic Solution; Chloromycetin Ophthalmic Ointment; Chloromycetin for Ophthalmic Solution; Chloroptic Ophthalmic Solution; Chloroptic S.O.P.; Econochlor Ophthalmic Ointment; Econochlor Ophthalmic Solution; Fenicol Ophthalmic Ointment; I-Chlor Ophthalmic Solution; Ocu-Chlor Ophthalmic Ointment; Ocu-Chlor Ophthalmic Solution; Ophtho-Chloram Ophthalmic Solution; Ophthochlor Ophthalmic Solution; Pentamycetin Ophthalmic Ointment; Pentamycetin Ophthalmic Solution; Sopamycetin Ophthalmic Ointment; Sopamycetin Ophthalmic Solution; Spectro-Chlor Ophthalmic Ointment; Spectro-Chlor Ophthalmic Solution.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antibacterial (ophthalmic)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Ocular infections (treatment)—Chloramphenicol is indicated in the topical treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by susceptible organisms, including Escherichia coli ; Haemophilus influenzae ; Klebsiella species; Enterobacter (Aerobacter) species; Neisseria species; Staphylococcus aureus ; streptococci, including Streptococcus hemolyticus and S. pneumoniae (Diplococcus pneumoniae) ; and Moraxella lacunata (Morax-Axenfeld bacillus). Chloramphenicol may also be effective against rickettsiae and the mycoplasma (PPLO) group of organisms. In serious ocular infections, topical chloramphenicol should be given concurrently with appropriate systemic antibacterials. {04}

[Blepharitis, bacterial (treatment)]
[Blepharoconjunctivitis (treatment)]
[Conjunctivitis, bacterial (treatment)]or
[Keratitis, bacterial (treatment)]—Chloramphenicol is used in the topical treatment of bacterial blepharitis, blepharoconjunctivitis, bacterial conjunctivitis, and bacterial keratitis.

[Keratitis, exposure (treatment)] or
[Keratitis, neuroparalytic (treatment)]—Chloramphenicol is used in the topical treatment of exposure keratitis and neuroparalytic keratitis when a secondary bacterial infection is present.

[Keratoconjunctivitis, bacterial (treatment)]—Chloramphenicol is used in the topical treatment of bacterial keratoconjunctivitis. {01}

Note: Not all species or strains of a particular organism may be susceptible to chloramphenicol.
Although rare, bone marrow aplasia, resulting in aplastic anemia and death, {03} has been reported with {03} the use of chloramphenicol ophthalmic preparations. Because of reported systemic toxicity, some USP medical experts recommend that ophthalmic chloramphenicol be reserved for serious ocular infections in which the etiologic organisms are resistant to all other ophthalmic antibiotics or for infections in which less toxic antibiotics are ineffective. However, other USP experts still consider ophthalmic chloramphenicol valuable because of its lipid solubility and excellent corneal penetration, as well as its low ocular toxicity when compared with other antibacterials commonly used in the eye (e.g., neomycin).


Unaccepted
Chloramphenicol is not effective against Pseudomonas aeruginosa or Serratia marcescens .


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    323.13

Mechanism of action/Effect:

Bacteriostatic; since chloramphenicol is lipid-soluble, it diffuses through the bacterial cell membrane and reversibly binds to the 50 S subunit of bacterial ribosomes where transfer of amino acids to growing peptide chains is prevented (perhaps by suppression of peptidyl transferase activity), thus inhibiting peptide bond formation and subsequent protein synthesis.

The mechanism for the irreversible aplastic anemia following ophthalmic use of chloramphenicol has not been established.

Absorption:

Intraocular and some systemic absorption occurs following topical application to the eye.

Distribution:

Aqueous humor—Measurable concentrations following topical application to the eye.


Precautions to Consider

Pregnancy/Reproduction

Problems in humans have not been documented.

Breast-feeding

Problems in humans have not been documented.

Pediatrics

Appropriate studies on the relationship of age to the effects of this medicine have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date.


Geriatrics


Appropriate studies on the relationship of age to the effects of this medicine have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problem exists:
» Previous allergy or toxic reaction to chloramphenicol{07}{08}{09}

Side/Adverse Effects

Note: Bone marrow hypoplasia, including aplastic anemia and death, has been reported following local application of chloramphenicol. {07} {08} {09}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent
    
Hypersensitivity{10} (burning, itching, redness, skin rash, swelling, or other sign of irritation not present before therapy)

Incidence rare {03}
    
Blood dyscrasias{09}{10} (pale skin, sore throat and fever, unusual bleeding or bruising, unusual tiredness or weakness)



Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
    
Blurred vision —for the ointment dosage form
    
burning or stinging{09}{10}



Those indicating possible irreversible bone marrow depression, possibly leading to aplastic anemia, and the need for immediate medical attention if they occur after medication is discontinued {07} {09} {10}
    
Pale skin
    
sore throat and fever
    
unusual bleeding or bruising
    
unusual tiredness or weakness




Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Chloramphenicol (Ophthalmic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Allergy to chloramphenicol

Proper use of this medication
Proper administration technique for ophthalmic solution and ointment

» Compliance with full course of therapy

» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose

» Proper storage

Precautions while using this medication
Checking with physician if no improvement within a few days


Side/adverse effects
Blurred vision may occur for a few minutes after application of ophthalmic ointments

Signs of potential side effects, especially blood dyscrasias and hypersensitivity reactions


General Dosing Information
At night the ophthalmic ointment may be used as an adjunct to the ophthalmic solution to provide prolonged contact with the medication.

Although some manufacturers recommend a dose of 2 drops of an ophthalmic solution at appropriate intervals, the conjunctival sac will usually hold only 1 drop.


Ophthalmic Dosage Forms

CHLORAMPHENICOL OPHTHALMIC OINTMENT USP

Usual adult and adolescent dose
Antibacterial (ophthalmic)
Topical, to the conjunctiva, a thin strip (approximately 1 cm) of ointment every three hours or more frequently. {10}


Usual pediatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


1% (Rx) [Ak-Chlor Ophthalmic Ointment] [Chlorofair Ophthalmic Ointment] [Chloromycetin Ophthalmic Ointment] [Chloroptic S.O.P. (chlorobutanol 0.5%)] [Econochlor Ophthalmic Ointment] [Ocu-Chlor Ophthalmic Ointment] [Spectro-Chlor Ophthalmic Ointment][Generic]

Canada—


1% (Rx) [Chloromycetin Ophthalmic Ointment] [Chloroptic S.O.P.] [Fenicol Ophthalmic Ointment] [Pentamycetin Ophthalmic Ointment] [Sopamycetin Ophthalmic Ointment]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For the eye.
   • Continue medicine for full time of treatment.


CHLORAMPHENICOL OPHTHALMIC SOLUTION USP

Usual adult and adolescent dose
Antibacterial (ophthalmic)
Topical, to the conjunctiva, 1 drop every one to four hours.


Usual pediatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


0.5% (Rx) [Ak-Chlor Ophthalmic Solution (chlorobutanol 0.5%)] [Chloracol Ophthalmic Solution (chlorobutanol)] [Chlorofair Ophthalmic Solution (may contain chlorobutanol 0.5%)] [Chloroptic Ophthalmic Solution (chlorobutanol 0.5%)] [Econochlor Ophthalmic Solution] [I-Chlor Ophthalmic Solution] [Ocu-Chlor Ophthalmic Solution] [Ophthochlor Ophthalmic Solution] [Spectro-Chlor Ophthalmic Solution][Generic]

Canada—


0.25% (Rx) [Pentamycetin Ophthalmic Solution (parabens)] [Sopamycetin Ophthalmic Solution (parabens 0.08%)]


0.5% (Rx) [Ak-Chlor Ophthalmic Solution (chlorobutanol)] [Chloroptic Ophthalmic Solution (phenylmercuric nitrate 0.004%)] [Ophtho-Chloram Ophthalmic Solution{13}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Note: Some manufacturers recommend storing between 2 and 8 °C (36 and 46 °F) until the medication is dispensed.


Stability:
Some manufacturers recommend that the solution be discarded 20 or 21 days after date dispensed.

Auxiliary labeling:
   • For the eye.
   • Continue medicine for full time of treatment.
   • Beyond-use date.

Note: Dispense in original unopened container. Some manufacturers also recommend dispensing in original carton to protect the ophthalmic solution from light.



CHLORAMPHENICOL FOR OPHTHALMIC SOLUTION USP

Usual adult and adolescent dose
Antibacterial (ophthalmic)
Topical, to the conjunctiva, 1 drop every three hours or more frequently. {09}


Usual pediatric dose
See Usual adult and adolescent dose.

Size(s) usually available:
U.S.—


25 mg with 15 mL of sterile distilled water (by varying the quantity of diluent, solutions ranging in strength from 0.16 to 0.5% may be prepared) (Rx) [Chloromycetin for Ophthalmic Solution{09}]

Canada—


25 mg with 15 mL of sterile distilled water (by varying the quantity of diluent, solutions ranging in strength from 0.16 to 0.5% may be prepared) (Rx) [Chloromycetin for Ophthalmic Solution]

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect diluent from freezing.

Preparation of dosage form:
To prepare a 0.5, 0.25, or 0.16% solution, add 5, 10, or 15 mL, respectively, of sterile distilled water to the 25-mg bottle.

Stability:
After reconstitution, solutions retain their potency for 10 days if stored at room temperature.

Auxiliary labeling:
   • For the eye.
   • Continue medicine for full time of treatment.
   • Beyond-use date.



Revised: 09/30/1993



References
  1. Indications Index review, 1986.
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  1. Panel comments, Chloramphenicol (Ophthalmic), 8/30/85.
  1. Chloromycetin for Ophthalmic Solution pkg insert, PD (U.S.), PDR 1988, pp 1531-32.
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  1. USP DI 1990, Chloramphenicol (Systemic) monograph, pp 889-892.
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  1. PDR-90, Chloromycetin for Ophthalmic Solution, PD, p 1585.
  1. PDR-90, Chloromycetin Ophthalmic Ointment, PD, p 1586.
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  1. PI (Canada) Ophtho-Chloram solution, Kenral: Issued 7/86, received 3/90.
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