Chloroptic® (chloramphenicol ophthalmic ointment, USP) is a sterile topical anti-infective product for ophthalmic use.

Contains:

Active: chloramphenicol 1% (10 mg/g)

Preservative chlorobutanol (chloral deriv.) 0.5% (5 mg/g)

Inactives: white petrolatum; mineral oil; polyoxyl 40 stearate; polyethylene glycol 300 and petrolatum (and) lanolin alcohol.

Clinical Pharmacology:   Chloramphenicol is a broad-spectrum antibiotic originally isolated from Streptomyces venezuelae . 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. It has been noted that chloramphenicol is found in measurable amounts in the aqueous humor following topical application to the eye. Development of resistance to chloramphenicol can be regarded as minimal for staphylococci and many other species of bacteria.

and Usage:   Chloramphenicol should be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated (See Boxed Warning ). Bacteriological studies should be performed to determine the causative organisms and their sensitivity to chloramphenicol.

Chloroptic® ointment is indicated for the treatment of surface ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms.

Chloramphenicol is active against the following common bacterial eye pathogens:

Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species Moraxella lacunata (Morax-Axenfeld bacillus), and Neisseria species. This product does not provide adequate coverage against: Pseudomonas aeruginosa or Serratia marcescens .

Contraindications:   This product is contraindicated in persons sensitive to any of the components.

:

  SEE BOXED WARNING

Precautions:    General:   The prolonged use of antibiotics may occasionally result in overgrowth of nonsusceptible organisms, including fungi. If new infections appear while using this medication or clinical improvement is not observed within 1 week, the drug should be discontinued and appropriate measures should be taken.

In all serious infections the topical use of chloramphenicol should be supplemented by appropriate systemic medication.

Ophthalmic ointments may retard corneal wound healing.

Information for Patients:   Do not touch tube tip to any surface as this may contaminate the ointment.

Carcinogenesis, Mutagenesis and Impairment of Fertility:   No long-term studies have been conducted in animals or in humans to evaluate the carcinogenic potential or effects on fertility with chloramphenicol. However, there is some clinical evidence that aplastic anemia due to chloramphenicol may be associated with subsequent development of leukemia.

Pregnancy: Pregnancy Category C:   Chloramphenicol has been shown to be embryocidal and teratogenic in rat, mouse, rabbit and chicken embryos/fetuses (See below). There are no adequate and well-controlled studies in pregnant women. Chloramphenicol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Embryotoxic Effects:   Significantly lower numbers of live fetuses and an increase in the number of early embryonic resorptions occurred after pregnant rats were treated orally with 500 mg/kg (equivalent to 7500 times the recommended maximum daily adult topical ophthalmic dose of 1% ophthalmic ointment) from days 5 to 15 of their pregnancy. Similar findings were seen with groups receiving higher oral doses (1000 mg/kg or 2000 mg/kg) at various dosing intervals. Female mice receiving 1000 mg/kg orally from days 6 to 12 of their pregnancy showed a significant increase in the number of resorptions. Female rabbits receiving the same oral dosing (1000 mg/kg) from days 8 to 11 had an increase in the number of resorptions of embryos without placentation. Chloramphenicol (2.5 mg) injected into chicken eggs resulted in a 20% embryo mortality rate one day after administration, which increased to 100% embryo mortality on the 11th day of incubation.

Teratogenicity:   When given to female rats orally at 2000 mg/kg from days 6 to 8 of pregnancy, 36% of the fetuses exhibited either an omphalocele or an umbilical hernia, with costal fusions. Fetuses of the rats treated with 1000 mg/kg orally from days 7 to 12 of pregnancy or 2000 mg/kg from days 11 to 13, and of mice treated with 1000 mg/kg from days 6 to 12, had a higher incidence of missing ossification of the phalangeal nuclei of the forelegs and hindlegs and of the 5th sternebra. This correlated with a decrease in the average weight of the fetuses. Rabbit fetuses displayed more frequent absence of the phalangeal nuclei of the forelegs than control when pregnant rabbits received 500 mg/kg orally on days 6 to 15 of pregnancy. More frequent missing ossification of the phalangeal nulcei of the forelegs and hindlegs and an increase in the number of unevenly ossified vertebrae was seen in the fetuses of rabbits when pregnant females were given 1000 mg/kg from days 6 to 9 of pregnancy. Teratogenic effects of chloramphenicol (0.5 mg) when injected into chicken eggs , included malformations of the beak, eyes and legs.

Nursing Mothers:   Because of the potential for serious, adverse reactions in nursing infants from chloramphenicol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:   Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions:   Blood dyscrasias have been reported in association with the use of chloramphenicol (See ).

Allergic or inflammatory reactions due to individual hypersensitivity and occasional burning or stinging may occur with the use of Chloroptic Ophthalmic Ointment.

Dosage and Administration:   A small amount (approximately 1/2 inch) of ointment should be placed in the lower conjunctival sac every three hours. Administration should be continued day and night for the first 48 hours, after which the interval between applications may be increased. Treatment should be continued for approximately 7 days. Treatment should be continued for at least 48 hours after the eye appears normal. Treatment should not be continued for more than three weeks without re-evaluation by the prescribing physician.

How Supplied:   Chloroptic® (chloramphenicol ophthalmic ointment, USP) 1% is supplied sterile in ophthalmic ointment tubes in the following size:

3.5 g--NDC 0023-0301-04

Note: Store between 15°-25°C (59°-77°F).

Rx only.