Pentamycetin Liq 2.5mg/mL Product Monograph

INDICATIONS AND CLINICAL USE

PENTAMYCETIN, Ophthalmic Solution and Ointment

Treatment of superficial ocular infections involving the conjunctiva and/or the cornea, caused by microorganisms shown by bacteriological studies to be susceptible to chloramphenicol.

PENTAMYCETIN/HC, Eye and Ear Suspension and Ointment

For topical use in superficial ocular and auditory infections, such as non-purulent conjunctivitis and otitis externa, caused by microorganisms shown by bacteriological studies to be susceptible to chloramphenicol. Hydrocortisone acetate has anti-inflammatory effects.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of PENTAMYCETIN & PENTAMYCETIN/HC and other antibacterial drugs, PENTAMYCETIN & PENTAMYCETIN/HC should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

WARNINGS

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 agent would be expected to

provide effective treatment.

Susceptibility/Resistance

Development of Drug Resistant Bacteria

Prescribing PENTAMYCETIN or PENTAMYCETIN/HC in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of resistant organisms.

Potential for Microbial Overgrowth

The prolonged use of chloramphenicol may occasionally result in overgrowth of non-susceptible microorganisms including fungi. If new infection occur, discontinue use and institute alternative therapy.

CONTRAINDICATIONS

Sensitivity to chloramphenicol with signs of local irritation, symptoms of burning, angioneurotic edema, itching, urticaria, vesicular and maculopapular dermatitis. If these signs appear, withdraw the medication and consult your physician.

Hypersensitivity to any components of the medication.

PENTAMYCETIN/HC Suspension and Ointment are especially contraindicated in epithelial herpes simplex, keratitis, vaccina, varicella, viral diseases of the cornea and conjunctiva, tuberculosis of the eye; fungal diseases of the eye, acute purulent untreated infections of the eye, which, like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid.

PRECAUTIONS AND ADVERSE REACTIONS

It should be borne in mind that a patient may become sensitized to chloramphenicol when it is applied topically. Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases causing thinning of the cornea or sclera, perforation has been known to occur. It is recommended that intraocular pressure be checked frequently.

Safety of the use of corticosteroids during pregnancy has not been substantiated.

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

DOSAGE AND ADMINISTRATION

PENTAMYCETIN, Ophthalmic Solutions

2 drops of the ophthalmic solution to the affected eye(s) every 3 hours or more often if necessary.

PENTAMYCETIN Ophthalmic Ointment

A small amount of ointment to the affected eye(s) every 3 hours or more often if necessary.

PENTAMYCETIN/HC, Eye and Ear Suspension

2 drops to the affected eye(s) or into the affected ear(s) every 3 hours or more often if necessary.

PENTAMYCETIN/HC, Eye and Ear Ointment

A small amount of ointment to the affected eye(s) or into the affected ear(s) every 3 hours or more often if necessary.

Decrease the frequency after 48 hours; the treatment should be continued at least 48 hours after the affected eyes (the affected ears) return to normal.

OVERDOSAGE

DOSAGE FORMS, COMPOSITION AND PACKAGING; STORAGE AND STABILITY

PENTAMYCETIN (Chloramphenicol Ophthalmic Solution USP 0.25%) 10 mL Each milliliter contains 2.5 mg (0.25%) of chloramphenicol and 0.5% chlorobutanol as preservative in a sterile buffered solution. Available in bottle with dropper. Refrigerate (2-8ºC) until dispensing. Protect from freezing. After dispensing, the solution may be stored at room temperature for 21 days; after that period, discard unused portion. Avoid contamination of the tip of the dropper. Do not use if the dropper-tip cap is detached from the security ring.

PENTAMYCETIN (Chloramphenicol Ophthalmic Solution USP 0.5%) 10 mL Each milliliter contains 5 mg (0.5%) of chloramphenicol and 0.5% chlorobutanol as preservative in a sterile buffered solution. Available in bottle with dropper. Refrigerate (2-8ºC) until dispensing. Protect from freezing. After dispensing, the solution may be stored at room temperature for 21 days; after that period, discard unused portion. Avoid contamination of the tip of the dropper. Do not use if the dropper-tip cap is detached from the security ring.

PENTAMYCETIN (Chloramphenicol Ophthalmic Ointment USP 1%) 3.5 g Each gram contains 10 mg (1%) of chloramphenicol in a sterile petrolatum base. Available in collapsible tube. Avoid contamination of the tip of the tube. Store between 15 and 30ºC. Protect from freezing.

PENTAMYCETIN/HC (Chloramphenicol 0.2% and Hydrocortisone Acetate 1% Eye and Ear Suspension) 5 mL

Each milliliter contains 2 mg (0.2%) of chloramphenicol, 10 mg (1.0%) hydrocortisone acetate in a sterile buffered vehicle. Shake well before each use. Available in bottle with dropper. Refrigerate (2-8ºC) until dispensing. Protect from freezing. After dispensing, the solution may be stored at room temperature for 21 days; after that period, discard unused portion. Avoid contamination of the tip of the dropper. Do not use if the dropper-tip cap is detached from the security ring.

PENTAMYCETIN/HC (Chloramphenicol 1% and Hydrocortisone Acetate 1% Eye and Ear Ointment) 3.5 g

Each gram contains 10 mg (1%) of chloramphenicol and 10 mg (1%) hydrocortisone acetate in a sterile petrolatum base. Available in collapsible tube. Avoid contamination of the tip of the tube. Store between 15 and 30ºC. Protect from freezing.