CHLORAMPHENICOL 1% ophthalmic ointment

CHLORAMPHENICOL 1% ophthalmic ointment contains in each tube:

CHLORAMPHENICOL USP………………………………………….50 mg

PHARMACEUTICAL FORM: Eye ointment

INDICATION: Chloramphenicol is a broad-spectrum antibiotic applied topically for a variety of superficial bacterial infections of the cornea, conjunctiva and eyelids.

DOSAGE AND ADMINISTRATION

Topical administration to the eye only.
Adults, children aged 2 years and over and elderly.

The recommended dose is a small amount of ointment (- lcm) to be applied to the affected eye(s). The ointment should be applied either at night if eye drops are used during the day, or 3 to 4 times a day if the eye will advise on the most suitable treatment. Treatment should continue for 5 days even if symptoms improve. Hold the tube in hand for several minutes to warm it up before use. Lie down or tilt your head backward and look at the ceiling. Squeeze a small amount of ointment (about1 cm) inside the lower lid. Do not touch the tip of the tube or cap to the eye, fingers or any surface. Close the eye gently and roll the eyeball in all directions while the eye is closed. Temporary blurring may occur.

CONTRAINDICATIONS

Chloramphenicol eye drops are contraindicated in patients with a history of hypersensitivity or toxicity to chloramphenicol or any other component of the preparation. Chloramphenicol should not be used in patients who have experienced myelosuppression during previous exposure to chloramphenicol and in patients with family history of blood dyscrasias.

PRECAUTIONS AND WARNINGS

Bone marrow hypoplasia, including aplastic anemia and death, has be rarely reported following local application of chloramphenicol, Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment, Ophthalmic agents may retard coal wound healing.
The use of this antibiotic, as with other antibiotics, may result in the overgrowth of non-susceptible organisms including fungi. If infection caused by non-susceptible organisms appear during therapy, its use 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. The mechanism for the irreversible aplastic anemia following ophthalmic use of chloramphenicol has not been established.

 DRUG INTERACTIONS 

The concomitant administration of chloramphenicol with other drugs liable to depress bone mamos function should be avoided.

USE DURING PREGNANCY AND LACTATION

There are no adequate and well-controlled studies in pregnant women. Chloramphenicol has been shown to cross the placental barrier, but it is not known whether chloramphenicol can cause fetal harm when administered to a pregnant woman. Chloramphenicol should be med during pregnancy only if the potential benefit justifies the potential risk to the fetus. In view of the fact that chloramphenicol may appear in breast milk, use of the product during lactation should be avoided.

EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINE

Chloramphenicol may cause transient blurring of vision; Patients should be warned not to drive or operate hazardous machinery unless vision is clear.

ADVERSE EFFECTS

Transient burning or stinging sensations may occur with the use of chloramphenicol eye ointment. Serious side effects include hypersensitivity reactions that may manifest as angioneurotic oedema, anaphylaxis, urticaria, fever, and vesicular and maculopapular dermatitis. Treatment must be discontinued immediately in such cases. Bone marrow depression, including the idiosyncratic type of irreversible and fatal aplastic anemia that is recognized to occur with systemic therapy has been reported in association with topical administration of chloramphenicol.

SYMPTOMS AND TREATMENT OF OVERDOSAGE 

In view of the relatively small amount of chloramphenicol in Chloramphenicol eye ointment, overdosage with this product is unlikely to constitute hazard. If irritation, pain, selling, lacrimation or photophobia occur after undesigned eye contact, the exposed eye(s) should be irrigated for at least 15 minutes. If symptoms persist after this, an ophthalmological examination should be considered.

PHARMACOLOGY AND PHARMACOKINETICS 

Chloramphenicol is a broad-spectrum antibiotic with bacteriostatic activity and is effective against a wide range of gram-negative and gram-positive organisms. Chloramphenicol exerts its antibacterial effect by binding bacterial ribosomes and inhibiting bacterial protein synthesis at an early stage. Chloramphenicol enters the aqueous humor following topical application. Chloramphenicol is widely distributed in body tissues and fluids: it enters the CSF, giving concentrations of about 50% of those existing in the blood even in the absence of inflamed meninges; it diffuses across the placenta into the fetal circulation, into breast milk, and into the aqueous and vitreous humor of the eye. Up to about 60% of the circulation is bound to plasma protein. The half-life of chloramphenicol has been reported to range from 1.5 to 4 hours, the half-life is prolonged in patients with severe hepatic impairment and is also much longer in neonates. Renal impairment has relatively link effect on the half-life of the active drug. due to its extensive metabolism but may lead to accumulation of inactive metabolites. Chloramphenicol is excreted mainly in urine. The absorption, metabolism, and excretion of chloramphenicol are subject to considerable interindividual variation, especially in infants and children, making monitoring of plasma concentrations necessary to determine pharmacokinetic in a given patient.

Susceptibility

The following bacterial species are recognized as conjunctival pathogens and may be susceptible to chloramphenicol. However due to the prevalence of acquired resistance to chloramphenicol in these species, the results of susceptibility testing should be taken into account if these are available. If no susceptibility test result is available, the choice of antibacterial agent should be influenced by local information on the likely prevalence of resistance to chloramphenicol in species that are commonly pathogenic in the eye Staphylococcus aureus, Streptococcus pneumonia, other bete-haemolytic streptococci, Hemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae.

Resistance

Acquired resistance to chloramphenicol has been described in all the above species. Most commonly this is mediated by bacterial production of a chloramphenicol acetyl transferase that inactivates the drug Chloramphenicol is not generally active against the enteric and is not active against non-fermenters such as Pseudomonas aeruginosa.
Following topical application to the eye, chloramphenicol may be absorbed into the aqueous humor, Sufficient chloramphenicol may be absorbed from the eye to appear in the systemic circulation.

Specific data on systemic absorption from this dosage presentation is not available.

STORAGE

Store protected from moisture, freezing and excessive heat at a temperature not exceeding 25°C. Once opened, the ointment should be unlined within 10 days, discard the remaining ointment thereafter. KEEP MEDICINES OUT OF REACH OF CHILDREN'

PRESENTATION

Dosage form: Ophthalmic ointment: 10mg/g ointment-Boxes of 50 tubes.

TROGE MEDICAL GMBH

Milch Strasse 19.20148 Hamburg, Germany. Tel: +49 40-44 18 44 0