ARISTOPHEN

Sterile Eye Drops

Composition:

Each ml contains Chloramphenicol BP 5 mg.

Preservative: Phenylmercuric Acetate 0.002%

Vehicle: Hydroxypropyl Methylcellulose 0.5%

Inactives and purified water

Properties and actions:

Chloramphenicol is a low molecular weight, predominantly lipophilic antibiotic and is effective against Gram-positive and Gram-negative bacteria, and also against spirochaete, salmonella, rickettsiae and chlamydiae (trachoma). The mechanism of action has been shown to be by selective inhibition of bacterial protein synthesis. Chloramphenicol is moderately effective against Proteus (20-50% resistance), Serratia (30-70%), Klebsiella (60-70%), Enterobacter (20-50%), E. Coli (20%), Staph. aureus (20-30%), Enterococci (30-35%), Streptococci (2%), Salmonellae (4-9%), Haemophilus influenzae (0-1%) and Diplococci (0-1%). Chloramphenicol is ineffective against Pseudomonas, Mycobacterium, fungi and Protozoa. Known resistance to this antibiotic has not changed significantly in recent years.

Pharmacokinetics:

Chloramphenicol penetrates the cornea thoroughly and therapeutically effective concentration are detectable in the aqueous humour only 15 to 30 minutes after local administration. The half-life is 3-5 hours. In the inflamed eye, the retention time is expected to be shorter. At present there are no data available on the extent of systemic absorption of Chloramphenicol following topical administration to the eye. Upto 50% of the sero-concentration have been detected in breast milk.

Indications:

Bacterial infections of the anterior segment of the eye (cornea, conjunctiva, uvea anterior), lids and tear ducts. Infection prophylaxis pre-and post operatively, after chemical or other burns. Trachoma, herpes zoster ophthalmicus. For prophylactic and therapeutic irrigation of the tear ducts. Chloramphenicol is indicated if the infective agent is resistant to other antibiotics.

Dosage & Administration:

Insert one drop into the conjunctival sac 2-4 times per day. In acute cases up to 1 drop every hour. In order to keep the systemic resorption as low as possible, the tear flow should be blocked by pressing with the  finger on the side of the nose, near to the corner of the eye, for 1-2 minutes after instillation.

Restriction in use:

Contraindications:

• Hypersensitivity to the ingredients
• Acute intermittent porphyria
• Severe blood disorders and hepatic dysfunctions due to bone marrow depression
• New-born babies
• Family history of bone marrow depression.

Precautions:

Chloramphenicol should not be used for more than 10 days. If no improvement is seen after 7-8 days of treatment, other therapeutic measures should be considered. Chloramphenicol therapy is associated with a potential risk of aplastic anaemia or other hematodyscrasias. A careful risk/benefit evaluation should therefore be made in each individual case. The product should only be used where alternative therapies are ineffective and/or contraindicated.

Pregnancy and lactation:

Animal experiments with Chloramphenicol have shown adverse effects on the foetus. However, no controlled human studies are available. Aristophen should not be given to pregnant patients or to newborn babies, nor to nursing mothers  (Pregnancy category: C.)

Adverse Reactions:

Shortly after application a slight burning sensation and a bitter taste in the mouth may occur. Allergic reactions in the form of palpebral eczema have been reported in rare cases. Partially irreversible hematodyscrasia (aplastic anemia, pancytopenia, leukopenia, thrombocytopenia, agranulocytosis) has been observed in isolated cases following topical use of Chloramphenicol. However, the severity and the moment of manifestation of such partially irreversible and lethal effects did not correlate with the commonly elevated dosage used in these studies.

Neuritis nervi after topical use of Chloramphenicol has been reported in isolated cases which recovered after discontinuation of the treatment.

Interactions:

Chloramphenicol should not be administered simultaneously with bactericidal substances (penicillins, cephalosporins, gentamicin, tetracyclines, polymyxin B, or vancomycin) since bacteriostatic antibiotics may inhibit bactericidal antibiotics. Furthermore Chloramphenicol should not be administered at the same time as systemic treatment with drugs which have an adverse effect on hematopoiesis, nor simultaneously with sulphonylureas, coumarin derivatives, hydantoins and methotrexate (precautionary measured).

Overdose:

Overdoses through local administration is not known. In case of accidental oral intake, specific measures to reduce resorption should be taken. There is no specific antidote.

Incompatibilities:

Chloramphenicol is incompatible with carbenicillin, vitamin B- complex, and vitamin C.

Additional Information:

• Store below 30° C and protected from light.

• Close the bottle immediately after use.

• Do not use for longer than one month after opening the bottle.

• If the pack is unopened, Aristophen can be used up to the expiry date indicated with “EXP” on the pack.

Packing:

Aristophen Sterile Eye Drops is supplied in 10 ml plastic dropper bottle.