ARISTOPHEN
Sterile
Eye Ointment
Composition:
Each gm of Sterile Eye Ointment contains: Chloramphenicol BP
10 mg.
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 throughly, and therapeutically
effective concentrations 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, conjunctive, 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:
It should be applied thinly and evenly to the conjunctival
sac(s) at night (if eye drops used during the day) or 3-4
times daily (if eye ointment used alone).
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 new-born 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).
Incompatibilities:
Chloramphenicol is incompitible with
carbenicillin, vitaminB-complex, and vitamin C.
Pharmaceutical Precautions:
