Optomycin Chloramphenicol Eye Ointment

OPTOMYCIN EYE OINTMENT
CHLORAMPHENICOL EYE OINTMENT BP 1 % w/w

 

COMPOSITION

Chloramphenicol BP 1% w/w
Sterile Ointment Base q.s

 

PHARMACOLOGY

Chloramphenicol is a potent inhibitor of bacterial protein synthesis, and exerts its effects by interfering with the transfer of activated amino acids from soluble RNA to ribosomes. Escherichia coli, Haemophilus influenzae, Staphylococcus aureus, Streptococcus haemolyticus, Morax-Axenfeld, Klebsiella/Enterobacter species and others. Entobacteriaceae are variably resistant while Pseudomonas and Mycobacteria are usually resistant.

 

INDICATIONS & USES

Chloramphenicol is a broad spectrum antibiotic applied topically for a variety of superficial bacterial infections of the cornea, conjunctivitis and eye-lids.

 

DOSAGE AND ADMINISTRATION

Children over 2 months of age and adults: Instill a small quantity of the ointment every 6 hours into the lower conjunctival sac. Both eyes should always be treated. Treatment should continue during the night. Do not stop treatment until well after clinical use.

Hold the tube in hand for several minutes to warm before use. Lie down or tilt the head backward and look at the ceiling. Squeeze a small amount ointment (about 1 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

Neonates and babies weighing less than 5 kg should not be treated with Optomycin Eye Ointment unless absolutely no therapeutic alternative is available.

 

WARNINGS & PRECAUTIONS

FOR OPHTHALMIC & EXTERNAL USE ONLY.
Chloramphenicol is absorbed systemically from the eye and toxicity has been reported following chronic exposure. Bone marrow hypoplasias, including aplastic anemia and death, have been reported following topical use of chloramphenicol. Whilst the hazard is a rare one, it should be borne in mind when assessing the benefits expected from the use of the compound.

Where Optomycin Eye Ointment is used on a long – term or intermittent basis, it may be advisabIe to perform a routine blood profile before therapy and at appropriate intervals thereafter to detect any haemopoietic abnormalities.

In severe infections the topical use of chloramphenicol should be supplemented by appropriate systemic treatment. The prolonged use of antibiotics may occasionally result in overgrowth of non-susceptible organisms, including fungi, If any new infection appears during the treatment, the antibiotic should be discontinued and appropriate measures taken. Chloramphenicol should be reserved for use only for infections for which it is specifically indicated.

Chloramphenicol does not provide-adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.

It is recommended that all types of contact lenses be avoided during ocular infections. Optomycin Eye Ointment may smear over the surface of contact lenses.

 

SIDE EFFECTS

Very rarely even the use of ophthalmological chloramphenicol preparations may give rise to the bone marrow damage with impaired blood cell production. Although this has usually only been observed after long term treatment, Chloramphenicol treatment should be limited to 2 weeks. Neonates are more sensitive to the toxic effects of Chloramphenicol.

 

STORAGE

Keep in a cool & dry place away from light. Keep the tube tightly closed. Keep out of reach of children.

 

PRESENTATION

Available in tube of 5 grams.

 

INFORMATION FOR PATIENTS

• Optomycin Eye Ointment is sterile when packed. Patients should be advised do not touch the dispensing tip to any surface & keep the tube tightly closed since this may contaminate the ointment.

• If irritation persists or increases discontinue the use of Optomycin Eye Ointment immediately and consult the physician.

• Use the ointment within one month after the opening the tube.

• Keep out of the reach of Children.

 

Manufactured by

DEEPCARE HEALTH PVT. LTD.

Ahmedabad – 382 225