CHLORCOM Ointment | Chloramphenicol Polymyxin B Sulphate

MECHANISM OF ACTION:

Polymyxin B Sulfate interacts with the lipopolysaccharide of the cytoplasmic outer membrane of Gram-negative bacteria, altering membrane permeability and causing cell death. Chloramphenicol is lipid-soluble, allowing it to diffuse through the bacterial cell membrane. It then reversibly binds to the L16 protein of the 50S subunit of bacterial ribosomes, where transfer of amino acids to growing peptide chains is prevented (perhaps by suppression of peptidyl transferase activity), thus inhibiting peptide bond formation and subsequent protein synthesis.

Unbound dexamethasone crosses cell membranes and binds with high affinity to specific cytoplasmic glucocorticoid receptors. This complex binds to DNA elements (glucocorticoid response elements) which results in a modification of transcription and hence, protein synthesis in order to achieve inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, suppression of humoral immune response, and reduction in edema or scar tissue. The anti-inflammatory actions of dexamethasone are thought to involve phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes susceptible organisms.

INDICATIONS:

Chlorcom is indicated for ocular bacterial infections.

DOSAGE:

Half an inch ribbon of chlorcom Ointment before sleeping up to 5 days or as prescribed by doctor.

CONTRAINDICATIONS:

The use of chlorcom is contraindicated in patients with hypersensitivity to any ingredient of the formulations, who have experienced bone marrow suppression during previous exposure to chloramphenicol, known personal or family history of blood dyscrasias including aplastic anaemia, with fungal eye infections, Herpes simplex keratitis, Vaccinia, Varicella and other viral infection of cornea or conjunctiva.

WARNINGS & PRECAUTIONS:

Chloramphenicol is absorbed systemically from the eye and systemic toxicity has been reported. It is recommended that all types of contact lenses be avoided during ocular infections. The prolonged use of antibiotics may occasionally result in overgrowth of non-susceptible organisms, including fungi. If new infections appear the drug should be discontinued and appropriate measures instituted.

The risk of corticosteroid-induced raised intraocular pressure and/or cataract formulation is increased in predisposed patients (e.g. diabetes). Topical ophthalmic corticosteroids may slow corneal wound healing. Topical NSAIDs are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes.

ADVERSE REACTIONS:

The adverse reactions reported with topical corticosteroids especially under occlusive dressings include burning sensation, itching, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis and allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Effects on ability to drive and use machine

Patients should be cautioned against engaging in activities requiring complete mental alertness and motor coordination such as operating machinery until their response to chlorcom is known.

USE IN SPECIAL POPULATION

Paediatric: Safety and efficacy in children has not been established.

Geriatric: Safety and efficacy in elderly patient has not been established

Liver impairment: Use with caution.

Renal failure: Use with caution.

Pregnancy and lactation: The safety of topical chloramphenicol in pregnancy and lactation has not been established. Chloramphenicol may be absorbed systemically following the use of eye ointment and may cross the placenta and appear in breast milk. Therefore, this product is not recommended for use during pregnancy and lactation.

STORAGE AND HANDLING:

Use the ointment within one month after opening the container. Keep medicine out of reach of children. FOR EXTERNAL USE ONLY. Store in a cool, dark & dry place. Do not allow to freeze.

PRESENTATION:

Chlorcom Ointment is available in 5gm tube.

SHELF LIFE:

As mentioned on the outer carton