CHLORCOM-H​

CHLORCOM-H | Chloramphenicol with Hydrocortisone Acetate Eye Ointment

Composition:

Chloramphenicol IP…………………………………………………………………………….1.0% w/v

Hydrocortisone Acetate IP……………………………………………………………………0.5% w/v

Sterile Paraffin Base…………………………………………………………………………….q.s.

Mechanism of Action: Chlorcom H eye ointment is an anti-bacterial and steroid combined medicinal product formulated to treat infections. Chloramphenicol is a broad spectrum antibacterial effective against various numbers of microorganisms causing infection while hydrocortisone acetate belongs to the class of corticosteroid having variable actions such as anti-inflammatory, anti-edematous and anti-allergic actions. Chloramphenicol penetrates into bacterial cell membrane and reversibly bind to the 16L protein of 50S subunit of bacterial ribosome which inhibits the transfer of amino acid to the growing peptide chain as a result bacterial protein synthesis inhibited automatically and cause cell death. The anti-inflammatory action of hydrocortisone acetate is thought to be enhancement of lipocortin-1 synthesis which prevents the contact of phospholipase A2 with arachidonic acid leads to suppression of prostaglandins and leukotrienes inflammation causing chemicals.

Indications: Chlorcom H eye ointment is indicated for the treatment of Conjunctivitis, inflammation of eye and eyelids, wounds around the eyes and bacterial infection of cornea.

Dosage: Apply 1.5 cm of eye ointment every three hours for up to 5 days or as directed by doctor.

Contraindications: The use of Chorcom H 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 corticosteroid 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 specially under occlusive dressings include burning sensation, itching, irritation, 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 H is known.

Use in Special Popilation:

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 me 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: Store in a cool & dry place at a temperature not exceeding 30°C. Do not freeze. Sterile until opened.

Presentation: Chlorcom H eye ointment is available in 5 gm tube.

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