Al-Tinez Visions Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Tel: 01-7418609, 08296588658, 0708900917

Brand Name



ALPA LABORATORIES LTD. 33/2, A.B. Road, Pigdamber -453 446, lndore (M.P.)

Therapeutic Class

Anti-infective/Corticosteroid combinations, Eye/Ear

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Drops (NRN:A4-0887): Dexamethasone Sodium Phosphate BP 0.1% w/v, Chloramphenicol BP 1.0% w/v Phenylmercuric Nitrate BP (As Preservative) 0.002% w/v Sterile aqueous vehicle q.s.

Pack size: Available as 10 mL vial.



The anti-Infective components of Dexamethasone and Chloramphenicol Eye/Ear Drops are intended to provide action against specific organisms susceptible to them.

Polymyxin-B, a cyclic lipopeptide antibiotic, is bactericidal for a variety of Gram-negative organisms, especially Pseudomonas aeruginosa.

It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components.


• The treatment of, surface ocular Infections Involving the conjunctiva and/or cornea caused by susceptible organisms.

• For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.

• For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection of a risk of bacterial ocular infection exists.


The use of Dexamethasone and Chloramphenicol Eye/Ear Drops is contraindicated in patients with hypersensitivity to any ingredient of the formulations.

The use is also contraindicated in epithelial herpes keratitis (dendritic keratitis), vaccinia, varicella other viral diseases of the cornea and conjunctive, mycobacterial infections of the eye and fungal diseases of ocular structures.


• The prolonged use of antibiotics may occasionally result in overgrowth or nonsusceptible organisms, including fungi. If new Infections appear the drug should be discontinued and appropriate measures instituted.

• Dexamethasone and Chloramphenicol Eye/Ear Drops should be used with care in cases of perforated eardrum and in longstanding cases of chronic otitis media due to the possibility of ototoxicity.

• Prolonged use of Dexamethasone and Chloramphenicol Eye/Ear Drops may result in glaucoma and posterior subcapsular cataract formation If these products are used for 10 days or longer, intra-ocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.

Pregnancy & Lactation:

There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit Justifies the potential risk to the fetus.

Steroids appear in human milk following oral administration of the drug. Since systemic absorption may occur on topical application, caution should be exercised when Dexamethasone and Chloramphenicol Eye/Ear Drops is used by a nursing woman.


No known drug-drug interaction. However, like all other drugs, consult with your healthcare provider.

Adverse Effects

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

Blood dyscrasias have been reported in association with the use of chloramphenicol.

Dosage & Administration

For Eye:

The usual recommended dose is 2 drops to be instilled in the affected eye every 3 hours. Administration should be continued day and night for the first 48 hours, after which the interval between applications may be increased Treatment should be continued for at least 46 hours after the eye appears normal

For Ear:

The usual recommended dose in adults 1s 4 drops of the suspension to be instilled Into the affected ear lid or qid. The dose in infants and children is 3 drops to be instilled Into the affected ear lid or qid.


Viral, fungal or tuberculosis infection, Glaucoma.

Storage/Handling Recommendations

Store the vial well closed in a cool and dark place.

Keep all medicines out of reach of Children.

Review Date

2016-05-10 11:04:01