Betadrone-N-Eye Ointment

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by Wisdom Support Desk

                (Betamethasone Sodium Phosphate 0.10% W/W, Neomycin Sulphate 0.50% W/W)

Composition:

Each gram contains

Neomycin Sulphate…………………………………………………..………… 5mg

Betamethasone Sodium Phosphate…………………………………………….. 1mg

CLINICAL PHARMACOLOGY:

Pharmacodynamic:

Betamethasone is a glucocorticod which has a topical anti inflammatory activity. Neomycin is a broad spectrum amino glycoside antibiotic which is active against many strains of Gram-negative bacteria but not against pseudomonas spp aminoglycoside and is also active against many strains of staphylococcus aureus.

INDICATIONS

Betamethasone Sodium Phosphate is used in the topical treatment of allergic and inflammatory conditions of the eyes. Neomycin sulphate is used in the management of infections of the eye. Betadrone-N-Eye Ointment is used for the short term treatment of steroid responsive inflammatory conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of viral and fungal disease.

CONTRAINDICATIONS

-Hypersensitivity to any component of the formulation.

-Betadrone-N-Eye Ointment is contraindicated in viral, fungal, tuberculous or purulent conditions of the eye

-Use is contraindicated if glaucoma is present or herpetic keratitus (e.g. dendritic ulcer) is considered a possibility, use of topical steroids in the latter condition can lead to an extension of the ulcer and marked visual deterioration.

WARNINGS/PRECAUTIONS

Treatment with corticosteroid/antibiotic combinations should not be continued for more than 7days in the absence of any clinical improvement, since prolonged use may lead to occult extension of infection due to the masking effect of the steroid. Prolonged use may also lead to skin sensitization and the emergency resistant organisms. Treatment with corticosteroid antibiotic combinations should not 0

Safety for use in pregnancy and lactation has not been established. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. However, this finding has not been proven in humans but precautions in usage are needed.

KEEP OUT OF THE REACH OF CHILDREN

ADVERSE REACTIONS/SIDE EFFECTS

Topical corticosteroid use may result in increased intraocular pressure leading to optic nerve damage, reduced visual activity and visual field defects. Intensive or prolonged use of topical corticosteroids may lead to formation of posterior sub capsular cataracts. Hypersensitivity reactions usually of the delayed type, may occur leading to irritation, burning, stinging, itching and dermatitis.

SYMPTOMS OF OVERDOSAGE AND ANTIDOTE

Long-term intensive topical use may lead to systemic effects. Oral ingestion of the contents of one tube (5g) of ointment is unlikely to lead to any serious adverse effects.

DOSAGE AND ADMINISTRATION

Adults (including the elderly) and children. A small amount should be placed beneath the lower lid two or three times daily and/or at night. Treatment should be the lowest effective dose for the shortest possible time. Betadrone-N-Eye Ointment should not be given for more than 7 days, unless under expert supervision.

STORAGE CONDITION

Store in cool dry place protected from light.

PRESENTATION

Available in tube of 5grams.