Betadrone®-N Eye / Ear Drops and Eye Ointment
(Betamethasone Sodium Phosphate 0.1% + Neomycin Sulphate 0.5%)
Each ml of Betadrone®-N Eye / Ear drops contains 1mg Betamethasone Sodium Phosphate and 5mg Neomycin Sulphate.
Each gram of Betadrone®-N Eye Ointment contains 1mg Betamethasone Sodium Phosphate and 5mg Neomycin Sulphate.
Betamethasone is a glucocorticod which has a topical anti inflammatory activity. Neomycin is a broad spectrum aminoglycoside which is active against many strains of Gram-negative bacteria but not Pseudomonas spp. and is also active against many strains of Staphylococcus aureus.
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 / Ear Drops is used for short time treatment of inflammatory conditions of the eye and ear. In allergic conjunctivitis and in bacterial infections of the external ear.
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.
-Hypersensitivity to any component of the formulation.
– Betadrone®-N is contraindicated in viral, fungal, tuberculous or purulent conditions of the eye
-Use is contraindicated if glaucoma is present or herpetic keratitis (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
Betadrone®-N should not be administered to red eyes until definite diagnosis is carried out.
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 be continued or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.
PREGNANCY AND LACTATION
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.
One to two drops of Betadrone®-N Eye / Ear Drops should be placed in each affected eye up to six times daily and two to three drops into affected ear every two or three hours.
A small amount of Betadrone®-N Eye Ointment 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.
Store below 30oC. Protect from light.
Betadrone®-N Eye / Ear Drops is available in sterile lupolen bottle containing 10ml of the drops.
Betadrone®-N Eye Ointment is available in tube of 5 grams.