Long term intensive topical use may lead to systemic effects. Oral ingestion of the contents of one bottle (up to 10ml) is unlikely to lead to any serious adverse effects.
24 months from manufacture.
28 days from first opening.
Hypersensitivity to any of the preparations components. Viral, fungal, tuburculous 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 this condition can lead to extension of the ulcer and marked visual deterioration. Otitis externa should not be treated when the eardrum is perforated due to the risk of ototoxicity.
Benzalkonium Chloride Solution
Disodium Edetate
Sodium Phosphate
Purified Water
Eye, ear or nose drops.
Hypersensitivity reactions, usually of the delayed type, may occur leading to irritation, burning, stinging, itching and dermatitis.
Use of topical steroids may result in increased intraocular pressure leading to optic nerve damage, reduced visual acuity and visual field defects.
Intensive or prolonged use of topical corticosteroids may lead to the formation of posterior subcapsular cataracts. In those diseases causing thinning of the cornea or sclera, corticosteroid therapy may result in thinning of the globe leading to perforation.
None available.
For the topical treatment of inflammatory non-infected conditions of the eye, ear or nose.
Betamethasone Sodium Phosphate is a corticosteroid used topically in the treatment of inflammatory conditions.
No data available.
26/11/2008
Vistamethasone Drops or Betamethasone Drops.
Martindale Pharmaceuticals Limited
Bampton Road,
Harold Hill,
Romford,
RM3 8UG
Store upright below 25°C.
Protect from light.
5 or 10ml of the sterile solution is contained in a low density polythene bottle and dropper nozzle sealed by a tamper evident high density polythene cap.
PL 00156/0083
Betamethasone Sodium Phosphate 0.1% w/v
Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding.
Prolonged use may lead to the risk of adrenal suppression in infants. Ophthalmological treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.
May cause transient blurring of vision on instillation into the eye.
Warn patient not drive or operate hazardous machinery unless vision is clear.
Dosage schedule:
Administration for topical ocular use.
Adults, Elderly and Children:
Initially one or two drops to be instilled into the affected eye(s) every two hours. Frequency of administration should be reduced once the condition is under control.
Administration for topical otic use.
Adults, Elderly and Children:
Initially two or three drops to be instilled into the affected ear(s) every three to four hours. Frequency of administration should be reduced once the condition is under control.
Administration for topical nasal use.
Adults, Elderly and Children:
Two or three drops to be instilled into each nostril twice daily as required.
No special instructions.
26/11/2008
