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BETNESOL-N is a brand name for Neomycin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Eye 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. Ear Otitis externa or other steroid responsive conditions where prophylactic antibiotic treatment is also required. Nose…
Verbatim from this product's MHRA label. Tap a section to expand.
The frequency of dosing depends on the clinical response. If there is no clinical response within 7 days of treatment, the drops should be discontinued. Treatment should be the lowest effective dose for the shortest possible time. Normally, Betnesol-N Drops should not be given for more than 7 days, unless under expert supervision.
After more prolonged treatment (over 6 to 8 weeks), the drops should be withdrawn slowly to avoid relapse. Eyes 1 or 2 drops applied to each affected eye up to six times daily depending on clinical response. Ears 2 or 3 drops instilled into the ear three or four times daily.
Nose 2 or 3 drops instilled into each nostril two or three times daily.
Hypersensitivity reactions, usually of the delayed type, may occur leading to irritation, burning, stinging, itching and dermatitis. Topical corticosteroid use may result in corneal ulceration, 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 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.
Mydriasis, ptosis, epithelial punctate keratitis and glaucoma have also been reported following ophthalmic use of corticosteroids. Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Following nasal administration, the most common effects are nasal irritation and dryness, although sneezing, headache, lightheadedness, urticaria, nausea, epistaxis, rebound congestion, bronchial asthma, perforation of the nasal septum, ulceration of the nasal septum, anosmia, parosmia and disturbance to sense of taste have also been reported.
Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses. It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored.
If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid, if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should also be given to referring the patient to a paediatric specialist.
A patient information leaflet should be supplied with this product. Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding. Treatment with corticosteroid/antibiotic combinations should not be continued for more than 7 days 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 sensitisation and the emergence of resistant organisms. Ophthalmological treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.
Aminoglycoside antibiotics may cause irreversible, partial or total deafness when given systemically or when applied topically to open wounds or damaged skin. This effect is dose related and is enhanced by renal or hepatic impairment.
Although this effect has not been reported following topical ocular use, the possibility should be considered when high dose topical treatment is given to small children or infants. 1555A>G mutation, including cases where the patient’s aminoglycoside serum levels were within the recommended range.
Some cases were associated with a maternal history of deafness and/or mitochondrial mutation. While no cases were identified with neomycin, based on a shared mechanism of action there is the potential for a similar effect with neomycin.
These mitochondrial mutations are rare, and the penetrance of this observed effect is unknown. Nasal administration of corticosteroids is not advised if an untreated nasal infection is present or if the patient has pulmonary tuberculosis or following nasal surgery (until healing has occurred).
Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.
Viral, fungal, tuberculous or purulent conditions of the eye. Fungal infections of the nose or ear. 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.
Otitis externa should not be treated when the eardrum is perforated because of the risk of ototoxicity. Corticosteroids should not be used in patients with a perforated tympanic membrane. Hypersensitivity to any component of the preparation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Neomycin in United Kingdom.
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4) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
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 which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
005% w/v benzalkonium chloride in each dose. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Contact lenses should be removed before using this medicine and reinserted 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eyes or disorders of the cornea. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time. 23% w/v phosphates in each dose.
In patients suffering from severe damage to the cornea, phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.