Otomix Topical Spray
Dexamethasone + Neomycin + Glacial acetic acid ear prep
0.1% + 0.5% + 2%
Opsonin Pharma Limited
| Pack size | 5 ml |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 300.00 AED |
Indications
Otomix Topical Spray is used for:
Otitis externa
Adult Dose
Adults
Ear Spray
Apply 1 spray 3 times a day
One metered dose (60 mg) to be administered directly into each affected ear three times daily.
Treatment should be continued for two days after symptoms have disappeared.
Discontinue treatment if there is no clinical improvement after 7 days.
Child Dose
Ear Spray
Children 2 years of age and over
Apply 1 spray 3 times a day
One metered dose (60 mg) to be administered directly into each affected ear three times daily.
Treatment should be continued for two days after symptoms have disappeared.
Discontinue treatment if there is no clinical improvement after 7 days.
Renal Dose
Elderly
Apply 1 spray 3 times a day
One metered dose (60 mg) to be administered directly into each affected ear three times daily.
Treatment should be continued for two days after symptoms have disappeared.
Discontinue treatment if there is no clinical improvement after 7 days.
Administration
Contra Indications
Hypersensitivity to the active substances or to any of the excipients of this ear drop.
The product should not be used in patients where a perforated tympanic membrane has been diagnosed or is suspected or where a tympanostomy tube (grommet) is in situ.
The product should not be used in infants and neonates under 2 years of age.
Precautions
When otitis externa is treated topically with preparations containing aminoglycosides, in patients who have a perforation of the tympanic membrane, there is an increased risk of drug induced deafness. It is therefore important to ensure that there is no perforation in such patients.
It is important to exclude chronic alternate diagnoses, including chronic otitis media, before treatment is commenced.
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 infections due to the masking effect of the steroid.
In children there is a theoretical risk that sufficient steroid may be absorbed to cause adrenal suppression, with prolonged use increasing this risk of adrenal suppression in children.
Avoid prolonged use. Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms.
Due to potentially immature renal function in children toxicity may develop, thus caution is warranted when administering neomycin in this age group.
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. This possibility should be considered when high doses or prolonged treatment is given to small children.
Pregnancy-Lactation
Pregnancy
There are no adequate data on the use of dexamethasone in pregnant women. Studies in animals have shown topical administration of corticosteroids to cause reproductive toxicity. There is a risk of foetal ototoxicity if aminoglycoside antibiotics preparations are administrated during pregnancy. This ear spray is not recommended during pregnancy.
Lactation
No reports describing the use of neomycin or dexamethasone during human lactation are available and the effects on the nursing infant from exposure to the drug in milk are unknown. Maternal use of topical preparations generally carries less risk than a systemically administered drug. A risk to the breast-fed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from this ear spray therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Interactions
Adverse Effects
Side effects of Dexamethasone + Neomycin + Glacial acetic acid ear prep :
Skin and subcutaneous tissue disorders: Some patients may experience a transient stinging or burning sensation for the first few days of treatment.
Skin hypersensitivity reactions (immediate and delayed) leading to irritation, paraesthesia, burning, stinging, itching and dermatitis.
Eye disorders: Blurred vision has been reported with corticosteroid use; for dexamethasone, the frequency is not known
Mechanism of Action
Dexamethasone is a well-established topical anti-inflammatory steroid.
Neomycin sulfate is an established antibiotic with a well-characterised broad spectrum of activity.
Acetic acid functions to produce a low pH, which assists in controlling bacterial infections.
Note
Otomix 0.1% + 0.5% + 2% Topical Spray manufactured by Opsonin Pharma Limited. Its generic name is Dexamethasone + Neomycin + Glacial acetic acid ear prep. Otomix is availble in Bangladesh.
Farmaco BD drug index information on Otomix Topical Spray is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.