Otozambon

Otozambon

Manufacturer:

Zambon
Full Prescribing Info
Contents
Polymyxin B sulfate, neomycin sulfate, betamethasone base, lidocaine HCl.
Description
Each mL contains polymyxin B sulfate 10,000 IU, neomycin sulfate 3390 IU (equivalent to neomycin base 3.75 mg), betamethasone base 1 mg and lidocaine HCl 40 mg. It also contains benzalkonium chloride 0.1 mg, propylene glycol, glycerol and water as excipients.
Action
Pharmacology: Betamethasone is a glucocorticosteroid which has an anti-inflammatory activity.
Neomycin and polimyxin B sulfate are considered active against the following microorganisms: Gram-positive (ie, Staphylococcus epidermidis and Staphylococcus aureus) and gram-negative (ie, Enterobacter, Eschericia, Haemophilus, Klebsiella and Proteus spp).
Lidocaine has an anesthetic activity for relief of pain associated with infections.
Indications/Uses
Treatment of otitis externa associated with bacterial infections which require corticosteroid therapy.
Dosage/Direction for Use
Instill with the proper dropper in the external auricular tube at a dose of 4-5 drops 2-4 times daily, depending on the severity of the disease.
Contraindications
Hypersensitivity to any of the components of Otozambon.
Infections due to herpes simplex, vaccinia and varicella.
Patients with a perforated tympanic membrane; with viral, fungal and tuberculosis infections.
Special Precautions
Treatment should be discontinued promptly if sensitization or irritation occurs.
Otozambon should be discontinued if general pain of tympanic membrane occurs due to possible toxicity of neomycin.
Frequent use may result in overgrowth of nonsusceptible organisms and fungi.
If the infection does not improve after 1 week, cultures and susceptibility tests should be repeated to verify the identity of organism and to determine whether therapy should be changed. When using neomycin to treat secondary infection in the chronic dermatoses eg, chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin in these conditions is more liable than normal skin to become sensitized to many substances. The manifestation of sensitization to neomycin is skin redness with swelling, dry scaling and itching.
In prolonged use of neomycin, it is advisable to do periodic examination to determine whether treatment should be discontinued or not.
Cross-sensitization may occur in concomitant use with other aminoglycosides. It could be prevented by using one or more antibiotics as follows: Kanamycin, paromomycin, streptomycin and gentamicin.
Otozambon should be used carefully in patients with high fever as this condition may reduce drug potency.
If deterioration signs occur, treatment should be discontinued and future treatment with neomycin be avoided.
Treatment should not be continued for >7 days.
Use in pregnancy & lactation: Topical corticosteroid should be used with caution in pregnant women and nursing mothers.
Use In Pregnancy & Lactation
Topical corticosteroid should be used with caution in pregnant women and nursing mothers.
Adverse Reactions
Allergic sensitization.
The local adverse reactions which have been reported with topical corticosteroids are burning, itching and irritation.
Stinging and burning sensation have been reported when Otozambon passed through the middle ear.
Storage
Store in a cool place (15°-25°C).
ATC Classification
S02CA - Corticosteroids and antiinfectives in combination ; Used in the treatment of ear diseases.
Presentation/Packing
Ear drops 8 mL x 1's.
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