Otal ear drops
Anti-inflammatory & broad spectrum antibacterial agent with topical anesthetic
Composition :
Each 1 00 ml contains:
– Framycetin sulphate 390mg
Equivalent to 300 mg Framycetin base
– Gramicidin 2.5mg
– Dexamethasone 100mg
– Cinchocaine HCI 1 gm
Pharmacological properties :
Framycetin sulphate
A fermentation product of streptomyces fradii, framycetin is a bactericidal for many gram + ve & gram -ve organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding to ribosomal RNA, causing misreading of the bacterial
genetic code.
Gramicidin
Is a bactericidal for a variety of gram + ve organisms. It increases the permeability of the bacterial cell membrane to inorganic cations by forming a network of channels through the normal lipid bi-Iayer of the membrane.
Dexamethasone
Is a synthetic flourinated coriticosteroid that suppresses the inflammatory response, with an additional anti-edematous & anti-pruritic effects.
Cinchocaine
Topical anesthetic of the amide type that is used for the surface anesthesia.
Indications :
• For the treatment of superficial bacterial infections of the external auditory canal, caused by organisms sensitive to the antibiotics in Otal” ear drops
• In cases of severe inflammatory conditions of the external ear including edema, pruritus & other dermal reactions of the external auditory meatus.
• For the relief of pain in cases of otalgia. Otal” ear drops is recommended for usage in cases of:
1-Acute diffuse otitis externa.
2-Furunculosis of the external auditory canal.
3-Acute congestive or serous otitis media with an intact ear drum.
Adverse effects :
As with any topical therapy hypersensitivity reactions including contact dermatitis, burning, erythema, rash & urticaria could occur in some cases, if so discontinuation of therapy & consultation of physician is recommended.
Precautions :
– Topical corticosteroid, when used in combination with framycetin, may mask the clinical signs of fungal & viral infections.
– otal” ear drops is not recommended in cases of perforated tympanic membrane.
Contra indications :
– This product is contraindicated in those individuals who have shown hypersensitivity to any of its components & in cases of viral or fungal infections.
– Not.!9 be used for the eyes
Dosage :
The external auditory canal should be cleansed & dried with a sterile cotton applicator
• Adults:
3-5 drops of Otal” should be instilled into the affected ear(s) 3-4 times daily
• Infants & children below 3 years of age:
2-3 drops otal'” are suggested because of the smaller capacity of the ear canal.
• Alternatively:
A cotton wick or gauze saturated with the solution is to be inserted into the external auditory canal & should be kept moist by adding further solution every 4 hrs.
The wick should be replaced every 24 hrs.
Patient information :
– Do not touch the applicator tip
– Replace cap after use
– Not to be use-clOy more1han one patient
How supplied :
Plastic dropper bottles of Sml sterile solution.
Keep all medicaments out of reach of children
Product of:
AMOUN PHARMACEUTICAL CO. SAE.
EI-Obour City, Cairo, Egypt.
