Saturday, September 7, 2013


Anti-inflammatory & broad spectrum 
antibacterial agent with topical anesthetic Composition 
Each 100 ml contains: - Framycetin ulpht.._......._.390mg Equivalent to 300 mg Framycetin base - Gramicidin_.___...-.-..__.___2.5mg - Dexamethasorw ._ 100mg - Cinchocaine HCL_ ... .1gm 
Pharmacological properties 
Framycelin sulphate 
A fermentation product of streptomyces fradii, framycetin is a bactencidal for many gram 
+ ye & gram -ye organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding to ribosomal RNP causing misreading of the bacterial genetic code. Gramicidin Is a bactericidal for a variety of gram + ye organisms. It increases the permeability of the bacterial cell membrane to inorganic cations by forming a network of channels through the normal lipid bi-layer of the membrane. De.xamelho.sone Is a synthetic flourinated coriticosteroid that suppresses the inflammatory response, with an additional anti-edematous & anti-prurilic effects. 
Topical anesthetic of the amide type that is used for the surface anesthesia. 
• 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 
3Acute congestive or serous otitis media with an intafë drum. 
Adverse effects 
As with any topical therapy hypersensitivity reactions induding contact dermatitis, burning. erythema, rash & urticaria could occur in some cases, if so discontinuation of therapy & consultation of physician is recommended. 
- 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 panic membrane. Contraindications - This product is contraindicated in those individuals who have shown hypersensitivity to any of its components & in cases of viral or fungal infections. 
Not.tobe used forihaeyes 
- 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 his. 
Patient information •Do not touch the applicator tip 
•Replace cap after use 
• Not to be used by more than one patient 
IIow supplied 
Plastic dropper bottles of 5ml sterile solution. 
Keep all medicaments out of reach of children AMOUN PHARMACEUTICAL (0.0 SAE. El-Obour City, Cairo, Egypt.

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