Otal ear drops for otitis externa

Otal Ear Drops

1. Name of the medicinal product :

Otal” Ear Drops.

2. Qualitative and quantitative composition :

Each 1 ml contains: Framycetin sulphate micronized Eq. to 3 mg Framycetin, Gramicidin 0.025 mg Dexamethasone Micronized 1 mg, Cinchocaine HCL 10 mg Eq. to 9.0394 mg Cinchocaine.
Inactive ingredients: Disodium Hydrogen phosphate 12 H20, Monosodium dihydrogen phosphate 2H20, Propylene glycol, Glycerol , Sodium Metabisulphite, water.

3. Phannaceutical from :

Ear drops

4. Clinical particulars :

4.1 Therapeutic indications
Otitis Externa

42 Posology and method of administration
Adults (and the Elderly) and Children: Two or three drops instilled into the ear three or four times daily.
Treatment duration should be short (not to exceed 7 days)

4.3 Contra indications
Otitis Externa should not be treated when the eardrum is perforated because of the risk of ototoxicity.
Hypersensitivity to framycetin sulphate, dexamethasone, gramicidin or to any of the excipients.

4.4 Special warnings and precautions for use

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. Prolonged use may also lead to skin sensitisation and the emergence of resistant
organisms. Prolonged use may lead to the risk of adrenal suppression in infants.
Aminoglycosides 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 ocular use, the possibility should be considered when high dose topical is given to small children or infants.

4.5 Interaction with other medicinal products and other forms of interaction :
None relevant to topical use

4.6 Fertility, pregnancy and lactation
Safety for use in pregnancy and lactation has not been established. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk oLsuch effects in the human oetus. There is a risk of foetal
ototoxicity if aminoglycoside antibiotics preparations are administrated during pregnancy.

4.7 Effects on ability to drive and use machines
None relevant to topical use in ear.

4.8 Undesirable effects
Hypersensitivity reactions, usually of the delayed type, may occur leading to irritation, burning, stinging, itching and dermatitis.

4.9 Overdose
Long-term intensive topical use may lead to systemic effects.
Oral ingestion of the contents of one bottle (up to 10ml) is unlikely to lead to any serious adverse effects.

5. Pharmacological properties :

5.1 Pharmacodynamic properties
Framycetin Sulphate is an aminoglycoside antibiotic with a spectrum of activity similar to that of neomycin, this includes Staph. aureus and most clinically significant gram negative organisms.
Gramicidin is an antimicrobial cyclic polypeptide active in vitro against many gram positive bacteria. It is used for the local treatment of susceptible infections, sometimes in combination with other antimicrobial agents and frequently with a corticosteroid.
Dexamethasone is a synthetic gtucocorticoid and has the general properties as other corticosteroids.
Cinchocaine is a local anesthetic added to reduce local inflammatory pain in external ear.

5.2 Pharmacokinetic properties
Framycetin Sulphate absorption occurs from inflamed skin and wounds. Once absorbed it is rapidly excreted by the kidneys in active form. It has been reported to have a half life of 2-3 hours.
Gramicidin has properties similar to those of Tyrothricin and is too toxic to be administered systemically.
Dexamethasone is readily absorbed from the. gas fro-intestinal tract. It has a biological half-life in plasma of about 190 minutes.

5.3 Preclinical safety data
Not applicable.

6. Phannaceutical particulars :

6.1 Incompatibilities
Not applicable.

6.2 Shelf life
2 years.

6.3 Special precautions for storage
Store at temperature not exceeding 25°C.

6.4 ature and contents of container
Carton 80x contains Opaque White (LOPE) plastic bottle with Opaque white (LOPE)
Plastic dropper and opaque white (HDPE) plastic screw cap containing 5 ml
solution + insert leaflet

6.5 Special precautions for disposal and other handling
No special requirements.

7. Product of :

Amoun pharmaceutical co s.a.e

EI-Obour City, Cairo, Egypt.