Dexatrol for the short term treatment of steroid responsive conditions of the eye and infections of the external ear canal

Ophthalmic & Otic Suspension & Ophthalmic Ointment

Composition :

Each 1 ml or 1 gm contains:
Dexamethasone                                      1 mg
Neomycin (as sulphate )                       3.5 mg
Polymyxin B sulphate                           6000 Units
Inactive Ingredients:
Drops: HydroxypropyJ methylcellulose, benzalkonium chloride 10 % solution, disodium edentate, sodium chloride, polysorbate 80, sodium hydroxide or hydrochloric acid, water for injection.
Ointment: Anhydrous lanolin, chlorobutanol, yellow soft paraffin.

Therapeutic indications :

– dexatrol is indicated for the short term treatment of steroid responsive conditions of the eye when prophylactic antlbionc treatment is also required, after excluding the presence of rungal
and viral disease.
– Dexatrol is indicated for infections of the external ear canal caused by susceptible organisms; mastoidectomy cavity infections or chronic suppurative otitis media.

Posoloav and Method of Administration :

Children and adults (Including the Elderly):
Eye Drops: Apply 1-2 drops to each affected eye up to 6 times daily or, more frequently if required.
Ear Drops: In external ear canallnfectlon: Before administration, the external ear should be thoroughly cleaned. Apply 4 drops 3-4 times daily.
Topical to Mastoldectcmy cavity or Ear canal: Apply 4-10 drops 3-4 times daily.
Ointment : apply asmall amount into the conjunctival saclsl up to 3-4 limes daily or, may be used adjunctively with drops at bedtime

Contraindications :

– Hypersensitivity to the active substances or to any component of the preparation.
– Epithelial Herpes Simplex keratitis.
– Vaccinia, varicella, or other vtral jnfecttcn of cornea and conjunctiva (except Herpes Zoster keratitis).
– Fungal diseases of ocular structures.
– Mycobacterial ocular infections.

Special warnings and precautions for use :

As with all antibacterial preparations, profonged use may lead 10 overgrowth or non-susceptible bacterial strains or fungi. If superinfection occurs, appropriate therapy should be initiated.
Patients using ophthalmiC preparations containing neomycin sulphate should be advised tc consult a physician if ocular pain, redness, swelling, or irritation worsens or persists.
Serious adverse reactions Induding neurotoxldry, ototoxicity and nephrotoxfclty have occurred in patients receiving systemic neomycin or when applide topically to open wounds or damaged skin nephrotoxic and neurotoxic reaction have also occurred with systemic polymyxin B although these effects have not been reported following topical ocular use of this product caution is advised when used concomitantly with systemic aminoglycosid or polymyxin B therapy . Prolonged use of ophthalmic steroids may result In ocular hypertension and/or glaucoma with damage to the optic nerve reduced visual ocuity and visual field defects and posterior subcapsular cataract formation in patients receiving prolonged ophthalmic corticosteroid therapy intraocular pressure should be checked routinely and freqently in those diseases causing thinning of the cornea or sclera perforations have been known to occur with the use of topical corncosterotds. Cortfcosterotds may reduce resistance to and aid In the establishment of bacterial, viral, or funga Infections and mask the clinical signs of infection, preventing recognition of ineffectiveness of the antfbtonc. or may suppress hypersensitivity reactions to substances in the product. Funga
Infection should be suspected In patients with persistent corneal ulceration who have been or are receiving ehese drugs and corticosteroid therapy should be discontinued if fungal infection occurs to avoid the risk of enhancement of herpetic corneal disease frequent slit lamp examination is essential.
Contact lens wear Is not recommended during treatment of an ocular infection. Therefore patient should be advised not to wear contact lenses during treatment with dexatrol
cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft conrac lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion

Interaction with other medicinal products :

No Interaction studies have been performed. Concomitant and/or sequential use of an aminoglycoside [neomycin] and other systemic
oral, or topical drugs that have neurotoxic, ototoxic, or nephrotoxic effects may result or additive toxicity and should be avoided, whenever possible. If more than one ophthalmic medicinal product is being used, the medicines must b administered at least 5 minutes apart.,

Pregnancy and lactation :

Pregnancy: There are no or limited amount of data from the use of the components of Dexatrol dexamethasone , neomycin as sulphate and polymyxin B sulphate in pregnant women Studties in animals with some active components of dexatrol have shown reproductive toxicity Dexatrol is not recommended during pregnancy.
Lactation: It is unknown whether topical ophthalmic dexamethasone, neomycin or polymyxin B are excreted in human and aminoglycosides may be distribute A decision must be made whether to discontinue breast-feeding or to discontinue therapy wtrl
Dexatrol taking into account the benefit of breast-feedinq for the child and the benefit of the product to the woman.

Effects on ability to drive and to use machines :

dexatrol has no or ngligible influence on the abillity to drive and use machines as with any other eye drop, temporarily blurred vision or other visual disturbances may affect the ability to  drive or use machines. If transient blurred vision occurs upon Instillation, the patient must wait  until the vision dears before driving or using machinery.

Undesirable effects :

The following adverse effects are classified according to the followinq convention: very common I
1110), common (Ot 1/100 to <1110), uncommon (Ot 1/1,000 to <111(0), rare (Ot 1/10,000 t                                                                    Immune system disorders:
Not known: hypersensltlvtty (systemic or ccoten.
Nervous system disorders:
Not known: headache.
Eye disorders:Uncommon: keratitis, increased mtraocular pressure, eye Irritation, eye pruritus, ocular discomfort eye swelling,
bescnption of selected adverse events: Due to the steroid component, in diseases causing thinning of the cornea or sclera there is a higher risk for perforation especially after long
treatments (See Section Special Warnings and Precautions for use!
Topical ophthalmic steroid use may result in Increased tntraoculer-pressure with damage to the optic nerve, reduced visual acuity and visual field defects. Also it may lead to posterior
subcapsular cataract formaUon (See Section Special Warnings and Precautions for use). Sensitivity to topically-administered aminoglycosides may occur in some patients (See Section Special Warnings and Precautions for use). Systemic side effects may occur with extensive use.

Overdose :

No case of overdose has been reported.
Signs and symptoms of an overdosage of Dexatrol may be similar to adverse reaction effects seen in some patients (punctuate keratitis, erythema, increased lacrimation, oedema and lid itching).
A topical ophthalmic overdose of Dexatrol may be flushed from the eyeis) with lukewarm water.

Pharmacokinetic properties :

Dexamethasone, like other cortlcosrerolds, is absorbed rapidly after oral administration and has a biological half-life of about 190 minutes. Sufficient absorption may occur after topical application
to the skin and eye to produce systemic effects. Intraocular penetration of dexamethasone occurs in significant amounts and contributes to the effectiveness or dexamethasone in anterior segment polymyxin B sulphate Is not absorbed from the gastrointestinal tract or through Intact skin, although the intact corneal epithelium prevents penetration into the corneal stroma, therapeutic concentrations do enter the stroma after epithelial damage. Good stromal penetration occurs after epithelial abrasion following topical instillation. subconjunctival Injection, or corneal bath. No significant polymyxin B penetration into the vitreous is demonstrable after parenteral or local administration af the drug neomycin is poorly absorbed from the gastrointestinal trac and after
topical administration an insufficient amount is absorbed to produce systemic effects. Absorption has been reported to occur from wounds and Inflamed skin. After absorption neomycin is rapidly excreted by the kidneys in active form.

Storage :

Store at a temperature not exceeding 30″C and after opening to be used within 28 da s at room temperature.
keep away from direct sunlight.
Keep the container tightly closed.

Packaging :

Dexatrol ophthalmJc & Otic Suspension: 5 ml Plastic dropper bottle.
Dexatrol Ophthalmic Ointment: Ophthalmic tube of 5 gm.

Produced by :

E. I. P. I. CO.