Dexatrol Eye Drops 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: Hydroxypropyl methylcellulose, benzalkonium chloride 10 % solution, disodium edentate, sodium chloride, polysorbate 80, sodium hydroxide or hydrochloric acid, water for injection.
Dexatrol Eye Drops Therapeutic indications :
– Dexatrol is indicated for the short term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral disease (other drugs used for similar conditions: Tobradex eye drops ).
– Dexatrol is indicated for infections of the external ear canal caused by susceptible organisms, mastoidectomy cavity infections or chronic suppurative otitis media.
Dexatrol Eye Drops 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 canal lnfectlon: Before administration, the external ear should be thoroughly cleaned. Apply 4 drops 3-4 times daily.
Topical to Ear canal:Apply 4-10 drops 3-4 times daily.
Ointment : apply asmall amount into the conjunctival sac up to 3-4 limes daily or, may be used adjunctively with drops at bedtime
Dexatrol Eye Drops Contraindications :
– Hypersensitivity to the active substances or to any component of the preparation.
– Epithelial Herpes Simplex keratitis ( Hepatic Eye Diseases ).
– Vaccinia, varicella, or other viral infection of cornea and conjunctiva.
– Fungal diseases of ocular structures ( Fungal Keratitis ).
– Mycobacterial ocular infections.
Dexatrol Eye Drops Special warnings and precautions for use :
As with all antibacterial preparations, prolonged use may lead to overgrowth of non-susceptible bacterial strains or fungi. If superinfection occurs, appropriate therapy should be initiated.
Patients using ophthalmic preparations containing neomycin sulphate should be advised to consult a physician if ocular pain, redness, swelling, or irritation worsens or persists.
Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity 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 frequently in those diseases causing thinning of the cornea or sclera perforations have been known to occur with the use of topical corncosteroids.
Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral, or fungal infections and mask the clinical signs of infection, preventing recognition of ineffectiveness of the antibiotic. or may suppress hypersensitivity reactions to substances in the product. Fungal infection should be suspected in patients with persistent corneal ulceration who have been or are receiving these 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 Contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.
Dexatrol Eye Drops 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.,
Dexatrol Eye Drops 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.
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 negligible 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 clears before driving or using machinery.
Dexatrol Eye Drops Undesirable effects :
Immune system disorders:
Not known: hypersensitivity (systemic or ccoten.
Nervous system disorders:
Not known: headache.
Eye disorders:Uncommon: keratitis, increased mtraocular pressure, eye Irritation, eye pruritus, ocular discomfort eye swelling,
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 intraocular pressure with damage to the optic nerve, reduced visual acuity and visual field defects. Also it may lead to posterior subcapsular cataract formation (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.
Dexatrol Eye Drops 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).
Dexatrol Eye Drops Pharmacokinetic properties :
Dexamethasone, like other corticosteroids, 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 ophthalmic & Otic Suspension: 5 ml Plastic dropper bottle.
Dexatrol Ophthalmic Ointment: Ophthalmic tube of 5 gm.
Produced by :
EGYPTIAN INT PHARMACEUTICAL INDUSTRIES CO.
E. I. P. I. CO.
10 TH OF RAMADAN CITY , TENTH, EGYPT
