Dexatrol Eye Ointment 5 g

Trade Name:

Dexatrol 

Eye Ointment

5 g

Composition:

Each 1 ml or 1g contains:

Dexamethasone 1 mg

Neomycin (as sulfate)… 3.5 mg

Polymyxin-B-sulfate……… ….. 6000 IU

Benzalkonium chloride…0.04 mg

Properties:

Dexatrol combines two antibiotics, neomycin and polymyxin B, with dexamethasone, an anti-inflammatory corticosteroid. The antibiotics are highly active against a wide range of Gram-positive and Gram -negative organisms including: Staphylococcus aureus, H.influenzae, E.coli, Enterobacter, Klebsiella, Neisseria, Proteus species and Pseudomonas aeruginosa. The potent anti-inflammatory activity of dexamethasone makes it ideal in controlling the inflammation associated with bacterial infections.

Dexamethasone is a synthetic glucocorticoid with potent anti-inflammatory activity. Polymyxin B is a cyclic lipopeptide that penetrates the cell wall of gram-negative bacilli to destabilize the cytoplasmic membrane. It is generalły less active against gram-positive bacteria. Neomycin is an aminoglycoside antibiotic that primarily exerts its effect on bacterial cells by inhibiting polypeptide assembly and synthesis on the ribosome.

Indications:

– Conjunctivitis, keratitis, blepharoconjunctivitis, keratoconjunctivitis, corneal ulcers, nonpurulent blepharitis, scleritis, episcleritis and sclera conjunctivitis.

Directions for use:

– The usual dose for adults:

Apply the required amount of ointment to the conjunctival sac of the affected eye(s) in the morning and before bedtime. 

-Wash your hands.

-Tilt your head back.

-Place your finger on the cheek just below the eye and gently pull downward until a V-shaped pocket is formed between the eyeball and the lower eyelid.

– Place a small amount of ointment into the V-shaped pocket. Do not allow the tip of the tube touch the eye to avoid contaminating the ointment.

-Look down before closing your eye.

-Close the tube immediately after use.

– If your doctor has prescribed other eye drops or ointments to use with Dexatrol®, apply each medicine at least 5 minutes apart. Eye ointments should be applied last.

– If you have applied too much Dexatrol®, wash it off with warm water.

– If you forget to apply Dexatrol®, do so as soon as you remember.

– Do not use a double dose to make up for a missed dose.

Side effects:

Hypersensitivity (systemic or ocular), headache, keratitis, increased intraocular pressure, eve discomfort, corneal thinning, photophobia, blurred vision, mydriasis, eye pain, eye swelling, foreign body sensation in eyes, increased lacrimation, ocular hyperaemia.

Contraindications:

-Hypersensitivity to the active substances or to any component of the preparation, aenia, varicella, or other viral infection of cornea and conjunctiva.

-Fungal diseases of ocular structures

-Mycobacterial ocular infections

Warnings and precautions:

• As With all antibacterial preparations prolonged use may lead to overgrowth of non-susceptible
• For topical use only, not for injection or ingestion.
• If bacterial strains or fungi superinfection occurs, appropriate therapy should be initiated.
• Sensitivity to topically-applied aminoglycosides may occur in sorme patients. Cross-sensitivity to other aminoglycosides may also occur. If signs of serious reactions or hyperserısitivity occur, patients using ophthalmic preparations containing neomycin sulphate should be advised to discontinue use of Dexatrol.
• Consult a physician if ocular pain, redness, swelling or irritation worsens or persists.
• Serious adverse reactions includıng neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic neomycin or when applied topically to open wounds or damaged skin

Nephrotoxic and Neurotoxic reactions have also occurred with systemic polymyxin B. Although these effects havé not been reported following topical ocular use of this product, caution is advised when used concomitantly with systemic aminoglycoside 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 acuity 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 these diseases causing thinning of the cornea or sclera, perforations have been known to occur.

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.

• Contact lens wear is not recommended during treatment of an ocular infection.
• Dexatrol ophthalmic suspension contains benzalkonium chloride as a preservative which may cause eye irritation and is known to discolor soft contact lenses. 

Pregnancy and lactation:

Dexatrol is not recommended during pregnancy.

Because systemic corticosteroids and aminoglycosides may be distributed into milk, a risk to the sucking child cannot be excluded and decision must be made whether to discontinue breast-feeding or to discontinue therapy with Dexatrol taking into account the benefit of breastfeeding for the child and the benefit of the product to the woman.

• Effects on ability to drive and to use machines:

Dexatroł has no influence on the ability to drive and use machines.

• Keep out of reach of children.

Storage:

Store at a temperature not exceeding 30°C.

Use within 28 days after opening.

Package:

Carton box holds a tube 5 g and an insert leaflet