DEXATOBRIN@
Ophthalmic Suspension & Ointment
Composition :
Each 1 ml (suspension) or 1 9 (ointment) contains:
Tobramycin 3 mg
Dexamethasone 1 mg
Excipients: Suspension: Benzalkonium chloride, polysorbate 80, disodium edetate, hydroxypropyl methylcellulose E4, sodium chloride, sodium sulfale anhydrous, sulfuric acid or sodium hydroxide, water for injection.
Ointment: Anhydrous lanolin, chlorobutanol, ye.llow soft paraffin.
Properties :
Dexatobrin® contains the aminoglycoside antibiotic tobramycin and the anti-inflammatory corticosteroid dexamethasone, This combination exerts anti-inflammatory and antibacterial activity against inflammation and infections due to bacteria susceptible to tobramycin, such as Staphylococci, including S. aureus, S. epidermidis, Streptococci including some of group A- betahemolytic
species, Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus species, Haemophilus influenzae, and some Neisseria species. Dexamethasone, being a potent anti-inflammatory agent, controls the undesirable phases of inflammation associated with bacterial infections.
Indications :
-Ocular inflammations with bacterial infections due to bacteria susceptible to tobramycin, such as infections of palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
– Chronic anterior uveitis and corneal injury from chemicals, radiation, burns, or penetration of foreign bodies,
Dosage and Administration :
OphthalmiC suspension: Starting dose: 1 – 2 drops every 2 hours till improvement occurs. Then the dosage may be decreased to 1 – 2 drops every 4 – 6 hours.
OphthalmiC ointment: A small amount of the ointment (1 – 1.5 cm) should be applied to the lower eyelid twice daily in the morning and just before bedtime.
Precautions :
– Prolonged therapy with Dexatobrin®, as with other antibiotics, may result in superinfection with nonsusceptible organisms, including fungi. -Extended use of topical corticosteroid may cause glaucoma.
– Dexatobrin@should be used with caution in patients suffering Irom glaucoma.
– Contact lenses should be removed prior 10 admInistration of DexatobrinLenses may be re-inserted 15 minutes following administration of the drug.
Pregnancy and Lactation :
nexarobrtne should be used during pregnancy (Category C) only ij the potential benefit justifies the potential risk: to the letus.
Dexatobrln@should be used wlth caution during lactation.
Contra-indications :
– Hypersensitivity to the product.
– Mycobacterial infections of the eye.
– Funqal and viral infections of the eye (e.g. Herpes si nple)l or dendritic keratitis).
Side Effects :
As with other antibiotics, sensitivity reactions, such as itching sensation, swelling of eyelids, and redness of the conjunctiva, may occur in some patients. Other side effects caused by dexamethasone may include elevation of inlraocular pressure and development of secondary infection particularly with long-term applications.
Storage :
Dexatobrinra Ophthalmic Suspension: Store at temperature below 2r C.
Dexatobrin@Ophthalmic Ointment: Store at temperature 15· – 25· C.
How Supplied :
Oexatobrin® Ophthalmic Suspension: 5 ml Plastic dropper bottle.
Dexatobrtnm Ophthalmic Ointment: Ophthalmic tubes of 5 g each.
PRODUCED BY :
EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.
E.I. P.I. CO.
Oth OF RAMADAN CITY TENTH, EGYPT
