Skip to content

Obradex Ointment

Obradex Ointment Tobramycin 3mg / Dexamethasone 1mg is a gamma-irradiated sterile eye ointment of 3.5 gm. It is a prescription-only medication. Tobramycin is an antibiotic that kills bacteria that cause eye infections. Dexamethasone is a corticosteroid (anti-inflammatory) that reduces redness, swelling, and irritation in the eyes caused by infection or allergy.

Clinical Pharmacology: Corticosteroids suppress the inflammatory response to a variety of agents and may delay or slow healing. Since corticosteroids may inhibit the body’s defense mechanism against infection, a concomitant antimicrobial agent may be used when this inhibition is considered clinically significant.

Dexamethasone is a potent corticoid. The antibiotic component in the combination (Tobramycin) is included to provide action against susceptible strains of different microorganisms.

Package Contains: Each pack of Obradex ointment contains an ointment tube of 3.5 gram & a leaflet. It is also available as eye drops of 5ml.

Composition: Each gram contains: Obradex Ointment

Tobramycin 3 mg.

Dexamethasone 1 mg.

(USP Specifications)

Dosage: As directed by the ophthalmologist.

Indications & Usage: Obradex is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, where the inherent risk of steroid use in certain infective conjunctivitis is accepted to obtain a diminution in edema and inflammation.

They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies. The use of a combination drug with anti-infective components is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

Dosage & Administration: Apply a small strip of ointment (approximately 1/2 inch) into the conjunctival sac(s) of the affected eye every 6 to 8 hours. Care should be taken not to discontinue therapy prematurely; no more than 8g should be prescribed initially.

Adverse Reactions/ Side Effects: Exact incidence figures are not available. The most frequent adverse reactions to topical ocular Tobramycin are localized ocular toxicity and hypersensitivity, including lid itching and swelling, and conjunctival erythema. However, if topical ocular Tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

The reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary infection: The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

Warnings: Not for injection into the eye. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction does occur, discontinue use. Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

Precautions (General): The possibility of fungal infections of the cornea should be considered after long-term steroid dosing. As with other antibiotic preparations, prolonged use may result in overgrowth of non-susceptible organisms, includ

ing fungi. If super infection occurs, appropriate therapy should be initiated. When multiple prescriptions are required, or whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

Pregnancy Category C: Corticosteroids have been found to be teratogenic in animal studies.

Nursing Mothers: It is not known whether this drug is excreted in human milk.

Pediatric Use: Safety and effectiveness in children have not been established.

Precaution /Instructions: Keep out of the reach of children. Store between 15°C to 30°C. Protect from sunlight, heat and freezing. For further details, see the enclosed leaflet. Ointment can be used within 4 weeks after first opening the tube.

Obradex Ointment back

Manufactured & Buy Online: 

Obradex Ointment is manufactured by: Vega Pharmaceuticals (Pvt.) Ltd.

This is the link to the manufacturer: https://vegapharmaceuticals.com

You can buy it online at: h https://derma.pk

You can also buy it from any nearby pharmacy.