- ANTI-INFECTIVE AGENTS
- OPHTHALMOLOGICAL DRUGS
- ANTI-INFLAMMATORY AGENTS
- Pharmaceutical Form : Eye Ointments
- Composition : Tobramycin 3 mg+ Dexamethasone 1 mg /1 g
- Active Substance : Tobramycin+ Dexamethasone
TOBRAMED-D (tobramycin and dexamethasone ophthalmic suspension and ophthalmic oint.) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use in inflammatory cases associated with bacterial infections Streptococci, or Staphylococci
TOBRAMED-D Ophthalmic Suspension and ophthalmic oint. are 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 conjunctivitides 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 an anti-infective component 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.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:
Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae Pseudomonas aeruginosa , Klebsiella pneumoniae
Epithelial herpes simplex keratitis (dendritic keratitis), varicella, and many other viral diseases of the cornea and conjunctiva.
Fungal diseases of ocular structures. Hypersensitivity to a component of the medication
*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
*Intraocular pressure should be routinely monitored. *In diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroid *In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection
* Contact lenses should not be worn during the use of this product.
*The possibility of fungal infections of the cornea should be considered after long-term steroid Dosing.
* There are no adequate and well controlled studies in pregnant women.
* Systemically administered corticosteroids appear in human milk and could suppress growth It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk., caution should be exercised when TOBRAMED-D Ophthalmic Suspension or ophthalmic oint. is administered to a nursing woman.
*Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
*Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component
*The most frequent adverse reactions to topical ocular tobramycin are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema
* Other adverse reactions have not been reported; 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 with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing
*The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. 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. .
DOSAGE AND ADMINISTRATION
One or two drops instilled into the conjuctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical Signs
Ophthalmic oint. Apply a small amount into the conjunctival sac(s) up to three or four times daily
Packing : ophthalmic suspension 10 ml. tube 5 gr ophthalmic ointment .