Bactericidal, anti-inflammatory, anti-allergic.
Pharmacokinetics and pharmacodynamics in humans
The anti-inflammatory and antiallergic effect of dexamethasone present in Tedexa, is effective when administered topically, thanks to its high solubility in aqueous medium and easy combination with tear fluid or nasal mucus. The onset of the effect is immediate and it prolongs its local activity in a variable way according to the amount of tears and secretion of the nasal mucosa, therefore its administration varies according to these factors.
Corticosteroids suppress the inflammatory response to a variety of agents and are likely to delay or lengthen healing. Because corticosteroids can inhibit the body’s defense mechanism against infection, concomitant use of an antimicrobial drug is recommended when this inhibition is considered clinically significant. Dexamethasone is a powerful steroid.
The antibiotic component of the combination (tobramycin), are included to provide action against susceptible organisms. In vitro studies have shown that the antibiotic tobramycin is active against susceptible strains of the following micro-organisms: Staphylococci, including S. aures and S. epidermidis (coagulose-positive and coagulose-negative) and penicillin-resistant strains. Streptococci, including some from the beta-hemolytic group and some non-hemolytic species and some strains of Streptococcus pneumoniae, pseudomona aeuroginosa, Escherichia coli, Klebsiella peumoniae, Enterobacter aerógenes, Proteus mirabilis, Morganella morganii, most strains of Proteus influenzae and H. Aegyptius, Moraxella lacunata and Anicetobacter calcoaceticus and some species of neisseria.
Bacterial sensitivity studies show that in some cases, gentamicin-resistant organisms can remain susceptible to tobramycin. A significant tobramycin-resistant bacterial population has not yet been detected; however, bacterial resistance can develop after prolonged use. There are no data available on the extent of systemic absorption from Tedexa ophthalmic suspension; however, it is known that systemic absorption can occur with drugs applied topically at the ocular level.
Each ml contains:
Tobramycin 0.3 mg
Dexamethasone 0.1 mg
Excipients and purified water C.S.
Posology and administration
Administration route: Ophthalmic.
Shake well before use. One or two drops instilled into the conjunctival sac every four to six hours. During the initial 24 to 48 hours, the dosage can be increased to one or two drops every two hours. The frequency should be gradually decreased as improvement in clinical signs is obtained. Act with caution to discontinue therapy prematurely. Concomitant use of corticosteroids and tobramycin may mask the clinical signs of infection by bacteria, fungi, and viruses.
Keep at a temperature between 15 ° C and 25 ° C. Protect from freezing.
Box with dropper bottle with 5 ml of suspension.
Indications and uses
Tedexa is indicated in inflammatory eye conditions that respond to steroids and in which there is also a risk of a superficial bacterial eye infection or the existence of it.
Ocular steroids are indicated in inflammations of the palpebral and bulbar conjunctiva, cornea and anterior segment of the eye, to obtain a decrease in edema or inflammation. It is also indicated in chronic anterior uveitis and corneal wounds due to chemical, thermal, or radioactive burns or foreign body penetration. The use of a combination of drugs with an anti-infective component is indicated when the risk of superficial ocular infection is high or when there is a potentially dangerous number of bacteria at the ocular level.
Tedexa is contraindicated in: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, chickenpox, and many other viral diseases of the cornea and conjunctiva. Mycobacterial eye infection, fungal infection of the eye structures. Hypersensitivity to any component of the formula. The use of Tedexa is always contraindicated after the uncomplicated removal of a foreign body.
Hypersensitivity to topically applied aminoglycosides may occur in some patients. If a hypersensitivity reaction occurs, use should be discontinued. Prolonged use of steroids can cause glaucoma, with damage to the optic nerve, defects in visual acuity and visual field, and formation of posterior subcapsular cataract. Intraocular pressure should be recorded routinely, even if this is difficult in children and in few cooperative patients. Prolonged use can suppress the patient’s defense response and thus increase the risk of secondary eye infections. In those diseases that cause a thinning of the cornea or sclera, perforations have been reported with the use of topical steroids. In acute purulent infections of the eyeball, steroids can mask the infection and thus promote it. Corticosteroid application can activate, exacerbate, or mask eye infections from viruses, bacteria, or fungi.
Precautions or recommendations for use during pregnancy and lactation
It should be administered with caution to pregnant women, since its chronic use can cause hypoadrenalism in the product.
Care should be taken when administering these drugs to lactating women.
Safety and effectiveness in children have not been established.
Concomitant use of corticosteroids and tobramycin may mask the clinical signs of infections by bacteria, fungi, or viruses.
The presence of corticosteroids can suppress hypersensitivity reactions to the antibiotic or other components of the formula.
Adverse reactions have occurred with the combination of steroids and anti-infectives or a combination of both. The most frequent adverse reactions against topical ocular administration of tobramycin are: pruritus, eyelid edema and conjunctival erythema. Reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequently optic nerve damage, formation of posterior subcapsular cataract and delayed healing.