drugs

TOBRADEX ® Tobramycin + Dexamethasone

TOBRADEX Ear Drops ® is a drug based on Tobramycin + Dexamethasone

THERAPEUTIC GROUP: Antimicrobials - Aminoglycosides

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications TOBRADEX ® Tobramycin + Dexamethasone

TOBRADEX Ear Drops ® is indicated in the treatment of inflammatory diseases of the external ear and middle ear supported by bacterial infections sensitive to tobramycin.

Mechanism of action TOBRADEX ® Tobramycin + Dexamethasone

TOBRADEX Ear Drops ® combines two active ingredients that are particularly effective in ensuring a prompt remission of the auricular symptoms linked to infections of the external auditory canal and the middle ear.

More precisely this medicine contains:

  • Tobramycin: an antibiotic belonging to the aminoglycoside family, able to carry out its own bacteriostatic and bactericidal action by permeating the bacterial wall and inhibiting protein synthesis by binding to the 30S ribosomal subunit.
  • Dexamethasone: synthetic corticosteroid responsible for an impressive anti-inflammatory activity linked to the inhibition of phospholipase A2, a key enzyme in the transformation of membrane phospholipids into arachidonic acid, a direct precursor of a series of chemical mediators with pro-inflammatory activity known as prostaglandins.

Different studies have shown that the local application of tobramycin can significantly reduce the risk of ototoxicity, generally linked to the use of systemic aminoglycosides, thus making the administration of TOBRADEX to the ear effective and safe.

Studies carried out and clinical efficacy

1 THE TOBRAMINE IN PROFILASSI SURGICAL

J Ocul Pharmacol Ther. 2012 Mar 15. [Epub ahead of print]

Interesting work that demonstrates how prophylaxis with tobramycin following keratoplasty surgery can be effective in improving the post-operative clinical course, reducing the development of adverse reactions.

2 . TOBRAMINE AND IMMUNE SYSTEM

Muscle Nerve. 1997 May; 20 (5): 631.

Case report denouncing the unmasking and exacerbation of myasthenia gravis in a previously asymptomatic patient following topical administration of tobramycin and dexamethasone. However, the molecular mechanisms not yet known seem to affect the effects of these drugs on immune defenses.

3. THE EFFECTIVENESS OF TOBRAMICINE / DESAMETASONE IN THE TREATMENT OF MEDIUM OTITIS

Kulak Burun Bogaz Ihtis Derg. 2002 Mar-Apr; 9 (2): 106-11.

Trial that demonstrates the efficacy of topical administration of tobramycin and dexamethasone in the treatment of suppurative otitis media, resulting effective even in the short term.

Method of use and dosage

TOBRADEX ® ear drops

Sterile suspension for topical use by 3 mg of tobramycin and 1 mg of dexamethasone.

Despite the specific dosage and the relative dosage schedule should be defined by your doctor based on the clinical condition of the patient, in principle the application of four drops 3-4 times a day in the external auditory canal should be sufficient to guarantee a prompt remission of the symptomatology in progress.

Warnings TOBRADEX ® Tobramycin + Dexamethasone

The presence in TOBRADEX of auricular drops ® of corticosteroids such as dexamethasone makes therapy with this medicine unsuitable for pediatric patients given the high susceptibility to hormonal changes in the hypothalamic-pituitary axis and to the side effects induced by corticosteroid therapy.

The use of TOBRADEX Ear Drops ® must necessarily be supervised by your doctor in order to avoid the appearance of potentially dangerous adverse reactions.

For this reason, if signs and symptoms of hypersensitivity to the drug appear, it would be useful to immediately consult your doctor with whom to evaluate the possibility of suspending the therapy in progress.

Prolonged use of antibiotics could promote the growth of microorganisms resistant to common antibiotic therapy, which could further compromise the patient's health.

PREGNANCY AND BREASTFEEDING

The absence of studies able to characterize the pharmacokinetic properties and the relative safety profile for the dexamethasone and tobramycin fetus taken topically, limits the use of TOBRADEX Ear drops ® during pregnancy and in the subsequent period of breastfeeding at exclusively in cases of real need and under strict medical supervision.

Interactions

The presence of tyloxapol, makes the administration of TOBRADEX ear drops ® with tetracyclines incompatible.

Contraindications TOBRADEX ® Tobramycin + Dexamethasone

The use of TOBRAL ® is contraindicated in case of hypersensitivity to the active ingredient and to the relative excipients, during breastfeeding, in patients suffering from viral pathologies with cutaneous localization and in children under the age of 2 years.

Undesirable effects - Side effects

The use of TOBRADEX Ear Drops ® has only been associated in rare cases with hypersensitivity manifestations such as itching, redness and pain during application.

Topical use significantly reduces the potential side effects commonly associated with systemic therapy with aminoglycosides, especially nephro and ototoxicity.

Note

TOBRADEX Ear Drops ® is a prescription drug.