TOBRAL ® Tobramicina

TOBRAL ® is a drug based on Tobramycin

THERAPEUTIC GROUP: Antimicrobials - Aminoglycosides

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

Indications TOBRAL ® Tobramicina

TOBRAL ® is indicated in eye clinic in the treatment of eye infections and related appendages supported by tobramycin sensitive microorganisms.

Mechanism of action TOBRAL ® Tobramycin

Tobramycin, an active ingredient belonging to the category of aminoglycosides, is a natural antibiotic extracted for the first time by Streptomices, and is particularly effective in vitro and in vivo for the bacteriostatic and bactericidal action against pathogenic microorganisms responsible for eye diseases .

Like other aminoglycosides, torbramycin also performs its therapeutic action by permeating the wall and the bacterial membrane and avidly binding to the 30S ribosomal subunit, so as to inhibit the lengthening of the peptide chain and seriously compromise the functional and metabolic properties of the microorganism.

The topical use guaranteed by the application of TOBRAL ® also allows to minimize some of the side effects such as nephrotoxicity and ototoxicity, described instead for the systemic administration of aminoglycosides.

Different studies have also demonstrated the great microbicidal efficacy of tobramycin against staphylococcus aureus and pseudomonas aeruginosa, responsible for infectious diseases in patients with impaired and immunocompromised.

Studies carried out and clinical efficacy

1 SAFETY AND EFFECTIVENESS OF TOBRAMINE IN PEDIATRIC AGE

Paediatr Drugs. 2012 Apr 1; 14 (2): 119-30.

Yet another clinical trial that demonstrates the safety and therapeutic efficacy of topical ophthalmic use of tobramycin at 0.3% for the short-term treatment of blepharoconjunctivitis in pediatric patients.

2 . TOBRAMICINE AND PURULENT BACTERIAL CONJUNCTIVITIS

J Fr Ophtalmol. 2010 Apr; 33 (4): 241-8. Epub 2010 Mar 10.

Work demonstrating the effectiveness of topical treatment for 7 days with 0.3% tobramycin in purulent bacterial conjunctivitis, guaranteeing rapid remission of the signs in over 96% of treated patients.

3. REFRIGERATION OF TOBRAMICINA

Can J Ophthalmol. 2007 Dec; 42 (6): 883-4.

Interesting case report that reports the appearance of bronchospasm following the application of tobramycin based eye drops in a patient with no previous history of asthma or atopias.

Method of use and dosage

TOBRAL ®

Eye drops at 0.3% tobramycin (equivalent to 0.3 g of tobramycin per 100 ml of solution);

Ointment for ophthalmic use with 0.3% tobramycin (equal to 0.3 g of tobramycin per 100 g of product).

Despite the definition of the dosage scheme it is up to the doctor, after having very carefully considered the severity of the patient's clinical picture, generally the dosages recommended are:

2- 4 drops per day of eye drops 3-4 times a day;
2-4 applications of ointment per day.

Warnings TOBRAL ® Tobramicina

Although the topical use of tobramycin definitely limits the risks of ototoxicity and nephrotoxicity, it would be appropriate in any case to request continuous medical monitoring throughout the therapeutic process, especially for patients suffering from nephropathies and auditory-vestibular pathologies.

Inadequate use of antibiotics could facilitate the spread of microbial strains resistant to common antibiotic therapy.

TOBRAL ® proved to be safe even for pediatric patients.

PREGNANCY AND BREASTFEEDING

Despite the low systemic absorption of tobramycin linked to the topical use of the medicine, it would be appropriate to limit the use of TOBRAL ® during pregnancy and breastfeeding, to cases of real need.

Any therapy should be supervised by the specialist doctor.

Interactions

The presence among the excipients of tyloxapol, necessary to preserve the chemical and physical properties of the eye drops, makes the intake of TOBRAL ® incompatible with that of tetracycline.

Contraindications TOBRAL ® Tobramicina

The use of TOBRAL ® is contraindicated in case of hypersensitivity to the active ingredient, to structurally related drugs and to the relative excipients.

Undesirable effects - Side effects

Despite the topical use of tobramycin it greatly limits the side effects generally associated with the systemic administration of aminoglycosides, the application of TOBRAL ® could determine with some frequency the appearance of adverse reactions from hypersensitivity such as conjunctivitis, pruritus, edema and redness.