Leading the way to safer medication
 Crosscheck  Recommender

TOBRADEX Eye drops, suspension (2015)

Active ingredients: Dexamethasone Tobramycin

Product Name and Form

TOBRADEX 3mg/ml/1mg/ml Eye Drops, Suspension.

Pharmaceutical form

Eye Drops, Suspension.

White to off-white suspension.

Qualitative and Quantitative Composition

Each ml contains: Tobramycin 3mg, Dexamethasone 1mg.

For full list of excipients, see section 6.1

Chemical substance
Description
Dexamethasone

Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity. It has an approximately 7 times greater anti-inflammatory potency than prednisolone, another commonly prescribed corticosteroid. At high doses it reduces the immune response.

Tobramycin

Tobramycin is an aminoglycoside antibiotic produced by Streptomyces tenebrarius. It acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope and eventual cell death. It is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations.

List of excipients

Disodium edetate
Hydroxyethylcellulose
Benzalkonium chloride
Purified water
Sodium chloride
Sodium sulphate anhydrous
Sulphuric acid for pH adjustment and / or
Sodium hydroxide for pH adjustment
Tyloxapol

Pack sizes and Marketing

5ml dropper container (LDPE) and screw cap (polypropylene).

Pack size: 1 × 5ml.

Marketing authorization holder
Authorization dates

Alcon Laboratories UK, Ltd., Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

31/01/2001 / 30/04/2010

Marketing authorization number:

PL 00649/0119