TOBRADEX

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug TOBRADEX contains a combination of these active pharmaceutical ingredients (APIs):

1 Dexamethasone UNII 7S5I7G3JQL - 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. Read about Dexamethasone

2 Tobramycin UNII VZ8RRZ51VK - 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. Read about Tobramycin

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
TOBRADEX Eye drops, suspension	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC
TOBRADEX Ophthalmic suspension	FDA, National Drug Code (US)	MPI, US: SPL/Old
TOBRADEX Ophthalmic ointment	FDA, National Drug Code (US)	MPI, US: SPL/Old

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
S01CA01	Dexamethasone and antiinfectives	S Sensory organs → S01 Ophthalmologicals → S01C Antiinflammatory agents and antiinfectives in combination → S01CA Corticosteroids and antiinfectives in combination
Discover more medicines within S01CA01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 500903401160319, 500903402175311
Country: CA	Health Products and Food Branch	Identifier(s): 00778907, 00778915
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 1070-MEE-0615, 26.015-10-04
Country: EE	Ravimiamet	Identifier(s): 1124266, 1150276
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 61575
Country: FR	Base de données publique des médicaments	Identifier(s): 66302120
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 140063, 146719, 162763, 37483
Country: HK	Department of Health Drug Office	Identifier(s): 33403, 33404
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1007700, 1074800, 1080370, 1080500, 1081607, 1082310, 1089623
Country: MT	Medicines Authority	Identifier(s): MA1249/02801, MA1249/02802
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 161M91, 228M92
Country: NG	Registered Drug Product Database	Identifier(s): B4-3477
Country: NL	Z-Index G-Standaard	Identifier(s): 13627759, 13627767
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 86614, 86622
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 5239
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100108415, 100324857, 100325644, 100330467, 100335520, 100335536, 100344950, 100345500, 100359873, 100362125, 100398005, 100403982, 100420058, 100420874, 100426813, 100426954, 100429875, 100441758, 100443208, 100448186, 100451652
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W63594001, W63595001
Country: SG	Health Sciences Authority	Identifier(s): 04309P, 04438P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 10283381, 10283382
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699504710168
Country: US	FDA, National Drug Code	Identifier(s): 0065-0647, 0065-0648, 0065-0652, 0078-0876
Country: ZA	Health Products Regulatory Authority	Identifier(s): X/15.3/91, X/15.3/92