MAXITROL

This brand name is authorized in United States. It is also authorized in Brazil, Canada, Croatia, Ecuador, Estonia, Finland, Hong Kong SAR China, Ireland, Israel, Lithuania, Mexico, New Zealand, Nigeria, Poland, Romania, Singapore, Spain, Tunisia, UK.

Active ingredients

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

1
UNII 057Y626693 - NEOMYCIN SULFATE
 

Neomycin is an aminoglycoside antibiotic and acts by binding to polysomes, inhibiting protein synthesis and generating errors in the transcription of the genetic code.

 
Read more about Neomycin
2
UNII 19371312D4 - POLYMYXIN B SULFATE
 

Polymixin B is bactericidal against a wide range of gram negative bacilli. It exerts a bactericidal effect by binding to acid phospholipids in the cell wall and membranes of the bacterium, thereby rendering ineffective the osmotic barrier normally provided by the cell membrane.

 
Read more about Polymyxin B
3
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 more about Dexamethasone

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 MAXITROL Eye drops, suspension MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

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

ATC Group 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)
BR Câmara de Regulação do Mercado de Medicamentos 500902601166312, 500902602170313
CA Health Products and Food Branch 00042676, 00358177
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 1072-MEE-0615, 25.910-09-04
EE Ravimiamet 1124301
ES Centro de información online de medicamentos de la AEMPS 42610, 5730-2005-01, PL00649-5915R
FI Lääkealan turvallisuus- ja kehittämiskeskus 486886
GB Medicines & Healthcare Products Regulatory Agency 14965, 43787
HK Department of Health Drug Office 16912, 17041
HR Agencija za lijekove i medicinske proizvode HR-H-013807789, HR-H-641598573
IE Health Products Regulatory Authority 73105
IL מִשְׂרַד הַבְּרִיאוּת 3246, 742
LT Valstybinė vaistų kontrolės tarnyba 1012840, 1012841, 1066138, 1077966, 1078906, 1078907, 1085353, 1085793, 1087839
MX Comisión Federal para la Protección contra Riesgos Sanitarios 63496, 64134
NG Registered Drug Product Database 04-1570, A4-1744
Switch country to Nigeria in order to find specific presentations of MAXITROL
NZ Medicines and Medical Devices Safety Authority 945, 946
PL Rejestru Produktów Leczniczych 100042165, 100046170, 100079441, 100132336, 100257701, 100257753, 100257990, 100260809, 100265882, 100283443, 100288593, 100324840, 100343205, 100360853, 100360988, 100365508, 100383334, 100393657, 100398991, 100406029, 100406874, 100421537, 100426300, 100455218, 100458049, 100458277, 100458596, 100460302, 100460310, 100467943
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W63598001
SG Health Sciences Authority 04358P
TN Direction de la Pharmacie et du Médicament 10283441
US FDA, National Drug Code 0065-0631, 0078-0771, 0998-0630

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