MAXITROL Eye drops, suspension Ref.[50678] Active ingredients: Dexamethasone Neomycin Polymyxin B

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom

Product name and form

MAXITROL EYE DROPS.

Pharmaceutical Form

Eye drops, suspension.

White sterile suspension for topical ocular administration.

Qualitative and quantitative composition

1 ml suspension contains 1 mg dexamethasone, 6000 IU polymyxin B sulphate, 3500 IU neomycin sulphate (as base).

Excipient(s) with known effect: 1 ml suspension contains 0.04 mg benzalkonium chloride.

For a full list of excipients, see section 6.1.

Active Ingredient 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.

Neomycin

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

Polymyxin B

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.

List of Excipients

Sodium chloride
Polysorbate 20
Benzalkonium chloride
Hydroxypropyl methylcellulose
Hydrochloric acid/sodium hydroxide
Purified water

Pack sizes and marketing

5 ml & 10 ml DROP-TANIER, natural LDPE bottles and plugs with polystyrene or polypropylene caps.

Marketing authorization holder

Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom

Marketing authorization dates and numbers

PL 00101/1000

24 January 1991

Drugs

Drug Countries
MAXITROL Brazil, Canada, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Mexico, Nigeria, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States

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