MAXITROL %w/v Eye Drops Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DEXAMETHASONE, POLYMYXIN B SULFATE, NEOMYCIN SULFATE

Available from:

Alcon Laboratories (UK) Ltd

ATC code:

S01CA01

INN (International Name):

DEXAMETHASONE, POLYMYXIN B SULFATE, NEOMYCIN SULFATE

Dosage:

%w/v

Pharmaceutical form:

Eye Drops Suspension

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Corticosteroids and antiinfectives in combination

Authorization status:

Authorised

Authorization date:

1988-04-01

Patient Information leaflet

64770-3
MAXITROL
®
0.1  % W/V, 6000 IU/ML, 3500 IU/ML EYE DROPS, SUSPENSION
DEXAMETHASONE, POLYMYXIN B SULPHATE, NEOMYCIN SULPHATE
PACKAGE LEAFLET - INFORMATION FOR THE USER
MAXITROL contains a steroid, dexamethasone 
and two antibiotics, neomycin sulphate and 
polymyxin B sulphate.
IT IS USED FOR THE SHORT TERM TREATMENT of 
inflammation of the eye, where administration  
of an antibiotic is also required to prevent an  
eye infection.
1. WHAT MAXITROL IS AND WHAT IT 
IS USED FOR
2. BEFORE YOU USE MAXITROL
3. HOW TO USE MAXITROL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE MAXITROL
6. FURTHER INFORMATION
DO NOT USE MAXITROL...
• If you have ANY TYPE OF INFECTION of the eye 
that is not being treated including viral, fungal 
or untreated parasitic eye infections or 
Tuberculosis of the eye. Use of steroids may
make infections worse.
• If you are ALLERGIC to dexamethasone, 
polymyxin B, neomycin or to any of the  
other ingredients listed in section 6.
Ask your doctor for advice.
TAKE SPECIAL CARE...
• Only use MAXITROL in your eye(s).
• Consult your doctor or pharmacist before 
using this medicine if you have a disorder 
causing a THINNING OF THE EYE TISSUES.
• If you experience ALLERGIC REACTIONS with
MAXITROL, discontinue use and consult your 
doctor. Allergic reactions may vary from
localized itching or skin redness to severe 
allergic reactions (anaphylactic reaction) or 
serious skin reactions. These allergic reactions 
may occur with other topical or systemic 
antibiotics of the same family 
(aminoglycosides).
• Consult your doctor or pharmacist if your 
symptoms get worse or persist. You may
become more susceptible to eye infections 
with the use of this product.
• Steroids applied to the eye may delay the 
healing of your eye wound. Topical NSAIDs 
(Non-Steroidal Anti Inflammatory Drugs-
Medications) are also known to slow or delay 
healing. Concomitant use of topical NSAIDs 
and topical steroids may 

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maxitrol 0.1% w/v, 6000 IU/ml, 3500 IU/ml eye drops, suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml suspension contains 1 mg Dexamethasone, 6000 IU Polymyxin B Sulphate, 3500 IU Neomycin Sulphate (as base)
Excipients:
1ml suspension contains 0.04 mg Benzalkonium Chloride
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, suspension
White to pale yellow opaque suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Maxitrol Eye Drops is indicated for the short-term treatment of steroid responsive conditions of the eye when
prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Children and Adults (including the Elderly)
Apply one or two drops to each affected eye up to six times daily or, more frequently if required.
Heptic and renal impairment
Maxitrol Eye Drops has not been studied in these subject populations.
Method of administration
For ocular use only. Not for injection or ingestion.
Shake the bottle well before use.
After cap is removed, if tamper evident snap collar is loose, remove before using product.
In order to prevent contamination of the dropper tip and the suspension, caution should be exercised to ensure
that the dropper tip does not touch the eyelids, the surroundings of the eye, or any other surfaces.
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the
systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic
adverse reactions.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients.
Herpes simplex ker