MAXITROL Eye Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

NEOMYCIN SULFATE, POLYMYXIN B SULFATE, DEXAMETHASONE

Available from:

Alcon Laboratories (UK) Ltd

ATC code:

S01CA01

INN (International Name):

NEOMYCIN SULFATE, POLYMYXIN B SULFATE, DEXAMETHASONE

Pharmaceutical form:

Eye Ointment

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maxitrol 0.1% w/w, 6000 IU/g, 3500 IU/g eye ointment.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexamethasone 1mg/g (0.1% w/w).
Polymyxin B Sulphate 6,000 IU/g.
Neomycin Sulphate (as Base) 3,500 IU/g.
Also contains:
Methyl parahydroxybenzoate (E218) 0.05% w/w
Propyl parahydroxybenzoate (E216) 0.01% w/w
Liquid Lanolin 3.0% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye Ointment
A white to very pale yellow homogenous translucent ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MAXITROL eye ointment 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 a small amount into the conjunctival sac(s) up to three to four times daily or, may be used adjunctively with
drops at bedtime.
Do not let the tip of the tube touch your eye
For topical ophthalmic use only. Not for injection or ingestion.
Hepatic and renal impairment
Maxitrol Eye Ointment has not been studied in these subject populations.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients.
Herpes simplex keratitis.
Vaccinia, varicella, and other viral infection of cornea or conjunctiva
Fungal diseases of ocular structures or untreated parasitic eye infections.
Mycobacterial ocular infections.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 23/12/2016_
_CRN 2178784_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with all antibacterial preparation