MAXITROL OINTMENT

Dexamethasone Ph.Eur 1mg/g

Polymyxin B Sulphate EP 6000 IU/g

Neomycin Sulphate (as base) 3500 IU/g

For excipients see 6.1.

Eye ointment

White to very pale yellow greasy homogeneous ointment for topical

administration.

Maxitrol 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.

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.

Hypersensitivity to neomycin or to any component of the preparation. (Cross-sensitivity with other aminoglycoside antibiotics may occur). Herpes simplex and other viral diseases of the cornea and conjuctiva, fungal disease, ocular tuberculosis, amoeba infections and untreated purulent infections.

Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding.

Prolonged use should be avoided as it may lead to skin sensitisation and the emergence of resistant organisms.

Neomycin may cause irreversible partial or total deafness when given systemically or when applied topically to open wounds or damaged skin. This effect is dose-related and is enhanced by renal or hepatic impairment. Although this effect has not been reported following topical ocular use the possibility should be considered when high dose topical treatment is given to small children or infants.

Because of the risk of “steroid glaucoma” and cataract formation the intraocular pressure and the lens must be checked frequently during use of this preparation.

To avoid the risk of enhancement of herpetic corneal disease, frequent slip lamp examination is essential.

Topical steroids may mask or enhance the activity of acute purulent eye infections. In such cases antibiotic therapy is mandatory.

Persistent corneal ulceration following long-term topical steroid use may be due to fungal invasion.

Topical corticosteroids are not effective in mustard gas keratitis or Sjorgren's keratoconjunctivitis.

None relevant to topical use.

Safety for use in pregnancy and lactation has not been established. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth with retardation. There may therefore be a very small risk of such effects in human pregnancy. Use only when it is considered essential by the physician.

May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery unless vision is clear.

Hypersensitivity reactions, usually of the delayed type, occur frequently with local treatment with neomycin. Irritation, burning, stinging, itching and dermatitis may occur. Topical steroid use may result in increased intraocular pressure leading to optic nerve disease, reduced visual acuity and visual field defects. Intensive or prolonged use of topical corticosteroids may lead to formation of posterior subcapsular cataracts. In those diseases causing thinning of the cornea or sclera, perforation of the globe may occur. Viral and fungal infections may be exacerbated by steroids. Systemic side effects may occur with extensive use.

Long-term intensive topical use may lead to systemic effects. Oral ingestion of the contents of one tube is unlikely to lead to any serious adverse effects.

Pharmacotherapeutic Group; Antiinflammatory and antiinfectives in combination

ATC Code: SO1C A01

Maxitrol contains dexamethasone, neomycin sulphate and polymyxin B sulphate as active constituents.

Dexamethasone is a synthetic glucocorticoid with a potent anti-inflammatory activity. The relative anti-inflammatory potency of dexamethasone is 25 times that of cortisone, but its effects on sodium and water retention, potassium loss and abnormal sugar metabolism are minimal.

Neomycin is a broad spectrum antibiotic, highly sensitive gram negative organisms include: E. coli, Enterobacter aerogenes, K.pneumoniae, Pasteurella, Pr.vulgaris, Salmonella, Shigella, Haemophilus influenzae, Neisseria meningitidis, Vibrio cholerae, and Bordetella pertussis.

Gram positive microorganisms that are inhibited include: Bacillus anthracis, Corynebacterium diptheriae, Staph. aureus, Strep. facecalis, Listeria monocytogenes and M. tuberculosis. Borrelia and Leptospira interrogans (icterohaemorrhagiae) are also suppressed. Strains of Pseudomonas aeruginosa are resistant to neomycin.

Polymyxin B sulphate is active only against gram negative bacteria and is particularly active against Pseudomonas aeruginosa. Other sensitive organsims are: Enterobacter, Escerichia coli, Klebsiella, Salmonella, Pasteurella, Bordetella and Shigella. However, protens and most strains of Neisseria, Providentia and Serratia are resistant to Polymyxin B. Most sensitive organisms are inhibited by 0.1 to 0.2 units/ml.

Dexamethasone, like other corticosteroids, is absorbed rapidly after oral administration and has a biological half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects. Intraocular penetration of dexamethasone occurs in significant amounts and contributes to the effectiveness of dexamethasone in anterior segment inflammatory disease.

Polymyxin B sulphate is not absorbed from the gastrointestinal tract or through intact skin, although the intact corneal epithelium prevents penetration into the corneal stroma, therapeutic concentrations do enter the stroma after epithelial damage. Good stromal penetration occurs after epithelial abrasion following topical instillation, subconjunctival injection, or corneal bath. No significant polymyxin B penetration into the vitreous is demonstrable after parenteral or local administration of the drug.

Neomycin is poorly absorbed from the gastrointestinal tract and after topical administration an insufficient amount is absorbed to produce systemic effects. Absorption has been reported to occur from wounds and inflamed skin. After absorption neomycin is rapidly excreted by the kidneys in active form.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Methylparaben, Propylparaben, Liquid lanolin, Petrolatum

None known.

Unopened 30 months, after opening 28 days.

Do not store above 25°C. Keep away from direct sunlight. Do not refrigerate. Keep the container tightly closed.

3.5 g metal tube with nozzle and screw cap.

Do not touch the top of the tube to any surface as this may contaminate the contents.

Alcon Laboratories (UK) Ltd

Pentagon Park

Boundary Way

Hemel Hempstead

HP2 7UD

0649/5916R

18th October 1997/ April 2001

17^th November 1998