INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo MAXITROL® Ophthalmic suspension
MAXITROL® Ophthalmic ointment

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

MAXITROL® Ophthalmic suspension
MAXITROL
® Ophthalmic ointment

COMPOSITION:
MAXITROL Ophthalmic Suspension:
Each mL contains:
Polymyxin B sulphate 6 000 units
Neomycin sulphate 3 500 units
Dexamethasone 1,0 mg
Preserved with benzalkonium chloride 0,004% (m/v)
MAXITROL Ophthalmic Ointment:
Each g contains:
Polymyxin B sulphate 6 000 units
Neomycin sulphate 3 500 units
Dexamethasone 1,0 mg
Preserved with methylparaben 0,05% (m/v)
and propylparaben 0,01% (m/v)
PHARMACOLOGICAL CLASSIFICATION:
A.15.3 Combination antibiotics and/or sulphonamides and corticosteroids.

PHARMACOLOGICAL ACTION:
Polymyxin B is effective against gram-negative bacteria and is bactericidal. The following organisms are highly susceptible: Enterobacter, Escherichia, Haemophilus, Klebsiella, Pasteurella, Salmonella, Shigella, Vibrio and Pseudomonas. Development of resistant strains occur infrequently. Neomycin sulphate is a broadspectrum antibiotic. Gram-negative species that are highly sensitive are E. coli, Enterobacter, Aerobacter aerogenes, K. pneumoniae, Pasteurella, Pr. vulgaris, Salmonella, Shigella, H. influenzae, N. meningitidis, V. cholerae and B. pertussis. Gram-positive microorganisms that are inhibited include Bacillus anthracis, C. diphtheriae, Staph. aureus, Strep. faecalis, List. monocytogenes and M. tuberculosis. Borelia and Leptospira interrogans are also suppressed. The sensitivity of Pseud. aeruginosa is variable. Neomycin is active against tubercle bacilli, regardless of their susceptibility to streptomycin. Dexamethasone is a 16-methyl substituted hydrocortisone analog with the highest anti- inflammatory potency and it readily penetrates the cornea.

INDICATIONS:
In the management of infectious ocular inflammations produced by organisms which are sensitive to the antibiotics neomycin sulphate and polymyxin B sulphate. Acute or chronic non-purulent conjunctivitis, blepharoconjunctivitis and keratoconjunctivitis; non-specific superficial keratitis; deep keratitis; acne rosacae keratitis; iridocyclitis; mild acute iritis, recurrent marginal ulceration and corneal ulcer (use with care in those diseases causing thinning of the cornea because of the danger of perforation); non-purulent blepharitis; scleritis; episcleritis; scleroconjunctivitis; herpes zoster ophthalmicus (do not use in herpes simplex); and post; operatively to aid in the prevention of ophthalmic cases of infections.

WARNINGS:
As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved preparations cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.

CONTRA-INDICATIONS:
Contra-indicated in tubercular, fungal and most viral lesions of the eye (herpes simplex-dendritic keratitis); vaccinia varicella, acute purulent conjunctivitis and acute purulent blepharitis and in those persons who have shown hypersensitivity to any of its components. Mechanical lacerations and abrasions.

DOSAGE AND DIRECTIONS FOR USE:
MAXITROL
®Ophthalmic Suspension: Instil one to two drops topically in the conjunctival sac(s) four to six times daily. Dosage may be reduced after three to four days when satisfactory improvement has been obtained. SHAKE BOTTLE WELL BEFORE USE.

MAXITROL
®Ophthalmic Ointment: Apply a small amount of ophthalmic ointment into the conjunctival sac(s) three to four times daily. When favourable response is observed dosage may be reduced gradually to once a day application for several days.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Corticosteroids delay wound healing, promote development and spread of infection and may mask evidence of its progression until sight is lost. Perforation has been known to occur with the use of topical steroids in those diseases of the eye which cause thinning of the cornea or sclera.
Employment of steroid medication in the treatment of stromal herpes simplex requires great caution; frequent slit lamp microscopy is mandatory. Steroid medication may give rise to serious exacerbations of herpes infections of the eye.
Prolonged use may result in glaucoma, damage to the optic nerve, defects in visual acuity and fields of vision, posterior subcapsular cataract formation, or may aid in the establishment of secondary ocular infection from the pathogens liberated from ocular tissue.
As fungal infections of the cornea are particularly prone to develop coincidentally with long-term topical steroid applications, fungus invasion must be suspected in any persistent corneal ulceration where a steroid has been used or is in use.
Prolonged use may give rise to the development of iatrogenic glaucoma. Intraocular pressure should be monitored frequently. If the eye has not responded within 48 hours, the patient should be referred to an ophthalmologist because of the possibility of inducing corneal abscess, fungal keratopathy or glaucoma.
Prolonged local use of neomycin should be avoided as it may lead to sensitisation. Hypersensitivity reactions, usually of the delayed type have occurred during local treatment with neomycin but may be masked by the dexamethasone.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
As for side effects and special precautions above. Discontinue use immediately.

IDENTIFICATION:
MAXITROL
®Ophthalmic Suspension: White to pale yellow, opaque suspension.
MAXITROL
®Ophthalmic Ointment: Translucent ointment.

PRESENTATION:
MAXITROL
®Ophthalmic Suspension: Low density polyethylene bottle containing 5 mL.
MAXITROL
®Ophthalmic Ointment: Ophthalmic ointment tube containing 3,5 g.

STORAGE INSTRUCTIONS:
Keep in a cool place, below 25°C. Keep out of reach of children.
Suspension: Do not use more than 30 days after opening.

REFERENCE NUMBER:
MAXITROL
®Ophthalmic suspension: H.1145 (Act 101/1965)
MAXITROL
®Ophthalmic ointment: H.1158 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alcon Laboratories (SA) (Pty) Limited
Surrey Avenue
RANDBURG 2194

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 1981

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