Drugs List

Therapeutic Indications

Uses

Ocular inflammatory conditions. where topical steroid & antibiotic is required

Contraindications

Ocular infection Herpes simplex keratitis Glaucoma Pregnancy Breastfeeding Wearing of contact lenses

Precautions and Warnings

Family history of glaucoma Corneal damage Diabetes mellitus
Family history of diabetes mellitus Monitor intraocular pressure frequently - risk of steroid glaucoma Check ocular lens frequently - risk of cataract formation Prolonged use may cause raised intraocular pressure Advise patient blurred vision may affect ability to drive/operate machinery May mask symptoms or signs of infections Prolonged or high dose may lead to adrenal suppression Prolonged use may result in ocular infections May cause perforation of eye in disorders that thin the sclera or cornea Exclude fungal infection before treatment Exclude bacterial infection before treatment Exclude tubercular infection before treatment Exclude viral infection before treatment Treat and control infections prior to commencing therapy Exclude raised intraocular pressure, cataracts & infection before repeating Possible systemic absorption of steroid In combined therapy, administer eye products at least five minutes apart Contact lenses should not be worn during treatment Monitor herpetic corneal disease (slit lamp examinations) If visual disturbances occur, perform ophthalmic evaluation Advise patient to avoid touching the eye/other surfaces with container tip To reduce systemic absorption compress lacrimal sac during administration Contains benzalkonium chloride. Not to be used with soft contact lenses If soft contact lenses worn,insert them 15 minutes after using eye drops
Discontinue if severe hypersensitivity reactions occur
May decrease glucose tolerance in patients with diabetes mellitus
Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus

Pregnancy and Lactation

Pregnancy

Use of the combination of dexamethasone with neomycin and polymyxin is contraindicated in pregnancy.

The manufacturer notes that there is little data on the use of this medication in pregnant woman and does not recommend its use.

Aminoglycosides, such as neomycin, do cross the placenta after intravenous dosing in pregnant women. Exposure to aminoglycosides has been shown to induce ototoxicity and nephrotoxicity, however, considering the ocular route of this product, neomycin is not expected to cause the same toxicity.
Prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation and hypoadrenalism in the infant.
Animal studies show reproductive toxicity after exposure to some of the active components, although with doses far greater than the clinical daily exposure to eye preparations.

Lactation

Use of the combination of dexamethasone with neomycin and polymyxin is contraindication in breastfeeding.

The manufacturer notes that it is unknown if the topical combinations of this medication are excreted in human milk and a risk to the breastfed infant cannot be excluded, a decision should be made whether to cease breastfeeding or stop taking the medication.

Side Effects

Side Effects Hypersensitivity reactions Increased intra-ocular pressure Systemic effects (on prolonged use) Subcapsular cataract Optic nerve damage Reduced visual acuity Visual field defects Blurred vision Reddening of eyes Corneal thinning Scleral thinning Headache Ocular discomfort Keratitis Conjunctivitis Ocular pruritus Sensation of foreign body in eye Increased lacrimation Ocular hyperaemia Ptosis Ocular pain Mydriasis Ocular irritation Photophobia Eye swelling Visual disturbances Cushing's syndrome Adrenal suppression Ulcerative keratitis Stevens-Johnson syndrome

Presentation

Ocular eye drops (preservative containing) and ointment containing dexamethasone, polymyxin B sulfate and neomycin sulfate.

Drugs List

Therapeutic Indications

Uses

Ocular inflammatory conditions. where topical steroid & antibiotic is required

Dosage

Adults

Children

Contraindications

Ocular infection Herpes simplex keratitis Glaucoma Pregnancy Breastfeeding Wearing of contact lenses

Precautions and Warnings

Family history of glaucoma Corneal damage Diabetes mellitus
Family history of diabetes mellitus Monitor intraocular pressure frequently - risk of steroid glaucoma Check ocular lens frequently - risk of cataract formation Prolonged use may cause raised intraocular pressure Advise patient blurred vision may affect ability to drive/operate machinery May mask symptoms or signs of infections Prolonged or high dose may lead to adrenal suppression Prolonged use may result in ocular infections May cause perforation of eye in disorders that thin the sclera or cornea Exclude fungal infection before treatment Exclude bacterial infection before treatment Exclude tubercular infection before treatment Exclude viral infection before treatment Treat and control infections prior to commencing therapy Exclude raised intraocular pressure, cataracts & infection before repeating Possible systemic absorption of steroid In combined therapy, administer eye products at least five minutes apart Contact lenses should not be worn during treatment Monitor herpetic corneal disease (slit lamp examinations) If visual disturbances occur, perform ophthalmic evaluation Advise patient to avoid touching the eye/other surfaces with container tip To reduce systemic absorption compress lacrimal sac during administration Contains benzalkonium chloride. Not to be used with soft contact lenses If soft contact lenses worn,insert them 15 minutes after using eye drops
Discontinue if severe hypersensitivity reactions occur
May decrease glucose tolerance in patients with diabetes mellitus
Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus

Pregnancy and Lactation

Pregnancy

Use of the combination of dexamethasone with neomycin and polymyxin is contraindicated in pregnancy.

The manufacturer notes that there is little data on the use of this medication in pregnant woman and does not recommend its use.

Aminoglycosides, such as neomycin, do cross the placenta after intravenous dosing in pregnant women. Exposure to aminoglycosides has been shown to induce ototoxicity and nephrotoxicity, however, considering the ocular route of this product, neomycin is not expected to cause the same toxicity.
Prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation and hypoadrenalism in the infant.
Animal studies show reproductive toxicity after exposure to some of the active components, although with doses far greater than the clinical daily exposure to eye preparations.

Lactation

Use of the combination of dexamethasone with neomycin and polymyxin is contraindication in breastfeeding.

The manufacturer notes that it is unknown if the topical combinations of this medication are excreted in human milk and a risk to the breastfed infant cannot be excluded, a decision should be made whether to cease breastfeeding or stop taking the medication.

Side Effects

Side Effects Hypersensitivity reactions Increased intra-ocular pressure Systemic effects (on prolonged use) Subcapsular cataract Optic nerve damage Reduced visual acuity Visual field defects Blurred vision Reddening of eyes Corneal thinning Scleral thinning Headache Ocular discomfort Keratitis Conjunctivitis Ocular pruritus Sensation of foreign body in eye Increased lacrimation Ocular hyperaemia Ptosis Ocular pain Mydriasis Ocular irritation Photophobia Eye swelling Visual disturbances Cushing's syndrome Adrenal suppression Ulcerative keratitis Stevens-Johnson syndrome

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: October 2017

Reference Sources

Summary of Product Characteristics: Maxitrol Eye Drops. Novartis Pharmaceuticals UK Limited. Revised June 2020.

Summary of Product Characteristics: Maxitrol Ointment. Novartis Pharmaceuticals UK Limited. Revised June 2020.