Drugs List

Therapeutic Indications

Uses

Otitis externa - infective
Steroid-responsive eye conditions where prophylactic antibiotic required

Administration

To be instilled into the ears or eyes

Wash hands prior to use.

Avoid contact of the container with the eye or other surfaces as contamination leading to ophthalmic infection may occur.

Contraindications

Glaucoma
Perforated tympanic membrane
Undiagnosed red eye

Precautions and Warnings

Breastfeeding
Pregnancy

May mask symptoms or signs of infections
Advise patient blurred vision may affect ability to drive/operate machinery
Exclude fungal infection before treatment
Exclude raised intraocular pressure, cataracts & infection before repeating
Exclude tubercular infection before treatment
Exclude viral infection before treatment
Discard any remaining solution 28 days after opening
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Possible ototoxicity when used at high doses in susceptible groups
Prolonged use may result in infection due to resistant organisms
Prolonged/excessive use may lead to adrenal suppression
Discontinue if no improvement occurs within 7 days
Avoid long term use
Not to be used with contact lenses
Soft contact lenses should not be worn during treatment

Small children and Infants may be at greater risk of aminoglycoside induced deafness due to systemic absorption if high dose topical treatment is administered.

Pregnancy and Lactation

Pregnancy

Safety in pregnancy has not been established.

Animal studies have shown that topical administration of corticosteroids can produce foetal abnormalities including cleft palate and growth retardation, there may therefore be a small risk of such effects in the human foetus.

Risk of foetal ototoxicity if aminoglycoside antibiotic preparations are given during pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Caution is advised as there is no evidence of safety if used during lactation.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Blurred vision (transient)
Burning sensation (local)
Corneal thinning
Dermatitis
Glaucoma
Hypersensitivity reactions
Increased intra-ocular pressure
Irritation (localised)
Itching sensation (local)
Optic nerve damage
Perforation of the ocular globe
Posterior subcapsular cataracts
Reduced visual acuity
Scleral thinning
Stinging
Thinning of the ocular globe
Visual field defects

Presentation

Drops containing framycetin, dexamethasone and gramicidin

Drugs List

Therapeutic Indications

Uses

Otitis externa - infective
Steroid-responsive eye conditions where prophylactic antibiotic required

Dosage

If there is no response within 7 days, the drops should be discontinued.

Apply this preparation last if using eye drops concomitantly.

Leave an interval of at least 5 minutes before instilling another ophthalmic medication.

Adults

Elderly

Children

Administration

To be instilled into the ears or eyes

Wash hands prior to use.

Avoid contact of the container with the eye or other surfaces as contamination leading to ophthalmic infection may occur.

Contraindications

Glaucoma
Perforated tympanic membrane
Undiagnosed red eye

Precautions and Warnings

Breastfeeding
Pregnancy

May mask symptoms or signs of infections
Advise patient blurred vision may affect ability to drive/operate machinery
Exclude fungal infection before treatment
Exclude raised intraocular pressure, cataracts & infection before repeating
Exclude tubercular infection before treatment
Exclude viral infection before treatment
Discard any remaining solution 28 days after opening
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Possible ototoxicity when used at high doses in susceptible groups
Prolonged use may result in infection due to resistant organisms
Prolonged/excessive use may lead to adrenal suppression
Discontinue if no improvement occurs within 7 days
Avoid long term use
Not to be used with contact lenses
Soft contact lenses should not be worn during treatment

Small children and Infants may be at greater risk of aminoglycoside induced deafness due to systemic absorption if high dose topical treatment is administered.

Pregnancy and Lactation

Pregnancy

Safety in pregnancy has not been established.

Animal studies have shown that topical administration of corticosteroids can produce foetal abnormalities including cleft palate and growth retardation, there may therefore be a small risk of such effects in the human foetus.

Risk of foetal ototoxicity if aminoglycoside antibiotic preparations are given during pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Caution is advised as there is no evidence of safety if used during lactation.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Blurred vision (transient)
Burning sensation (local)
Corneal thinning
Dermatitis
Glaucoma
Hypersensitivity reactions
Increased intra-ocular pressure
Irritation (localised)
Itching sensation (local)
Optic nerve damage
Perforation of the ocular globe
Posterior subcapsular cataracts
Reduced visual acuity
Scleral thinning
Stinging
Thinning of the ocular globe
Visual field defects

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 (https://www.toxbase.org/).

Further Information

Last Full Review Date: December 2013

Reference Sources

Summary of Product Characteristics, Sofradex ear/eye drops, Sanofi-Aventis, November 2012

Joint Formulary Committee. British National Formulary. 66th ed. London: BMJ Group and Pharmaceutical Press; 2013. Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [Accessed on [4 December 2013]].

Paediatric Formulary Committee. BNF for Children 2013-2014. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2013. Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications [Accessed on [4 December 2013]].