Drugs List

Therapeutic Indications

Uses

Topical prophylaxis and treatment of inflammation after ocular surgery

Contraindications

Children under 18 years
Breastfeeding
History of herpes simplex keratitis
Ocular infection
Undiagnosed red eye

Precautions and Warnings

Wearing of contact lenses
Glaucoma
Pregnancy

Exclude fungal invasion in cases of corneal ulceration
May mask symptoms or signs of infections
Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Check ocular lens frequently - risk of cataract formation
Monitor intraocular pressure frequently - risk of steroid glaucoma
May cause perforation of eye in disorders that thin the sclera or cornea
Prolonged use may cause raised intraocular pressure
Prolonged use may result in ocular infections
Not recommended for use longer than 2 weeks
Advise patient to avoid touching the eye/other surfaces with container tip
Remove contact lenses before use and re-insert 15 minutes after use

Pregnancy and Lactation

Pregnancy

Use loteprednol etabonate with caution in pregnancy.

The manufacturer notes that the potential risk for humans is unknown and this medication should not be used in pregnancy unless clearly necessary.

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

Loteprednol etabonate is contraindicated in breastfeeding.

It is not known whether loteprednol etabonate is excreted in human milk. Excretion in breast milk has not been investigated in animal studies.

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

Asthenia
Blurred vision (transient)
Breast neoplasm
Chest pain
Chills
Conjunctival hyperaemia
Conjunctival papillae
Corneal disorders
Cough
Diarrhoea
Dizziness
Dry eyes
Dry skin
Eczema
Epiphora
Facial oedema
Fever
Headache
Increased intra-ocular pressure
Iritis
Keratoconjunctivitis
Migraine
Nausea
Nervousness
Ocular burning
Ocular discharge
Ocular discomfort
Ocular irritation
Ocular pain
Pain
Paraesthesia
Pharyngitis
Photophobia
Rash
Rhinitis
Sensation of foreign body in eye
Taste disturbances
Tinnitus
Twitching
Urethritis
Urinary tract infections
Urticaria
Uveitis
Vomiting
Weight gain

Presentation

Eye drops containing loteprednol etabonate

Drugs List

Therapeutic Indications

Uses

Topical prophylaxis and treatment of inflammation after ocular surgery

Dosage

Adults

Elderly

Contraindications

Children under 18 years
Breastfeeding
History of herpes simplex keratitis
Ocular infection
Undiagnosed red eye

Precautions and Warnings

Wearing of contact lenses
Glaucoma
Pregnancy

Exclude fungal invasion in cases of corneal ulceration
May mask symptoms or signs of infections
Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Check ocular lens frequently - risk of cataract formation
Monitor intraocular pressure frequently - risk of steroid glaucoma
May cause perforation of eye in disorders that thin the sclera or cornea
Prolonged use may cause raised intraocular pressure
Prolonged use may result in ocular infections
Not recommended for use longer than 2 weeks
Advise patient to avoid touching the eye/other surfaces with container tip
Remove contact lenses before use and re-insert 15 minutes after use

Pregnancy and Lactation

Pregnancy

Use loteprednol etabonate with caution in pregnancy.

The manufacturer notes that the potential risk for humans is unknown and this medication should not be used in pregnancy unless clearly necessary.

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

Loteprednol etabonate is contraindicated in breastfeeding.

It is not known whether loteprednol etabonate is excreted in human milk. Excretion in breast milk has not been investigated in animal studies.

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

Asthenia
Blurred vision (transient)
Breast neoplasm
Chest pain
Chills
Conjunctival hyperaemia
Conjunctival papillae
Corneal disorders
Cough
Diarrhoea
Dizziness
Dry eyes
Dry skin
Eczema
Epiphora
Facial oedema
Fever
Headache
Increased intra-ocular pressure
Iritis
Keratoconjunctivitis
Migraine
Nausea
Nervousness
Ocular burning
Ocular discharge
Ocular discomfort
Ocular irritation
Ocular pain
Pain
Paraesthesia
Pharyngitis
Photophobia
Rash
Rhinitis
Sensation of foreign body in eye
Taste disturbances
Tinnitus
Twitching
Urethritis
Urinary tract infections
Urticaria
Uveitis
Vomiting
Weight gain

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: July 2014

Reference Sources

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com [Accessed on 2.07.14].

Summary of Product Characteristics: Lotemax 0.5% Eye Drops, Suspension, Bausch & Lomb UK Ltd, October 2012.