Drugs List

Therapeutic Indications

Uses

Keratoconjunctivitis sicca
Vernal keratoconjunctivitis

Severe keratitis in adults with dry eye disease (keratoconjunctivitis sicca), which has not improved despite treatment with tear substitutes.

Treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.

Contraindications

Children under 4 years
Breastfeeding
Ocular infection
Ocular or periocular malignancies
Periocular infection

Precautions and Warnings

Children aged 4 to 18 years
Wearing of contact lenses
Glaucoma
History of viral ocular infection
Ocular herpes simplex infection
Pregnancy

Advise patient blurred vision may affect ability to drive/operate machinery
Exclude ocular & periocular malignacies or pre-malignancies before therapy
Exclude ocular or periocular infection prior to treatment
Not all available brands are licensed for all indications
Not all available brands/formulations are licensed for use in children
Treatment to be prescribed under the supervision of a specialist
Contains cetalkonium chloride - May cause eye irritation
Administer other ophthalmic products at least 15 minutes apart
For single use only
To reduce systemic absorption compress lacrimal sac during administration
KCS: Response to treatment should be reassessed every 6 months
Female: Ensure adequate contraception during treatment
Advise patient to avoid touching the eye/other surfaces with container tip
KCS: Remove contact lenses before use and re-insert at wake-up time
VKC: Use of contact lenses not recommended

Pregnancy and Lactation

Pregnancy

Use ciclosporin with caution during pregnancy.

The manufacturer advises that ciclosporin eye drops are not recommended during pregnancy and that they should only be used when the benefits outweigh the risks. Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin at exposure considered sufficiently in excess of the maximum human exposure, indicating little relevance to the clinical use of this medication. Data available from organ transplant recipients indicate that, compared with other immunosuppressive agents, ciclosporin treatment imposes no increased risk of adverse effects on the course or outcome of pregnancy, however there is an increased risk of premature birth. Exposure to ciclosporin does not justify termination of pregnancy. A detailed foetal ultrasound examination should be offered to confirm normal morphologic development in the case of first-trimester exposure.

Lactation

Ciclosporin is contraindicated during breastfeeding.

The manufacturer advises that at therapeutic doses of ciclosporin in eye drops, it is unlikely that sufficient amounts would be present in breastmilk. However, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from this medication, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. Ciclosporin is excreted into breastmilk, although the concentrations are relatively low. A risk to neonates cannot be excluded. Schaefer considers that this drug should pose no obstacle to breastfeeding, as long as breastfeeding did not take place for at least four hours after ciclosporin administration so as to avoid peak ciclosporin levels in milk.

Side Effects

Application site reaction
Blepharitis
Blurred vision (transient)
Chalazion
Conjunctival hyperaemia
Conjunctival irritation
Conjunctival oedema
Conjunctivitis
Corneal decompensation
Corneal deposits
Corneal infiltrates
Corneal scar
Cough
Eyelid erythema
Eyelid oedema
Eyelid pruritus
Headache
Increased lacrimation
Iridocyclitis
Keratitis
Lacrimal gland disorder
Ocular discharge
Ocular discomfort
Ocular hyperaemia
Ocular irritation
Ocular pain
Ocular pruritus
Ophthalmic herpes zoster
Sensation of foreign body in eye
Upper respiratory tract infection

Drugs List

Therapeutic Indications

Uses

Keratoconjunctivitis sicca
Vernal keratoconjunctivitis

Severe keratitis in adults with dry eye disease (keratoconjunctivitis sicca), which has not improved despite treatment with tear substitutes.

Treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.

Dosage

Adults

Children

Additional Dosage Information

Contraindications

Children under 4 years
Breastfeeding
Ocular infection
Ocular or periocular malignancies
Periocular infection

Precautions and Warnings

Children aged 4 to 18 years
Wearing of contact lenses
Glaucoma
History of viral ocular infection
Ocular herpes simplex infection
Pregnancy

Advise patient blurred vision may affect ability to drive/operate machinery
Exclude ocular & periocular malignacies or pre-malignancies before therapy
Exclude ocular or periocular infection prior to treatment
Not all available brands are licensed for all indications
Not all available brands/formulations are licensed for use in children
Treatment to be prescribed under the supervision of a specialist
Contains cetalkonium chloride - May cause eye irritation
Administer other ophthalmic products at least 15 minutes apart
For single use only
To reduce systemic absorption compress lacrimal sac during administration
KCS: Response to treatment should be reassessed every 6 months
Female: Ensure adequate contraception during treatment
Advise patient to avoid touching the eye/other surfaces with container tip
KCS: Remove contact lenses before use and re-insert at wake-up time
VKC: Use of contact lenses not recommended

Pregnancy and Lactation

Pregnancy

Use ciclosporin with caution during pregnancy.

The manufacturer advises that ciclosporin eye drops are not recommended during pregnancy and that they should only be used when the benefits outweigh the risks. Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin at exposure considered sufficiently in excess of the maximum human exposure, indicating little relevance to the clinical use of this medication. Data available from organ transplant recipients indicate that, compared with other immunosuppressive agents, ciclosporin treatment imposes no increased risk of adverse effects on the course or outcome of pregnancy, however there is an increased risk of premature birth. Exposure to ciclosporin does not justify termination of pregnancy. A detailed foetal ultrasound examination should be offered to confirm normal morphologic development in the case of first-trimester exposure.

Lactation

Ciclosporin is contraindicated during breastfeeding.

The manufacturer advises that at therapeutic doses of ciclosporin in eye drops, it is unlikely that sufficient amounts would be present in breastmilk. However, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from this medication, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. Ciclosporin is excreted into breastmilk, although the concentrations are relatively low. A risk to neonates cannot be excluded. Schaefer considers that this drug should pose no obstacle to breastfeeding, as long as breastfeeding did not take place for at least four hours after ciclosporin administration so as to avoid peak ciclosporin levels in milk.

Side Effects

Application site reaction
Blepharitis
Blurred vision (transient)
Chalazion
Conjunctival hyperaemia
Conjunctival irritation
Conjunctival oedema
Conjunctivitis
Corneal decompensation
Corneal deposits
Corneal infiltrates
Corneal scar
Cough
Eyelid erythema
Eyelid oedema
Eyelid pruritus
Headache
Increased lacrimation
Iridocyclitis
Keratitis
Lacrimal gland disorder
Ocular discharge
Ocular discomfort
Ocular hyperaemia
Ocular irritation
Ocular pain
Ocular pruritus
Ophthalmic herpes zoster
Sensation of foreign body in eye
Upper respiratory tract infection

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 2018

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Ikervis 1 mg/ml eye drops, emulsion. Santen Oy. Revised July 2019.

Summary of Product Characteristics: Verkazia 1mg/ml eye drops, emulsion. Santen Oy. Revised July 2019.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 24 October 2018