Drugs List

Therapeutic Indications

Uses

Conjunctivitis - allergic
Inflammatory (non-infective) conjunctival diseases

Contraindications

Children under 18 years
Wearing of contact lenses
Ocular herpes simplex infection
Ocular infection
Ocular tuberculosis
Raised intra-ocular pressure
Undiagnosed red eye

Precautions and Warnings

Breastfeeding
Pregnancy

May mask symptoms or signs of infections
Advise patient ability to drive or operate machinery may be impaired
Exclude fungal infection before treatment
Treat and control infections prior to commencing therapy
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
Contains phosphate: Risk of calcification in existing notable cornea damage
May cause perforation of eye in disorders that thin the sclera or cornea
Prolonged use may result in ocular infections
Advise patient to avoid touching the eye/other surfaces with container tip

Pregnancy and Lactation

Pregnancy

Use hydrocortisone with caution during pregnancy.

At the time of writing there is limited published information regarding the use of hydrocortisone eye drops in pregnancy.

Hydrocortisone readily crosses the placenta. Schaefer (2015) suggests that there is inconclusive evidence that corticosteroids result in an increased incidence of congenital abnormalities however, a possible association with clefts cannot be excluded. When administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. Hypoadrenalism may occur in the neonate following prenatal exposure but usually resolves spontaneously following birth and is rarely clinically important.

Corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, patients with normal pregnancies may be treated as though they were in the non-gravid state.

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

Use hydrocortisone with caution in breastfeeding.

It is unknown whether hydrocortisone eye drops are excreted in human milk.

Corticosteroids are excreted in small amounts in breast milk, and both Schaefer (2015) and Briggs (2015) report that there are no reports to date of the use of hydrocortisone during lactation. Schaefer recommends that prednisolone and methylprednisolone, although more potent, are the systemic corticosteroids of choice during lactation.

Glucocorticoids systemically administered are excreted in breast milk, which may cause suppression of growth or of endogenous corticosteroid production. There may also be other undesirable effects.

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 and stinging of the eyes

Presentation

Eye drops containing hydrocortisone (as sodium phosphate) (preservative-free).

Drugs List

Therapeutic Indications

Uses

Conjunctivitis - allergic
Inflammatory (non-infective) conjunctival diseases

Dosage

Duration of treatment will vary from a few days to a maximum of 14 days. To avoid relapse, it may be recommended to gradually taper off to 1 administration every other day.
Single-dose container contains enough solution to treat both eye.
A more potent corticosteroid should be used if there is insufficient response.

Adults

Contraindications

Children under 18 years
Wearing of contact lenses
Ocular herpes simplex infection
Ocular infection
Ocular tuberculosis
Raised intra-ocular pressure
Undiagnosed red eye

Precautions and Warnings

Breastfeeding
Pregnancy

May mask symptoms or signs of infections
Advise patient ability to drive or operate machinery may be impaired
Exclude fungal infection before treatment
Treat and control infections prior to commencing therapy
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
Contains phosphate: Risk of calcification in existing notable cornea damage
May cause perforation of eye in disorders that thin the sclera or cornea
Prolonged use may result in ocular infections
Advise patient to avoid touching the eye/other surfaces with container tip

Pregnancy and Lactation

Pregnancy

Use hydrocortisone with caution during pregnancy.

At the time of writing there is limited published information regarding the use of hydrocortisone eye drops in pregnancy.

Hydrocortisone readily crosses the placenta. Schaefer (2015) suggests that there is inconclusive evidence that corticosteroids result in an increased incidence of congenital abnormalities however, a possible association with clefts cannot be excluded. When administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. Hypoadrenalism may occur in the neonate following prenatal exposure but usually resolves spontaneously following birth and is rarely clinically important.

Corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, patients with normal pregnancies may be treated as though they were in the non-gravid state.

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

Use hydrocortisone with caution in breastfeeding.

It is unknown whether hydrocortisone eye drops are excreted in human milk.

Corticosteroids are excreted in small amounts in breast milk, and both Schaefer (2015) and Briggs (2015) report that there are no reports to date of the use of hydrocortisone during lactation. Schaefer recommends that prednisolone and methylprednisolone, although more potent, are the systemic corticosteroids of choice during lactation.

Glucocorticoids systemically administered are excreted in breast milk, which may cause suppression of growth or of endogenous corticosteroid production. There may also be other undesirable effects.

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 and stinging of the eyes

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: February 2018

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd 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, 9th edition (2015) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Softacort 3.35mg/ml eye drops, solution in single-dose container. Laboratoires THEA. Revised March 2017.