Drugs List

Therapeutic Indications

Uses

Eye - non-infected inflammatory conditions

Contraindications

Soft contact lenses
Breastfeeding
Herpes simplex keratitis
Ocular infection
Undiagnosed red eye

Precautions and Warnings

Children under 18 years
Glaucoma
History of herpes simplex keratitis
Pregnancy

May mask symptoms or signs of infections
Advise patient blurred vision may affect ability to drive/operate machinery
Exclude raised intraocular pressure, cataracts & infection before repeating
Treat and control infections prior to commencing therapy
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
Possible systemic absorption of steroid
Prolonged or high dose may lead to adrenal suppression
May cause corneal perforation in patients with thin corneal/scleral tissue
May cause perforation of eye in disorders that thin the sclera or cornea
May cause posterior subcapsular cataracts and glaucoma in long term use
Prolonged use may result in ocular infections
Prolonged/excessive use may lead to adrenal suppression
Systemic side effects may occur
Treatment may adversely affect wound healing
Advise patient to avoid touching the eye/other surfaces with container tip
Contact lenses should not be worn during treatment
If soft contact lenses worn,insert them 15 minutes after using eye drops

Pregnancy and Lactation

Pregnancy

Use prednisolone acetate with caution in pregnancy.

Most information available relates to use of systemically administered corticosteroids and its direct applicability to use of prednisolone for ophthalmic use is not known.

Prednisolone is the biologically active form of prednisone. The placenta can oxidise prednisolone to inactive prednisone or less active cortisone. Prednisone crosses the placenta only to a small extent and there is little risk to the developing foetus.

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

Prednisolone is contraindicated in breastfeeding.

Prednisolone is the biologically active form of prednisone. Both prednisolone and prednisone can be found in human milk in low levels. Most authorities conclude that levels are so low, that even with systemic maternal treatment, no adverse effects are anticipated.

The manufacturer notes that use of this medication is not recommended in breastfeeding.

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

Acute anterior uveitis
Adrenal suppression
Blurred vision (transient)
Burning and stinging of the eyes
Corneal or scleral malacia
Corneal thinning
Dermatitis
Dysgeusia
Epithelial punctate keratitis
Glaucoma
Headache
Hypersensitivity reactions
Increased intra-ocular pressure
Mydriasis
Ocular irritation
Ocular itching
Optic nerve damage
Perforation of the ocular globe
Posterior subcapsular cataracts
Pruritus
Ptosis
Rash
Reduced visual acuity
Scleral thinning
Urticaria
Visual field defects

Presentation

Eye drops containing prednisolone acetate (preservative containing).

Drugs List

Therapeutic Indications

Uses

Eye - non-infected inflammatory conditions

Dosage

Adults

Children

Contraindications

Soft contact lenses
Breastfeeding
Herpes simplex keratitis
Ocular infection
Undiagnosed red eye

Precautions and Warnings

Children under 18 years
Glaucoma
History of herpes simplex keratitis
Pregnancy

May mask symptoms or signs of infections
Advise patient blurred vision may affect ability to drive/operate machinery
Exclude raised intraocular pressure, cataracts & infection before repeating
Treat and control infections prior to commencing therapy
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
Possible systemic absorption of steroid
Prolonged or high dose may lead to adrenal suppression
May cause corneal perforation in patients with thin corneal/scleral tissue
May cause perforation of eye in disorders that thin the sclera or cornea
May cause posterior subcapsular cataracts and glaucoma in long term use
Prolonged use may result in ocular infections
Prolonged/excessive use may lead to adrenal suppression
Systemic side effects may occur
Treatment may adversely affect wound healing
Advise patient to avoid touching the eye/other surfaces with container tip
Contact lenses should not be worn during treatment
If soft contact lenses worn,insert them 15 minutes after using eye drops

Pregnancy and Lactation

Pregnancy

Use prednisolone acetate with caution in pregnancy.

Most information available relates to use of systemically administered corticosteroids and its direct applicability to use of prednisolone for ophthalmic use is not known.

Prednisolone is the biologically active form of prednisone. The placenta can oxidise prednisolone to inactive prednisone or less active cortisone. Prednisone crosses the placenta only to a small extent and there is little risk to the developing foetus.

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

Prednisolone is contraindicated in breastfeeding.

Prednisolone is the biologically active form of prednisone. Both prednisolone and prednisone can be found in human milk in low levels. Most authorities conclude that levels are so low, that even with systemic maternal treatment, no adverse effects are anticipated.

The manufacturer notes that use of this medication is not recommended in breastfeeding.

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

Acute anterior uveitis
Adrenal suppression
Blurred vision (transient)
Burning and stinging of the eyes
Corneal or scleral malacia
Corneal thinning
Dermatitis
Dysgeusia
Epithelial punctate keratitis
Glaucoma
Headache
Hypersensitivity reactions
Increased intra-ocular pressure
Mydriasis
Ocular irritation
Ocular itching
Optic nerve damage
Perforation of the ocular globe
Posterior subcapsular cataracts
Pruritus
Ptosis
Rash
Reduced visual acuity
Scleral thinning
Urticaria
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: April 2017.

Reference Sources

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.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Pred Forte. Allergan Ltd. Revised February 2017.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 August 2017