Drugs List

Therapeutic Indications

Uses

Seasonal allergic conjunctivitis treatment

Contraindications

Children under 3 years

Precautions and Warnings

Soft contact lenses
Pregnancy

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
Advise patient to avoid touching the eye/other surfaces with container tip
If soft contact lenses worn,insert them 15 minutes after using eye drops

Preserved formulation contains benzalkonium chloride, which may cause eye irritation and may discolour soft contact lenses.

Pregnancy and Lactation

Pregnancy

Use ketotifen with caution in pregnancy.

The manufacturer notes there is little data from the use of ketotifen eye drops in pregnant women. Animal studies using maternally toxic oral doses showed increased pre- and postnatal mortality but no teratogenicity. Systemic levels after ocular administration are much lower than after oral use.

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

Ketotifen is considered safe for use in breastfeeding.

Ketotifen has been shown to enter breast milk in animal studies, however it is not known if it is excreted into human breast milk. It is unknown if enough drug enters systemic circulation after topical administration to produce significant quantities in breast milk. This drug has a molecular weight of 425.5, an oral bioavailability of 50% and is distributed widely throughout the body. Based on these kinetics, it is unlikely that this drug would pose a significant risk to breastfed infants.

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

Allergic contact dermatitis
Allergic reaction
Blurred vision (transient)
Conjunctivitis
Dry eyes
Dry mouth
Eczema
Epithelial punctate keratitis
Exacerbation of pre-existing asthma
Exacerbation of pre-existing eczema
Eye irritation
Eye pain
Eyelid oedema
Eyelid pruritus
Eyelid reaction
Facial oedema
Headache
Hypersensitivity reactions
Ocular oedema
Photophobia
Punctate epithelial erosions of eye (transient)
Rash
Somnolence
Subconjunctival haemorrhage
Urticaria

Presentation

Eye drops containing ketotifen as hydrogen fumarate (preservative containing and preservative-free).

Drugs List

Therapeutic Indications

Uses

Seasonal allergic conjunctivitis treatment

Dosage

Preservative-free eye drops: The contents of the single-dose container are sufficient for 1 administration into both eyes.

Adults

Children

Contraindications

Children under 3 years

Precautions and Warnings

Soft contact lenses
Pregnancy

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
Advise patient to avoid touching the eye/other surfaces with container tip
If soft contact lenses worn,insert them 15 minutes after using eye drops

Preserved formulation contains benzalkonium chloride, which may cause eye irritation and may discolour soft contact lenses.

Pregnancy and Lactation

Pregnancy

Use ketotifen with caution in pregnancy.

The manufacturer notes there is little data from the use of ketotifen eye drops in pregnant women. Animal studies using maternally toxic oral doses showed increased pre- and postnatal mortality but no teratogenicity. Systemic levels after ocular administration are much lower than after oral use.

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

Ketotifen is considered safe for use in breastfeeding.

Ketotifen has been shown to enter breast milk in animal studies, however it is not known if it is excreted into human breast milk. It is unknown if enough drug enters systemic circulation after topical administration to produce significant quantities in breast milk. This drug has a molecular weight of 425.5, an oral bioavailability of 50% and is distributed widely throughout the body. Based on these kinetics, it is unlikely that this drug would pose a significant risk to breastfed infants.

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

Allergic contact dermatitis
Allergic reaction
Blurred vision (transient)
Conjunctivitis
Dry eyes
Dry mouth
Eczema
Epithelial punctate keratitis
Exacerbation of pre-existing asthma
Exacerbation of pre-existing eczema
Eye irritation
Eye pain
Eyelid oedema
Eyelid pruritus
Eyelid reaction
Facial oedema
Headache
Hypersensitivity reactions
Ocular oedema
Photophobia
Punctate epithelial erosions of eye (transient)
Rash
Somnolence
Subconjunctival haemorrhage
Urticaria

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 2018

Reference Sources

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

Summary of Product Characteristics: Ketofall 0.25mg/ml eye drops, solution in single-dose container. Pharma Stulln GmbH. Revised October 2017.

Summary of Product Characteristics: Zaditen 0.25mg/ml eye drops, solution. Thea Pharmaceuticals Ltd. Revised September 2014.