Drugs List

Therapeutic Indications

Uses

Perennial allergic conjunctivitis treatment
Seasonal allergic conjunctivitis treatment

Contraindications

Children under 4 years

Precautions and Warnings

Children aged 4 to 12 years
Soft contact lenses
Breastfeeding
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
Not licensed for all indications in all age groups
Not recommended for use longer than 6 weeks
Advise patient to avoid touching the eye/other surfaces with container tip
Consult doctor if no improvement is seen within 48 hours of treatment
If soft contact lenses worn,insert them 15 minutes after using eye drops

Pregnancy and Lactation

Pregnancy

Use azelastine with caution in pregnancy.

At high oral doses in animals; foetal death, growth retardation and an increased incidence of skeletal abnormalities occurred during reproduction toxicity testing. Local ocular application will result in minimal systemic exposure.

It is not known if azelastine crosses the human placenta. The molecular weight and prolonged elimination half-life suggest that the drug could cross to the foetus.

Animal data suggest that the risk to the foetus is low. The absence of human pregnancy experience prevents a full assessment of the risk. Caution should be exercised when azelastine eye drops are used during pregnancy.

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 azelastine with caution in breastfeeding.

The prolonged elimination half-lives of the parent drug and major active metabolite and the relatively low molecular weight (about 382 for the free base) suggest that the drugs will be excreted into breast milk. The manufacturer states that it is excreted into breastmilk. Local ocular application will result in minimal systemic exposure. It is doubtful if clinically significant amounts will be excreted into breastmilk. Briggs states that it is probably compatible with breastfeeding (Briggs 2008).

However, this is an extremely bitter product. It is possible that even minuscule amounts in milk could alter the taste of milk leading to rejection by the infant. The manufacturer does not recommend the use of azelastine eye drops during lactation.

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 reaction
Bitter taste
Blurred vision (transient)
Eye irritation
Pruritus
Rash

Presentation

Eye drops containing azelastine hydrochloride

Drugs List

Therapeutic Indications

Uses

Perennial allergic conjunctivitis treatment
Seasonal allergic conjunctivitis treatment

Dosage

Adults

Elderly

Children

Contraindications

Children under 4 years

Precautions and Warnings

Children aged 4 to 12 years
Soft contact lenses
Breastfeeding
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
Not licensed for all indications in all age groups
Not recommended for use longer than 6 weeks
Advise patient to avoid touching the eye/other surfaces with container tip
Consult doctor if no improvement is seen within 48 hours of treatment
If soft contact lenses worn,insert them 15 minutes after using eye drops

Pregnancy and Lactation

Pregnancy

Use azelastine with caution in pregnancy.

At high oral doses in animals; foetal death, growth retardation and an increased incidence of skeletal abnormalities occurred during reproduction toxicity testing. Local ocular application will result in minimal systemic exposure.

It is not known if azelastine crosses the human placenta. The molecular weight and prolonged elimination half-life suggest that the drug could cross to the foetus.

Animal data suggest that the risk to the foetus is low. The absence of human pregnancy experience prevents a full assessment of the risk. Caution should be exercised when azelastine eye drops are used during pregnancy.

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 azelastine with caution in breastfeeding.

The prolonged elimination half-lives of the parent drug and major active metabolite and the relatively low molecular weight (about 382 for the free base) suggest that the drugs will be excreted into breast milk. The manufacturer states that it is excreted into breastmilk. Local ocular application will result in minimal systemic exposure. It is doubtful if clinically significant amounts will be excreted into breastmilk. Briggs states that it is probably compatible with breastfeeding (Briggs 2008).

However, this is an extremely bitter product. It is possible that even minuscule amounts in milk could alter the taste of milk leading to rejection by the infant. The manufacturer does not recommend the use of azelastine eye drops during lactation.

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 reaction
Bitter taste
Blurred vision (transient)
Eye irritation
Pruritus
Rash

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: September 2016

Reference Sources

Summary of Product Characteristics: Optilast Eye Drops. Meda Pharmaceuticals. Revised June 2015.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 27 September 2016.

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.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 27 September 2016.