Drugs List

Therapeutic Indications

Uses

Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.

Contraindications

Children under 3 years
Pregnancy (see Pregnancy)
Breastfeeding (see Lactation)

Precautions and Warnings

Convulsions have been reported vary rarely during ketotifen therapy. As ketotifen may lower the seizure threshold, it should be used with caution in patients with a history of epilepsy.

Patients, especially those taking the oral solution (elixir), should avoid alcoholic drinks.

Oral solution (elixir) contains alcohol.

Oral solution contains methyl and propyl hydroxybenzoates, which may cause allergic reactions in some patients.

Oral solution contains maltitol and therefore should not be administered to patients with hereditary fructose intolerance.

Some formulations contain lactose and therefore should not be administered to patients with galactosaemia. Use caution in patients with lactose intolerance and glucose-galactose malabsorption syndrome.

During the first few days of treatment, reactions may be impaired. Patients should be warned not to take charge of vehicles or machinery until effect of ketotifen treatment on the individual is known.

Pregnancy and Lactation

Pregnancy

Due to a lack of information concerning safety in pregnancy, ketotifen oral formulations are contraindicated in 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 14-17 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 excreted in breast milk and is contraindicated in breast feeding women.

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

Drowsiness
Dry mouth
Dizziness
CNS stimulation
Excitation
Irritability
Insomnia
Nervousness
Weight gain
Cystitis
Hepatitis
Increases in hepatic enzymes
Convulsions
Erythema multiforme
Stevens-Johnson syndrome
Skin reactions

Drugs List

Therapeutic Indications

Uses

Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.

Dosage

Adults

Elderly

Children

Contraindications

Children under 3 years
Pregnancy (see Pregnancy)
Breastfeeding (see Lactation)

Precautions and Warnings

Convulsions have been reported vary rarely during ketotifen therapy. As ketotifen may lower the seizure threshold, it should be used with caution in patients with a history of epilepsy.

Patients, especially those taking the oral solution (elixir), should avoid alcoholic drinks.

Oral solution (elixir) contains alcohol.

Oral solution contains methyl and propyl hydroxybenzoates, which may cause allergic reactions in some patients.

Oral solution contains maltitol and therefore should not be administered to patients with hereditary fructose intolerance.

Some formulations contain lactose and therefore should not be administered to patients with galactosaemia. Use caution in patients with lactose intolerance and glucose-galactose malabsorption syndrome.

During the first few days of treatment, reactions may be impaired. Patients should be warned not to take charge of vehicles or machinery until effect of ketotifen treatment on the individual is known.

Pregnancy and Lactation

Pregnancy

Due to a lack of information concerning safety in pregnancy, ketotifen oral formulations are contraindicated in 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 14-17 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 excreted in breast milk and is contraindicated in breast feeding women.

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

Effects on Ability to Drive and Operate Machinery

As reactions may be impaired, patients should be advised not to drive or operate machinery until the effect of the treatment is known.

Counselling

Patients should be warned not to take charge of vehicles or machinery until effect of ketotifen treatment on the individual is known. Reactions may be impaired during the first few days of treatment.

Advise patients, especially those taking the oral solution (elixir), to avoid alcoholic drinks.

Side Effects

Drowsiness
Dry mouth
Dizziness
CNS stimulation
Excitation
Irritability
Insomnia
Nervousness
Weight gain
Cystitis
Hepatitis
Increases in hepatic enzymes
Convulsions
Erythema multiforme
Stevens-Johnson syndrome
Skin reactions

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 ).

Shelf Life and Storage

Store below 25 degrees C

Further Information

Last Full Review Date: December 2011

Reference Sources

British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.

BNF for Children (2011-2012) Pharmaceutical Press, London.

Summary of Product Characteristics: Zaditen elixir 1mg/5ml. Defiante Farmaceutica. Revised October 2009.

Summary of Product Characteristics: Zaditen tablets 1mg. Defiante Farmaceutica. Revised October 2009.