Drugs List

Therapeutic Indications

Uses

Chronic idiopathic urticaria
Seasonal allergic rhinitis - treatment

Contraindications

Children under 6 years

Precautions and Warnings

Breastfeeding
Cardiovascular disorder
Epileptic disorder
Hepatic impairment
Pregnancy
Renal impairment

Advise ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for use in children under 12 years
Not all available strengths are licensed for all indications
Avoid antacids within 2 hours of dose
Grapefruit, orange or apple juice may decrease absorption

Pregnancy and Lactation

Pregnancy

Fexofenadine should be used only if clearly indicated in pregnancy.

There are no adequate data from the use of fexofenadine in pregnant women. Animal studies have suggested a moderate risk.

In rats, doses producing an exposure equal to or in excess of 3 times the human exposure obtained from the maximum recommended human oral daily dose, were associated with a decrease in the number of implantations and an increase in the number of post-implantation losses. No evidence of teratogenicity was noted in pregnant rats and rabbits at oral doses up to 4 and 47 times the recommended human maximum dose, respectively. However, dose-related decreases in pup weight gain and survival were observed in rats at 3 times the recommended human maximum dose.

In a reproductive toxicity study in mice, fexofenadine did not impair fertility, was not teratogenic and did not impair pre- or postnatal development.

It is not known if fexofenadine crosses the human placenta to the foetus. The molecular weight is low enough however, that transfer to the foetus should be expected.

Oral antihistamines should be avoided during pregnancy, especially during the first trimester. The older first generation antihistamines are drugs of choice 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 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

Fexofenadine should be used with caution in breastfeeding.

Fexofenadine is excreted into human breast milk in small amounts. There is no information on the effect that this quantity of fexofenadine may have on a nursing infant.

High doses of antihistamine given by injection may decrease basal serum prolactin in non-lactating women and in early postpartum women. Suckling-induced prolactin secretion is not affected by antihistamine pre-treatment of postpartum women. Whether lower doses of antihistamines have the same effect on serum prolactin or whether the effects on prolactin have any consequences on breastfeeding success have not been studied.

Because of its lack of sedation and low milk levels, maternal use of fexofenadine would not be expected to cause any adverse effects in 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

Anaphylaxis
Angioedema
Chest tightness
Diarrhoea
Dizziness
Drowsiness
Dyspnoea
Fatigue
Flushing
Headache
Hypersensitivity reactions
Insomnia
Nausea
Nervousness
Nightmares
Palpitations
Pruritus
Rash
Sleep disturbances
Tachycardia
Urticaria

Presentation

Tablets containing fexofenadine hydrochloride

Drugs List

Therapeutic Indications

Uses

Chronic idiopathic urticaria
Seasonal allergic rhinitis - treatment

Dosage

Adults

Elderly

Children

Contraindications

Children under 6 years

Precautions and Warnings

Breastfeeding
Cardiovascular disorder
Epileptic disorder
Hepatic impairment
Pregnancy
Renal impairment

Advise ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for use in children under 12 years
Not all available strengths are licensed for all indications
Avoid antacids within 2 hours of dose
Grapefruit, orange or apple juice may decrease absorption

Pregnancy and Lactation

Pregnancy

Fexofenadine should be used only if clearly indicated in pregnancy.

There are no adequate data from the use of fexofenadine in pregnant women. Animal studies have suggested a moderate risk.

In rats, doses producing an exposure equal to or in excess of 3 times the human exposure obtained from the maximum recommended human oral daily dose, were associated with a decrease in the number of implantations and an increase in the number of post-implantation losses. No evidence of teratogenicity was noted in pregnant rats and rabbits at oral doses up to 4 and 47 times the recommended human maximum dose, respectively. However, dose-related decreases in pup weight gain and survival were observed in rats at 3 times the recommended human maximum dose.

In a reproductive toxicity study in mice, fexofenadine did not impair fertility, was not teratogenic and did not impair pre- or postnatal development.

It is not known if fexofenadine crosses the human placenta to the foetus. The molecular weight is low enough however, that transfer to the foetus should be expected.

Oral antihistamines should be avoided during pregnancy, especially during the first trimester. The older first generation antihistamines are drugs of choice 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 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

Fexofenadine should be used with caution in breastfeeding.

Fexofenadine is excreted into human breast milk in small amounts. There is no information on the effect that this quantity of fexofenadine may have on a nursing infant.

High doses of antihistamine given by injection may decrease basal serum prolactin in non-lactating women and in early postpartum women. Suckling-induced prolactin secretion is not affected by antihistamine pre-treatment of postpartum women. Whether lower doses of antihistamines have the same effect on serum prolactin or whether the effects on prolactin have any consequences on breastfeeding success have not been studied.

Because of its lack of sedation and low milk levels, maternal use of fexofenadine would not be expected to cause any adverse effects in 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

Anaphylaxis
Angioedema
Chest tightness
Diarrhoea
Dizziness
Drowsiness
Dyspnoea
Fatigue
Flushing
Headache
Hypersensitivity reactions
Insomnia
Nausea
Nervousness
Nightmares
Palpitations
Pruritus
Rash
Sleep disturbances
Tachycardia
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: May 2014

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com [Accessed on 14.05.14].

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications https://www.medicinescomplete.com [Accessed on 14.05.14].

Summary of Product Characteristics: Telfast 30mg tablets. Sanofi. Revised May 2012.

Summary of Product Characteristics: Telfast 120mg tablets. Sanofi. Revised September 2013.

Summary of Product Characteristics: Telfast 180mg tablets. Sanofi. Revised September 2013.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Fexofenadine. Last revised: September 7, 2013.
Last accessed: May 15, 2014.