Fexofenadine

Registered South African indications:

• Symptoms associated with seasonal allergic rhinitis
• Symptoms associated with chronic idiopathic urticaria

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy (fct)
• Lactation (fct)
• Children below 12 years (fct)

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients

South African recommendations

• Pregnancy (sus) (South African recommendations)
• Pregnancy (Recommendations in other jurisdictions)
• Breastfeeding (sus) (South African recommendations)
• Breastfeeding (Recommendations in other jurisdictions)
• Renal impairment
• Hepatic impairment
• Elderly
• Cardiovascular disease

Forms avail. in SA and covered in this monograph: fct, tab

South African registered indications and dosages

Symptoms associated with seasonal allergic rhinitis

• Oral (fct, tab): 120mg, dly

Symptoms associated with chronic idiopathic urticaria

• Oral (fct, tab): 180mg, dly

Paed. forms avail. in SA and covered in this monograph: fct, tab, sus

South African registered indications and dosages

Symptoms associated with seasonal allergic rhinitis

Oral (fct, tab)

• Younger than 12 years: Contraindicated
• 12 years and older: See adult dosage

Symptoms associated with seasonal allergic rhinitis
- Such as sneezing, rhinorrhoea, itchy nose/palate/throat, itchy/watery/red eyes

Oral (sus)

• Younger than 2 years: Not established for use
• Between 2-11 years: 30mg (5ml), twice daily

Symptoms associated with chronic idiopathic urticaria

Oral (fct, tab)

• Younger than 12 years: Contraindicated
• 12 years and older adult dosage

Symptoms associated with chronic idiopathic urticaria
- Uncomplicated skin manifestations

Oral (sus)

• Between 6-24 months: 15mg (2.5ml), twice daily
• Between 2-11 years: 30mg (5ml), twice daily

Pregnancy

South African recommendations

Film-coated tablets

• Contraindicated
• Safety in pregnancy has not been established. Fexofenadine should not be taken during pregnancy

Suspension 

• Caution
• The safety of fexofenadine in pregnancy has not been established

Recommendations in other jurisdictions

• Caution
• There are no adequate data from the use of fexofenadine hydrochloride in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development. Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary

Breastfeeding

South African recommendations

Film-coated tablets

• Contraindicated
• Safety in lactation has not been established. Fexofenadine has been detected in breast milk
• Fexofenadine should not be taken during lactation

Suspension

• Caution
• The safety of fexofenadine in lactation has not been established
• It is not known if fexofenadine is excreted in human milk. There are no adequate and well controlled studies in women during lactation
• Because many drugs are excreted in human milk, caution should be exercised when fexofenadine is administered to a nursing woman

Recommendations in other jurisdictions

• Caution; not recommended
• There are no data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers fexofenadine was found to cross into human breast milk. Therefore fexofenadine hydrochloride is not recommended for mothers breastfeeding their babies
• Fexofenadine hydrochloride should not be used during breastfeeding unless clearly necessary

Fertility

South African recommendations

• No information available

Recommendations in other jurisdictions

• No human data on the effect of fexofenadine hydrochloride on fertility are available. In mice, there was no effect on fertility with fexofenadine hydrochloride treatment

South African recommendations

• Caution; dose adjustment recommended
  Adults
  Based on increases of bioavailability and half-life: Oral (fct, tab): 60mg, once daily is recommended as the starting dose in patients with decreased renal function
  Paediatrics
  Between 6-24 months: Oral (sus): Initial: 15mg (2.5ml), once daily
  Between 2-11 years: Oral (sus): Initial: 30mg (5ml), once daily

Recommendations in other jurisdictions

•  Caution; no dose adjustment recommended

Recommendations below are applicable to South Africa and other jurisdictions

• Caution; no dose adjustment recommended

Recommendations below are applicable to South Africa and other jurisdictions

• Caution; no dose adjustment recommended

Central Nervous System Disorders

• Headache
• Drowsiness
• Dizziness
• Insomnia
• Nervousness
• Sleep disorders
• Nightmares
• Fatigue

Cardiovascular Disorders

• Tachycardia
• Palpitations

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders

• Nausea
• Diarrhoea
• Dyspepsia

Endocrine and Metabolic Disorders

• Dysmenorrhoea

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria
• Pruritus

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Anaphylaxis
• Angioedema
• Flushing

• Erythromycin
• Ketoconazole
• Aluminium and magnesium containing antacids  
• Fruit juice (sus)

None routine

Fexofenadine is a second generation histamine-receptor antagonist. It competes with free histamine for binding at H1-receptors in the gastrointestinal tract, large blood vessels, and bronchial smooth muscle. This inhibits the action of endogenous histamine, which leads to temporary relief of the negative symptoms caused by histamine.  

Tablet 120mg

• Fastaway (Dr Reddy)
• Fenofex fct (Ranbaxy)
• Fexaway (Adcock)
• Fexo (Cipla Medpro)
• Fexo-Fast (Sandoz)
• Fexofenadine Biotech 120 (Biotech)
• Telfast (Sanofi) originator
• Tellerge (Pharmacare)

Tablet 180mg

• Fastaway (Dr Reddy)
• Fexaway (Adcock)
• Fenofex fct (Ranbaxy)
• Fexo (Cipla Medpro)
• Fexo-Fast (Sandoz)
• Fexofenadine Biotech 180 (Biotech)
• Telfast (Sanofi) originator
• Tellerge (Pharmacare)

Suspension (per 5ml) 30mg

• Telfast suspension (Sanofi) originator