Bilastine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of bilastine.
Drugs List
Therapeutic Indications
Uses
Seasonal and perennial allergic rhino-conjunctivitis
Urticaria
Dosage
Treatment should be taken one hour before or two hours after food or fruit juice.
Adults
Tablet
20mg once daily.
Children
Tablet
Children over 12 years
20mg once daily
Orodispersible tablet and oral solution
Children aged 6 to 12 years weighing at least 20kg
10mg orodispersible tablet once daily or 4ml of 2.5mg/ml oral solution once daily
Children aged under 6 years and weighing less than 20kg
Not recommended
Patients with Renal Impairment
In patients with moderate or severe renal impairment, co-administration of bilastine with P-glycoprotein inhibitors, such as ketoconazole, erythromycin, cyclosporine, ritonavir or diltiazem, may increase plasmatic levels of bilastine and, therefore, increase the risk of adverse effects of bilastine.
Additional Dosage Information
Allergic rhinitis: Limit the treatment to the period of allergens exposure.
Seasonal allergic rhinitis: Discontinue treatment after symptoms have resolved and reinitiate when symptoms return.
Perennial allergic rhinitis: Treatment may continue during the allergen exposure periods.
Urticaria: Duration of treatment depends on the type, duration and symptoms.
Contraindications
Children under 6 years
Children weighing less than 20kg
Precautions and Warnings
Children 6 to 12 years
Breastfeeding
Pregnancy
Renal impairment
Advise patient not to drive until they know how the medicine affects them
Not all formulations are suitable for use in children under 12 years
Oral liquid contains hydroxybenzoate: caution in hypersensitivity
Grapefruit juice should not be taken simultaneously
Pregnancy and Lactation
Pregnancy
Use bilastine with caution in pregnancy.
The manufacturer does not recommend using bilastine during pregnancy. At the time of writing animal studies have not indicated any direct or indirect harmful effects with respect to reproductive toxicity, parturition or postnatal development.
Lactation
Use bilastine with caution in breastfeeding.
The manufacturer advises that the patient either discontinues bilastine treatment or discontinues breastfeeding, taking into account the benefit of breastfeeding to the child and the benefit of bilastine therapy to the mother. Animal data reports have shown excretion of bilastine in breast milk however presence in human breast milk is unknown.
Side Effects
Abdominal pain
Alanine aminotransferase increased
Allergic conjunctivitis
Anaphylaxis
Angioedema
Anxiety
Aspartate aminotransferase increased
Asthenia
Diarrhoea
Dizziness
Dry mouth
Dyspepsia
Dyspnoea
ECG changes
Eczema
Elevated triglyceride levels
Erythema
Fatigue
Gamma glutamyl transferase (GGT) increased
Gastritis
Headache
Hypersensitivity reactions
Increase in creatinine
Increased appetite
Insomnia
Loss of consciousness (transient)
Nasal discomfort
Nasal dryness
Nausea
Ocular irritation
Oedema of the lips
Oral herpes
Palpitations
Prolongation of QT interval
Pruritus
Pyrexia
Rash
Rhinitis
Right bundle branch block
Sinus arrhythmia
Somnolence
Stomach discomfort
Tachycardia
Thirst
Tinnitus
Upper abdominal pain
Urticaria
Vertigo
Vomiting
Weight gain
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: December 2020
Reference Sources
Summary of Product Characteristics: Ilaxten 20mg tablets. Menarini International Operations Luxembourg S.A. Revised August 2019.
Summary of Product Characteristics: Ilaxten 10mg orodispersible tablets. Menarini International Operations Luxembourg S.A. Revised February 2019.
Summary of Product Characteristics: Ilaxten 2.5mg/ml oral solution. Menarini International Operations Luxembourg S.A. Revised February 2019.
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