Avarinex Syrup

AVARINEX Syrup is indicated for the relief of symptoms associated with allergic rhinitis (AR). AVARINEX Syrup is also indicated for the short-term relief of symptoms associated with chronic idiopathic urticaria (CIU).

Children 2 to 5 years of age: 2.5 mL (1.25 mg) AVARINEX Syrup once a day.
Children 6 to 11 years of age: 5 mL (2.5 mg) AVARINEX Syrup once a day.
Adults and adolescents (12 years of age and over): 10 mL (5 mg) AVARINEX Syrup once a day.
Patients with hepatic or renal impairment should be given 5mg AVARINEX on alternate days initially.
If the child is less than 5 years old, enquire if the child is using other medicines that contain propylene glycol or alcohol.

Method of administration
For oral use. The dose can be taken with or without a meal.

• Hypersensitivity to desloratadine or to any of the excipients listed in section 6.1.
• Pregnancy and lactation (see section 4.6).
• Cross sensitivity to other antihistamines
• Porphyria

Seizures
Desloratadine should be administered with caution in patients with medical or familial history of seizures, and mainly young children (see section 4.8), being more susceptible to develop new seizures under desloratadine treatment.

Efficacy and safety of desloratadine syrup have not been established for treatment periods in excess of 4 weeks. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment.

Special populations
Renal and hepatic function impairment
Patients with hepatic or renal impairment should be given 5mg AVARINEX on alternate days initially.
Paediatric population
In children below 2 years of age, the diagnosis of allergic rhinitis is particularly difficult to distinguish from other forms of rhinitis. The absence of upper respiratory tract infection or structural abnormalities, as well as patient history, physical examinations, and appropriate laboratory and skin tests should be considered.

Approximately 6 % of adults and children 2- to 11-year old are phenotypic poor metabolisers of desloratadine and exhibit a higher exposure (see section 5.2). The safety of desloratadine in children 2- to 11-years of age who are poor metabolisers is the same as in children who are normal metabolisers. The effects of desloratadine in poor metabolisers < 2 years of age have not been studied.

AVARINEX syrup should be discontinued prior to skin tests allergen extracts as it may inhibit the cutaneous histamine response, thus producing false-negative results. AVARINEX syrup should be discontinued at least 48 hours before test.

AVARINEX contains:
Sucrose
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Propylene Glycol
This medicine contains 500 mg propylene glycol in each 5 mL which is equivalent to 20-25 mg/kg body weight.
Sorbitol Solution
Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.

No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose ketoconazole, erythromycin, azithromycin, fluoxetine and cimetidine interaction trials. (see section 5.1).

Paediatric population
Interaction studies have only been performed in adults. Desloratadine syrup taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1). However, cases of alcohol intolerance and intoxication have been reported during post-marketing use. Therefore, caution is recommended if alcohol is taken concomitantly.

There is no effect of food or grapefruit juice on the disposition of desloratadine.

Pregnancy
A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicates no malformative nor foeto/neonatal toxicity of desloratadine. AVARINEX should not be used during pregnancy see section 4.3

Breast-feeding
Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of desloratadine on newborns/infants is unknown. Avarinex is not recommended for use during breastfeeding.

Fertility
There are no data available on male and female fertility

AVARINEX Syrup lacks significant sedative effects. Patients should however be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks.

Summary of the safety profile
Paediatric population
The overall incidence of adverse events in children 2 through 11 years of age was found to be similar for the desloratadine and placebo groups, in clinical trials. No adverse events were seen in subjects between 6 and 11 years of age following a single 2.5 mg dose of desloratadine oral solution.

In a clinical trial with adolescent patients, 12 through 17 years of age, the most common adverse event was headache.

Adults and adolescents
The most frequent of adverse events reported in excess of placebo were fatigue, dry mouth and headache.

Metabolism and nutrition disorders
Frequency unknown: Increased appetite

Psychiatric disorders
Less frequent: Hallucinations
Frequency Unknown: Abnormal behaviour, aggression

Nervous system disorders
Frequent: Headache, insomnia
Less frequent: Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures

Cardiac disorders
Less frequent: tachycardia, palpitations
Frequency unknown: QT prolongation

Gastrointestinal disorders
Frequent: Dry mouth, diarrhoea
Less frequent: Abdominal pain, nausea, vomiting, dyspepsia

Hepatobiliary disorders
Less frequent: Elevations of liver enzymes, increased bilirubin, Hepatitis
Frequency unknown: Jaundice

Skin and subcutaneous tissue disorders
Less frequent: Photosensitivity

Musculoskeletal and connective tissue disorders
Less frequent: Myalgia

General disorders and administration site conditions
Frequent: Fatigue, fever
Less frequent: Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
Frequency unknown: Asthenia

Investigations
Frequency unknown: weight increased

Paediatric population
Other undesirable effects reported during the post-marketing period in paediatric patients with an unknown frequency included QT prolongation, dysrrhythmia, bradycardia, abnormal behaviour, and aggression.

Reporting side effects
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: hppts://www.sahpra.or.za/Publications/Index/8

The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.

Treatment
In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended. Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.

Symptoms
Based on a multiple dose clinical trial in adults and adolescents, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.