A clear, viscous, orange liquid.
1 ml of syrup contains desloratadine 0.5 mg as calculated on 100% substance.
Pharmacology: Pharmacodynamics: Desloratadine is a non-sedating long-acting histamine antagonist with potent, selective peripheral H1-receptor antagonist activity. Desloratadine has demonstrated antiallergic, antihistaminic, and anti-inflammatory activity.
Pharmacodynamic Properties: After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the drug is effectively excluded from entry to the central nervous system (CNS).
In addition to antihistaminic activity, desloratadine has demonstrated antiallergic and anti-inflammatory activities from numerous studies. These studies have shown that desloratadine inhibit the broad cascade of events that initiate and propagate allergic inflammation including, the release of proinflammatory cytokines including IL-4, IL-6, IL-8, IL-13, the release of important proinflammatory chemokines such as RANTES (Regulated upon Activation, Normal T-cell Expressed and Secreted), superoxide anion production by activated polymorphonuclear neutrophils, eosinophil adhesion and chemotaxis, the expression of the adhesion molecules such as P-selectin, IgE-dependent release of histamine, prostaglandin (PGD2), and leukotriene (LTC4), the acute allergic bronchoconstrictor response and allergic cough in animal models.
Pharmacokinetics: Desloratadine plasma concentrations can be detected within 30 minutes of desloratadine administration. Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours. The degree of accumulation of desloratadine was consistent with its half-life (approximately 27 hours) and a once daily dosing frequency. In adults and adolescents, the bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg.
Desloratadine is moderately bound (83%-87%) to plasma proteins. There is no evidence of clinically relevant drug accumulation following once daily dosing of desloratadine (5 mg to 20 mg) for 14 days.
The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore some interactions with other drugs cannot be fully excluded. Desloratadine does not inhibit CYP3A4 or CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
In a single dose trial using a 7.5 mg dose of desloratadine, there was no effect of food (high-fat, high caloric breakfast) on the disposition of desloratadine. In another study, grapefruit juice had no effect on the disposition of desloratadine.
Avenez Syrup is indicated for the rapid relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge and itching, congestion/stuffiness, as well as ocular itching, tearing and redness.
Avenez Syrup is also indicated for the relief of symptoms associated with urticaria such as the relief of itching and the size and number of hives.
The prescriber should be aware that most cases of rhinitis below 2 years of age are of infections origin and there are no data supporting the treatment of infectious rhinitis with Avenez Syrup.
Children 1 through 5 years of age: 2.5 ml (1.25 mg) once a day, with or without a meal for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.
Children 6 through 11 years of age: 5 ml (2.5 mg) once a day, with or without a meal for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.
In adults and adolescents (12 years of age and over): 10 ml (5 mg) once a day, with or without a meal for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or less than 4 weeks) should be managed in accordance with the evaluation of patient's disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during allergen exposure periods.
For oral use. The product can be taken with or without food.
In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended.
Based on a multiple dose in adults and adolescents, in which up to 45 mg of desloratadine was administered (9 times the clinical dose), no clinically relevant effects were observed.
Desloratadine is not eliminated by hemodialysis; it is not known if it is eliminated by peritoneal dialysis.
Hypersensitivity to the active substance or to any of the excipients.
Efficacy and safety of Avenez Syrup in children under 1 years of age have not been established.
Desloratadine should be administered with caution in patients with a medical or family history of seizures. In particular, young children may be more susceptible to developing new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment.
Effects on Ability to Drive and Use Machines: No effects on the ability to drive and use machines have been observed.
No overall effect on rat fertility was observed with desloratadine at an exposure that was 34 times higher than the exposure in humans at the recommended clinical dose.
No teratogenic or mutagenic effects were observed in animal trials with desloratadine. Since no clinical data on exposed pregnancies are available with desloratadine, the safe use of Avenez Syrup during pregnancy has not been established. Avenez Syrup is not to be used during pregnancy unless the potential benefits outweigh the risks.
Desloratadine is excreted into breast milk, therefore the use of Avenez Syrup is not recommended in breast-feeding women.
In infants and toddlers aged 6 to 23 months, the most frequent adverse events reported were diarrhoea, fever and insomnia.
In a range of indications including SAR and CIU, at the recommended dose of 5 mg daily, the most frequent adverse events reported were fatigue, dry mouth, and headache.
Very rare cases of hypersensitivity reactions, including anaphylaxis and rash have been reported during the marketing of desloratadine. In addition, cases of tachycardia, palpitations, psychomotor hyperactivity, somnolence, seizures, elevations of liver enzymes, hepatitis, increased bilirubin and increased appetite have been reported very rarely.
No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose, ketoconazole, erythromycin, azithromycin, fluoxetine and cimetidine interaction.
There was no effect of food or grapefruit juice on the disposition of desloratadine.
Avenez Syrup taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol.
Store in original package below 30°C.
Once the bottle is opened the product can be used for 90 days.
R06AX27 - desloratadine ; Belongs to the class of other antihistamines for systemic use.
Avenez syr 0.5 mg/mL
60 mL x 1's
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