Avorius

Avorius

desloratadine

Manufacturer:

Avo

Distributor:

Apex
Full Prescribing Info
Contents
Desloratadine.
Description
Desloratadine 5mg.
Action
Pharmacotherapeutic Group: antihistamines - H1 antagonist. ATC Code: R06A X27.
Pharmacology: Pharmacodynamics: Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the substance is excluded from entry to the central nervous system.
Desloratadine has demonstrated antiallergic properties from in vitro studies. These include inhibiting the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on endothelial cells. The clinical relevance of these observations remains to be confirmed.
Pharmacokinetics: Desloratadine plasma concentrations can be detected within 30 minutes of 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. 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 medicine 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 medicinal products can not be fully excluded. Desloratadine does not inhibit CYP3A4 in vivo, and in vitro studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
Indications/Uses
For the rapid relief of symptoms associated with seasonal allergic rhinitis eg. sneezing, nasal discharge and itching, congestion/stuffiness, as well as ocular itching, tearing & redness. Avorius is also indicated for the relief of symptoms associated with chronic idiopathic urticaria eg. relief of itching and the size and number of hives.
Dosage/Direction for Use
Adults and Adolescents (12 years of age and older): One tablet once a day regardless of mealtime 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.
Mode of administration: For oral use.
Overdosage
In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended.
Contraindications
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
Special Precautions
Efficacy and safety of Desloratadine Tablets in children under 12 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.
Use In Pregnancy & Lactation
None of data on exposed pregnancies are available with desloratadine, hence safety of desloratadine during pregnancy has not been established. As a precautionary measure, it is preferable to avoid the use of desloratadine during pregnancy.
Desloratadine is excreted into breast milk, therefore the use of Desloratadine is not recommended in breast-feeding women.
Side Effects
Summary of the safety profile: The most frequent of adverse reactions reported are fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %).
Paediatric population: In 12 through 17 years of age, the most common adverse event was headache; this occurred in 5.9 % of patients treated with desloratadine.
Tabulated list of adverse reactions: The adverse reactions reported in excess of placebo and other undesirable effects reported during the post-marketing period are listed in the following table. Frequencies are defined as very common, common, uncommon, rare, very rare and not known (cannot be estimated from the available data). (See table.)

Click on icon to see table/diagram/image
Drug Interactions
The co-administration of desloratadine with erythromycin, azithromycin, ketoconazole, fluoxetine or cimetidine resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but no clinically relevant changes in the safety profile of desloratadine were observed.
Storage
Store below 30°C. Protect from moisture.
ATC Classification
R06AX27 - desloratadine ; Belongs to the class of other antihistamines for systemic use.
Presentation/Packing
FC tab 5 mg (light blue colored, round shaped, biconvex, with both side plain) x 1 x 10's.
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