Aroled

Film-coated tablet: Each film-coated tablet contains: Desloratadine 5 mg.
Syrup: Each 5 mL (1 teaspoonful) contains: Desloratadine 2.5 mg.

Pharmacology: Desloratadine is a major metabolite of loratadine, antagonist with selective peripheral H1-receptor antagonist activity.
Pharmacodynamics: After oral administration, Desloratadine selectively blocks peripheral histamine H1-receptor. It does not cross the blood-brain barrier to any great extent. Desloratadine has demonstrated in addition to antihistamine activity, anti-allergic and anti-inflammatory activity from numerous in vitro (mainly conducted on cells of human origin) and in vivo studies. These studies have shown that Desloratadine inhibits the broad cascade of events that initiate and propagate allergic inflammation.
Pharmacokinetics: Film-coated tablet: 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 is consistent with its half-life (approximately 27 hours) and a once daily dosing frequency. The bioavailability of Desloratadine is dose proportional over the range of 5 mg-20 mg.
Syrup: Desloratadine plasma concentrations can be detected within 30 mins of Desloratadine administration.
Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours and once daily dosing frequency. The bioavailability of Desloratadine is dose proportional over the range of 5mg-20mg. 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-20 mg) for 14 days.

Desloratadine is indicated for the symptomatic relief of allergic conditions including rhinitis and urticaria .

Film-coated tablet: Adults and adolescents (>12 years of age): One tablet once a day regardless of mealtime. Or as prescribed by the physician.
Improvement of symptoms associated with seasonal allergic rhinitis usually becomes noticeable within 1-2 hours after administration of Desloratadine.
Syrup: Adult and Adolescents: 12 years old & above: 10 mL.
Children: 6-11 years old: 5 mL.
1-5 years old: 2.5 mL.
6-11 months old: 2 mL.
To be taken once daily.
Or as prescribed by the physician.

In the event of overdose, consider standard measures to remove unabsorbed active substance.
Symptomatic and supportive treatment is recommended. 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.

Desloratadine lacks significant sedative effects, however, some individuals may still experience the sedative effects.
Effects on ability to drive and use machines: A few patients treated with non-sedating antihistamine have experienced drowsiness. Therefore it is prudent to exercise caution before driving or operating machinery. The effect of a drug on a particular patient can be ascertained after the first few doses.
Film-coated tablet: Safety and efficacy of Desloratadine in children under 12 years of age have not been established.

Safety in pregnancy and lactation has not been established.

Nervous system disorders: Frequent: headache, somnolence.
Less frequent: Dizziness, fatigue.
Cardiac Disorders: Less frequent: Tachycardia.
Respiratory, thoracic and mediastinal disorders: Less frequent: Dyspnoea.
Frequent: Pharyngitis.
Gastrointestinal disorders: Frequent: Dyspepsia, nausea.
Less frequent: Dry mouth, dyspepsia.
Skin and subcutaneous tissue disorders: Less frequent: Oedema, pruritus, rash, urticaria.
Musculoskeletal, connective tissue and bone disorders: Less frequent: Myalgia.
Reproductive system and breast disorders: Less frequent: Dysmenorrhoea.
General disorders and administration site conditions: Less frequent: Anaphylaxis.
Liver: Abnormal hepatic function including jaundice, hepatitis, and hepatic necrosis has been reported rarely.

Desloratadine taken concomitantly with alcohol does not potentiate the performance impairing effects of alcohol.
Co-administration of Desloratadine with ketoconazole increases the maximum Desloratadine concentration (Cmax) by 45% and the area under the time concentration curve (AUC) by 37%.
Co-administration of Desloratadine with erythromycin increased the Cmax of Desloratadine by 24% and the AUC by 14%. The increase of Cmax and AUC of Desloratadine when co-adminstered with either ketoconazole or erythromycin did not cause any clinical relevant adverse events in the populations studied.

Film-coated tablet: Store at temperatures not exceeding 30°C. Keep tablets in original container.
Syrup: Store at temperatures not exceeding 30°C. Protect from light.

Antihistamines & Antiallergics

R06AX27 - desloratadine ; Belongs to the class of other antihistamines for systemic use.

Rx