(and dosage form):
Each film-coated tablet contains desloratadine 5 mg
A 5.7.1 Antihistaminics
Desloratadine is a major metabolite of loratadine, and 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. It does not cross the blood-brain barrier to any great extent.
Desloratadine has demonstrated in addition to antihistaminic 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.
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.
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.
DESODENE is indicated for the relief of symptoms associated with seasonal allergic rhinitis.
Hypersensitivity to the active substance or to any of the excipients.
DESODENE lacks significant sedative effects, however, some individuals may still experience the sedative effects.
Safety and efficacy of DESODENE in children under 12 years of age have not been established.
Effects on ability to drive and use machines
A few patients treated with non-sedating anti-histamines 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.
DESODENE taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol.
Co-administration of DESODENE with ketoconazole increases the maximum desloratadine concentration (Cmax) by 45% and the area under the time concentration curve (AUC) by 37%. Co-administration of DESODENE with erythromycin increased the Cmax of desloratadine by 24% and the AUC by 14%.
The increase of Cmax and AUC of desloratadine when co-administered with either ketoconazole or erythromycin did not cause any clinical relevant adverse events in the populations studied.
PREGNANACY AND LACTATION
Safety in pregnancy and lactation has not been established.
DOSAGE AND DIRECTIONS FOR USE
Adults and adolescents (> 12 years of age): One tablet once a day regardless of mealtime. Improvement of symptoms associated with seasonal allergic rhinitis usually becomes noticeable within 1 2 hours after administration of DESODENE.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Nervous system disorders
Frequent: Headache, somnolence
Less frequent: Dizziness, fatigue
Less frequent: Tachycardia
Respiratory, thoracic and mediastinal disorders
Less frequent: Dyspnoea,
Frequent: Dyspepsia, nausea
Less frequent: Dry mouth, dyspepsia
Skin and subcutaneous tissue disorders
Less frequent: Oedema, pruritis, 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
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS 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 hemodialysis; it is not known if it is eliminated by peritoneal dialysis.
Dark blue coloured, round shaped, biconvex film-coated tablets, embossed RDYon one side and 227on the other side.
30 film-coated tablets in white HDPE bottles and/or 10 film-coated tablets in Alu/Alu or PVC/Alu blisters
Store below 25ºC.
Protect from light.
Keep tablets in original container.
Keep blisters in carton until required for use.
Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Dr. Reddys Laboratories (Pty) Ltd
381 Rossouw Street
DATE OF PUBLICATION OF THE PACKAGE INSERT
New addition to this site: March 2010
Source: Pharmaceutical Industry
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