Deslodine

Deslodine

desloratadine

Manufacturer:

Stallion Labs

Distributor:

Ambica

Marketer:

Ambica
Full Prescribing Info
Contents
Desloratadine.
Action
Pharmacology: Desloratadine is a major metabolite of loratadine and is a nonsedating long-acting histamine 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: Desloratadine plasma concentrations can be detected within 30 min of desloratadine administration. Desloratadine is well-absorbed with maximum concentration achieved after approximately 3 hrs; the terminal phase half-life (t½) is approximately 27 hrs and a once daily dosing frequency. The bioavailability of desloratadine is dose proportional over the range of 5-20 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 (5-20 mg) for 14 days.
Indications/Uses
For the symptomatic relief of allergic conditions including rhinitis and urticaria.
Dosage/Direction for Use
Adults and Adolescents ≥12 years: 10 mL.
Children 6-11 years: 5 mL; 1-5 years: 2.5 mL; 6-11 months: 2 mL. All doses to be taken once daily.
Overdosage
In the event of overdosage, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxy desloratadine are not eliminated by hemodialysis.
Contraindications
Hypersensitivity to desloratadine, loratadine or to any of the ingredients of Deslodine.
Special Precautions
Desloratadine lacks significant sedative effects, however, some individuals may still experience the sedative effects.
Effects on the Ability to Drive or Operate Machinery: A few patients treated with nonsedating 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 1st few doses.
Use in pregnancy: Safety in pregnancy and lactation has not been established.
Use in lactation: Safety in pregnancy and lactation has not been established.
Use in children: The safety and effectiveness of desloratadine tablets in pediatric patients <12 years of age have not been established.
Use in the elderly: Dose selection for an elderly patient should be cautious. Carefully read the instructions before use and ask the physician for further information.
Use In Pregnancy & Lactation
Use in pregnancy: Safety in pregnancy and lactation has not been established.
Use in lactation: Safety in pregnancy and lactation has not been established.
Adverse Reactions
Liver: Abnormal hepatic function including jaundice, hepatitis and hepatic necrosis has been reported rarely.
Drug Interactions
Desloratadine taken concomitantly with alcohol did 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-administered with either ketoconazole or erythromycin did not cause any clinical relevant adverse events in the populations studied.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
ATC Classification
R06AX27 - desloratadine ; Belongs to the class of other antihistamines for systemic use.
Presentation/Packing
Syr 2.5 mg/5 mL x 60 mL x 1's.
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