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Therapeutic Category
- ANTIALLERGICS
- Pharmaceutical Form : Syrup
- Composition : Desloratadine 2.5 mg/ 5 ml
- Active Substance : Desloratadine
CLINICAL PHARMACOLOGY :
Desloratadine is a long acting Tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity.
Desloratadine inhibites histamine release from human mast cells in vitro .
INDICATIONS AND USAGE :
Allergic Rhinitis : Claramix is indicated for the relief of the nasal and non nasal Symptoms of allergic rhinitis ( seasonal and perennial )
Chronic idiopathic Urticaria : Claramix is indicated for the symptomatic relief of Pruritus , reduction in the number of hives , and size of hives in patients with chronic idiopathic urticaria .
CONTRAINDICATIONS :
Claramix is contraindicated in patients who are hypersensitive to this Medication or to any of its ingredients , or to Loratadin .
ADVERSE REACTIONS :
The following spontaneous adverse events have been reported during the marketing of Desloratadine : tachycardia , and rarely hypersensitivity reactions ( such as rash , pruritus , Urticaria , edema , dyspnea, and anaphylaxis ),Fatigue , headache
PRECAUTIONS :
Pregnancy : there are , however , no adequate and well-controlled studies in pregnant women .Because animal reproduction studies are not always predictive of human response , Claramix should be used during pregnancy only if clearly needed .
Nursing Mothers : Desloratadine passes into breast milk , therefore a decision should be made Whether to discontinue nursing or to discontinue Claramix , taking into account the importance of the drug to the mother .
Geriatric Use :
In general dose selection for an elderly patient should be cautious , reflecting the greater frequency of decreased hepatic , renal, or cardiac function , and of concomitant disease or other drug therapy .
Information for Patients :
As there are no food effects on bioavailability , patients can be instructed that Tablets may be taken without regard to meals Patients should be advised not to increase the dose or dosing frequency as studies have not demonstrated increased effectiveness at higher doses and somnolence may occur .
Drug Interactions :
Desloratadine at the clinical dose of 5 mg has been co-administered with Azithromycin , fluoxetine , ketoconazole and with cimetidine .
DOSAGE AND ADMINISTRATION :
SYRUP : the dose for children aged two to five years is 2.5 ml of Claramix syrup eq.(1.25 mg Desloratadine ) once daily.
For children aged six to 11 years is 5 ml of Claramix syrup eq.( 2.5 mg Desloratadine ) once daily .
TABLETS: in adults and children 12 years of age and over ; the recommended dose of Claramix tablets is 5 mg once daily. in patients with liver or renal impairment , a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data .
OVERDOSAGE :
In the event of overdose , consider standard measures to remove any 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 .
STORAGE CONDITIONS : store up to 30oC
PACKING : Tablet : box of10- 30 coated tablet .