Product Name

Alanor
Tablets
Composition
Each Tablet Contains: Desloratadine ………. 5 mg


Pack
10's


INDICATION & USAGE


Desloratadine is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis, for the relief of the nasal and non nasal symptoms of perennial allergic rhinitis, for the symptomatic relief of pruritus, reduction in the number and size of hives, in patients with chronic idiopathic urticaria.

DOSAGE AND ADMINISTRATION


Adults and children 12 years of age and over: The recommended dose is 5 mg once daily.
Children 6 to 11 years of age: The recommended dose of Alenor is 2.5 mg once daily.

DESCRIPTION
Desloratadine is a histamine H1 receptor antagonist for oral use. The empirical formula of desloratadine is C19H19ClN2 and the molecular weight is 310.8.The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo [5, 6] cyclohepta [1, 2-b] pyridine.

PHARMACOLOGICAL ACTIONS
Pharmacodynamic properties
Desloratadine is a long-acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Single and repeated 5 mg doses of desloratadine have shown that the drug exhibits an antihistaminic effect by 1 hour; this activity may persist for as long as 24 hours.
Pharmacokinetic properties
Absorption: Following oral administration of desloratadine 5 mg, the maximum plasma concentration is achieved at approximately 3 hours. Food has no effect on the bioavailability of desloratadine.
Distribution: Desloratadine and 3-hydroxydesloratadine are approximately 82% to 87%and 85% to 89%, bound to plasma proteins, respectively.
Metabolism: Desloratadine is extensively metabolized to 3-hydroxydesloratadine, an active metabolite, which is subsequently glucuronidated.
Excretion: The mean elimination half-life of desloratadine is 27 hours. The drug is equally excreted in urine and feces as metabolic products.

CONTRAINDICATIONS
Desloratadine is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine.

ADVERSE EFFECTS
Tachycardia, palpitations, psychomotor hyperactivity, seizures and elevated liver enzymes including bilirubin.

WARNINGS AND SPECIAL PRECAUTIONS
Pregnancy
Pregnancy category C
There are, however, no adequate and well controlled studies in pregnant women. Desloratadine should be used during pregnancy only if clearly needed.
Nursing mothers
Desloratadine is excreted into breast milk; therefore the drug should be administered with caution taking into account the importance of the drug to the mother.
Renal & Hepatic impairment
It is recommended that in patients with renal impairment the dosage of desloratadine should be adjusted.

DRUG INTERACTIONS
An increase in plasma concentrations of desloratadine and 3-hydroxydesloratadine were observed when the drug was co-administered with erythromycin, fluoxetine or cimetidine.

OVERDOSAGE
In case of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxydesloratadine are not eliminated by hemodialysis.

STORAGE
Store at room temperature.
Protect from light, heat and moisture.
Keep all medicines out of the reach of children.

PRESENTATION
Alenor 5 mg tablet, alu alu pack of 10’s.

 
 
 
 
 
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