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Latest Drugs
Drug Description
Each ml of syrup contains 1mg loratadine. The quantity of sucrose in the loratadine syrup composition is 600 mg/ml. The amount of sucrose per 5 ml (5 mg) dose is 3 grams.Presentation
Syrup Clear, colourless to light yellow syrup.Indications
Clarityn Allergy Syrup is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.Adult Dosage
Adults and children over 12 years of age :
10mg once daily (10ml (10mg) of the syrup once daily).
The syrup may be taken without regard to mealtime.
Children 2 to 12 years of age are dosed by weight:
Bodyweight more than 30kg : 10mg once daily (10ml (10mg) of the syrup once daily).
Bodyweight 30kg or less : 5ml (5mg) of the syrup once daily.
Efficacy and safety of Clarityn Allergy Syrup in children under 2 years of age has not been established.
Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10mg every other day is recommended for adults and children weighing more than 30kg and for children weighing 30kg or less, 5ml (5mg) every other day is recommended.
No dosage adjustments are required in the elderly or in patients with renal insufficiency.
Contra Indications
Clarityn Allergy Syrup is contraindicated in patients who are hypersensitive to the active substance or to any of the excipients in these formulations.
Special Precautions
Clarityn Allergy Syrup should be administered with caution in patients with severe liver impairment.
This medicinal product contains sucrose; thus patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose isomaltase insufficiency should not take this medicine.
The administration of Clarityn Allergy Syrup should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.
Interactions
When administered concomitantly with alcohol, Clarityn Allergy Syrup has no potentiating effects as measured by psychomotor performance studies.
Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in elevated levels of loratadine, which may cause an increase in adverse events.
Adverse Reactions
In clinical trials in a paediatric population children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).
In clinical trials involving adults and adolescents in a range of indications including AR and CIU, at the recommended dose of 10mg daily, adverse reactions with loratadine were reported in 2% of patients in excess of those treated with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%). Other adverse reactions reported very rarely during the post-marketing period are listed in the following table.
|
Immune System disorders |
Anaphylaxis |
|
Nervous system disorders |
Dizziness |
|
Cardiac disorders |
Tachycardia, palpitation |
|
Gastrointestinal disorders |
Nausea, dry mouth, gastritis |
|
Hepatobiliary disorders |
Abnormal hepatic function |
|
Skin and subcutaneous tissue disorders |
Rash, alopecia |
|
General disorders and administration site conditions |
Fatigue |
Manufacturer
Schering-Plough LtdDrug Availability
GSL – General Sales ListUpdated
05 May 2010Advert for Healthcare Professionals Only
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