Loraday syrup
Active ingredients: Each 5 ml contains:
Loratadine 5 mg
Mode of Action:
LORADAY is a non-sedating antihistamine with selective peripheral H1-receptor antagonistic activity and does not have sedative effects at the recommended dose.
Indications:
LORADAY is used for the relief of symptoms associated with seasonal allergic rhinitis and chronic idiopathic urticaria in adults and children over the age of 2 years.
Posology:
Adults and children ≥ 12 years: 10 ml (10 mg) of the syrup, once daily
Children 2 to 11 years:
• Body weight > 30 kg: 10 ml (10 mg) of the syrup, once daily
• Body weight ≤ 30 kg: 5 ml (5 mg) of the syrup, once daily.
Precautions:
• Safety and efficacy of Loratadine in children under 2 years of age have not been established.
• Used with caution in patients with severe hepatic impairment.
• Loraday syrup should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.
Contraindications:
• Hypersensitivity to the active substance or any of the excipients.
• Pregnancy and breastfeeding.
• Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency.
Undesirable effects:
In clinical trials involving adults and adolescents, 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%). In clinical trials in a pediatric population, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).
Pharmacokinetic properties:
• Loratadine is rapidly and well-absorbed. Concomitant ingestion of food can delay slightly the absorption of loratadine but without influencing the clinical effect. The bioavailability parameters of loratadine and of the active metabolite are dose proportional.
• Loratadine is highly bound (97% to 99%) and its active metabolite moderately bound (73% to 76%) to plasma proteins.
• After oral administration, loratadine is rapidly and well absorbed and undergoes an extensive first pass metabolism, mainly by CYP3A4 and CYP2D6.
• Approximately 40% of the dose is excreted in the urine and 42% in the feces over a 10-day period and mainly in the form of conjugated metabolites. Approximately 27% of the dose is eliminated in the urine during the first 24 hours. Less than 1% of the active substance is excreted unchanged in active form, as loratadine or DL. The mean elimination half-lives in healthy adult subjects were 8.4 hours (range = 3 to 20 hours) for loratadine and 28 hours (range = 8.8 to 92 hours) for the major active metabolite.
Storage and disposal:
• Keep in a safe place, out of reach and sight of children.
• Store below 30° C.
How to use?
Adults and children ≥ 12 years: 10 ml (10 mg) of the syrup, once daily
Children 2 to 11 years:
• Body weight > 30 kg: 10 ml (10 mg) of the syrup, once daily
• Body weight ≤ 30 kg: 5 ml (5 mg) of the syrup, once daily.
Ingredients
Loratadine 5 mg
