Each tablet contains: Loratadine 10 mg.
AVOTYNE 10 mg Tablet is a white oval-shaped tablet, one side with score, the other side with "CCP" mark.
ATC code: R06AX13.
Pharmacology: Pharmacodynamics: Loratadine is a tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity. It is a long-acting non-sedating antihistamine.
Loratadine has no clinically significant sedative or anticholinergic properties in the majority of the population and when used at the recommended dosage.
During long-term treatment there were no clinically significant changes in vital signs, laboratory test values, physical examinations or electrocardiograms.
Loratadine has no significant H2-receptor activity. It does not inhibit norepinephrine uptake and has practically no influence on cardiovascular function or on intrinsic cardiac pacemaker activity.
Pharmacokinetics: After oral administration, loratadine is rapidly and well absorbed and undergoes an extensive first pass metabolism, mainly by CYP3A4 and CYP2D6. The major metabolite-desloratadine (DL) - is pharmacologically active and responsible for a large part of the clinical effect. Loratadine and DL achieve maximum plasma concentrations (Tmax) between 1-1.5 hours and 1.5-3.7 hours after administration, respectively.
Increase in plasma concentrations of loratadine has been reported after concomitant use with ketoconazole, erythromycin and cimetidine in controlled trials, but without clinically significant changes (including electrocardiographic).
Loratadine is highly bound (97% to 99%) and its active metabolite moderately bound (73% to 76%) to plasma proteins.
In healthy subjects, plasma distribution half-lives of loratadine and its active metabolite are approximately 1 and 2 hours, respectively. Approximately 40% of the dose is excreted in the urine and 42% in the faeces 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 bioavailability parameters of loratadine and of the active metabolite are dose proportional.
The pharmacokinetic profile of loratadine and its metabolites is comparable in healthy volunteers and in healthy geriatric volunteers.
Haemodialysis does not have an effect on the pharmacokinetics of loratadine or its active metabolite in subjects with chronic renal impairment.
Concomitant ingestion of food can delay slightly the absorption of loratadine but without influencing the clinical effect.
Loratadine and its active metabolite are excreted in the breast milk of lactating women.
Avotyne 10 mg Tablet is indicated for the relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge (rhinorrhea) and itching, as well as ocular itching and burning.
Nasal and ocular signs and symptoms are relieved rapidly after oral administration. Avotyne 10 mg Tablet is also indicated for relief of symptoms and signs of chronic urticaria and other allergic dermatologic disorders.
The tablet is taken orally and may be taken without regard to meal time.
Adults and children over 12 years of age: 10 mg once daily (one tablet once daily).
Children 2 to 12 years of age are dosed by weight: Bodyweight more than 30 kg: 10 mg once daily (one tablet once daily).
Bodyweight less than 30 kg: 5 mg once daily (half tablet once daily).
Efficacy and safety of Avotyne 10 mg Tablet 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 have reduced clearance of loratadine.
An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg, and for children weighing 30 kg or less, 5 mg every other day is recommended.
No dosage adjustments are required in the elderly or in patients with renal insufficiency.
Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia and headache have been reported with overdoses.
In the event of overdose, general symptomatic and supportive measures are to be instituted and maintained for as long as necessary. Administration of activated charcoal as a slurry with water may be attempted. Gastric lavage may be considered. Loratadine is not removed by haemodialysis and it is not known if loratadine is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment.
Avotyne 10 mg Tablet is contraindicated in patients who are hypersensitive to the active substance or to any of the excipients in these formulations.
Safety and efficacy of Avotyne 10 mg Tablet in children younger than two years old have not yet been established. So they are not recommended to take this drug.
Avotyne 10 mg Tablet should be administered with caution in patients with severe liver impairment.
This medicinal product contains lactose; thus patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The administration of Avotyne 10 mg Tablet should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.
Effects on ability to drive and use machines: There has been no reports of impairment in driving ability, in patients receiving loratadine. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.
Pregnancy: Loratadine was not teratogenic in animal studies. The safe use of loratadine during pregnancy has not been established. The use of Avotyne 10 mg Tablet during pregnancy is therefore not recommended.
Loratadine is excreted in breast milk, therefore the use of loratadine is not recommended in breast-feeding women.
The most frequent adverse reactions reported were somnolence, headache, increased appetite, nervousness, fatigue and insomnia. Other adverse reactions reported very rarely are listed in the following table. (See table.)
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When administered concomitantly with alcohol, Avotyne 10 mg Tablet have no potentiating inhibition effects on CNS.
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.
Store below 30°C. Protect from light and moisture.
R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.
Avotyne tab 10 mg
1 × 10's;10 × 10's
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