Claritin tablets 10mg №10×1

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Claritin tablets 10mg in a blister in pack No. 10×1
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Oval tablets of white or almost white color with a “flask and bowl” icon, a break line and the number “10” on one side and a flat surface on the other side, without foreign inclusions. The main active ingredient Loratadine Release form Tablets Dosage 10 mg Pharmacological properties Pharmacodynamics Mechanism of action Loratadine (the active ingredient of Claritin®) is a tricyclic antihistamine with selective activity for peripheral H1 receptors. Pharmacodynamic effects In most patients, when used at the recommended dose, loratadine does not have clinically significant sedative (hypnotic) or anticholinergic properties. With long-term treatment, there were no clinically significant changes in vital signs, laboratory tests, physical examination or ECG. Loratadine does not have significant activity on H1 receptors. The drug does not inhibit norepinephrine uptake and has little or no effect on the cardiovascular system or pacemaker activity. Histamine skin test studies after a single dose of 10 mg showed that the antihistamine effect occurs after 1-3 hours, peaks after 8-12 hours, and lasts more than 24 hours. There was no development of resistance to the action of the drug after 28 days of loratadine use. Clinical efficacy and safety More than 10,000 people (aged 12 years and older) have been treated with loratadine (10 mg tablets) in controlled clinical trials. Loratadine (tablets) 10 mg once daily was more effective than placebo and as effective as clemastine in improving symptoms (nasal and non-nasal) of allergic rhinitis. In these studies, drowsiness occurred less frequently with loratadine than with clemastine and at about the same rate as with terfenadine and placebo. Of the participants in these studies (aged 12 years and older), 1000 people with chronic idiopathic urticaria were enrolled in placebo-controlled studies. Loratadine 10 mg once daily was more effective than placebo in the treatment of chronic idiopathic urticaria, as evidenced by the improvement in pruritus, erythema, and allergic rash. In these studies, the frequency of drowsiness with loratadine was similar to that with placebo. Children Approximately 200 children (aged 6 to 12 years) with seasonal allergic rhinitis received loratidine (syrup) at doses up to 10 mg once daily in controlled clinical trials. In another study, 60 children (aged 2 to 5 years) received loratadine (syrup) at a dose of 5 mg once a day. No unintended adverse reactions were observed. Efficacy in children was similar to that in adults. Pharmacokinetics Absorption Loratadine is rapidly and well absorbed. The use of the drug during meals may slightly delay the absorption of loratadine, but this does not have any effect on the clinical effect. The bioavailability of loratadine and its active metabolite is dose proportional. Distribution Loratadine actively binds (from 97% to 99%) with plasma proteins, and its active metabolite – with moderate activity (from 73% to 76%). In healthy volunteers, the plasma half-life of loratadine and its active metabolite is approximately 1 and 2 hours, respectively. Biotransformation After oral administration, loratadine is rapidly and well absorbed and undergoes extensive first-pass metabolism in the liver, mainly by CYP3A4 and CYP2D6. The main metabolite of desloratadine is pharmacologically active and is more responsible for the clinical effect. Loratadine and desloratadine reach maximum plasma concentrations (Tmax) 1-1.5 hours and 1.5-3.7 hours after administration, respectively. Withdrawal. Approximately 40% of the dose is excreted in the urine and 42% in the feces over 10 days, mainly in the form of conjugated metabolites. Approximately 27% of the dose is excreted in the urine during the first 24 hours. Less than 1% of the active substance is excreted in unchanged active form – as loratadine or desloratadine. In adult healthy volunteers, the mean half-life of loratadine was 8.4 hours (range 3 to 20 hours) and the main active metabolite was 28 hours (range 8.8 to 92 hours). Impaired renal function In patients with chronic renal impairment, the AUC and maximum plasma concentration (Cmax) of loratadine and its active metabolite increased compared to those in patients with normal renal function. The mean half-life of loratadine and its active metabolite did not differ significantly from that in healthy subjects. In patients with chronic renal impairment, hemodialysis does not affect the pharmacokinetics of loratadine and its active metabolite. Impaired liver function In patients with chronic alcoholic liver disease, the AUC and Cmax of loratadine were two times higher, and its active metabolite did not change significantly compared with those in patients with normal liver function. The half-life of loratadine and its active metabolite is 24 and 37 hours, respectively, and increases with the severity of liver disease. Elderly patients The pharmacokinetics of loratadine and its active metabolite were similar in middle-aged healthy adult volunteers and healthy elderly volunteers. Features of pharmacokinetics in children, in patients with impaired functions of the cardiovascular system have not been studied, and there are no data. Indications for use Claritin is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children weighing more than 30 kg. Dosing and Administration Orally. The tablets can be taken with or without food. Dosage Adults and children over 12 years of age: 10 mg (1 tablet) once a day. Children For children aged 2 to 12 years, the dosage depends on body weight. With a body weight of more than 30 kg: 10 mg (1 tablet) 1 time per day. With a body weight of 30 kg or less: tablets at a dose of 10 mg are not intended for use in children weighing less than 30 kg. There are other dosage forms suitable for children aged 2 to 12 years weighing 30 kg or less. The safety and efficacy of Claritin in children under 2 years of age have not been studied and no data are available. Patients with hepatic impairment Patients with severe hepatic impairment should be treated at a lower starting dose as clearance of loratadine may be reduced. For adults and children weighing over 30 kg, the recommended starting dose is 10 mg every other day. Patients with impaired renal function No dose adjustment is necessary for patients with impaired renal function. Elderly patients No dose adjustment is necessary for elderly patients. If you miss taking the next dose of the drug, you must take the missed dose as soon as possible, then return to the usual regimen. Do not take a double dose of medicine to make up for a missed dose. Use during pregnancy and lactation Pregnancy. There are very few data on the use of loratadine in pregnant women. Animal studies have shown no direct or indirect adverse effects regarding reproductive toxicity. As a precautionary measure, the use of Claritin should be avoided whenever possible during pregnancy. Lactation. Physicochemical data suggest that loratadine/metabolites are excreted in breast milk. Since a risk to the child cannot be excluded, Claritin® should not be used during lactation. Influence on the ability to drive vehicles and other mechanisms Claritin has no or little effect on the ability to drive vehicles and mechanisms. However, the patient must be informed that dizziness has been reported very rarely, which may affect the ability to drive vehicles and mechanisms. Precautions Claritin should be used with caution in patients with severe hepatic impairment. The composition of the drug includes lactose. For this reason, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency and glucose-galactose malabsorption should not take this medicine. The use of Claritin must be discontinued at least 48 hours before skin testing, as antihistamines may neutralize or otherwise reduce positive skin test reactions in determining the reactivity index. Interaction with other drugs When used simultaneously with alcohol, Claritin does not have potentiating effects, which is confirmed by studies of psychomotor function. Potential interactions may occur with all known inhibitors of CYP3A4 or CYP2D6 with increased levels of loratadine, which may be accompanied by an increased incidence of adverse reactions. In controlled studies, an increase in plasma concentrations of loratadine was reported after simultaneous use with ketoconazole, erythromycin and cimetidine without clinically significant changes (including ECG). Children Interaction studies have only been performed in adults. Contraindications Hypersensitivity to the active substance or any of the excipients Composition Each tablet contains 10 mg loratadine; excipients: lactose monohydrate, magnesium stearate, corn starch. Overdose Overdose of loratadine increases the incidence of anticholinergic symptoms. In case of overdose, drowsiness, tachycardia and headache have been reported. In case of overdose, symptomatic and supportive treatment should be carried out for as long as necessary. It is possible to use activated carbon in the form of an aqueous suspension. You can also do gastric lavage. Loratadine is not excreted from the body during hemodialysis; the effectiveness of peritoneal dialysis in removing the drug is unknown. After emergency treatment, the patient’s condition should be monitored. Side effectA brief description of the safety profile. In clinical studies involving adults and adolescents, when using loratadine at the recommended dose of 10 mg per day for indications including allergic rhinitis and chronic idiopathic urticaria, adverse reactions were reported in 2% of patients, which exceeded the rate among patients who received placebo. The most common adverse reactions reported more frequently than placebo were: drowsiness (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%) . List of Adverse Reactions Adverse reactions reported during the post-marketing period are listed below according to organ system classes. The frequency is defined as: very often (? 1/10), often (? 1/100 to < 1/10), infrequently (? 1/1000 to < 1/100), rare (? 1/10000 to < 1/1000 ), very rare (< 1/10000), not known (cannot be estimated from the available data). Within each frequency group, adverse reactions are listed in descending order of severity. Immune system disorders: very rarely - anaphylaxis (including angioedema). Nervous system disorders: very rarely - dizziness. Cardiac disorders: very rarely - tachycardia, palpitations. From the gastrointestinal tract: very rarely - nausea, dry mouth, gastritis. Liver and biliary tract disorders: very rarely - liver dysfunction. Skin and subcutaneous tissue disorders: very rarely - rash, alopecia. Violations of the general condition and associated with the way the drug is used: very rarely - fatigue. Children In clinical studies involving children aged 2 to 12 years, the following adverse reactions occurred, which were reported more often than with placebo: headache (2.7%), nervousness (2.3%) and fatigue (1% ). If any of the above reactions occur, or a reaction not specified in the instructions for use, you should consult a doctor. Storage conditions Store at a temperature not exceeding 25 ° C, out of the reach of children. Buy Claritin tablets 10 mg No. 10x1 Price for Claritin tablets 10 mg No. 10x1