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Description
oval-shaped pills of white or almost white color, not containing foreign inclusions, on one side there is a risk, trademark Cup and flask and number 10, the other side is smooth.
Active ingredients
Loratadine
Release form
Pills
Composition
1 tablet contains: - active ingredient - loratadine 10 mg; - excipients - lactose monohydrate 71.3 mg, corn starch 18 mg, magnesium stearate 0.7 mg.
Pharmacological effect
Loratadine - the active substance of the drug Claritin - is a tricyclic compound with a pronounced antihistamine effect and is a selective blocker of peripheral H1-histamine receptors. It has a fast and long anti-allergic effect. Onset of action - within 30 minutes after taking the drug Klaritin inside. The antihistamine effect reaches a maximum after 8-12 hours from the onset of action and lasts for more than 24 hours. Loratadine does not penetrate the blood-brain barrier and does not affect the central nervous system. It has no clinically significant anticholinergic or sedative effect, i.e. does not cause drowsiness and does not affect the speed of psychomotor reactions when used in the recommended doses. Taking the drug Claritin does not prolong the QT interval on the ECG. During long-term treatment, there were no clinically significant changes in vital signs, physical examination data, laboratory results or electrocardiography. Loratadine does not have significant selectivity for H1-histamine receptors. It does not inhibit the reuptake of norepinephrine and has virtually no effect on the cardiovascular system or the function of the pacemaker.
Pharmacokinetics
Loratadine is rapidly and well absorbed in the gastrointestinal tract. The time to reach the maximum concentration (Tmax) of loratadine in blood plasma is 1-1.5 hours, and its active metabolite desloratadine is 1.5-3.7 hours. Eating increases the time to reach the maximum concentration (Tmax) of loratadine and desloratadine by approximately 1 hour, but does not affect the efficacy of the drug. The maximum concentration (Сmax) of loratadine and desloratadine does not depend on food intake.In patients with chronic kidney disease, the maximum concentration (Cmax) and the area under the concentration-time curve (AUC) of loratadine and its active metabolite increase compared with patients with normal renal function. The half-life of loratadine and its active metabolite does not differ from those in healthy patients. In patients with alcoholic liver damage, Cmax and AUC of loratadine and its active metabolite are doubled compared with these indicators in patients with normal liver function. Loratadine has a high degree (97-99%), and its active metabolite is moderate (73 -76%) plasma protein binding. Loratadine is metabolized to desloratadine through the cytochrome P450 ZA4 system and, to a lesser extent, the cytochrome P450 2D6 system. Excreted through the kidneys (approximately 40% of the ingested dose) and through the intestines (approximately 42% of the ingested dose) for more than 10 days, mainly in the form of conjugated metabolites. Approximately 27% of the ingested dose is eliminated through the kidneys within 24 hours after taking the drug. Less than 1% of the active substance is excreted through the kidneys in unchanged form within 24 hours after taking the drug. The bioavailability of loratadine and its active metabolite is dose-dependent. The pharmacokinetic profiles of loratadine and its active metabolite in adults and elderly healthy volunteers were comparable. The half-life of loratadine is from 3 to 20 hours (average of 8.4 hours), and desloratadine is from 8.8 to 92 hours (average of 28 hours) ; in elderly patients, respectively, from 6.7 to 37 hours (average 18.2 hours) and from 11 to 39 hours (average 17.5 hours). The half-life increases with alcoholic liver damage (depending on the severity of the disease) and does not change if there is chronic renal insufficiency. Hemodialysis in patients with chronic renal insufficiency does not affect the pharmacokinetics of loratadine and its active metabolite.
Indications
- Seasonal (pollinosis) and perennial allergic rhinitis and allergic conjunctivitis - elimination of symptoms associated with these diseases - sneezing, itching of the nasal mucosa, rhinorrhea, burning sensation and itching in the eyes, tearing.
Contraindications
- Intolerance or hypersensitivity to loratadine or any other component of the drug. - Age up to 2 years (for syrup), 3 years (for pills). - Breastfeeding period. - Patients with rare hereditary diseases (impaired galactose tolerance, Lapp's lactase deficiency malabsorption of glucose-galactose) due to the presence of lactose, which is part of the pills, patients with deficiency of sucrase / isomaltase, intolerance to fructose, glucose-galactose malabsorption - due to the presence of sucrose, giving into the syrup.
Precautionary measures
- Severe abnormal liver function. - Pregnancy (see section Use during pregnancy and during breastfeeding).
Use during pregnancy and lactation
The safety of loratadine during pregnancy has not been established. Use of the drug Claritin is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. Loratadine and its active metabolite are excreted in breast milk, therefore, when prescribing the drug during breastfeeding, the issue of discontinuing breastfeeding should be resolved.
Dosage and administration
Inside, regardless of meal times. Adults. including the elderly, and adolescents aged 12 and older, Claritin is recommended to be taken in a dose of 10 mg (1 tablet or 2 teaspoons (10 ml) of syrup) once a day. When using the drug in elderly patients and in patients with chronic renal dose adjustment deficiency is not required. For children aged 2 to 12 years, the dose of Claritin is recommended to be prescribed depending on body weight: - with a body weight of 30 kg or less, 5 mg (1 tsp (5 ml) of syrup) 1 time per day, - With a body weight of more than 30 kg - 10 mg (2 teaspoons (10 ml) of syrup or 1 tablet) 1 time per day. Grown up Children and children with a body weight of more than 30 kg with severe liver dysfunction should have an initial dose of 10 mg (2 teaspoons (10 ml) of syrup or 1 tablet) every other day, with a body weight of 30 kg or less - 5 mg (1 teaspoon (5 ml) of syrup) every other day.
Side effects
In clinical studies involving children aged 2 to 12 years, taking the drug Claritin more often than in the placebo group, headache (2.7%), nervousness (2.3%), fatigue (1%) were observed. In clinical trials involving adults, adverse events, which were observed more often than when using a placebo (dummy), occurred in 2% of patients taking the drug Claritin.In adults, when using the drug Claritin, more often than in the placebo group, headache (0.6%), drowsiness (1.2%), increased appetite (0.5%) and insomnia (0.1%) were observed. In addition, in the post-marketing period there were very rare reports (<1/10 000) about dizziness, fatigue, dry mouth, gastrointestinal disorders (nausea, gastritis), allergic reactions in the form of rash, anaphylaxis, alopecia, abnormal liver function, palpitations and tachycardias.
Overdose
Symptoms: drowsiness, tachycardia, headache. In case of overdose, you should immediately consult a doctor. Treatment: symptomatic and supportive therapy. It is possible to wash the stomach, taking adsorbents (crushed activated carbon with water). Loratadine is not excreted by hemodialysis. After providing emergency care, it is necessary to continue monitoring the patient's condition.
Interaction with other drugs
Eating does not affect the effectiveness of Claritin. The drug Claritin does not enhance the effect of alcohol on the central nervous system. When loratadine was taken together with ketoconazole, erythromycin or cimetidine, there was an increase in plasma concentration of loratadine, but this increase was not clinically significant, including according to electrocardiography.
special instructions
Children aged 2 to 3 years old are recommended to take the drug Claritin in the form of syrup. The drug Claritin should be stopped 48 hours before skin tests, because antihistamine drugs can distort the results of the diagnostic study. control mechanisms No negative effect of Claritin on ability to drive a car or to perform other activities, requiring increased concentration of attention. However, in very rare cases, some patients experience drowsiness while taking the drug Claritin, which can affect their ability to drive and work with machinery.
Storage conditions
At a temperature not higher than 25 ° С. Keep out of the reach of children.