Claritin - instructions for use, dose, side effects, contraindications

Description:Oval-shaped tablets of white or almost white color, not containing extraneous inclusions, on one side there is a risk, the trademark "Cup and flask" and the figure "10", the other side is smooth.

Pharmacotherapeutic group:Antiallergic - H1 histamine receptor blocker

ATX: & nbsp

R.06.A.X Other antihistamines for systemic use

R.06.A.X.13 Loratadin

Pharmacodynamics:

Loratadin, the active substance of the drug Claritin®, is a tricyclic compound with a pronounced antihistamine effect and is a selective blocker peripheral H₁-gistaminovyh receptors. It has a fast and long-lasting antiallergic effect. The onset of action is within 30 minutes after taking the Claritin® drug 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. Does not have a clinically significant anticholinergic or sedative effect, i.e. does not cause drowsiness and does not affect the rate of psychomotor reactions when administered at recommended doses. Reception of Claritin® does not lead to lengthening of the interval QT on the ECG.

With prolonged treatment, there were no clinically significant changes in the indices of vitalfunctions, physical examination data, laboratory test results or electrocardiography. Loratadin does not have a significant selectivity with respect to H₂-histamine receptors. It does not inhibit norepinephrine reuptake and has virtually no effect on the cardiovascular system or rhythm driver function.

Pharmacokinetics:

Loratadine is rapidly and well absorbed in the gastrointestinal tract. The time to reach the maximum concentration (T_m_Oh) loratadine in blood plasma - 1-1,5 hours, and its active metabolite desloratadine - 1,5-3,7 hours. The intake of food increases the time to reach the maximum concentration (T_m_Oh) loratadine and desloratadine for about 1 hour, but does not affect the effectiveness of the drug. The maximum concentration (C_m_Oh) loratadine and desloratadine is not dependent on food intake. In patients with chronic kidney disease, the maximum concentration (C_ma_x) and the area under the curve "concentration-time" (AUC) loratadine and its active metabolite are increased in comparison with patients with normal renal function. The half-lives of loratadine and its active metabolite do not differ from those in healthy patients. In patients with alcoholic liver damage C_m_Oh and AUC loratadine and its active metabolite are doubled in comparison with these parameters in patients with normal liver function.

Loratadine has a high degree (97-99%), and its active metabolite - a moderate degree (73-76%) of binding to plasma proteins.

Loratadine is metabolized in desloratadine through the cytochrome P450 3A4 system and, to a lesser extent, the cytochrome P450 system 2D6. It is excreted through the kidneys (approximately 40% of the ingested dose) and through the intestine (approximately 42% of the ingested dose) for more than 10 days, mainly as conjugated metabolites. Approximately 27% of the ingested dose is excreted through the kidneys within 24 hours after taking the medication. Less than 1% of the active substance is excreted through the kidneys unchanged within 24 hours after taking the drug.

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 ranges from 3 to 20 hours (an average of 8.4 hours), and desloratadine is from 8.8 to 92 hours (an average of 28 hours); in elderly patients, respectively, from 6.7 to 37 hours (an average of 18.2 hours) and from 11 to 39 hours (an average of 17.5 hours).The elimination half-life increases with alcoholic liver damage (depending on the severity of the disease) and does not change with chronic renal failure.

Conducting hemodialysis in patients with chronic renal failure does not affect the pharmacokinetics of loratadine and its active metabolite.

Indications:

Seasonal (pollinosis) and all-the-year-round 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, lacrimation.

Chronic idiopathic urticaria.

Contraindications:

Intolerance or hypersensitivity to loratadine or any other component of the drug.

Children under 3 years old and body weight less than 30 kg.

Breastfeeding period.

Patients with rare hereditary diseases (impaired galactose tolerance, Lactase Lactase deficiency or glucose-galactose malabsorption).

Carefully:

Severe liver dysfunction.

Pregnancy (see the section "Application during pregnancy and during breastfeeding").

Pregnancy and lactation:

Safety of the use of loratadine during pregnancy is not established. Use of the drug Claritin® is only possible if the intended benefit to the mother exceeds the potential risk to the fetus.

Loratadine and its active metabolite are excreted in breast milk, so when prescribing a medication during breastfeeding, the question of stopping breastfeeding should be addressed.

Dosing and Administration:

Inside, regardless of meal time.

Adults, including the elderly, and adolescents over 12 years of age, it is recommended that the drug Claritin® be given at a dose of 10 mg (1 tablet) once a day.

When using the drug in elderly patients and patients with chronic renal failure, dose adjustment is not required.

Children at the age of 3 to 12 years with a body weight of more than 30 kg - 10 mg (1 tablet) 1 time per day.

Adults and children with a body weight of more than 30 kg with severe impairment of liver function, the initial dose should be 10 mg (1 tablet) every other day.

Side effects:

In clinical studies involving children aged 2 to 12 years who took the drug Claritin® more often than in the placebo group ("pacifiers"), headache (2.7%), nervousness (2.3%), fatigue (1 %).

In adult clinical trials, adverse events observed more frequently than with placebo occurred in 2% of patients taking Claritin®. In adults, Claritin® was more likely than in the placebo group to have headache (0.6%), drowsiness (1.2%), increased appetite (0.5%), and insomnia (0.1%). In addition, in the postmarketing period there were very rare reports (<1/10 000) of dizziness, fatigue, dry mouth, gastrointestinal disorders (nausea, gastritis), allergic reactions in the form of rash, anaphylaxis, including angioedema, alopecia, impaired liver function, palpitations, tachycardia and convulsions.

Overdose:

Symptoms: drowsiness, tachycardia, headache.

In case of an overdose, immediately consult a doctor.

Treatment: symptomatic and supportive therapy. maybe gastric lavage, intake of 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:

The intake of food does not affect the effectiveness of the drug Claritin®.

The drug Claritin® does not enhance the effects of alcohol on the central nervous system.

When co-administration of loratadine with ketoconazole, erythromycin, or cimetidine, an increase in loratadine plasma concentration was noted, but this increase was not clinically significant, including electrocardiography data.

Special instructions:The drug Claritin® should be discontinued 48 hours before the skin tests, as antihistamines may distort the results of the diagnostic study.

Effect on the ability to drive transp. cf. and fur:

There was no adverse effect of the drug Claritin® on the ability to drive a car or perform other activities that require increased concentration of attention.

However, in very rare cases, some patients experience drowsiness when taking Claritin®, which may affect their ability to drive vehicles and work with mechanisms.

Form release / dosage:Tablets 10 mg.

Packaging:

For 7, 10 or 15 tablets in blisters made of polyvinyl chloride and aluminum foil. For 1, 2 or 3 blisters together with instructions for use in a cardboard bundle.

Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

4 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N013494 / 01

Date of registration:12.12.2007 / 29.08.2016

Expiration Date:Unlimited

The owner of the registration certificate:BAYER, AO BAYER, AO Russia

Manufacturer: & nbsp

SCHERING-PLOUGH LABO, N.V. Belgium

Representation: & nbspBAYER, AOBAYER, AO

Information update date: & nbsp24.01.2018

Illustrated instructions

Instructions

Claritin® (Claritin®)