The instruction for medical use
of Klaritin Torgovoye medicine a name
Mezhdunarodnoye the unlicensed
name Loratadin Lekarstvennaya a form
of the Tablet of 10 mg
One tablet contains
active agent: loratadin 10 mg,
excipients: lactoses monohydrate, starch corn, magnesium stearate.
Oval tablets from white till almost white color, with risky for a break and an engraving in the form of a symbol a flask in a bowl and figure 10 on one party of a tablet and smooth on the other hand, free from visible foreign inclusions
Antihistaminic drugs of systemic action. Antihistaminic drugs of systemic action others. Loratadin
the ATX R06AX13 Code
Pharmacokinetics Loratadin properties is quickly soaked up and metabolized in
digestive tract. Semi-removal time in blood plasma of a loratadin is 1 hour, and its active metabolite 2 hours. Elimination half-life of a loratadin averages 8.4 hours (varies from 3 to 20 hours), and a dezloratadina of 28 hours (varies from 8.8 to 92 hours). Impact on the area under a curve concentration time (AUC) of metabolites is higher in comparison with influence of the loratadin.
Loratadin has higher affinity to blood plasma proteins (97% of 99%), in comparison with its active metabolites (73% of 76%).
It is removed with urine (about 40%) and a stake (about 42%) within 10 days, generally in the form of the conjugated metabolites.
Clinical trial revealed that the pharmacokinetic profile of a loratadin and its metabolites is comparable between young and elderly volunteers.
The maximum plasma concentration of Cmax and AUC of a loratadin and its metabolites increases at patients with chronic kidney disease, in comparison with healthy patients. Such patients have an elimination half-life of a loratadin and its metabolites in insignificant degree differed from healthy patients. Carrying out a hemodialysis did not influence pharmacokinetics of a loratadin and its active metabolite.
At chronic alcoholic damage of a liver of Cmax and AUC value of a loratadin increased twice though in general the pharmacokinetic profile at these patients not considerably differed from a profile at healthy patients. Elimination half-life at a loratadin and its metabolites makes 24 hours and 37 hours respectively and increases in a liver failure.
Klaritin’s pharmacodynamics antihistamine selection blocker of peripheral H1-histamine receptors.
At most of patients of Klaritin does not show anticholinergic and sedative action, when using in the recommended doses.
At long-term treatment clinically significant changes of key indicators of the vital functions, indicators of laboratory tests, external examination or the ECG were not observed.
Loratadin has no significant activity concerning H2 receptors. Drug does not inhibit absorption of Norepinephrinum and practically does not influence the cardiovascular system or activity of a pacemaker of heart.
The antiallergic effect develops within the first 1-3 hours after administration of drug, reaches a maximum within 8-12 hours and 24 hours last. Development of resistance to effect of drug after 28 days of use of a loratadin was not noted.
– symptomatic treatment of allergic rhinitis
– symptomatic treatment of allergic diseases of skin
the Route of administration and doses
Adults and children are more senior than 12 years: 10 mg (1 tablet) of 1 times a day.
Children from the 6th to 12 years: with the body weight & gt, 30 kg 10 mg (1 tablet) of 1 times a day,
with the body weight & lt, 30 kg 5 mg (& frac12, tablets) 1 time a day.
Patients with a liver failure should appoint drug in lower initial dose as decrease in clearance of a loratadin is possible. For adults and children with body weight more than 30 kg the recommended initial dose makes 10 mg every other day.
Side effects are distributed according to the frequency of their emergence during clinical trials and use during the post-marketing period: very often (1/10), it is frequent (from 1/100 to & lt, 1/10), infrequently (from 1/1000 to & lt, 1/100), is rare (1/10000 to & lt, 1/1000), is very rare (& lt, 1/10000), it is unknown (frequency cannot be determined from the available data).
Disturbance from the immune system is very rare: an anaphylaxis, including a Quincke’s disease
of Disorder from nervous system: dizziness,
Disturbance spasms from a cardiovascular system: tachycardia, palpitation
Gastrointestinal disorders: nausea, dryness in a mouth, gastritis
Gepatobilliarny disorders: disturbance of functions of a liver
of Disturbance from skin and hypodermic cellulose: rash, alopecia
General disturbances: fatigue
the Nervousness (2.3%), a headache (2.7%) and fatigue (1%) met more often at children aged from 2 up to 12 years.
– hypersensitivity to any component of drug
– the lactation period
– the children’s age up to 6 years
At joint appointment with Klaritin alcohol does not influence the speed of psychomotor reactions.
Increase in level of a loratadin is noted that can be followed by increase in frequency of emergence of side reactions at joint appointment with CYP3A4 or CYP2D6 inhibitors. Though at joint reception with ketokonazoly, erythromycin and Cimetidinum noted increase in concentration of a loratadin in blood plasma, but this increase was not shown clinically in any way, including according to the ECG.
Patients with heavy disturbances of functions of a liver should appoint Klaritin with care.
Klaritin contains lactose. Therefore he should not be appointed to the patients having the rare hereditary diseases connected with intolerance of fructose, deficiency of Lapp-lactases enzyme, glucose galactose malabsorption.
Administration of drug Klaritin should be stopped in 48 hours prior to carrying out skin diagnostic allergoprob for prevention of false results.
Pregnancy and the period of a lactation
Purpose of the tablets Klaritin during pregnancy is justified only if the potential advantage for the woman exceeds potential risk for a fruit. Drug gets into breast milk therefore it is necessary to make a choice between the termination of administration of drug or the termination of breastfeeding.
Features of influence of medicines on ability of control of vehicles and potentially dangerous mechanisms
In the recommended doses Klaritin does not affect ability to run vehicles or difficult technical devices. However patients have to be notified on potential risk
in connection with development of symptoms of dizziness which can affect ability to run vehicles or difficult mechanisms.
Symptoms: drowsiness, tachycardia and headache.
Treatment: symptomatic and maintenance therapy during the necessary span. Gastric lavage, the crushed activated carbon with water. Loratadin is not brought by a hemodialysis. After rendering emergency aid the patient has to remain under medical observation.
The form of release and packing
On 10 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 1 planimetric packing together with the instruction for medical use in the state and Russian languages put in a pack cardboard
to Store at a temperature not higher than 25 wasps.
To store out of children’s reach!
A period of storage
not to apply after an expiration date
According to the prescription
Shering-Plau Labo Producer of N.V., Belgium
the Owner of the registration certificate
of Bayer Konsyyumer Ker AG, Switzerland
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of Bayer KAZ LLP in
Republic of Kazakhstan, 050057, Almaty, Timiryazeva 42, Expo City, peahens. 15
Bodies.: + 7 (727) 258 80 40 (148)