Klaritin
Producer: Schering-Plough Corp. (Shering-Plau of Box.) USA
Code of automatic telephone exchange: R06AX13
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Tablets. Active agent - лоратадин 10 mg.
Excipients - lactoses monohydrate, starch corn, magnesium stearate.
Syrup. Active agent - лоратадин 1 mg/ml.
Excipients - propylene glycol, глицерол, citric acid monohydrate (alternative citric acid anhydrous), Natrium benzoicum, the sucrose (granulated) fragrance artificial (peach), the water purified.
Pharmacological properties:
Pharmacodynamics. Klaritin - antihistaminic drug - a selective blocker of peripheral H1-histamine receptors. Possesses bystry and long antiallergic action. The beginning of action - within 30 minutes after reception. The antihistaminic effect reaches a maximum 8-12 hours later from the beginning of action and more than 24 hours last. Klaritin does not get through a blood-brain barrier and does not make impact on the central nervous system, has no anticholinergic and sedative effect (drowsiness), does not influence the speed of psychomotor reactions. Klaritin's reception does not lead to lengthening of an interval of QT on an ECG.
Pharmacokinetics. Klaritin is quickly soaked up in digestive tract. Time of achievement of the maximum concentration in a blood plasma of a loratadin - 1,3 hours, and its active metabolite - a dezloratadin - 2,5 hours. Meal increases time of achievement of the maximum concentration (Tmax) of a loratadin and dezloratadin approximately for 1 hour. The maximum concentration (Cmax) of a loratadin and dezloratadin does not depend on meal. The maximum concentration increases at elderly patients, patients with a chronic renal failure or alcoholic damage of a liver.
Loratadin is metabolized in дезлоратадин by means of P450 ZA4 cytochrome and, to a lesser extent, P450 2D6 cytochrome. It is removed with urine and with bile. The elimination half-life of a loratadin makes from 3 to 20 hours (on average 8,4 hours), and a dezloratadina - from 8,8 to 92 hours (on average 28 hours); elderly patients have respectively from 6,7 to 37 hours (on average 18,2 hours) and from 11 to 39 hours (on average 17,5 hours). The elimination half-life increases at alcoholic damage of a liver (depending on disease severity) and does not change in the presence of a chronic renal failure.
Carrying out a hemodialysis did not exert impact on pharmacokinetics of a loratadin and its active metabolite.
Indications to use:
- Seasonal (pollinosis) and year-round allergic rhinitises and allergic conjunctivitis - elimination of the symptoms connected with these diseases - sneezing, an itch of a mucous membrane of a nose, a rhinorrhea, a burning sensation and an itch in eyes, dacryagogues.
- Chronic idiopathic small tortoiseshell
- Skin diseases of an allergic origin.
Route of administration and doses:
Inside, irrespective of meal time.
Adult. including elderly, and Klaritin's reception in a dose of 10 mg (1 tablet or 2 teaspoons (10 ml) of syrup) is recommended to teenagers aged from 12 years once a day.
For patients with an abnormal liver function or a renal failure the initial dose has to make 1 tablet (10 mg) or 2 teaspoons (10 ml) of syrup every other day.
Children aged from 2 up to 12 years are recommended to appoint Klaritin's dose depending on body weight:
- at body weight less than 30 kg - 5 mg (1 teaspoon (5 ml) of syrup or 1/2 tablets) once a day.
- at the body weight of 30 kg and more - 10 mg (2 teaspoons (10 ml) of syrup or 1 tablet) once a day.
Features of use:
Klaritin's reception in the form of syrup is recommended to children under 3 years.
The negative effect of Klaritin on ability to driving or implementation of other activity demanding the increased concentration of attention is not revealed.
Side effects:
The undesirable phenomena which are listed below at Klaritin's use met frequency> 2% and approximately with the same frequency, as at use of placebo ("baby's dummy").
At adults the headache, fatigue, dryness in a mouth, drowsiness, gastrointestinal frustration (nausea, gastritis), and also allergic reactions in the form of rash were noted. Besides, there were rare messages on an anaphylaxis, an alopecia, abnormal liver function, heartbeat, tachycardia.
At children the headache, nervousness, sedative action were seldom noted. As well as adults, had a frequency of the specified phenomena at the same level, as at use of placebo ("baby's dummy").
Interaction with other medicines:
Meal does not exert impact on efficiency of drug.
Klaritin does not strengthen effect of alcohol on the central nervous system. At joint reception of Klaritin with ketokonazoly, erythromycin or Cimetidinum noted increase in concentration of a loratadin and its metabolite in plasma, but this increase was not shown clinically in any way, including according to an electrocardiography.
Contraindications:
- Intolerance or hypersensitivity to a loratadin or any other component of drug,
- age up to 2 years,
- lactation period.
With care.
- pregnancy,
- liver failure.
Use during pregnancy and a lactation.
Klaritin's use during pregnancy is possible only if the estimated advantage for mother exceeds potential risk for a fruit.
Klaritin is allocated with breast milk therefore at purpose of drug in the period of a lactation, it is necessary to resolve an issue of the breastfeeding termination.
Overdose:
Symptoms: drowsiness, tachycardia, headache. In case of overdose it is necessary to see a doctor immediately.
Treatment: a gastric lavage (preferably 0,9% chloride sodium solution), reception of adsorbents (the crushed absorbent carbon with water), symptomatic means.
Loratadin is not brought by means of a hemodialysis.
Storage conditions:
At a temperature not above 25 °C.
In the place, unavailable to children.
Issue conditions:
Without recipe
Packaging:
Tablets of 10 mg: on 7, 10 or 15 tablets in the blisters manufactured of polyvinylchloride and aluminum foil. On 1, 2 or 3 blisters together with the application instruction in a cardboard pack.
Syrup of 1 mg/ml: on 60 or on 120 ml in the bottles of dark glass corked by the aluminum screw traffic jams having a protective ring from accidental opening and polyethylene laying; on 1 bottle complete with a plastic spoon doser and the application instruction in a cardboard pack.