Loratadin
Producer: JSC Pharmak Ukraine
Code of automatic telephone exchange: R06AX13
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: loratadine;
1 tablet contains a loratadin in terms of 100% substance (0,01 g) of 10 mg;
excipients: potato starch, lactoses monohydrate, povidone, calcium stearate.
Pharmacological properties:
Loratadin – a tricyclic selection blocker of peripheral H1-histamine receptors. At use in the recommended dose has no clinically significant sedative and anticholinergic action. Loratadin significantly does not influence activity of H2-histamine receptors. Does not block capture of Norepinephrinum and actually does not influence cardiovascular system or activity of a pacemaker. After oral administration лоратадин it is well soaked up and metabolized under the influence of CYP3A4 and CYP2D6, mainly in дезлоратадин. Time of achievement of the maximum concentration of a loratadin and dezloratadin in a blood plasma makes 1-1,5 hours and 1,5-3,7 hours respectively. Loratadin and his metabolites well contact proteins of plasma.
Bioavailability of a loratadin and dezloratadin is directly proportional to a dose.
Drug does not get through a blood-brain barrier. The elimination half-life of means makes 24 hour, and a dezloratadina – 37 hours and increases at disturbance of functions of a liver depending on disease severity. It is removed with urine and a stake.
Indications to use:
Symptomatic treatment of a chronic idiopathic small tortoiseshell and allergic rhinitis.
Route of administration and doses:
Adults and children are more senior than 12 years accept on 1 tablet (10 mg) of 1 times a day.
Children up to 12 years with body weight it is more than 30 kg – 1 tablet (10 mg) of 1 times a day.
Children are more senior than 2 years with body weight less than 30 kg - 1 time a day on ½ tablets (5 mg).
Dose adjustment is not necessary to people of advanced age and patients with a renal failure.
Patients with heavy abnormal liver functions need to appoint a smaller initial dose because of possible reduction of clearance of a loratadin (the recommended initial dose – 10 mg every other day).
Features of use:
Patients with heavy abnormal liver functions need to appoint a smaller initial dose (watch the section "Route of Administration and Doses").
For prevention of false results it is necessary to stop Loratadin's reception not later, than in 48 hours prior to carrying out skin diagnostic аллергопроб.
Tablets Loratadin contain lactose therefore drug is not used to patients with rare hereditary forms of intolerance of a galactose, insufficiency of lactase or glyukozo-galaktozny malabsorption.
Use during pregnancy or feeding by a breast. It is not recommended to appoint drug during pregnancy or feeding a breast.
Ability to influence speed of response at control of motor transport or work with other mechanisms. Generally drug does not influence speed of response at control of motor transport or work with other mechanisms.
Nevertheless the patient needs to be informed on very rare cases of drowsiness which can influence ability to manage motor transport or work with other mechanisms.
Children.
Efficiency and safety of use of drug is not established to children under 2 years.
Side effects:
From immune system: anaphylaxis.
From a nervous system: dizziness, drowsiness, headache, nervousness, sleeplessness.
From cardiovascular system: tachycardia, heart consciousness.
From digestive tract: nausea, vomiting, dryness in a mouth, gastritis.
From a liver: disturbance of functions of a liver.
From skin and hypodermic fabric: rash, alopecia.
General manifestations: fatigue, the increased appetite.
Interaction with other medicines:
At simultaneous use of a loratadin with ketakonazoly, erythromycin, Cimetidinum noted increase in concentration of a loratadin in a blood plasma, but this increase was not shown clinically in any way, including according to the electrocardiogram.
Simultaneous use of a loratadin with CYP3A4 or CYP2D6 inhibitors can lead to increase in level of a loratadin that, in turn, strengthens side effects.
Drug does not strengthen effect of alcohol on psychomotor reactions.
Contraindications:
Drug is contraindicated to patients with hypersensitivity to active ingredient or to any other component of drug.
Overdose:
Symptoms: drowsiness, tachycardia and headache.
Treatment: gastric lavage, reception of absorbent carbon, symptomatic and maintenance therapy.
Loratadin is not brought by means of a hemodialysis, it is also unknown whether it is removed лоратадин by means of peritoneal dialysis.
After rendering acute management the patient has to remain under medical observation.
Storage conditions:
Period of validity. 3 years. Not to use drug after the termination of the period of validity specified on packaging. To store in the dry place at a temperature not above 25 °C. To store in the place, unavailable to children.
Issue conditions:
Without recipe
Packaging:
On 10 tablets in the blister. On 1 or 2 blisters enclosed in a pack.