Loratal 10 mg (10 tablets)

The instruction for medical use of LORATAL® medicine Trade name ЛОРАТАЛ® the International unlicensed name Loratadin Lekarstvennaya a form of the Tablet of 10 mg Structure One tablet contains active agent - loratadin 10.00 mg, excipients: lactoses monohydrate, starch corn, magnesium stearate the Description of the Tablet uniform, an oval form of white color, with marking 10 and mg divided among themselves risky on one party and marking of NOBEL on other party. Pharmacotherapeutic group Antihistaminic drugs of systemic action. Antihistaminic drugs of systemic action others. Loratadin the ATX R06AX13 Code the Pharmacological Loratadin Pharmacokinetics Absorption properties is quickly and well soaked up in digestive tract. The concomitant use of food slightly extends time of absorption of a loratadin and dezloratadin, but does not affect clinical effect. The bioavailability of a loratadin and its active metabolite is proportional to a dose. Distribution Loratadin has high degree (97% - 99%), and his main active metabolite dezloratadin - moderate degree (73% - 76%) linking with proteins of plasma. At healthy volunteers, the half-life period of a loratadin and its active metabolite in blood plasma is about 1 and 2 hours, respectively. Biotransformation After oral administration loratadin quickly and well is soaked up and exposed to presistemny metabolism under the influence of CYP3A4 and CYP2D6. The main metabolite - dezloratadin, is pharmacological active and is responsible for the most part of clinical effect. Time of achievement of the maximum concentration of a loratadin and dezloratadin in blood plasma (Tmax) is 1-1.5 h and 1.5-3.7 h after introduction, respectively. Elimination About 40% of the entered dose is removed with urine and 42% with a stake within 10 days, generally in the form of the conjugated metabolites. About 27% of the entered dose are removed with urine within the first 24 hours. Less than 1% are brought out of an organism in an invariable look. Elimination half-life at healthy adult volunteers makes 8.4 hours (varies from 3 to 20 hours) for a loratadin and 28 hours (varies from 8.8 to 92 hours) for the main active metabolite. A renal failure of AUC and Cmax Value at patients with chronic kidney disease increased in comparison with AUC and Cmax at patients with normal function of kidneys. Elimination half-life of a loratadin and its active metabolite considerably did not change. Carrying out a hemodialysis did not influence pharmacokinetics of a loratadin and its active metabolite at persons with chronic kidney disease. A liver failure At patients with chronic alcoholic damage of a liver the increase in AUC and Cmax values of a loratadin was observed twice while the pharmacokinetic profile of an active metabolite did not change in comparison with patients with normal function of a liver. Elimination half-life of a loratadin and its active metabolite made 24 hours and 37 hours, respectively, and increased depending on disease severity of a liver. Elderly the Pharmacokinetic profile of a loratadin and its active metabolite is comparable between young and elderly volunteers. The pharmacodynamics Loratadin – active agent of the drug LORATAL® - represents tricyclic connection with the significant antihistaminic action and is a selection blocker of peripheral H1-histamine receptors. At most of patients ЛОРАТАЛ® 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 electrocardiogram 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. After reception of 10 mg (one dose) or several doses of drug on the basis of conducting skin tests on a histamine it is found out that the significant antihistaminic action 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. Indications - symptomatic treatment of allergic rhinitis - a chronic idiopathic small tortoiseshell the Route of administration and doses Inside, irrespective of meal. Adults and children are more senior than 12 years: 10 mg (1 tablet) once a day. Children from 6 to 12 years: with the body weight & gt, 30 kg – 10 mg (1 tablet) once a day, with the body weight & lt, 30 kg – 5 mg (½ tablets) once 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 (1 tablet) every other day, with the body weight & lt, 30 kg – 5 mg (½ tablets) every other day. Duration of treatment depends on a clinical picture of a disease. With a renal failure At patients with a renal failure of correction of dosing it is not required from patients. Corrections of dosing, elderly At elderly people, it is not required. Side effects In clinical trials with participation of adults and teenagers in the range of the indications including allergic rhinitis and a chronic idiopathic small tortoiseshell in the recommended dose of 10 mg a day, the undesirable phenomena observed more often than at placebo use met at 2% of the patients accepting loratadin. More often, than in group of placebo, drowsiness (1.2%), a headache (0.6%), increase in appetite (0.5%) and insomnia (0.1%) were noted. Side effects are distributed according to the frequency of their emergence during use of drug during the post-marketing period: very often (≥ 1/10), it is frequent (≥ 1/100 to & lt, 1/10), infrequently (≥ 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 Children In clinical trials children aged from 2 up to 12 years, the most often found side reactions, than in group of placebo, had a headache (2.7%), nervousness (2.3%), fatigue (1%). Contraindications - hypersensitivity to a loratadin or to other components of drug - children's age up to 6 years - pregnancy and the period of a lactation Medicinal interactions At joint appointment with LORATAL® 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 a heavy liver failure should appoint special instructions ЛОРАТАЛ® with care. ЛОРАТАЛ® contains lactose. Therefore it 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 ЛОРАТАЛ® should be stopped in 48 hours prior to carrying out skin diagnostic allergoprob for prevention of false results. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms In the recommended doses ЛОРАТАЛ® does not affect ability to run vehicles or difficult technical devices. However patients have to be informed on potential risk in connection with development of symptoms of dizziness, drowsiness which can affect ability to run vehicles or potentially dangerous mechanisms. The overdose Overdose loratadiny leads to emergence of anticholinergic symptoms. 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 from an organism by a hemodialysis, it is also unknown whether is removed loratadin by means of peritoneal dialysis. 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 printing aluminum foil. On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a pack cardboard with the hologram of firm – producer. Storage conditions At a temperature not above 25 °C in the dry, protected from light place. To store out of children's reach! Not to apply a period of storage of 5 years after an expiration date. Prescription status According to the prescription Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer, Almaty, Shevchenko St., 162 E the Owner of the registration certificate of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan, Almaty, Shevchenko St., 162 E the Address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan accepting claims (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine: JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan, Almaty, Shevchenko St., 162 E Phone number: (+7 727) 399-50-50 Fax number: (+7 727) 399-60-60
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