Expiration date: 06/2025
The composition and form of issue:
Tablets. 1 tablet contains:
loratadine 10 mg
auxiliary substances: milk sugar MCC, calcium stearate, sodium starch of glycolate
in a contour acheikova package 7 or 10 PCs in a box 1 package (7 pieces), 1 or 3 packages (10 pieces).
Syrup 1 ml
loratadine 1 mg
excipients: sugar, propylene glycol benzoic acid citric acid ethyl alcohol 95% tropeolin About the flavorings distilled water
in bottles of 100 ml in a cardboard pack 1 bottle.
Description pharmaceutical form:
Tablets: white or almost white, ploskotsylindriceskie, with facet.
Syrup from light-yellow to yellow transparent liquid with a faint fruity odor.
Pharmacokinetics:
Suction. When administered in the recommended therapeutic dose of loratadine is rapidly and completely absorbed from the gastrointestinal tract. Determined concentrations of loratadine appear in the plasma within 15 min after administration. The time to reach Cmax of loratadine in plasma is 1.3–2.5 h, and the time to reach Cmax of its active metabolite — 2.5 hours Simultaneous eating and loratadine slows down the achievement of Cmax of loratadine and its active metabolite in plasma at 1 h, but the Cmax of these substances in plasma remains unchanged and no clinical manifestations of the interaction of loratadine with food not marked. In the elderly the time to reach Cmax increases up to 1.5 h, and in alcoholic liver disease increases with the severity of the disease. The contents of loratadine and its active metabolite in blood plasma reaches stationary level in most patients on the fifth day of admission. Connection with the plasma protein — 97%.
Metabolism. Loratadine is metabolised in the liver with the formation of the active metabolite of descarboethoxyloratadine mainly under the influence of the CYP3A4 isoenzyme of the cytochrome P450 and to a lesser extent under the influence of the CYP2D6 isoenzyme of cytochrome P450. In the presence of ketoconazole, which is a CYP3A4 inhibitor, loratadine is transformed into descarboethoxyloratadine mainly under the influence of CYP2D6.
Excretion. Loratadine is excreted by the kidneys and bile. The average T1/2 loratadine is 8.4 h (range from 3 to 20 h), and for the active metabolite — 28 hours (range 8.8 to 92 hours). In elderly patients T1/2 of loratadine increases to 18.2 hours (range from 6.7 to 37 h), and descarboetauxiloratadina — up to 17.5 h (range 11 to 38 hours). In alcohol-induced liver T1/2 increases with the severity of the disease. In patients with chronic renal failure and during hemodialysis the pharmacokinetics does not change.
Description pharmacological action:
H1-antihistamine non-Central and anticholinergic effects.
The action of the drug starts to develop within 30 minutes after administration and lasts for 24 hours
Long-term use of the drug does not cause development of resistance to its action.
Loratadine and its metabolites do not penetrate the GEB.
Indications:
Seasonal and year-round rhinitis (including pollinosis), allergic conjunctivitis, urticaria (including chronic idiopathic), angioedema, allergic reaction caused by the release of histamine itchy dermatitis allergic reaction to insect bites.
Contraindications:
Hypersensitivity to any component of the drug, pregnancy, lactation.
With caution: hepatic failure.
Application of pregnancy and breast-feeding:
When pregnant, you should refrain from the reception of Klarotadina. At the time of treatment should stop breastfeeding.
Side effects:
From the nervous system: anxiety, agitation (in children), fatigue, somnolence, hyperkinesis, paresthesia, tremor, amnesia, depression.
On the part of the skin and subcutaneous fat: dermatitis.
Urogenital and urinary system: change the color of urine, painful urge to urinate, dysmenorrhea, menorrhagia, vaginitis.
From the metabolic: weight gain, sweating, thirst.
From the side of musculoskeletal system: cramping calf muscles, artralgia, myalgia.
From the digestive system: changing taste, anorexia, constipation or diarrhea, dyspepsia, gastritis, flatulence, increased appetite, stomatitis.
The respiratory system: cough, bronchospasm, dryness of the nasal mucosa, sinusitis.
From the sensory organs: impaired vision, conjunctivitis, pain in eyes and ears.
Of the cardiovascular system: decreased or increased blood pressure, palpitations.
Allergic reactions: angioneurotic edema, urticaria, itching, photosensitization.
Other: back pain, chest pain, fever, chills, breast pain, blepharospasm, dysphonia.
Drug interactions:
When using loratadine at therapeutic doses, potentiating the action of alcohol is not revealed.
The combined use of loratadine with erythromycin, cimetidine and ketoconazole increase the concentration of loratadine in the blood plasma that has no clinical manifestations and has no effect on the ECG data.
Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, sikorin, rifampicin, phenylbutazone, tricyclic antidepressants) reduce the effectiveness of the drug.
Method of application and dose:
Inside. Adults and children over 12 years: 10 mg (1 table. or 2 measuring spoons syrup) 1 times a day. Daily dose — 10 mg.
Children 2 to 12 years with body weight less than 30 kg — 5 mg (1/2 table. or 1 measuring spoons syrup) 1 times a day. Daily dose of 5 mg.
Children with body weight over 30 kg — 10 mg (1 table. or 2 measuring spoons syrup) 1 times a day. Daily dose — 10 mg.
Overdose:
While taking loratadine, in doses greatly exceeding the recommended therapeutic dose of 10 mg (40-180 mg loratadine), adult patients can manifest symptoms such as headache, drowsiness, tachycardia. When loratadine children weighing less than 30 kg in the dose of 10 mg may experience extrapyramidal symptoms and palpitations.
Treatment: you should consult a doctor, to take measures to remove the drug from the gastrointestinal tract and decrease absorption (induction of vomiting, gastric lavage, administration of activated charcoal). If necessary, symptomatic therapy. Loratadine is not eliminated from the body during hemodialysis. Data on excretion of loratadine in peritoneal dialysis are not available.
Special instructions:
For patients with impaired liver or renal failure (glomerular filtration rate below 30 ml/min), the initial dose of the drug Claratin should be 10 mg (1 table. or 2 scoops) a day.
Not recommended for children under 2 years of age.
During treatment should refrain from activities potentially hazardous activities, require high concentration and psychomotor speed reactions.
