Composition
of 1 tab. :
– loratadine 10 mg
Auxiliary substances:
lactose,
calcium stearate,
colloidal silicon dioxide (aerosil),
ludipress.
Pharmacological action
Pharmaceutical group:
anti-allergic agent-H1-histamine receptor blocker.
Pharmaceutical action:
Loratadine is a long-acting H1-histamine receptor blocker. Inhibits the release of histamine and leukotriene C4 from mast cells. Prevents the development and eases the course of allergic reactions.
It has antihistamine, anti-allergic, antipruritic and anti-exudative effects. Reduces capillary permeability, prevents the development of tissue edema, relieves smooth muscle spasm. The anti-allergic effect develops in 30 minutes, reaches a maximum in 8-12 hours and lasts for 24 hours.
It does not affect the central nervous system and is not addictive (because it does not penetrate the blood-brain barrier).
Pharmacokinetics:
It is quickly and completely absorbed into the gastrointestinal tract. Tmax – 1,3-2,5 h; food intake slows it down by 1 h. Cmax in the elderly increases by 50%, with alcoholic liver damage, depending on the severity of the disease. Binding to plasma proteins is 97%. It is metabolized in the liver to form the active metabolite descarboethoxyloratadine with the participation of cytochrome P450 isoenzymes, CYP3A4 and, to a lesser extent, CYP2D6. Steady-state plasma concentrations of loratadine and its metabolite are reached on day 5 of use. It does not penetrate the BBB.
T 1/2 of loratadine – 3-20 hours (average 8.4 hours), active metabolite – 8.8-92 hours (average 28 hours); in elderly patients, respectively – 6.7-37 hours (average 18.2 hours) and 11-38 hours (17.5 hours). With alcoholic liver damage, T 1/2 increases depending on the severity of the disease. It is excreted by the kidneys and bile. In patients with CRF and during hemodialysis, the pharmacokinetics practically do not change
Indications
-seasonal and year-round allergic rhinitis (including pollinosis);- allergic conjunctivitis;— urticaria (including chronic idiopathic);- Angioedema; – allergic itchy dermatoses;- pseudoallergic reactions— – allergic reactions to insect bites; – pruritus of various etiologies.
Contraindications
-hypersensitivity;— pregnancy, lactation period— – children under 3 years of age. With caution: liver failure.
Side effects
The adverse events listed below occurred with a frequency of > 2% when using loratadine and approximately the same frequency as when using placebo (“pacifiers”).
In adults: headache, fatigue, dry mouth, drowsiness, gastrointestinal disorders (nausea, gastritis), as well as allergic reactions in the form of rashes. In addition, there were rare reports of anaphylaxis, alopecia, impaired liver function, palpitations, and tachycardia.
Rarely in children: headache, nervousness, sedation.
Interaction
Ethanol reduces the effectiveness of loratadine.
Erythromycin, cimetidine, ketoconazole, when combined with loratadine, increase the concentration of loratadine in blood plasma, without causing clinical manifestations and without affecting the ECG.
Inducers of microsomal oxidation (phenytoin, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) reduce the effectiveness of loratadine.
How to take, course of use and dosage
Inside. Adults and children over 12 years of age: 10 mg (1 tablet) 1 time/day. The daily dose is 10 mg.
Children from 3 to 12 years of age: 5 mg (1/2 tablet) 1 time/day. The daily dose is 5 mg.
Children with a body weight of more than 30 kg – 10 mg of the drug 1 time/day. The daily dose is 10 mg.
Special instructions
Influence on the ability to drive motor vehicles and manage mechanisms
During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Form of production
Loratadine Stada tablets are white or almost white in color, flat-cylindrical, with a chamfer.
Storage conditions
The drug should be stored at room temperature (15°C-25°C), in a dry, inaccessible place for children.
Shelf
life is 2 years.
Active ingredient
Loratadine
Dosage form
Tablets
Description
For adults, Pregnant women as prescribed by a doctor, Children over 2 years of age
Indications
Dermatosis, Dermatitis, Pollinosis, Conjunctivitis, Diathesis, Allergic Conjunctivitis, Insect Bites, Allergic Runny Nose, Urticaria, Allergy, Runny Nose
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