Composition
Active ingredient: Â
Loratadine 10 mg;
Auxiliary substances: Â
Lactose (milk sugar) – 77.5 mg,
Calcium stearate-1.0 mg,
Potato starch – 10.0 mg,
Croscarmellose Sodium (primellose) – 1.5 mg
Characteristics
Tablets of white or almost white color are flat-cylindrical in shape with a chamfer and risk.
Pharmacological 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 rapidly and completely absorbed in the gastrointestinal tract.
The time to reach the maximum concentration is 1.3-2.5 hours; food intake slows it down by 1 h. The maximum concentration 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 cross the blood-brain barrier.
The half-life of loratadine is 3-20 hours (average 8.4 hours), the 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, the elimination half-life increases depending on the severity of the disease. It is excreted by the kidneys and bile.
In patients with chronic renal failure and during hemodialysis, the pharmacokinetics practically do not change.
Indications
Seasonal and year-round allergic rhinitis, conjunctivitis, pollinosis, urticaria (including chronic idiopathic), angioedema, allergic itchy dermatoses; pseudoallergic reactions, allergic reactions to insect bites, itching of various etiologies.
Contraindications
Hypersensitivity. Pregnancy, lactation, and children under 3 years of age.
With caution: Â 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: Â 10 mg (1 tablet) 1 time a day. The daily dose is 10 mg.
Children from 3 to 12 years of age: 5 mg (1/2 tablet) 1 time a day. The daily dose is 5 mg.
Children with a body weight of more than 30 kg – 10 mg of the drug 1 time a day. The daily dose is 10 mg.
Overdose
Symptoms: Â drowsiness, tachycardia, headache. In case of overdose, consult a doctor.
Treatment: Â induction of vomiting, gastric lavage, taking activated charcoal.
Description
Anti-allergic agent – H1-histamine receptor blocker
Description
Tablets of white or almost white color are flat-cylindrical in shape with a chamfer and risk.
Complete set
Tablets 10 mg. 7 or 10 tablets in a contour cell package made of polyvinyl chloride film and aluminum foil printed varnished. 1,2 or 3 contour cell packages together with instructions for use in a cardboard pack.
Composition
Tablet Form of production
Storage conditions
In a dry place, protected from light, at a temperature not exceeding 25 °C. Keep out of reach of children.
Shelf
life is 3 years. Do not apply later than the time indicated on the package.
Active ingredient
Loratadine
Dosage form
Tablets
Description
For adults, Children over 3 years old
Indications
Urticaria, Insect Bites, Runny Nose, Diathesis, Allergic Runny nose, Dermatitis, Allergic Conjunctivitis, Pollinosis, Dermatosis, Allergy, Conjunctivitis
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