Loratadine-Vertex, tablets 10 mg 10 pcs

Pharmgroup:

An antiallergic agent – H1-histamine receptor blocker.

Pharmic action:

Loratadine is a blocker of H1 -histamine receptors (long-acting). Inhibits the release of histamine and leukotriene C4 from mast cells. It prevents the development and facilitates the course of allergic reactions.

It has antihistamine, anti-allergic, antipruritic and antiexudative action. It reduces capillary permeability, prevents the development of tissue edema, relieves smooth muscle spasm. Antiallergic effect develops after 30 minutes, reaches its maximum after 8-12 hours and lasts for 24 hours.

It does not affect the CNS and is not addictive (because it does not penetrate through the blood-brain barrier).

Pharmacokinetics:

It is quickly and completely absorbed in the gastrointestinal tract. Tmax is 1.3-2.5 h; ingestion slows it down by 1 h. Cmax in the elderly is increased by 50%, in alcoholic liver damage depending on the severity of the disease. The binding to plasma proteins is 97%. Metabolized in the liver with the formation of the active metabolite descarboethoxyloratadine with the participation of cytochrome P450 isoenzymes, CYP3A4 and, to a lesser extent, CYP2D6. Equilibrium concentration of loratadine and metabolite in plasma is reached on day 5 of administration. Does not penetrate through the HEB.

The T1/2 of loratadine is 3-20 h (mean 8.4 h), active metabolite is 8.8-92 h (mean 28 h); in elderly patients, respectively, 6.7-37 h (mean 18.2 h) and 11-38 h (17.5 h). In alcoholic liver damage the T1/2 increases depending on the severity of the disease. It is excreted by kidneys and with bile. Pharmacokinetics practically does not change in patients with CKD and in hemodialysis.

Indications

– Seasonal and year-round allergic rhinitis (incl. Allergic rhinitis (including pollinosis);
– Allergic conjunctivitis;
– Urticaria (incl. Chronic idiopathic);
– Quincke’s edema;
– Allergic pruritic dermatoses;
– pseudoallergic reactions;
– Allergic reactions to insect bites;
– Itching of different etiology.

Active ingredient

Composition

1 tablet:

– loratadine 10 mg

Associated substances:

lactose,

calcium stearate,

How to take, the dosage

Ingestion. Adults and children over 12 years: 10 mg (1 tablet) 1 time per day. The daily dose is 10 mg.

Children from 3 to 12 years: 5 mg (1/2 tablet) once daily. The daily dose is 5 mg.

In children with body weight over 30 kg – 10 mg of the drug once daily. The daily dose is 10 mg.

Interaction

Ethanol reduces the effectiveness of loratadine.

Eritromycin, cimetidine, ketoconazole when combined with loratadine increase the plasma concentration of loratadine without causing clinical manifestations and without affecting the ECG.

Microsomal oxidation inducers (phenytoin, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) decrease the effectiveness of loratadine.

Special Instructions

Impact on driving and operating machinery

At the time of treatment, it is necessary to refrain from potentially hazardous activities requiring increased concentration and rapid psychomotor reaction.

Contraindications

– Hypersensitivity to loratadine or any other component of the drug;

– Breast-feeding period;

– Age less than 6 years;

– Lactase deficiency lactose intolerance glucose-galactose malabsorption.

Side effects

The adverse events listed below occurred with loratadine with a frequency of > 2% and approximately the same frequency as with placebo (“pacifier”).

In adults: headache, fatigue, dry mouth, drowsiness, gastrointestinal disorders (nausea, gastritis), and allergic reactions in the form of rash. In addition, there have been rare reports of anaphylaxis, alopecia, impaired liver function, palpitations, and tachycardia.

In children rarely: headache, nervousness, sedation.

Overdose

Symptoms

Treatment

Symptomatic gastric lavage (preferably 09% sodium chloride solution) administration of adsorbents (crushed activated charcoal with water).

Loratadine is not excreted by hemodialysis.

Pregnancy use

The safety of using loratadine during pregnancy has not been established.

The drug should be used during pregnancy only when the expected therapeutic effect for the expectant mother exceeds the potential risk to the fetus. Loratadine and its active metabolite are excreted into the breast milk; therefore, if the drug is prescribed during breast-feeding, the question of stopping breast-feeding should be considered.

Similarities