Universal reference book for medicines
Product name: LORATADIN TEVA (LORATADIN TEVA)

Active substance: loratadine

Type: The blocker of histamine H 1 -receptors.
Anti-allergic drug
Manufacturer: Teva Pharmaceutical Industries (Israel) manufactured by TEVA Pharmaceutical Works Private (Hungary)
Composition, form of production and packaging
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Tablets 1 tab.
loratadine 10 mg

10 pieces.
- packings cellular planimetric (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2012.

PHARMACHOLOGIC EFFECT

Selective blocker (antagonist) of peripheral H1-histamine receptors.
It antiallergic, antipruritic and antiexudative action, inhibiting degranulation of mast cells and blocking secondary inflammatory mediators, such as prostaglandins and leukotrienes, and also reducing cytokine expression and adhesion of molecules. Loratadine does not penetrate the blood-brain barrier, has a weak affinity for alpha-andrenergic and muscarinic receptors. Does not affect the central nervous system, has almost no anticholinergic and sedative effect, does not cause addiction, is not incompatible with food, does not potentiate the effect of alcohol. Loratadine does not bind to H2-histamine receptors, does not inhibit the capture of noradrenaline and has virtually no effect on cardiovascular function (CCC) and heart rhythm.
PHARMACOKINETICS

When ingestion loratadine is well absorbed in the digestive tract.
Metabolised in the liver. Metabolism of loratadine is characterized by a pronounced effect of "first passage through the liver." Due to the metabolism, a pharmacologically active metabolite, dscarboethoxyloratadine, is formed, which has pharmacological effects characteristic of loratadine. In patients with normal liver and kidney function C max loratadine in the blood is achieved after 1.3 h, and descabroxetiloratadine - after 2.5 h. The indices of T 1/2 loratadine average about 8 hours, the active metabolite - an average of 28 hours. Equilibrium the concentration of loratadine and its active metabolite in plasma is reached by the 5th day of application. Loratadine binds to a large extent to plasma proteins (97-99%), decarboxetoxyloratadine binds to a lesser degree (73-76%). The volume of loratadine distribution is 119 l / kg. The area under the concentration-time curve (AUC) of loratadine and descaroboxetiloratadine depends on the dose of the drug. The intake of food has no significant effect on the pharmacokinetics (AUC of loratadine can be increased by 40% and its active metabolite by 15%), but the time to reach C max for 1 h slows down. Loratadine and its active metabolite penetrate into breast milk and create concentrations equivalent to concentrations in
plasma.

Metabolism of loratadine in the liver is carried out with the help of cytochrome P450 isoenzymes (mainly through CYP3A4 and to a lesser extent CYP2D6).

After 10 days, about 80% of loratadine in the form of metabolites is excreted almost equally by the kidneys (40%) and the intestines (42%).

In elderly patients, AUC and C max, loratadine and descarboetoxyloratadine are increased by 50%, with T 1/2 loratadine and its active metabolite averaging about 18 hours.

In patients with severe chronic renal insufficiency (CRF) (CK less than 30 ml / min), AUC and C max loratadine and descarboetoxyloratadine increase, and mean T1/2 - do not change in comparison with the values ​​of AUC, C max and T 1/2 y patients with normal renal function.
Elimination of loratadine in patients with decreased renal function does not significantly differ from excretion in healthy patients. Hemodialysis does not alter the pharmacokinetics of loratadine or its active metabolite in patients with CRF.
In patients with alcoholic liver damage, AUC and C max, loratadine is doubled, whereas AUC and C max descaboethoxyloratadine do not differ significantly from AUC and C max in patients with normal liver function.
The mean T 1/2 of loratadine and its metabolite 24 and 37, respectively, increase in proportion to the increase in severity of liver failure.
INDICATIONS

Symptomatic treatment:

- seasonal and year-round allergic rhinitis;

- chronic idiopathic urticaria.

DOSING MODE

Inside, before eating.

Adults and children over 12 years of age and with a body weight of more than 30 kg: 10 mg once a day.
Children from 3 to 12 years old with a body weight of more than 30 kg 10 mg once a day; with a body weight of less than 30 kg of 5 mg once a day.
The duration of treatment depends on the duration of the manifestation of the symptoms of the disease.
If the patient's condition does not improve within 3 days of starting treatment, then loratadine is not effective.
Patients with severe CRF (CC less than 30 ml / min) and with severe hepatic insufficiency: 5 mg once a day daily or 10 mg once a day every other day.
Elderly patients - dose adjustment is not required.
SIDE EFFECT

The incidence of adverse reactions is classified according to the recommendations of the World Health Organization: very often - not less than 10%;
often - not less than 1% and less than 10%; infrequently - not less than 0.1% and less than 1%; rarely - not less than 0.01% and less than 0.1%; very rarely - less than 0.01%, including isolated cases.
From the nervous system: often - headache, nervousness;
infrequently - insomnia, drowsiness; rarely - dizziness; children - headache, increased nervous excitability, sedation.
From the digestive system: infrequently - increased appetite;
rarely - nausea, gastritis, dry mouth, liver dysfunction.
Allergic reactions: rarely - skin rash, anaphylaxis.

From the cardiovascular system: rarely - tachycardia, a feeling of palpitations.

From the skin and subcutaneous tissues: rarely - alopecia.

Other: infrequent - a feeling of fatigue.

CONTRAINDICATIONS

- hypersensitivity to loratadine and other components of the drug;

- lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

- Pregnancy;

- the period of breastfeeding;

- Children under 3 years old.

With caution: severe CRF (CC less than 30 ml / min);
severe hepatic insufficiency.
PREGNANCY AND LACTATION

There is insufficient clinical data on the use of loratadine in pregnant women.
The use of loratadine in pregnancy is contraindicated.
Loratadin excreted in breast milk.
If loratadine should be used during lactation, breastfeeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER

With caution: CRF (QC less than 30 ml / min).

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Loratadine should be taken with caution in patients with severe hepatic insufficiency, since in such patients the clearance of loratadine can be reduced.

APPLICATION FOR CHILDREN

The safety and effectiveness of loratadine in children under 3 years of age is unknown, so the drug is contraindicated for use in this age group.
Children under 12 years of age with a body weight of less than 30 kg should use loratadine in lower doses.
SPECIAL INSTRUCTIONS

Loratadine should be taken with caution in patients with severe hepatic insufficiency, since in such patients the clearance of loratadine can be reduced.
The safety and effectiveness of loratadine in children under 3 years of age is unknown, so the drug is contraindicated for use in this age group.
Treatment with loratadine should be discontinued at least 48 hours before the conduct of skin-allergic tests, since antihistamines can hide or reduce positive skin reactions.
Loratadine can cause dry mouth in some patients, so people at risk should conduct oral hygiene because of the dangers of caries. Children under 12 years of age with a body weight of less than 30 kg should use loratadine in lower doses.
Impact on the ability to drive vehicles and manage mechanisms

When treating loratadine, care should be taken when driving vehicles and managing complex mechanisms, given that adverse reactions such as drowsiness and dizziness that affect attention-concentrating and psychomotor reactions may develop during use.

OVERDOSE

Symptoms: headache, drowsiness, tachycardia.
In children weighing less than 30 kg when ingested at a dose of more than 10 mg, extrapyramidal disorders, palpitations were noted.
Treatment: gastric lavage, reception of activated charcoal;
symptomatic and supportive therapy. For washing, 0.9% sodium chloride solution is used, in adults, water can be used for washing. Saline laxatives and enterosorbents are indicated for the rapid removal of loratadine from the gastrointestinal tract. Loratadine is not excreted by hemodialysis and peritoneal dialysis.
DRUG INTERACTION

Loratadine does not potentiate the effects of alcohol.

The intake of loratadine during meals can slightly delay absorption (on average by 1 h) without changing the clinical effect.

Erythromycin and cystoconazole (inhibitors of the isoenzyme CYP3A4), cimetidine (an inhibitor of the isoenzymes CYP3A4 and CYP2D6) increase C max ofloratadine and its active metabolite in the blood.
Clinically significant changes are absent. Loratadine reduces C max erythromycin in plasma by 15%.
TERMS OF RELEASE FROM PHARMACY

Without recipe.

TERMS AND CONDITIONS OF STORAGE

Keep out of the reach of children at a temperature of no higher than 25 ° C.

Shelf life - 3 years.

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