Loratadin tablets 10mg, Teva No. 7

• Symptomatic treatment of seasonal and perennial allergic rhinitis;

• Chronic idiopathic urticaria;

Inside, before eating.

Adults and children over 12 years old and weighing 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 , 5 mg once a day.

The duration of treatment depends on the duration of the symptoms of the disease.

If the patient's condition does not improve within 3 days after starting treatment, then loratadine is not effective.

Patients with severe chronic renal failure (CC less than 30 ml / min) and with severe hepatic impairment:

5 mg 1 time per day daily or 10 mg 1 time per day every other day.

Elderly patients:

No dose adjustment is required.

1 tablet contains:

Active ingredient: loratadine - 10.0 mg.

Excipients: lactose monohydrate 62.5 mg, corn starch 2.0 mg, pregelatinized starch 25.0 mg, magnesium stearate 0.5 mg.

• Hypersensitivity to loratadine and other components of the drug;

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

• pregnancy;

• breastfeeding period;

• children up to age 3 years.

With caution
Severe chronic renal failure (CC less than 30 ml / min); severe liver failure.

Trade name of the drug: Loratadin-Teva

International Non-Proprietary Name (INN): Loratadine

Dosage form:

pills

Composition:

1 tablet contains:
Active ingredient: loratadine - 10.0 mg.
Excipients: lactose monohydrate 62.5 mg, corn starch 2.0 mg, pregelatinized starch 25.0 mg, magnesium stearate 0.5 mg.

Description
Tablets of white oval shape. On one side - dividing risk and engraving 'L' and '10' on both sides of the risk.

Pharmacological group: antiallergic agent - H-1-histamine receptor blocker.

ATX code: R06AX13

Pharmacological properties
Pharmacodynamics
Selective blocker (antagonist) of peripheral H1-histamine receptors. It has antiallergic, antipruritic and antiexudative effects, inhibiting mast cell degranulation and blocking secondary inflammatory mediators such as prostaglandins and leukotrienes, as well as reducing cytokine expression and molecular adhesion. Loratadine does not cross the blood-brain barrier, has a weak affinity for alpha-andrenergic and muscarinic receptors. Does not affect the central nervous system, practically does not have anticholinergic and sedative effects, does not cause addiction, does not have incompatibility with food, does not potentiate the effect of alcohol. Loratadine does not bind to H2-histamine receptors, does not inhibit the seizure of norepinephrine, and practically does not affect the function of the cardiovascular system (CVS) and heart rate.

Pharmacokinetics
When taken orally, loratadine is well absorbed in the gastrointestinal tract (GIT). It is metabolized in the liver. Loratadine metabolism is characterized by a pronounced 'first pass through the liver' effect. As a result of metabolism, a pharmacologically active metabolite, descarboethoxyloratadine, is formed, which has pharmacological effects characteristic of loratadine. In patients with normal liver and kidney function, the maximum concentration (Cmax) of loratadine in the blood is reached after 1.3 hours, and descarboethoxyloratadine - after 2.5 hours.The half-life (T1 / 2) of loratadine is on average about 8 hours, the active metabolite is an average of 28 hours. Equilibrium plasma concentrations of loratadine and its active metabolite are reached by the 5th day of use. Loratadine is highly associated with plasma proteins (97-99%),decarboethoxyloratadine binds to a lesser extent (73-76%). The volume of distribution of loratadine is 119 l / kg. The area under the concentration-time curve (AUC) of loratadine and descarboethoxyloratadine is dose-dependent. Food intake does not have a significant effect on pharmacokinetics (AUC of loratadine can increase by 40%, and its active metabolite - by 15%), but the time to reach Cmax slows down by 1 hour. Loratadine and its active metabolite penetrate into breast milk and create concentrations equivalent to plasma concentrations.and its active metabolite - by 15%), but the time to reach Cmax slows down by 1 hour. Loratadine and its active metabolite penetrate into breast milk and create concentrations equivalent to plasma concentrations.and its active metabolite - by 15%), but the time to reach Cmax slows down by 1 hour. Loratadine and its active metabolite penetrate into breast milk and create concentrations equivalent to plasma concentrations.
The metabolism of loratadine in the liver is carried out using isoenzymes of the cytochrome P450 system (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 intestines (42%).
In elderly patients, the AUC and Cmax of loratadine and descarboethoxyloratadine increase by 50%, while the T1 / 2 of loratadine and its active metabolite averages about 18 hours.
In patients with severe chronic renal failure (CRF) (creatinine clearance (CC) less than 30 ml / min), the AUC and Cmax of loratadine and descarboethoxyloratadine increase, and the mean T1 / 2 do not change compared to the values ??of AUC, Cmax, and T1 / 2 in patients with normal renal function. The elimination of loratadine in patients with reduced renal function does not differ significantly from that in healthy patients. Hemodialysis does not alter the pharmacokinetics of loratadine or its active metabolite in patients with chronic renal failure.
In patients with alcoholic liver damage, the AUC and Cmax of loratadine are doubled, while the AUC and Cmax of descarboethoxyloratadine do not differ significantly from the AUC and Cmax in patients with normal liver function. The average T1 / 2 of loratadine and its metabolite are 24 and 37, respectively, and increase in proportion to the increase in the severity of liver failure.

Indications for use

• Symptomatic treatment of seasonal and perennial allergic rhinitis;

• Chronic idiopathic urticaria;

Contraindications

• Hypersensitivity to loratadine and other components of the drug;

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

• pregnancy;

• breastfeeding period;

• children up to age 3 years.

With caution
Severe chronic renal failure (CC less than 30 ml / min); severe liver failure.

Application during pregnancy and breastfeeding
There is not enough clinical data on the use of loratadine in pregnant women. The use of loratadine during pregnancy is contraindicated.
Loratadine is excreted in breast milk. If it is necessary to use loratadine during lactation, breastfeeding should be discontinued.

Method of administration and dosage

Inside, before eating.

Adults and children over 12 years old and weighing 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 , 5 mg once a day.

The duration of treatment depends on the duration of the symptoms of the disease.

If the patient's condition does not improve within 3 days after starting treatment, then loratadine is not effective.

Patients with severe chronic renal failure (CC less than 30 ml / min) and with severe hepatic impairment:

5 mg 1 time per day daily or 10 mg 1 time per day every other day.

Elderly patients:

No dose adjustment is required.

Side effect

The incidence of adverse reactions is classified according to the recommendations of the World Health Organization: very often - at least 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, in children: headache, increased nervous irritability, sedation.
From the digestive system: infrequently - increased appetite; rarely - nausea, gastritis, dry mouth, abnormal liver function.
Allergic reactions: rarely - skin rash, anaphylaxis,
From the CCC: rarely - tachycardia, palpitations.
On the part of the skin and subcutaneous tissues: rarely - alopecia.
Others: infrequently - feeling tired.

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

Interaction with other medicinal products

Loratadine does not potentiate the effects of alcohol.
Taking loratadine with food may slightly delay absorption (by an average of 1 hour) without changing the clinical effect.
Erythromycin and ketoconazole (inhibitors of the CYP3A4 isoenzyme), cimetidine (an inhibitor of CYP3A4 and CYP2D6 isoenzymes) increase the Cmax of loratadine and its active metabolite in the blood. There are no clinically significant changes.
Loratadine reduces the Cmax of erythromycin in plasma by 15%.

special instructions

Loratadine should be taken with caution in patients with severe hepatic impairment, as in such patients the clearance of loratadine may be reduced.
The safety and efficacy 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 interrupted at least 48 hours before skin allergy tests, as antihistamines can hide or reduce positive skin reactions.
Loratadine can cause dry mouth in some patients, so people at risk should do oral hygiene because of the threat of tooth decay.
Children under 12 years of age weighing less than 30 kg should use loratadine in lower doses.
Influence on the ability to drive vehicles and operate mechanisms
When treating with loratadine, care should be taken when driving vehicles and managing complex mechanisms, given that during use, side reactions such as drowsiness and dizziness may develop, affecting the ability to concentrate and psychomotor reactions.

Release form

Tablets 10 mg.
7 tablets in a blister.
1 blister in a cardboard box together with instructions for use.
10 tablets in a blister.
1 or 3 blisters in a cardboard box together with instructions for use.

Shelf life

3 years.
Do not use after the expiration date.

Storage conditions

At a temperature not higher than 25 ? C.
Keep out of the reach of children !

Conditions of dispensing from pharmacies

Without recipe.

Manufacturer
Pharmaceutical Plant TEVA Private Co Ltd., Hungary

Legal address:
Ќ-4042, Debrecen, st. Pallagi 13, Hungary

Address for receiving claims
119049, Moscow, st. Shabolovka, 10, bldg. 1, Concord Business Center.