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

Active substance: loratadine

Type: The blocker of histamine H 1 -receptors.
Anti-allergic drug
Manufacturer: NIZHFARM (Russia) manufactured by MAKIZ-PHARMA (Russia)
Composition, form of production and packaging
?
Tablets are white or almost white in color, flat-cylindrical, with a bevel.
1 tab.

loratadine 10 mg

Excipients: lactose, calcium stearate, silicon dioxide colloid (aerosil), ludipress.

7 pcs.
- packings of cellular contour (1) - packs cardboard.
7 pcs.
- packings cellular planimetric (2) - packs cardboard.
7 pcs.
- packings cellular planimetric (3) - packs cardboard.
10 pieces.
- packings of cellular contour (1) - packs cardboard.
10 pieces.
- packings cellular planimetric (2) - packs cardboard.
10 pieces.
- packings cellular planimetric (3) - packs cardboard.
?
Tablets are white or almost white in color, flat-cylindrical, with a bevel.
1 tab.

loratadine 10 mg

Excipients: lactose, calcium stearate, silicon dioxide colloid (aerosil), ludipress.

7 pcs.
- packings of cellular contour (1) - packs cardboard.
7 pcs.
- packings cellular planimetric (2) - packs cardboard.
7 pcs.
- packings cellular planimetric (3) - packs cardboard.
10 pieces.
- packings of cellular contour (1) - packs cardboard.
10 pieces.
- packings cellular planimetric (2) - packs cardboard.
10 pieces.
- packings cellular planimetric (3) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

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

PHARMACHOLOGIC EFFECT

Loratadin is a blocker of H1-histamine receptors (long-acting).
Inhibits the release of histamine and leukotriene C4 from mast cells. Prevents development and facilitates the course of allergic reactions. It has antihistamine, anti-allergic, antipruritic and antiexcudative action. Reduces the permeability of capillaries, prevents the development of edema of tissues, relieves spasm of smooth muscles. The antiallergic effect develops after 30 minutes, reaches a maximum in 8-12 hours and lasts for 24 hours. It does not affect the central nervous system and does not cause addiction (because it does not penetrate the blood-brain barrier).
PHARMACOKINETICS

Quickly and completely absorbed into the digestive tract.
T mах - 1,3-2,5 hours; the intake of food slows it down for 1 hour. From the age of the elderly it increases by 50%, with alcoholic damage to the liver, depending on the severity of the disease. The connection with plasma proteins is 97%. Metabolized in the liver with the formation of an active metabolite of descabroxetoxyloratadine with the participation of cytochrome P450, CYP3A4 and, to a lesser extent, CYP2D6 isoenzymes. The equilibrium concentration of loratadine and metabolite in plasma is reached on the 5th day of administration. Does not penetrate the BBB. T 1/2 loratadine - 3 to 20 hours (an average of 8.4 hours), active metabolite - 8.8-92 hours (an average of 28 hours); in elderly patients, respectively, 6.7-37 hours (an average of 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 with bile. In patients with CRF and during hemodialysis, the pharmacokinetics practically does not change.
INDICATIONS

- seasonal and year-round allergic rhinitis (including pollinosis);

- allergic conjunctivitis;

- urticaria (including chronic idiopathic);

- Quincke's edema;

allergic itching dermatoses;

- pseudoallergic reactions;

- allergic reactions to insect bites;

- itching of different etiology.

DOSING MODE

Inside.
Adults and children over 12 years: 10 mg (1 tab.) 1 time / day. The daily dose of 10 mg.
Children from 3 to 12 years , 5 mg (1/2 tab.) 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.
SIDE EFFECT

The adverse events listed below with loratadine occurred with a frequency> 2% and approximately the same frequency as with the placebo ("dummies").

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, palpitation, tachycardia.
Children rarely: headache, nervousness, sedation.

CONTRAINDICATIONS

hypersensitivity;

- pregnancy, lactation period;

- Children's age up to 3 years.

With caution: liver failure.

PREGNANCY AND LACTATION

Contraindicated in pregnancy, during lactation.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution: liver failure.

APPLICATION FOR CHILDREN

Contraindicated in childhood up to 3 years.

SPECIAL INSTRUCTIONS

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

OVERDOSE

Symptoms: drowsiness, tachycardia, headache.
In case of overdose, see a doctor.
Treatment: induction of vomiting, gastric lavage, reception of activated charcoal.

DRUG INTERACTION

Ethanol reduces the effectiveness of loratadine.

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

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

TERMS OF RELEASE FROM PHARMACY

Without recipe.

TERMS AND CONDITIONS OF STORAGE

List B. Keep out of reach of children, dry and protected from light, at a temperature of no higher than 25 ° C.

Shelf life - 3 years.

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