Lorapridin (Tablets) Instructions for Use

Marketing Authorization Holder

Bright Way, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

ATC Code

R06AX13 (Loratadine)

Active Substance

Loratadine (Rec.INN registered by WHO)

Dosage Form

Lorapridin

Tablets 10 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets are round, flat-cylindrical, white or almost white in color, with a score line and a bevel.

Excipients: corn starch, magnesium stearate, talc, sodium starch glycolate (primogel), colloidal silicon dioxide (aerosil), microcrystalline cellulose (101), lactose monohydrate (milk sugar).

7 pcs. – contour cell blisters – cardboard boxes.
7 pcs. – contour cell blisters (2) – cardboard boxes.
7 pcs. – contour cell blisters (3) – cardboard boxes.
7 pcs. – contour cell blisters (4) – cardboard boxes.
7 pcs. – contour cell blisters (5) – cardboard boxes.
7 pcs. – contour cell blisters (6) – cardboard boxes.
7 pcs. – contour cell blisters (7) – cardboard boxes.
7 pcs. – contour cell blisters (8) – cardboard boxes.
7 pcs. – contour cell blisters (9) – cardboard boxes.
7 pcs. – contour cell blisters (10) – cardboard boxes.
10 pcs. – contour cell blisters – cardboard boxes.
10 pcs. – contour cell blisters (2) – cardboard boxes.
10 pcs. – contour cell blisters (3) – cardboard boxes.
10 pcs. – contour cell blisters (4) – cardboard boxes.
10 pcs. – contour cell blisters (5) – cardboard boxes.
10 pcs. – contour cell blisters (6) – cardboard boxes.
10 pcs. – contour cell blisters (7) – cardboard boxes.
10 pcs. – contour cell blisters (8) – cardboard boxes.
10 pcs. – contour cell blisters (9) – cardboard boxes.
10 pcs. – contour cell blisters (10) – cardboard boxes.
7 pcs. – jars – cardboard boxes.
10 pcs. – jars – cardboard boxes.
14 pcs. – jars – cardboard boxes.
20 pcs. – jars – cardboard boxes.
21 pcs. – jars – cardboard boxes.
28 pcs. – jars – cardboard boxes.
30 pcs. – jars – cardboard boxes.
35 pcs. – jars – cardboard boxes.
40 pcs. – jars – cardboard boxes.
42 pcs. – jars – cardboard boxes.
49 pcs. – jars – cardboard boxes.
50 pcs. – jars – cardboard boxes.
56 pcs. – jars – cardboard boxes.
60 pcs. – jars – cardboard boxes.
63 pcs. – jars – cardboard boxes.
70 pcs. – jars – cardboard boxes.
80 pcs. – jars – cardboard boxes.
90 pcs. – jars – cardboard boxes.
100 pcs. – jars – cardboard boxes.

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

Systemic antihistamines; other systemic antihistamines

Pharmacological Action

It is a blocker of histamine H₁-receptors. It has an antiallergic, antipruritic, and anti-exudative effect.

It reduces capillary permeability, prevents the development of tissue edema, and reduces the increased contractile activity of smooth muscles caused by the action of histamine.

Pharmacokinetics

When taken orally at a therapeutic dose, Loratadine is rapidly absorbed from the gastrointestinal tract and is almost completely metabolized in the body.

The C_max of loratadine in plasma is reached within 1-1.3 hours, and that of the main active metabolite, descarboethoxyloratadine, is reached in approximately 2.5 hours.

When taken simultaneously with food, the bioavailability of loratadine and descarboethoxyloratadine increases by approximately 40% and 15%, respectively, the time to reach C_max increased by approximately 1 hour, while its values for these substances remained unchanged.

Plasma protein binding of loratadine is high – about 98%, and that of the active metabolite is less pronounced.

The average T_1/2 of loratadine is 8.4 hours, and that of descarboethoxyloratadine is 28 hours (8.8-92 hours).

Approximately 80% of loratadine is excreted as metabolites in urine and feces in equal proportions over 10 days, with about 27% excreted in urine within the first 24 hours.

Indications

Seasonal and perennial allergic rhinitis, conjunctivitis, acute urticaria and angioedema, symptoms of histaminergy caused by the use of histamine liberators (pseudoallergic syndromes), allergic reactions to insect bites, complex treatment of itchy dermatoses (contact allergic dermatitis, chronic eczema).

ICD codes

Dosage Regimen

Administer orally with water.

For adults and children over 12 years of age: take 10 mg once daily.

For children from 2 to 12 years of age: base the dose on body weight.

For children weighing more than 30 kg, administer 10 mg once daily.

For children weighing less than 30 kg, administer 5 mg once daily.

Take the tablet on an empty stomach, at least 1 hour before a meal.

Adjust the dosage regimen for patients with severe hepatic impairment or renal insufficiency.

For these patients, initiate therapy with a reduced frequency of 10 mg every other day.

The maximum daily dose for adults and children over 12 years is 10 mg.

Do not exceed the recommended therapeutic dose.

The duration of treatment depends on the indication and clinical response.

For seasonal allergic rhinitis, continue use throughout the exposure period.

Discontinue use if symptom control is inadequate or if adverse reactions occur.

Adverse Reactions

From the digestive system rarely – dry mouth, nausea, vomiting, gastritis; in some cases – impaired liver function.

From the central nervous system rarely – increased fatigue, headache, excitability (in children).

From the cardiovascular system rarely – tachycardia.

Allergic reactions rarely – skin rash; in isolated cases – anaphylactic reactions.

Dermatological reactions in some cases – alopecia.

Contraindications

Pregnancy, lactation, children under 2 years of age, hypersensitivity to loratadine.

Use in Pregnancy and Lactation

Loratadine should not be used during pregnancy and lactation.

In experimental studies on animals, Loratadine in medium doses did not have a negative effect on the fetus; when administered in high doses, some fetotoxic effects were observed.

Use in Hepatic Impairment

Patients with impaired renal or liver function require dose regimen adjustment.

Use in Renal Impairment

Patients with impaired renal or liver function require dose regimen adjustment.

Pediatric Use

Contraindicated in children under 2 years of age.

Special Precautions

The development of seizures cannot be completely ruled out when using loratadine, especially in predisposed patients.

Patients with impaired renal or liver function require dose regimen adjustment.

Drug Interactions

With the simultaneous use of loratadine with drugs that inhibit the CYP3A4 and CYP2D6 isoenzymes or are metabolized in the liver with their participation (including cimetidine, erythromycin, ketoconazole, quinidine, fluconazole, fluoxetine), a change in the plasma concentration of loratadine and/or these drugs is possible.

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

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.