Claritin tablets 10 mg # 10

Release form, composition and packaging

The tablets are white or almost white, free of foreign inclusions, oval, on one side there is a risk, the trademark Cup and flask" and the number "10", the other side is smooth.

1 tab.

loratadine 10 mg

lactose monohydrate - 71.3 mg, corn starch - 18 mg, magnesium stearate - 0.7 mg.

7 pcs.

- blisters (1) - cardboard packs.

7 pcs.

- blisters (2) - cardboard packs.

7 pcs.

- blisters (3) - cardboard packs.

10 pieces.

- blisters (1) - cardboard packs.

10 pieces.

- blisters (2) - cardboard packs.

10 pieces.

- blisters (3) - cardboard packs.

15 pcs.

- blisters (1) - cardboard packs.

15 pcs.

- blisters (2) - cardboard packs.

15 pcs.

- blisters (3) - cardboard packs.

pharmachologic effect

Antiallergic drug, selective blocker of peripheral histamine H1 receptors.

Loratadine is a tricyclic compound with a pronounced antihistamine effect.

Possesses fast and long-term anti-allergic action.

Loratadine does not penetrate the BBB and does not affect the central nervous system.

Has no clinically significant anticholinergic or sedative effect, i.e.

does not cause drowsiness and does not affect the speed of psychomotor reactions when used in recommended doses.

Taking Claritin does not prolong the QT interval on the ECG.

With long-term treatment, there were no clinically significant changes in vital signs, physical examination data, laboratory results or ECG.

Loratadine has no significant selectivity for histamine H2 receptors.

Does not inhibit the reuptake of norepinephrine and has virtually no effect on the cardiovascular system or pacemaker function.

After oral administration of the drug Claritin, the onset of action is within 30 minutes.

The antihistamine effect reaches a maximum after 8-12 hours from the onset of action and lasts more than 24 hours.

Pharmacokinetics

Suction

After taking the drug inside, loratadine is rapidly and well absorbed from the gastrointestinal tract.

Tmax of loratadine in blood plasma is 1-1.5 hours, and its active metabolite desloratadine is 1.5-3.7 hours. Food intake increases the Tmax of loratadine and desloratadine by approximately 1 hour, but does not affect the effectiveness of the drug.

Cmax of loratadine and desloratadine does not depend on food intake.

The bioavailability of loratadine and its active metabolite is dose-dependent.

Distribution

Loratadine is highly associated with plasma proteins 97-99%, and its active metabolite is moderately 73-76%.

Metabolism

Loratadine is metabolized to form desloratadine with the participation of the isoenzyme CYP3A4 and, to a lesser extent, CYP2D6.

Withdrawal

It is excreted by the kidneys (approximately 40% of the oral dose) and through the intestines (approximately 42% of the oral dose) for more than 10 days, mainly in the form of conjugated metabolites.

Approximately 27% of an oral dose is excreted by the kidneys within 24 hours after taking the drug.

Less than 1% of the active substance is excreted unchanged by the kidneys within 24 hours after taking the drug.

T1 / 2 of loratadine is from 3 to 20 hours (on average 8.4 hours), and desloratadine is from 8.8 to 92 hours (on average 28 hours).

Pharmacokinetics in special clinical situations

The pharmacokinetic profiles of loratadine and its active metabolite in adult and elderly healthy volunteers were comparable.

T1 / 2 of loratadine and desloratadine in elderly patients is, respectively, from 6.7 to 37 hours (average 18.2 hours) and from 11 to 39 hours (average 17.5 hours).

In patients with chronic kidney disease, the Cmax and AUC of loratadine and its active metabolite are increased compared with patients with normal renal function.

T1 / 2 of loratadine and its active metabolite does not differ from those in healthy patients.

T1 / 2 of loratadine and its active metabolite does not change with the presence

Dosage

10mg

Structure

1 tablet contains loratadine 10 mg

excipients: corn starch, lactose, magnesium stearate.

Indications

seasonal (hay fever) and year-round allergic rhinitis and allergic conjunctivitis (to eliminate symptoms associated with these diseases - sneezing, itching of the nasal mucosa, rhinorrhea, burning and itching sensations in the eyes, watery eyes)

chronic idiopathic urticaria

allergic skin diseases.

INN / Active ingredient

Loratadin

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 4 years

Contraindications

age up to 2 years (for syrup)

age up to 3 years (for tablets)

lactation period (breastfeeding)

rare hereditary diseases (violations of galactose tolerance, lapp lactase deficiency or glucose-galactose malabsorption) - due to the presence of lactose, which is part of the tablets

deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption - due to the presence of sucrose, which is part of the syrup

hypersensitivity to drug components.

The drug should be prescribed with caution in patients with severe liver dysfunction, during pregnancy

Specifications

Category

Allergy

Scope of the medicinal product

Leather

Release form

Tablet

Manufacturer country

Belgium

Package quantity, pcs

ten

Scope of application

Allergology

Vacation conditions

Without recipe

Brand name

Claritin

The amount of the dosage form in the primary package

10 pieces.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Anatomical and therapeutic characteristics

R06AX13 Loratadine

Dosage form

Pills

Expiration date in days

1460

The target audience

Children

Dosage (volume) of the substance in the preparation

10 mg

Package weight, g

3

Mode of application

:

apply regardless of meal time.

Adults, including the elderly, and adolescents from 12 years old are recommended in a dose of 10 mg (1 tablet or 2 teaspoons (10 ml) of syrup) 1 time per day.

For children from 2 to 12 years old, it is recommended to prescribe a dose of the drug depending on body weight: with a body weight of 30 kg or less - 5 mg (1 teaspoon (5 ml) of syrup) 1 time per day

with a mass of more than 30 kg - 10 mg (2 teaspoons (10 ml) of syrup or 1 tablet) once a day.

For adults and children with severe liver dysfunction, the initial dose should be: with a body weight of 30 kg or less - 5 mg (1 teaspoon (5 ml) of syrup) every other day, with a body weight of more than 30 kg - 10 mg (2 teaspoons ( 10 ml) syrup or 1 tablet) every other day.

Pharmaco-therapeutic group

:

Antiallergic agent - H1-histamine receptor blocker

Information on technical characteristics, delivery set, country of manufacture "