Desal solution 0.5mg / ml, 100ml

- Seasonal and year-round allergic rhinitis (elimination or relief of sneezing nasal congestion, mucus discharge from the nose itching in the nose itching of the palate itching and redness of the eyes with lacrimation);

- urticaria (reduction or elimination of itchy skin rash).

The method of application and dosage regimen of a particular drug depends on its form of release and other factors.

The optimal dosage regimen is determined by the doctor.

It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Adults and adolescents aged 12 years and older are prescribed orally, regardless of food intake, at a dose of 5 mg / day.

Children aged 1 to 5 years - 1.25 mg 1 time / day, aged 6 to 11 years - 2.5 mg 1 time / day.

active substance: desloratadine - 5.0 mg;

excipients: calcium hydrogen phosphate dihydrate - 140.3 mg, salting (microcrystalline cellulose - 98%, colloidal silicon dioxide - 2% - 21.6 mg, hypromellose (hydroxypropyl methylcellulose) - 3.6 mg, croscarmellose sodium (primellose) - 0, 9 mg, colloidal silicon dioxide (aerosil) - 1.8 mg, magnesium stearate - 1.8 mg;

shell composition: opadry II blue (polyvinyl alcohol - 40.0%, titanium dioxide (E171) - 24.66%, talc (E553b) - 14.80%, macrogol (polyethylene glycol) (E1521) - 20.20%, aluminum varnish based on indigo carmine (E132) - 0.34%) - 4.967 mg, simethicone emulsion 30% (water - 50.0-69.5%, dimethicone (polydimethylsiloxane) - 25.5-33.0%, macrogol (polyethylene glycol ) sorbitan tristearate - 3.0-7.0%, methylcellulose - 1.0-5.0%, silica gel - 1.0-5.0%) - 0.033 mg.

- Hypersensitivity to desloratadine loratadine as well as to other components of the drug;

- pregnancy and the period of breastfeeding;

- children under 12 years of age.

Carefully:

- Severe renal failure;

- a history of convulsions.

Trade name of the drug

Desloratadine

International non-proprietary name

Desloratadine

Dosage form

film-coated tablets

Composition

1 tablet contains:

active substance: desloratadine - 5.0 mg;

excipients: calcium hydrogen phosphate dihydrate - 140.3 mg, salting (microcrystalline cellulose - 98%, colloidal silicon dioxide - 2% - 21.6 mg, hypromellose (hydroxypropyl methylcellulose) - 3.6 mg, croscarmellose sodium (primellose) - 0, 9 mg, colloidal silicon dioxide (aerosil) - 1.8 mg, magnesium stearate - 1.8 mg;

shell composition: opadry II blue (polyvinyl alcohol - 40.0%, titanium dioxide (E171) - 24.66%, talc (E553b) - 14.80%, macrogol (polyethylene glycol) (E1521) - 20.20%, aluminum varnish based on indigo carmine (E132) - 0.34%) - 4.967 mg, simethicone emulsion 30% (water - 50.0-69.5%, dimethicone (polydimethylsiloxane) - 25.5-33.0%, macrogol (polyethylene glycol ) sorbitan tristearate - 3.0-7.0%, methylcellulose - 1.0-5.0%, silica gel - 1.0-5.0%) - 0.033 mg.

Description

Round, biconvex film-coated tablets, blue. Slight surface roughness is permissible. The color of the tablets at the break is white or white with a yellowish or pinkish tinge.

Pharmacotherapeutic group

Antiallergic agent - H2-histamine receptor blocker

ATX code

R06AX

Pharmacodynamics:

Long-acting antihistamine. Desloratadine is the primary active metabolite of loratadine. Inhibits the cascade of reactions of allergic inflammation, including the release of proinflammatory cytokines including interleukins (IL) IL-4 IL-6 IL-8 IL-13 release of proinflammatory chemokines (RANTES) production of superoxide anions by activated polymorphonuclear neutrophils adhesion of adhesion molecules such as adhesion of chemotaxis and chemotaxis P-selectin IgE - mediated release of histamine prostaglandin D2 and leukotriene C4. Thus, it prevents the development and facilitates the course of allergic reactions; it has an antipruritic and antiexudative effect; reduces capillary permeability; prevents the development of edema of the tissues of smooth muscle spasm.

The drug has no effect on the central nervous system (CNS), does not have a sedative effect and does not affect the speed of psychomotor reactions. In clinical and pharmacological studies of the use of desloratadine in the recommended therapeutic zone, there was no prolongation of the QT interval on the electrocardiogram (ECG).

Desloratadine begins to work within 30 minutes after ingestion and lasts for 24 hours.

Pharmacokinetics:

After taking the drug inside, desloratadine is well absorbed from the gastrointestinal tract (GIT). Determined in blood plasma 30 minutes after ingestion. The maximum concentration (Cmax) is reached on average 3 hours after ingestion. The bioavailability of desloratadine is dose-proportional at doses ranging from 5 mg to 20 mg.

Plasma protein binding of desloratadine is 83-87%. When used in adults and adolescents for 14 days at a dose of 5 mg to 20 mg 1 time per day, there are no signs of clinically significant cumulation of the drug.

The simultaneous intake of food or grapefruit juice does not affect the distribution of desloratadine (when used in a dose of 75 mg once a day). Does not penetrate the blood-brain barrier.

It is not an inhibitor of CYP3A4 and CYP2D6 isoenzymes and is not a substrate or inhibitor of P-glycoprotein. It is extensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine combined with glucuronide.

The half-life (T1 / 2) is 20-30 hours (on average, 27 hours). Desloratadine is excreted from the body in the form of a glucuronide compound and in small amounts unchanged (by the kidneys - less than 2% and through the intestines - less than 7%).

Indications:

- Seasonal and year-round allergic rhinitis (elimination or relief of sneezing nasal congestion, mucus discharge from the nose itching in the nose itching of the palate itching and redness of the eyes with lacrimation);

- urticaria (reduction or elimination of itchy skin rash).

Contraindications:

- Hypersensitivity to desloratadine loratadine as well as to other components of the drug;

- pregnancy and the period of breastfeeding;

- children under 12 years of age.

Carefully:

- Severe renal failure;

- a history of convulsions.

Pregnancy and lactation:

The use of the drug during pregnancy is contraindicated due to the lack of clinical data on the safety of the drug Desloratadine during this period. Desloratadine is excreted in breast milk; therefore, its use during breastfeeding is contraindicated.

Method of administration and dosage:

Inside, regardless of the meal. It is advisable to take the drug regularly at the same time of day. The tablet should be swallowed whole without chewing with a little water.

Adults and adolescents from 12 years old - 1 tablet (5 mg) 1 time per day.

For seasonal allergic rhinitis (with symptoms lasting less than 4 days a week or less than 4 weeks a year), the course of the disease should be assessed. If symptoms disappear, the drug should be discontinued; if symptoms reappear, the drug should be resumed.

For perennial allergic rhinitis (with symptoms lasting more than 4 days a week or more than 4 weeks a year), the drug should be taken during the entire period of exposure to the allergen.

Side effects:

According to the World Health Organization (WHO), unwanted effects are classified according to the frequency of their development as follows: very often (? 1/10) often (? 1/100 and <1/10) infrequently (? 1/1000 and <1 / 100) rarely (? 1/10000 and <1/1000) and very rarely (<1/10000) including isolated messages; frequency unknown - from the available data it was not possible to establish the frequency of occurrence.

From the side of the central nervous system: often - headache; very rarely dizziness drowsiness insomnia psychomotor hyperreactivity hallucinations convulsions: frequency unknown - abnormal behavior aggression.

From the side of the cardiovascular system: very rarely - tachycardia, palpitations; frequency unknown - prolongation of the QT interval.

From the digestive system: often - dry mouth; very rarely - abdominal pain nausea vomiting dyspepsia diarrhea.

From the liver and biliary tract: very rarely - an increase in the activity of liver enzymes, an increase in the concentration of bilirubin, hepatitis.

From the side of the musculoskeletal system: very rarely - myalgia.

Allergic reactions: very rarely - anaphylaxis angioedema shortness of breath itching skin rash urticaria.

On the part of the skin and subcutaneous tissues: frequency unknown - photosensitization.

Others: often - increased fatigue.

Post-registration period.

Children: frequency unknown - prolongation of the QT interval arrhythmia bradycardia abnormal behavior aggression.

If any of the side effects indicated in the instructions are aggravated or you notice any other side effects not indicated in the instructions, inform your doctor.

Overdose:

Symptoms Taking a dose 5 times the recommended dose did not lead to any symptoms. In clinical studies, the daily use of desloratadine in adults and adolescents at a dose of up to 20 mg for 14 days was not accompanied by statistically or clinically significant changes in the cardiovascular system. In a clinical and pharmacological study, the use of desloratadine at a dose of 45 mg per day (9 times higher than the recommended one) for 10 days did not cause prolongation of the QT interval and was not accompanied by the appearance of serious side effects.

Treatment. In case of accidental ingestion of a large amount of the drug, you should immediately consult a doctor. Recommended gastric lavage intake of activated charcoal; if necessary, symptomatic therapy. Desloratadine is not excreted during hemodialysis; the effectiveness of peritoneal dialysis has not been established.

Interaction:

When studying drug interactions with repeated joint use of desloratadine with ketoconazole erythromycin azithromycin fluoxetine and cimetidine, clinically significant changes in the concentration of desloratadine in plasma were not revealed.

The simultaneous intake of grapefruit juice does not affect the effectiveness of the drug.

Desloratadine does not enhance the effect of alcohol on the central nervous system; nevertheless, cases of alcohol intolerance and alcohol intoxication have been reported during post-registration use. Therefore, desloratadine should be used concurrently with alcohol with caution.

Special instructions:

Studies of the effectiveness of the drug Desloratadine in rhinitis of infectious etiology have not been conducted.

In the course of clinical studies, it was shown that increasing the dose and increasing the frequency of administration does not affect the effectiveness of the drug, therefore it is necessary to warn patients that it is not recommended to increase the dosage and frequency of administration.

Caution should be exercised when using Desloratadine in patients with a history of seizures, especially in pediatric patients. If seizures develop, the use of Desloratadine should be discontinued.

Impact on the ability to drive vehicles. Wed and fur .:

The potential for side effects such as dizziness and drowsiness should be taken into account. During the period of drug treatment, care should be taken when performing potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Release form / dosage:

Film-coated tablets 5 mg.

Packaging:

7 or 10 tablets in a blister strip packaging.

1 2 3 4 or 5 blister packs with instructions for use in a cardboard box.

Storage conditions:

In a dark place at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Shelf life:

4 years. Do not use after the expiration date.

Vacation conditions

Without recipe.