Universal reference book for medicines
Product name: DESAL (DESAL)

Active substance: desloratadine

Type: The blocker of histamine H 1 -receptors.
Anti-allergic drug
Manufacturer: ACTAVIS GROUP PTC ehf.
(Iceland) manufactured by ACTAVIS (Malta)
Composition, form of production and packaging
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The tablets covered with a film cover of blue color, round, biconcave, with engraving "LT" on one side.
1 tab.

desloratadine 5 mg

Excipients: microcrystalline cellulose - 55 mg, corn pregelatinized corn starch - 15 mg, mannitol - 22 mg, talc - 2.5 mg, magnesium stearate - 0.5 mg.

The composition of the film shell: opadrai blue 03F20404 (hypromellose 6cP - 1.9 mg, titanium dioxide (E171) - 0.61 mg, macrogol 6000 - 0.34 mg, dye indigo carmine aluminum varnish (E132) - 0.14 mg) - about 3 mg.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

An antihistamine long-acting drug, a blocker of peripheral histamine H 1 -receptors.
Desloratadine is the primary active metabolite of loratadine. Inhibits a cascade of reactions of allergic inflammation, incl. release of pro-inflammatory cytokines, including interleukins IL-4, IL-6, IL-8, IL-13, release of pro-inflammatory chemokines, production of superoxide anions by activated polymorphonuclear neutrophils, adhesion and chemotaxis of eosinophils, isolation of adhesion molecules such as P-selectin, IgE- mediated release of histamine, prostaglandin D 2 and leukotriene C 4 .
Thus, it prevents development and facilitates the course of allergic reactions, has antipruritic and antiexcudative action, reduces permeability of capillaries, prevents the development of edema of tissues, spasm of smooth muscles.

The drug has no effect on the central nervous system, has almost no sedative effect (does not cause drowsiness) and does not affect the rate of psychomotor reactions when taken in the recommended doses.
Does not cause an extension of the QT interval on the ECG.
The action of desloratadine begins within 30 minutes after ingestion and lasts for 24 hours.

PHARMACOKINETICS

Suction

After taking the drug inside desloratadine is well absorbed from the digestive tract.
It is determined in the blood plasma after 30 minutes, and C max is reached after about 3 hours. There were no clinically significant changes in the concentration of desloratadine in the blood plasma with multiple administration of ketoconazole and erythromycin. Bioavailability of desloratadine is proportional to the dose when taking a dose in the range from 5 mg to 20 mg.
Distribution

Binding to plasma proteins is 83-87%.
When used in adults and adolescents for 14 days at a dose of 5 mg to 20 mg 1 time / day, there are no signs of a clinically significant cumulation of desloratadine. The degree of cumulation of desloratadine is consistent with the value of T 1/2 and the frequency of its application 1 time / day.The values ​​of AUC and C max in children were similar to those in adults receiving 5 mg desloratadine.
Simultaneous intake of food or grapefruit juice does not affect the distribution of desloratadine (when taken at a dose of 7.5 mg 1 time / day).
Does not penetrate the BBB.
Metabolism

Enzymes responsible for the metabolism of desloratadine are not yet known, so it is impossible to completely exclude interactions with certain drugs.
It is not an inhibitor of CYP3A4 and CYP2D6 and is not a substrate or an inhibitor of P-glycoprotein. Intensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine, which is then glucuronized.
Excretion

The terminal phase of T 1/2 is about 27 hours. Desloratadine is excreted from the body in the form of a glucuronide compound and in a small amount in unchanged form (with urine less than 2% and through the intestine - less than 7%).

INDICATIONS

To ease or eliminate symptoms:

- Allergic rhinitis (sneezing, stuffy nose, rhinorrhea, itching in the nose, itching of the palate, itching and redness of the eyes, lacrimation);

- urticaria (skin itching, rash).

DOSING MODE

Inside, regardless of food intake.

Adults and adolescents (12 years and older) - 5 mg (1 tab.) 1 time / day.

SIDE EFFECT

Most often, the following undesirable reactions are noted: increased fatigue (1.2%), dryness of the oral mucosa (0.8%), headache (0.6%).

When using the drug in adults and adolescents at the recommended dose of 5 mg / day, the incidence of drowsiness is not higher than with placebo.

In the course of post-marketing surveillance, it is very rare
The following adverse reactions were noted.
Mental disturbances: hallucinations.

From the side of the central nervous system: dizziness, drowsiness, insomnia, psychomotor hyperactivity.

From the cardiovascular system: tachycardia, a feeling of palpitations.

On the part of the digestive system: abdominal pain, nausea, vomiting, indigestion, diarrhea.

From the liver and bile ducts: increased activity of liver enzymes, increased bilirubin concentration, hepatitis.

From the musculoskeletal system: myalgia.

Allergic reactions: anaphylaxis, angioedema, itching, rash, urticaria.

CONTRAINDICATIONS

- Pregnancy;

- the period of breastfeeding;

- Children under 12 years of age (efficacy and safety not established);

- Hypersensitivity to the active or any auxiliary substance of the drug.

With caution should be used in severe renal failure.

PREGNANCY AND LACTATION

The appointment of the drug in pregnancy is not recommended due to the lack of clinical data on the safety of its use in this period.

Desloratadine is excreted in breast milk, therefore its use during breast-feeding is not recommended.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution should be used in severe renal failure.

APPLICATION FOR CHILDREN

Contraindicated appointment of children under 12 years of age, tk.
efficiency and safety are not established.
SPECIAL INSTRUCTIONS

In the case of severe renal dysfunction, Dezal should be taken with caution.

Impact on the ability to manage vehicles and mechanisms

AT
Studies have not noted the influence of desloratadine on the management of vehicles. However, it should be borne in mind that very rarely some patients develop drowsiness, in this case care should be taken when driving vehicles and when working with mechanisms.
OVERDOSE

Symptoms: taking in a dose exceeding the recommended dose 9 times (45 mg) did not lead to the appearance of any clinically significant symptoms.
Possible development of drowsiness.
Treatment: it is necessary to wash the stomach, taking activated charcoal;
if necessary, symptomatic therapy. Desloratadine is not excreted in hemodialysis, the effectiveness of peritoneal dialysis is not established.
In case of accidental ingestion of a large amount of the drug, the patient should immediately consult a doctor.

DRUG INTERACTION

Clinically significant interaction with other drugs has not been identified (including with ketoconazole and erythromycin).

Desloratadine does not enhance the effect of ethanol on the central nervous system.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry, protected from light, at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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