Deza tab n / 5mg film about 10 pc

Description

Composition
Active substance:
1 tablet contains: 5.00 mg of desloratadine ;.
Excipients:
Microcrystalline cellulose 55.00 mg pregelatinized corn starch 15.00 mg mannitol 22.00 mg talc 2.50 mg magnesium stearate 0.50 mg; Foil sheath: Opadry Blue 03F20404 (hypromellose IWU – 1.90 mg titanium dioxide (E 171) 0.61 mg macrogol 6000 – 0.34 mg, dye indigo carmine aluminum lake (E 132) 0.14 mg) of about 3, 00 mg.
Description:
Round biconvex tablets, film-coated blue color, “1X” engraved on one side.
Product form:
Tablets, film-coated, 5 mg. 10 tablets in blister Al / Al.
1.2 or 3 blisters with instruction for medical use in a cardboard box.
Contraindications
Hypersensitivity to the active or any excipient the formulation; pregnancy; breastfeeding; age 12 years (effectiveness and safety have been established).
WITH CARE severe renal insufficiency.
Dosage
5 mg
Indications
To alleviate or eliminate symptoms: allergic rhinitis (sneezing, nasal congestion, rhinorrhea, itchy nose, itchy palate, itching and redness of the eyes, tearing); urticaria (itching, rash).
Interaction with other drugs
Clinically significant interactions with other drugs have been identified (including ketoconazole and erythromycin).
Desloratadine does not enhance the effect of ethanol on the central nervous system.
Overdose
Symptoms: receiving a dose exceeding the recommended 9 times (45 mg) did not lead to the emergence of any clinically significant symptoms. May develop drowsiness.
Treatment: to a gastric lavage, administration of activated charcoal; if necessary – symptomatic therapy. Desloratadine does not appear in hemodialysis, peritoneal dialysis efficacy has not been established.
In case of accidental application into a large amount of the drug should contact a doctor immediately.
pharmachologic effect
Pharmacological group:
Antiallergic agent – H1-histamine receptor blocker.
Pharmacodynamics:
Long acting antihistamine blocker peripheral H1 histamine receptors. Desloratadine is the primary active metabolite of loratadine. Inhibits the cascade of allergic inflammation, including release of pro-inflammatory cytokines including the interleukins IL-4, IL-b, IL-8, IL-13, the release of proinflammatory chemokines, production of superoxide anion by activated polymorphonuclear neutrophils adhesion and chemotaxis eosinophils selection adhesion molecules such as P-selectin, IgE – mediated release of histamine, prostaglandin D2 and leykotrienaS4.
Thus, it prevents the development and facilitates the allergic reactions, and possesses protivoekssudativnoe antipruritic effect, reduces capillary permeability, prevents the development of edema, smooth muscle spasm.
The drug has no effect on the central nervous system (CNS), virtually no sedative effect (does not cause drowsiness) and does not affect the speed of psychomotor reactions when taken at the recommended doses. It does not cause prolonged QT interval on the electrocardiogram.
Action desloratadine starts within 30 minutes after ingestion and continues for 24 hours.
Pharmacokinetics:
Suction
After receiving the drug inside Desloratadine is well absorbed from the gastrointestinal tract. Determined in blood plasma after 30 min, and the maximum concentration in plasma (Cmax) is achieved after about 3 hours. There were no clinically significant changes in desloratadine concentration in blood plasma during multiple reception ketoconazole and erythromycin. The bioavailability of desloratadine dozoproportsionalna when receiving a dose range from 5 mg to 20 mg.
Distribution
Communication plasma protein is 83-87%. In the application for adults and adolescents over 14 days in a dose of 5 mg to 20 mg 1 time / day evidence of clinically significant accumulation of desloratadine it is not marked. The degree of accumulation of desloratadine is consistent with the value of half-life and the frequency of its use once a day. area values ​​under the curve “concentration-time” and Cmax in children were similar to those in adults who received 5 mg desloratadine. Simultaneous food intake or grapefruit juice does not affect the distribution of desloratadine (when receiving a dose of 7.5 mg 1 time / day). It does not cross the blood-brain barrier.
Metabolism
The enzymes responsible for the metabolism of desloratadine, is not yet known, so we can not completely rule out interaction with some drugs. Not an inhibitor of isozyme CYP3A4 and CYP2D6, and is not a substrate or inhibitor of P-glycoprotein. It is extensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine, which is then glyukuroniziruetsya. breeding
The half-life (T1 / 2) is about 27 hours desloratadine excreted as glucuronide compound and a small amount of unaltered. (Kidney – less than 2% through the intestine and – less than 7%).
Pregnancy and breast-feeding
Use of the drug is contraindicated in pregnancy due to the lack of clinical data on the safety of its use in a given period.
Desloratadine is excreted in breast milk, therefore its use is contraindicated during breast-feeding.
Conditions of supply of pharmacies
Without recipe.
side effects
Most others are the following adverse reactions: fatigue (1.2%), dryness of the oral mucosa (0.8%), headache (0.6%).
In applying the drug in adults and adolescents in the recommended dosage of 5 mg / day no higher incidence of drowsiness than with placebo.
During post-marketing surveillance is rarely observed following adverse reactions.
Psychiatric disorders: hallucinations.
CNS: dizziness, somnolence, insomnia, psychomotor hyperactivity.
Cardio-vascular system: tachycardia, palpitations.
From the digestive system: abdominal pain, nausea, vomiting, dyspepsia, diarrhea.
Of the liver and biliary tract: increased activity of the liver enzyme, increasing the concentration of bilirubin, hepatitis.
On the part of the musculoskeletal system: myalgia.
Allergic reactions: anaphylaxis, angioedema, pruritus, rash, urticaria.
special instructions
In the case of pronounced renal dysfunction drug Desa should be taken with caution. The effect on the ability of control of vehicles and mechanisms
In studies there were no effect of desloratadine to drive vehicles. Note, however, that very rarely some patients may develop drowsiness, in this case, caution should be exercised when driving and operating machinery.
Storage conditions
In a dry, protected from light at a temperature not higher than 25 C.
Keep out of the reach of children!.
Dosing and Administration
Inside, regardless of the meal.
Adults and adolescents (12 years and older) – 1 tablet of 5 mg 1 time per day.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist