Desloratadine tab n / 5mg film about 10 pieces vertex

Description

Composition
Active substance:
1 tablet contains: desloratadine – 5.0 mg ;.
Excipients:
Calcium hydrogen phosphate dihydrate – 53.0 mg Microcrystalline cellulose – 27.5 mg Corn starch – 11.0 mg Talc – 2.5 mg magnesium stearate – 1.0 mg; film coating: dry mixture to a film coating comprising polyvinyl alcohol (40.0%), titanium dioxide (22.1%), macrogol 3350 (polyethylene glycol 3350) (20.2%), talcum (14.8%), lacquer aluminum based indigo carmine dye (2.8%), yellow iron oxide (ferric oxide) (0.1%) – 3.0 mg.
Description:
Round biconvex tablets, film-coated blue. The cross-sectional core of a white or nearly white.
Product form:
Tablets, film-coated, 5 mg. 7, 10, 15 or 30 tablets in blisters of PVC film and aluminum foil. 7, 10, 15 or 30 tablets in a bank of high-density polyethylene. 1 blisters of 7 tablets 1 or 3 blisters with 10 tablets, blisters 2 to 15 tablets, blisters 1 to 30 or 1 tablets bank together with instructions for use in a stack of cardboard.
Equipment is allowed to 2, 3 or 4 packs of cardboard in collective package of cardboard.
Contraindications
Hypersensitivity to any of the components included in the preparation, and loratadine; pregnancy and lactation; age 12 years.
Precautions: severe renal insufficiency.
Dosage
5 mg
Indications
Allergic rhinitis (elimination or alleviation of sneezing, nasal congestion, nasal mucus, itching nose, palate pruritus, itching and redness of the eyes, tearing); urticaria (reduction or elimination of itching, rashes).
Interaction with other drugs
Interactions with other drugs have been identified in studies with azithromycin, ketoconazole. erythromycin, fluoxetine and cimetidine. Eating does not affect the efficacy of the drug. Desloratadine does not increase the alcohol effects on the central nervous system.
pharmachologic effect
Pharmacological group:
Antiallergic agent – H1-histamine receptor blocker.
Pharmacodynamics:
H1-histamine receptor blocker of long-acting. It 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-6, IL-8, IL-13, the release of proinflammatory chemokines (RANTES), the 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 leukotriene C4. 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 with practically no sedative effect (does not cause drowsiness) and does not affect the speed of psychomotor reactions. It does not cause QT interval elongation in the electrocardiogram (ECG).
The action of the drug starts within 30 minutes after ingestion and continues for 24 hours.
Pharmacokinetics:
Suction
After taking the drug inside desloratadine well absorbed from the gastrointestinal tract, thus defined desloratadine plasma concentrations are reached within 30 minutes, and the maximum concentration – after about 3 h.
Distribution
desloratadine binding to plasma proteins is 83-87%. In the application for adults and adolescents over 14 days in a dose of 5 mg to 20 mg 1 time per day clinically significant drug accumulation is not observed. Simultaneous food intake or simultaneous use of grapefruit juice has no effect on the bioavailability of desloratadine and distribution (when receiving a dose of 7.5 mg 1 time per day). It does not cross the blood-brain barrier.
Metabolism
It undergoes extensive metabolism in the liver by hydroxylation to form 3-OH-desloratadine connected to glucuronide. Desloratadine not an inhibitor of isozyme CYP3A4 and CYP2D6, and is not a substrate or inhibitor of P-glycoprotein.
breeding
Excreted as glucuronide compound. A small amount excreted by the kidneys unchanged (
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 during pregnancy.
Desloratadine is excreted in breast milk, so the use of the drug during breast feeding is contraindicated.
Conditions of supply of pharmacies
Without a prescription.
side effects
Classification of the incidence of side effects according to the recommendations of the World Health Organization (WHO): very common> 1/10; often by> 1/100 to 1/1000 to 1/10000 to
Allergic reactions: very rare – anaphylaxis, angioedema, dyspnoea, pruritus, rash, urticaria, including; the frequency is unknown – photosensitivity.
On the part of the central nervous system: rarely – headache; very rarely – dizziness, somnolence, insomnia, psychomotor hyperactivity of, hallucinations, seizures.
With the cardiovascular system: very rarely – tachycardia, palpitations.
From the digestive system: rarely – dry mouth; very rare – abdominal pain, nausea, vomiting, dyspepsia, diarrhea, hepatitis.
On the part of the musculoskeletal system: very rarely – myalgia.
Laboratory findings: very rarely – increased activity of “liver” enzymes, increased bilirubin.
Other: often – fatigue; very rarely – pharyngitis, dysmenorrhea.
Overdose
symptoms
Receiving dose exceeding the recommended 5 times, does not cause any symptoms. Daily use of desloratadine in adolescents and adults at a dose of 20 mg for 14 days is not associated with a statistically or clinically significant changes of the cardiovascular system. Use of desloratadine in a dose of 45 mg per day (at 9 times the recommended) for 10 days did not cause QT interval elongation and the appearance was not accompanied by serious side effects.
Treatment
In case of accidental ingestion of large amounts of the drug should contact a doctor immediately. Recommended gastric lavage, administration of activated charcoal, if necessary, symptomatic therapy. Desloratadine does not appear in hemodialysis, peritoneal dialysis efficacy has not been established.
Interaction with other drugs
Interactions with other drugs have been identified in studies with azithromycin, ketoconazole, erythromycin, fluoxetine and cimetidine.
Eating does not affect the efficacy of the drug.
Desloratadine does not increase the alcohol effects on the central nervous system.
special instructions
Research on the effectiveness of desloratadine in rhinitis infectious etiology have been conducted.
Effects on ability to drive vehicles and mechanisms:
When receiving the recommended dose of desloratadine adverse impact on the management of vehicles and mechanisms have been noted.
However, in rare cases, some patients when medication is marked drowsiness or dizziness, which could affect the ability to drive and use machines.
Storage conditions
In the dark place at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Inside. Tablets should be swallowed whole without chewing, with a small amount of water.
The drug should preferably be taken at one and the same time of the day regardless of mealtime.
Adults and adolescents of 12 years of 1 tablet (5 mg), 1 time per day.
The duration of therapy depends on the duration of symptoms.
When seasonal (intermittent) allergic rhinitis (presence of symptoms lasting less than 4 days per week or a total duration of at least 4 weeks in a year) and the hives must be assessed for disease. With the disappearance of the symptoms, the drug should be discontinued at the re-emergence of symptoms the drug should be resumed.
At the year-round (persistent) allergic rhinitis (presence of symptoms lasting more than 4 days a week or a total duration of more than 4 weeks in a year), treatment may continue throughout the period of exposure to allergens.
To determine the duration of drug therapy should consult with a physician.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist