Desloratadine 5mg Genepharm medicine reduces symptoms of allergic rhinitis, urticaria (2 blisters x 15 tablets)

Dosage form Box of 2 blisters x 15 tablets
Specifications Desloratadine
Ingredient Genepharm S.A

Ingredient

Composition informationContent
Desloratadine5mg

Uses

indications

Desloratadine drugs are indicated in the following cases:

Desloratadine 5mg Genepharm is indicated in adults and adolescents 12 years and older to reduce the following symptoms:

  • Allergic rhinitis;
  • urticaria.

    Code ATC: R06AX27

    Mechanism of action

    Desloratadin is a long -acting antagonist, which does not cause drowsiness with selective antagonistic activity with H1 receptor. After drinking, desloratadin selectively inhibits peripheral H1 histamine receptors because this active ingredient cannot enter the central nervous system.

    Desloratadin has been shown to prevent allergies on in-vitro research. Inhibits the release of cytokines such as IL-4, IL-6, IL-8 and IL-13 from human base moisturizers and white blood cells, as well as inhibiting the adhesion of P-Selectin molecules on endothelial cells. The clinical relevance of these observations has not been confirmed.

    Clinical effects and safety

    In clinical trials with a dose of up to 20 mg of desloratadin daily used for 14 days, no effect on the heart has statistical or clinical significance. In pharmacological clinical trials, desloratadin is used at a dose of 45 mg per day (9 times the normal dose) for 10 days, no extension of QT distance. No clinical changes are not observed related to plasma desloratadin concentrations in drug interaction tests when coordinating desloratadin along with ketoconazole and erythromycin. Desloratadin completely does not enter the central nervous system. In controlled clinical trials, the normal dose group 5 mg daily, the drowsiness rate is not higher than the placebo group. When using a single dose of Desloratadin 7.5 mg daily does not affect mental mental activity in clinical trials. In the study of single dose in adults, Desloratadin 5 mg does not affect the standard assessment of flight performance including drowsiness or missions related to the flight. In pharmacological clinical trials, simultaneous use of desloratadine and alcohol does not increase behavioral weakness due to alcohol or increased drowsiness. There is no significant difference in mental mental test results between the group using desloratadin and the placebo group, whether not used or used with alcohol. In patients with allergic rhinitis, desloratadin works to reduce symptoms such as sneezing, runny nose and itching, as well as itchy eyes, watery and red eyes, and itchy mouth. The effect of controlling these symptoms of desloratadin lasts for 24 hours.

    for children

    The effect of the Desloratadin tablet is not well known in tests with patients who are teenagers aged 12 to 17. In addition to seasonal and seasonal classification, allergic rhinitis can be classified in a different way such as non -continuous allergic rhinitis and prolonged allergic rhinitis depending on the time of symptoms. Non -continuous allergic rhinitis is when symptoms appear less than 4 days in a week and lasts less than 4 weeks. Extended allergic rhinitis, the symptoms appear for 4 days or more for a week and lasts more than 4 weeks. Desloratadine has the effect of reducing the harmful effects of seasonal allergic rhinitis as evidenced by the total quality of life exploration related to rhinitis. The biggest improvement is seen in areas related to the usual issues and
    daily activities are limited by symptoms. Chronic spontaneous urticaria is studied as a clinical model for urticaria cases, because the physiological pathology is the same, regardless of the cause, and because chronic patients can easily recover. Because histamine release is a factor of all urticaria, desloratadine is thought to be effective reducing symptoms for urticarias besides chronic horned urticaria, as well as recommended in clinical instructions. In two placebo control studies in a group of spontaneous urticaria patients in 6 weeks, desloratadine has the effect of reducing itching, reducing the size and number of rashs after one day from the beginning of treatment. In each test, this effect lasts more than 24 hours between doses. A clinical trial of antihistamines is different from spontaneous urticaria, a small number of patients who are noticeable in response to antihistamines. Observed the improvement of itching symptoms of over 50% of the subjects, of which 55% of patients were treated with desloratadin and 19% of patients using placebo. The treatment with desloratadin is also meant to significantly reduce sleep intervention and daytime physiological function, soil-scales used to evaluate this effect.

    Dynamic pharmacokinetics

    absorption

    Desloratadine concentration in plasma can be detected after 30 minutes of taking the drug. Desloratadin is well absorbed with the peak concentration after about 3 hours. The sale time is about 27 hours. The accumulation of desloratadine is suitable for the sale time (about 27 hours) at a dose once a day. The bioavailability of desloratadine is proportional to the dose range from 5 mg to 20 mg.

    In a pharmacokinetic test, in which the patient's statistics are compared to those with seasonal allergic rhinitis, 4% of the subjects achieving high concentrations of desloratadin. This percentage may vary depending on the race. The peak desloratadin concentration is 3 times higher after 7 hours. Safety records of these subjects are no different from the common population.

    distribution

    Desloratadine is moderate (83% - 87%) for plasma proteins. There is no evidence of clinical accumulation after taking desloratadin once a day (5 mg to 20 mg) for 14 days.

    Biological metabolism

    enzymes are responsible for the metabolism of desloratadin, and therefore, some interactions with other drugs cannot be completely excluded.

    Desloratadin does not inhibit CYP3A4 on in-vivo, and on in-steria tests show that non-inhibitors CYP2D6 and not P-Glycoprotein inhibitors.

    Elimination

    In a single -dose test of 7.5 mg desloratadin, there is no effect of food (high fat, high calorie breakfast) for the use of desloratadin. In another study, grapefruit juice does not affect the use of desloratadin. The half -life of the final stage is about 89 hours.

    Patients with renal failure

    Desloratadin's dynamic pharmacokinetics in patients with chronic renal failure (CRI) are compared to healthy subjects in a single -dose and multi -dose research study. In the single -dose study, the contact with desloratadine is 2 and 2.5 times higher than patients with mild to medium and heavy CRIs compared to healthy people. In multi -dose study, stable state achieved after 11 and compared to healthy subjects, the level of contact with Desloratadin is 1.5 times higher in patients with mild to medium and 2.5 times Cri in patients with severe CRI. In both studies, the change of contact level (AUC and CMAX) of desloratadine and 3-hydroxydesloratadin is not clinically related.

    Preceptic safety data

    Desloratadin is a major metabolic substance of Loratadin. Precaessing research between desloratadine and loratadin shows no difference in nature as well as the toxicity of desloratadin and loratadin at concentrations that have the same effect of desloratadin. Preceptic data with desloratadin shows no special dangers for users, based on studies according to pharmacological safety regulations, gene toxicity, cancer risk, reproductive and developing ability. There is no risk of cancer in studies with desloratadine and loratadin.

  • Before taking Desloratadine 5mg Genepharm medicine reduces symptoms of allergic rhinitis, urticaria (2 blisters x 15 tablets)

    How to use

    oral tablets.

    Can take medicine when hungry or when full.

    Dosage

    Adults and adolescents (aged 12 years)

    Desloratadin's suggestions are a one -day tablet.

    In case of non -continuous allergic rhinitis (symptoms appear less than 4 days in a week or lasting less than 4 weeks), use suitable for the degree of condition and treatment may stop after the symptoms gradually disappear until they appear again.

    In the case of prolonged allergic rhinitis (symptoms appear for 4 days or more for a week and lasting more than 4 weeks), continuing treatment with drugs may be recommended for patients during allergies.

    For children

    Clinical trials on the effects of desloratadin on teenagers aged 12 to 17 are limited. Safety and effects of Desloratadin 5 mg film tablets in children under 12 years of age are not guaranteed. Specific data has not been studied.

    It is recommended that children under 12 years of age use syrup, no safety and effectiveness of desloratadine in children under 6 months old.

    Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

    Symptoms

    Based on a multi -dose clinical trial, including 45 mg Desloratadin (9 times
    than clinical dose), does not cause clinical related effects.

    Treatment

    In case of overdose, consider standard measures to eliminate the active ingredient that has not been absorbed. Recommendations for symptomatic and supportive treatment.

    Desloratadin is not excluded by a hemorrhage, it is unknown whether it is eliminated by peritoneal fertilizer.

    Children

    Unwanted effects related to overdose use, observed during use after circulation of drugs on the market is similar to the treatment dose, but at a higher level of influence.

    In case of emergency, call the 115 emergency center immediately or go to the nearest local health station.

    What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.

    Side Effects

    When using the drug, there are common unwanted effects (ADR) such as:

    Safety records

    In clinical trials, including indications for allergic rhinitis and spontaneous urticaria, with the recommended dose of 5 mg per day, the desired effect of Desloratadin has been reported over 3% of patients than placebo treatment groups. The most common side effect in the placebo group is fatigue (1.2%), dry mouth (0.8%) and headache (0.6%).

    Children's subjects

    In a clinical trial with 578 minor patients, from 12 to 17 years old, the most common side effect is headache; This occurs in 5.9% of patients treated with desloratadine and 6.9% of placebo patients.

    Sorting and listing table

    The frequency of side effects in clinical trials is reported more than the placebo group and other unwanted effects are still reported during the time after being circulated in the market listed in the following table.

    The frequency includes very popular (≥ 1/10), popular (≥ 1/100 to

    System Classification of Agency System frequency Sutta

    popular

    Very rare

    Headache, dizziness

    Dizziness, drowsy condition, insomnia, excessive nerve exercise, epilepsy

    cardiovascular disorders very rare fast heart rate, broken chest drum, long -lasting QT interval

    Very rare

    dry mouth

    Abdominal pain, nausea, vomiting, indigestion, diarrhea

    unknown

    Enzyme of the liver and the concentration of bilirubin increases

    Hepatitis Jaundice

    Skin and subcutaneous disorders unknown light sensitive light

    Very rare

    unknown

    tired

    Hypersensitivity reactions (such as hypersensitivity, angiography, shortness of breath, itching, rash and urticaria)

    asthma

    Other undesirable reactions are reported during the time after being marketed in children with unknown frequency including extending the QT, arrhythmia, and slow heart rate.

    Report on suspected side effects

    Report on suspected side effects after the drug product is licensed to circulate is very important. It allows to continue monitoring the balance between the benefits or risks of the drug. Health care experts are required to report any suspicious adverse reactions through the national reporting system.

    Instructions on how to handle ADR:

    Notify the physician with unwanted effects when using the drug.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    Desloratadine drugs are contraindicated in the following cases:

  • Hypersensitivity to desloratadin, any ingredients of the drug or with loratadin.
  • Be cautious when using

    Please see more information about the drug in the instruction sheet of the use of the drug attached.

    In case of severe renal failure, desloratadin should be used cautiously.

    The effect of the drug on driving and operating machinery

    desloratadin does not affect or affect the ability to drive and control machinery based on clinical trials. Patients should know that most of these drug users do not feel fallen asleep. However, depending on the response to different drugs of individual individuals, it is recommended that patients do not participate in activities that require high levels of elite, such as driving and machinery control, until the patient has begun to adapt to this medicine.

    Use drugs for women during pregnancy and lactation

    Pregnant women

    A large amount of data on pregnant women (more than 1,000 results of pregnant women) has shown that no deformities and toxicity for children's monthly children's monthly children. Animal research does not show direct or indirect harmful effects in the production of toxins. As a warning, pregnant women should limit the use of desloratadin during pregnancy.

    Women who are breastfeeding

    Desloratadin is determined in breast milk in women who are nourishing infants/young children with breast milk and are treating with desloratadin. The effect of desloratadine on infants/young children is still unknown. The decision not to continue breastfeeding or avoiding/avoiding the use of desloratadin depends on the benefits of breastfeeding and treatment benefits.

    reproductive age

    There is no data on the impact on reproductive age both men and women.

    Drug interaction

    does not observe clinical significance when using a combination of desloratadin tablets with erythromycin or ketoconazole in clinical trials.

    with children

    Research on drug interaction is only done on adults. In a clinical trial of pharmacokinetics, desloratadin when taken with alcohol is not effective to reduce the effect of alcohol. However, cases of intolerance and alcohol poisoning have been reported during use after circulation. Therefore, it should be recommended when using desloratadin with alcohol.

    Storage

    Store drugs in closed packaging, in a dry place, temperatures below 30 ° C, avoiding light and moisture.

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