Aerius 5mg Organon reduces allergic rhinitis, urticaria (1 blister x 10 tablets)
Dosage form Film bag tablets
Specifications Box of 1 blister x 10 tablets
Ingredient Desloratadine
Ingredient
| Composition information | Content |
| Desloratadine | 5mg |
Uses
indications
Aerius is indicated in the following cases:
After drinking, desloratadine selectively inhibits the peripheral H1 histamine receptor because the drug is completely absorbed into the central nervous system (CNS).
Determined the safety of Aerius Sirus in three clinical trials in children. Children from 6 months to 11 years old are treated for daily hypamine resistance 1 mg (6 to 11 months), 1.25 mg (1 to 5 years old) or 2.5 mg (6 to 11 years old). Treatment is well tolerated as recorded by subclinical tests, signs of survival, and electrocardiogram (ECG), including QTC. When using the dose recommends the same plasma desloratadine concentration between children and adults. Due to the similar results between adult patients and children in the study of seasonal allergic rhinitis/chronic urticaria (Seasonal Alermic Rhinitis/Chronic Idiopathic Urticaria - SAR/CIU), it is possible to external data on the efficiency of desloratadine in adults for children.
In a multi -dose clinical study, Desloratadine uses up to 20 mg/day for 14 days, not observing the impact on the heart is clinically or statistical significance. In a clinical pharmacological trial using desloratadine at a dose of 45 mg/day (9 times higher than the clinical dose) for 10 days, no QTC distance is not seen.
Desloratadine does not seep into the central nervous system. With a dose of 5 mg/day, the drowsiness rate is not higher than the placebo. In clinical trials using Aerius tablets at a dose of 7.5 mg/day, there is no impact on mental activity. In a single -dose study, Desloratadine 5 mg does not affect the standard assessment of flight performance including drowsiness or flight -related tasks.
Do not observe clinical changes related to plasma desloratadine concentrations in multi -dose interactive tests with ketoconazole, erythromycin, azithromycin, fluoxetine and cimetidine.
In clinical pharmacological tests, used at the same time with alcohol does not increase cognitive decline due to alcohol or increased drowsiness. There is no significant difference in mental mental test results between the group using desloratadine and Placeboo, whether used alone or with alcohol.
In patients with allergic rhinitis (AR), Aerius tablets have the effect of reducing symptoms such as sneezing, runny nose and itchy nose, congestion/stuffy nose, as well as itchy eyes, tearing and redness, itching throat. Aerius tablets control symptoms effectively within 24 hours.
Supplemented for the existing classification of seasonal and year -round allergic rhinitis, which can classify allergic rhinitis in another way such as interrupted allergic rhinitis and prolonged allergic rhinitis depending on the time of symptoms. Interrupted allergic rhinitis is determined when symptoms appear 4 weeks.
In two 4 -week trials in seasonal allergic rhinitis patients with asthma, desloratadine is effective in reducing the symptoms of seasonal and asthma allergic rhinitis, and reducing the use of beta inhibitors, does not adversely affect the maximum exhaled gas volume in a second (FEV1). Improving symptoms without reducing the lung function has strengthened the safety of the use of desloratadine for patients with seasonal allergic rhinitis with mild and medium asthma.
Due to the same pathophysiology, regardless of the cause and because chronic patients can be more selected, chronic spontaneous urticaria has been studied as a clinical trial for urticaria. The release of histamine is the cause of all urticaria, so the desloratadine is said to be effective reducing symptoms for urticarias besides chronic horned urticaria, as recommended in clinical instructions.
In experiments in adults and young people with spontaneous urticaria (CIU), Aerius tablet effectively reduces itching and reduces the size, the number of rash 1 day after the beginning of treatment. In each clinical trial, this effect maintains 24 hours between dosage. Treatment with Aerius tablets also improves sleep and daytime activity, is measured by interrupting sleep and daily activities.
Aerius tablets are effective in reducing the burden of seasonal allergic rhinitis as shown by the total quality of life exploration related to rhinitis-congenitis. The biggest improvement is recorded as areas related to practical issues and daily activities are limited by symptoms.
Dynamic pharmacokinetics
can quantify the plasma concentration of desloratadine within 30 minutes using desloratadine. Desloratadine is well absorbed with the maximum concentration achieved after about 3 hours; Sales time of waste after about 27 hours.
Desloratadine's accumulation level is suitable for the sale time of the drug (about 27 hours) and the dose once a day. The bioavailability of desloratadine is proportional to the dose of 5 mg to 20 mg.
Desloratadine is moderately cohesive (83% - 87%) with plasma proteins. There is no evidence of clinical accumulation after daily dosage (5 mg to 20 mg) in 14 days.
Before taking Aerius 5mg Organon reduces allergic rhinitis, urticaria (1 blister x 10 tablets)
How to use
oral tablets. Take the tablet with a glass of water.
Dosage
Adults and adults (≥ 12 years old): A Aerius 5 mg film tablet, 1 time/day or non -meal, to reduce symptoms related to allergic rhinitis (including non -continuous allergic rhinitis and prolonged allergic rhinitis) and urticaria. Only oral use.
Interrupted allergic rhinitis (symptoms that appear In prolonged allergic rhinitis (symptoms appear ≥ 4 days/week and last> 4 weeks), can be treated continuously during exposure to allergens.
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 do
do when overdose? Should treat symptoms and support treatment.
On a multi -dose clinical study in adults and young people using desloratadine up to 45 mg (9 times higher than the clinical dose) did not observe the clinical manifestation of the overdose.
Desloratadine is not excreted through hemolysis; It is unclear whether it is excreted through peritoneal.
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 Aerius you may experience unwanted effects (ADR):
In clinical trials in a variety of indications including allergic rhinitis and chronic urticaria, at the recommended dose of 5 mg/day, unwanted effects with Aerius have been reported in 3% of patients beyond the placebo -treated people. The most common unfavorable events reported in excess of the placebo are fatigue (1.2%), dry mouth (0.8%) and headache (0.6%).
Group of children's patients
In a clinical trial with 578 teenagers from 12 to 17 years old, the most common disadvantage is headache; This occurs in 5.9% of patients treated with desloratadine and 6.9% of placebo patients.
List of adverse reactions
The frequency of adverse reactions of the clinical trial is reported in excess of the placebo and other unwanted effects are reported in the after -sales stage listed in the following table.
The frequency is defined: Very common (≥ 1/10), common (≥ 1/100 to Unknown illusion abnormal behavior, aggression Very rare Headache Dizziness, drowsiness, insomnia Increase mental activity - movement, seizures Unknown extends the range of qt Very rare dry mouth Abdominal pain, nausea, vomiting, indigestion, diarrhea, increased appetite Unknown Increase liver enzyme, increase bilirubin, hepatitis jaundice
Skin disorders and subcutaneous skin disorders Drugs
common
Very rare
Unknown
tired
Hypersensitivity reaction (such as anaphylaxis, angioedema, shortness of breath, itching, rash and urticaria).
weakness
Other undesirable effects are reported during after -sales period in children with unknown frequency including extending the QT, arrhythmia, slow heart rate, abnormal and aggressive behavior.
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
Aerius drug is contraindicated in the following cases:
Be cautious when using
need to be very careful when taking the drug for patients in the following cases:
Not evaluating the safety and effectiveness of Aerius tablets in children under 12 years old.
Desloratadin should be used carefully in patients with a history of a history or a family of epilepsy. In particular, children may be prone to epilepsy when treating with desloratadine. Health workers may consider stopping using desloratadine in patients with epilepsy during treatment.
In case of severe renal failure, be careful when using Aerius.
Patients with rare genetic problems in tolerance Galactose, Lapp Lactase deficiency or absorbent Glucose-Galactose should not use this drug.
The effect of the drug on the ability to drive and operate machinery
does not observe that it affects the ability to drive and operate machinery.
Use drugs for women during pregnancy and lactation
generally do not see the fertility in mice with desloratadine dose 34 times higher than the clinical dose proposed for humans.
No observations of monitoring or gene mutations in animal tests using desloratadine. Because there is no clinical data on the use of desloratadine during pregnancy, Aerius' safety has not been determined during pregnancy. Do not use Aerius during pregnancy unless the benefits are out of risk.
Do not use Aerius for breastfeeding women due to desloratadine to be secreted into breast milk.
Drug interaction
does not observe the clinical interaction with Aerius tablets in clinical trials.
Food or grapefruit juice does not affect the allocation of desloratadine.
Drinking Aerius with alcohol does not increase the risk of perceptions of alcoholism
Storage
Leave a cool place, avoid light, temperatures below 30⁰C.
To be out of reach of children, read the instructions carefully before use.
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