Aerius 60ml organon syrup reduces allergic rhinitis, sneezing, runny nose, itchy nose, congestion

Dosage form Syrup
Specifications Box
Ingredient Desloratadine

Ingredient

Composition information	Content
Desloratadine	0.5mg/ml

Uses

indications

Aerius is indicated in the following cases:

To quickly reduce the symptoms related to allergic rhinitis, such as sneezing, runny nose and itchy nose, congestion/nasal congestion, as well as itching, tearing and redness, itchy throat and cough. Desloratadine selectively inhibits the peripheral H1 histamine receptor due to the absolutely non -absorbing drug 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 levels (see pharmacokinetics) 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 tablets effectively reduce itching and reduce size, the number of rash 1 day after the beginning of treatment.

In each clinical trial, this effect remains 24 hours between doses. 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 - conjunctivitis. 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.

The yeast has not been determined to be responsible for transforming the desloratadine, and so it has not completely excluded a few interactions with other drugs. In vivo studies with specific inhibitors CYP3A4 and CYP2D6 have shown that these yeasts are not important in the metabolism of desloratadine. Desloratadine does not inhibit CYP3A4 or CYP2D6 and nor a substrate or p-Glycoprotein inhibitor.

In a clinical study taking 1 dose of Desloratadine 7.5 mg, food (high -fat breakfast, rich in calori) does not affect the distribution of desloratadine. In another study, grapefruit juice does not affect the allocation of desloratadine.

In a diagonal study, using single -dose desloratadine shows that the formation of tablets and syrup has equivalent biological effects and is not affected by food (high -fat breakfast, rich in calories).

In separate single doses studies, with the recommended dose, the value of AUC and C. of the desloratadine in children is similar to that in adults using the dose of desloratadine syrup 5 mg.

Patients with renal failure

Desloratadine pharmacokinetics in patients with chronic renal impairment (CRI) are compared to the pharmacokinetics of the Desloratadine in healthy objects in a single -dose dose study and a multi -dose study. In single dose study, the level of desloratadine is about 2 and 2.5 times in the object of mild to moderate chronic kidney failure and severe chronic kidney failure compared to healthy objects.

In multi -dose research, stable state achieved after the 11th day and compared to healthy subjects, the desloratadine concentration is higher than -1.5 times in mild to moderate and higher chronic kidney failures - 2.5 times in severe chronic kidney failures. In both studies, the change of concentration (AUC and CMAX) of desloratadine and 3 - Hydroxydesloratadine has no clinical significance.

Before taking Aerius 60ml organon syrup reduces allergic rhinitis, sneezing, runny nose, itchy nose, congestion

How to use

Aerius drugs syrup.

Dosage

Children from 6 months to 11 months of age: 2 ml (1 mg) Aerius syrup, 1 time/day or no meals, to reduce symptoms related to allergic rhinitis (including interrupted allergic rhinitis and persistent allergic rhinitis) and urticaria.

Children from 1 to 5 years old: 2.5 ml (1.25 mg) Aerius syrup, take 1 time/day or do not have meals, to reduce symptoms associated with allergic rhinitis (including interrupted allergic and persistent allergic rhinitis) and urticaria.

Children from 6 to 11 years old: 5 ml (2.5 mg) Aerius syrup, taken 1 time/day or without meals, to reduce symptoms associated with allergic rhinitis (including interrupted allergic rhinitis and persistent allergic rhinitis) and urticaria.

Adults and adolescents (≥ 12 years): 10 ml (5 mg) Aerius syrup, taken 1 time/day to drink with or without meals, to reduce symptoms associated with allergic rhinitis (including interrupted allergic rhinitis and persistent allergic rhinitis) and urticaria. Only oral use.

Interimony allergic rhinitis (symptoms that appear 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 to 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 an 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 dose to compensate for missed dose.

Side Effects

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%).

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.

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 Mental disorders:

Very rare: illusion.

Unknown: abnormal behavior, aggression

Common: headache.

Very rare: tachycardia, chest drum.

Common: dry mouth.

Very rare: increased liver enzyme, increased bilirubin, hepatitis.

Unknown: Jaundice.

Unknown: Light sensitivity.

Very rare: muscle pain.

Common: fatigue. Search.

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:

Hypersensitivity to the active ingredient or any ingredient of the drug.

Caution when using

has not evaluated 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 malposure - Galactose should not use this drug.

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.

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.

Drug interaction

does not observe the clinical interaction with Aerius tablets in clinical trials.

Food or grapefruit juice does not affect the distribution of desloratadine.

Drinking Aerius along with alcohol does not increase the risk of alcoholic cognitive impairment.

Cavalry: Not applicable.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.