Rupafin 1mg/ml Hyphens oral solution treats symptoms of allergic rhinitis (120ml)

Dosage form Box X 120ml
Specifications Rupatadine

Ingredient

Composition information	Content
Rupatadine	120mg

Uses

indications

Rupafin is indicated in the following cases:

Treatment of symptoms of allergic rhinitis (including chronic allergic rhinitis) in children aged 6 - 11 years old.

ATC code: R06A x28

Rupatadine is a second -generation antihistamine, antihistamine antagonist, long -lasting, selective antagonistic activity on peripheral H1 receptors. Some of its metabolites (such as desloratadine and hydroxyl metabolites) still have antihistamines and may contribute to the total effect of the drug.

In Vitro, Rupatadine studies in high concentrations inhibit the collection of mast cells caused by immune and non -immune stimuli, as well as Cytokin release, especially TNFA in Mast cells and Monocyte cells. The clinical correlation of experimental data is still being verified.

Rupatadine oral solution has pharmacokinetic characteristics in children at the age of 6 - 11 years similar to adults (over 12 years old): Pharmacological effects are also observed (antihistamine effect, reducing urticaria symptoms) after 4 weeks of treatment. A study for double, randomly blind in children 6 - 11 years old with chronic allergic rhinitis shows that Rupatadine oral solution helps reduce symptoms in the nose (runny nose, nose tap - mouth - throat and/ears) better than placebo after 4 and 6 weeks of treatment. In addition, it is also observed that the quality of life of children with chronic allergic rhinitis with drugs has significantly improved compared to children with placebo.

Clinical trials on volunteers (n = 375) and patients (n = 2650) have allergic rhinitis and chronic spontaneous urticaria shows that when using Rupatadine tablets at a dose of 2 - 100 mg observed does not see significant effects on the ECG.

The European Medicines Agency (The European Medicines Agency) has abolished the company's compulsory order to submit the clinical research results of Rupatadine oral solution on all groups of patients with chronic rhinitis and jute.

pharmacokinetics

Take drugs on children

On a child subgroup (average age: 10 years old), Rupatadine is quickly absorbed after taking the average dose of Rupatadine 5 mg with the time of reaching the maximum concentration of TMAX blood of 0.5 hours after drinking. Maximum cmax maximum concentration is 2.5 ng/ml after taking a single dose. In terms of drug absorption, the total area of the area under the curve (AUC) is an average of 8.86 Nghe/ml. All of these values are similar to adults and adolescents.

Rupatadine's average selling time in children is 3.12 hours, shorter than tablets used for adults and adolescents.

Effect of food

There is no study on the interaction of Rupatadine oral solution with food. The effect of food has been studied in adults and adolescents with Rupatadine 10 mg.

Food increases the body absorption (AUC) Rupatadine about 23%. The maximum concentration in plasma (CMAX) is not affected by food. These differences have no clinical significance.

Metabolism and elimination

In a study of elimination of drugs in adults, 34.6 % of rupatadine used was found in urine, and in feces of 60.9 % in the samples obtained in 7 days.

Rupatadine when used by oral is significantly metabolized before blood circulation.

The unchanged active ingredient is found in feces and urine is negligible. This means that Rupatadine is almost completely metabolized. In vitro metabolic studies on human liver cells show that Rupatadine is mainly metabolized by Cytocrom P450 (CYP 3A4).

Before taking Rupafin 1mg/ml Hyphens oral solution treats symptoms of allergic rhinitis (120ml)

How to use

to open the bottle, we both press and rotate the bottle in the opposite direction.

Take the cylinder and poking into the bottle hole, upside down the bottle.

Smoke the amount of drugs to be taken at the prescribed dose.

Take medicine directly from the cylinder.

Wash the cylinder after use.

Dosage

Children from 6 to 11 years old.

Dosage for children weighing or over 25 kg: Take 5 ml of solution (5 mg of rupatadine) once a day, can be taken with food or not.

Safety and effectiveness of Rupatadine on children from 2 to 5 years old and weighing less than 25kg have not been set up.

It is not recommended to use this product for children under 2 years old because there is no enough research data on this group.

Adults and adolescents (over 12 years old): Using Rupatadine 10 mg will be more appropriate.

Patients with liver or renal failure: Due to the lack of clinical experience in patients with impaired liver or kidney function, it is not recommended to use rupatadine for these objects.

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 using overdose? In a study of the safety of Rupatadine, at a dose of 100mg/day for 6 days, the drug is still well tolerated. The most common side effect is drowsiness. If unfortunately swallowed a large amount of drugs, it is necessary to treat symptoms and take the necessary supplements.

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

Clinical trials with Rupatadine oral solution have been conducted on 371 children aged 6-11 years old. In which, 51 patients were treated with 2.5 mg Rupatadine, 140 patients using 140 mg Rupatadine and 180 patients to use placebo.

The frequency of adverse reactions is classified as follows:

Pho Sea (≥ 1/100 to Infections and parasites:

common: upper respiratory infection.

Popular: headache, drowsiness.

Uncommon: allergic eczema.

The frequency of unwanted effects occurs in patients treated with Rupatadine 10 mg in clinical trials as follows:

Infections and parasites:

Less: pharyngitis, rhinitis.

Nutrition and metabolic disorders:

Uncommon: Increasing appetite.

Central nervous system disorders:

Popular: Sleep, headache, dizziness.

Less: Nosebleeds, dry nose, cough, dry throat, mouth pain - throat.

Gastrointestinal disorders:

Popular: dry mouth.

Uncommon: rash.

Uncommon: back pain, arthritis, muscle pain.

Popular: fatigue, weakness.

Uncommon: increased blood phosphokinase, increased alanin aminotransferase, increased aspartat aminotransferase, abnormal results when checking liver function, weight gain.

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

Rupafin drugs contraindicated in the following cases:

Hypersensitivity to any ingredients of the drug.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

The effectiveness and safety of Rupatadine oral solution in children under 6 years old has not been set.

Do not use Rupatadine with pomelo juice.

Safety on the heart when using Rupatadine 10 mg tablets has been evaluated in detail in QT/QTC research in adults. When using Rupatadine at a dose of up to 10 times the dose of treatment does not cause any effect on the electrocardiogram and thus does not affect the safety of the heart. However, it is necessary to be cautious when using Rupatadine for patients who have been determined to have a prolonged QT interval, patients with unsure potassium reduced potassium, progressive patients with progressive arrhythmia such as clear clinical arrhythmia, patients with acute myocardial infarction.

When using 10 mg Rupaladine tablets for adults, unfavorable adverse reactions include increased blood phosphokinase, hyperlang aminotransferase, increased aspartat aminotransferase, abnormal results when testing liver function.

This drug contains sucrose, so it may not be good for teeth. Patients with rare genetic diseases include fructose intolerance, glucose/galactose absorption or a deficiency of sucraseisomaltase should not be taken.

Methyl parahydroxybenzoate drugs, which can cause allergic reactions (may be late reaction).

The effect of the drug on driving and operating machinery

on clinical trials has been conducted, Rupatadine 10 mg does not affect the ability to drive and operate machinery. However, it is necessary to be cautious if used before driving or operating machinery until the reactions with the patient's Rupatadine are shown.

Use drugs for women during pregnancy and lactation

Pregnant women

Rupatadine data is limited on some pregnant women showing no side effects of rupatadine in pregnant women or fetal health/infant health. So far, there is no other epidemiological data on the use of drugs for pregnant and lactating women. Animal research does not indicate direct or indirect effects on pregnant women, the development of the fetus, the process of childbirth or the development of babies. To be cautious, it is best to avoid using rupatadine during pregnancy.

breastfeeding women

Rupatadine is excreted through animal milk. It is not known whether Rupatadine is excreted through breast milk or not. It is necessary to consider the benefits of children when breastfeeding and mothers' benefits when treating drugs to decide to stop breastfeeding or stop/avoid using rupatadine.

Drug interaction

The studies on drug interaction of Rupatadine oral solution have not been done in children.

Research on drug interaction is only performed on adults and adolescents (over 12 years old) with Rupatadine 10 mg.

Interact with ketoconazole or erythromycin: simultaneously use Rupatadine 20mg and Ketoconazole or Erythromycin, increasing the body absorption of rupatadine to 10 times and 2-3 times. These changes are not related to the effects on QT interval or with an increase in adverse reactions compared to when used separately. However, caution should be used when using rupatadine simultaneously with these drugs as well as other ISOZE CYP3A4 inhibitors. This happens because grapefruit juice has one or several CYP3A4 inhibitors and can increase the plasma concentration of metabolic drugs through CYP3A4 as Rupatadine. Moreover, grapefruit juice can affect the intestinal transport systems such as Glicoprotein-P. Do not take the medicine simultaneously with grapefruit juice. A dose of 20mg will increase the harmful effects when drinking with alcohol. Rupatadine. It is still unknown about the risk of interacting with statins that some drugs are metabolized by isenzyme cytochrom P450 CYP3A4.

Therefore, be careful when using simultaneously Rupatadine with statin drugs.

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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