1mg/ml Ha Nam dipatin oral solution for allergic rhinitis and urticaria (20 tubes x 10ml)

Dosage form Box of 20 tubes x 10ml
Specifications Rupatadine
Ingredient VTYT Ha Nam Pharmaceutical Joint Stock Company

Ingredient

Composition information	Content
Rupatadine	1mg

Uses

indications

dipatin drugs are indicated in the following cases:

Symptomatic treatment in the following cases:

Allergic rhinitis (including chronic allergic rhinitis).

ATC code: R06A x28.

Rupatadin is a second -generation antihistamine, prolonged effect, selective antagonistic activity on peripheral H1 receptors. Some metabolites (such as desloratadine and hydroxylated) still have antihistamine and can contribute to the total effect of the drug.

In Vitro, Rupatadin studies at high concentrations inhibiting the grain loss of mast cells caused by immune or non -immune stimuli, as well as the release of cytokin, especially TNF, in Mast cells and monocen leukocytes (Monocyt). Clinical detection from experimental data is still required.

Rupatadin oral solution with pharmacokinetics records in children from 6 - 11 years old is similar to adults (> 12 years old): A pharmacological effect is also observed (prevent urticaria, antihistamine effect) after 4 weeks of treatment. A randomly blind study on children with chronic allergic rhinitis from 6 to 11 years old, has shown that the group of brave children of Rupatadin oral solution has the effect of reducing symptoms in the nose (runny nose and nasal tip, mouth, throat or ear) better than chronic allergic groups using Placebo after 4 to 6 weeks of treatment. In addition, the group using Rupatadin oral solution has a significant improvement in the quality of life compared to the Placebo group.

Chronic indefinite urticaria is studied as a clinical research model to evaluate the effectiveness of anti -H1 drugs on all urticaria conditions, because of the basic physiological characteristics is the same, regardless of the cause and at the same time, chronic patients can recover more easily later. Urticaria is a disease caused by mast, histamine and other intermediate cells (PAF and cytokin). Because Rupatadine has the ability to prevent the release of histamine and other inflammatory intermediaries, Rupatadin is thought to be an effective drug in the treatment of symptoms not only in chronic hives but also in other urticaria conditions according to clinical instructions.

The effect of Rupatadin oral solution in chronic hives in children from 2 to 11 years old has been shown in a random study, controlled, multi -center. Research has the participation of 206 children. Among them, 113 children from 2-5 years old and 93 children from 6 to 11 years old. The group treated with Rupatadin has 66 children, the Placebo group has 69 children and the Desloratadin group with 71 children. The rupatadine dose is 2.5mg in children with weight ≤ 25kg and 5mg in children with a weight> 25kg. The dose of deslorata-din is 1.25mg in children with weight ≤ 25kg and 2.5mg in children with a weight> 25kg. A significant improvement has been shown in the change of the average level of urticaria level (UA57, including urticaria and itching), after 6 weeks of treatment (Rupatadin - 11.77 compared to Placebo - 5.55; P

Clinical trials on volunteers (n = 375) and patients (n = 2650) suffer from allergic rhinitis and chronic indefinite urticaria do not show significant changes on the map when rupatadine is used at the dose from 2 - 100mg.

Dynamic pharmacokinetics

Children

Among the children from 2-5 years old and from 6 to 11 years old, Rupatadin is quickly absorbed and the maximum maximum medical concentration respectively respectively 1.9 and 2.5ng/ml after the dose is repeated. In terms of exposure, the total area of the area under the curve (AUC) is 10.4ng. All of these values are similar to the values achieved in adults and teenagers.

Rupatadin's sale time in 2-5 years old is 16.9 hours and in 6-11 years old children are 12.3 hours, longer than the report of tablets in adults and children.

The effect of food

There is no study of interaction between food and Rupatadin oral solution. Research on the effects of food on Rupatadin 10mg pharmacokinetics have been done in adults and teenagers. Food increases the level of body contact (AUC) with Rupatadin about 23%. The highest concentration in plasma (cm) is not affected by food. Clinical differences.

metabolism and elimination

In a study of adult elimination, 34.6% of rupatadine is found in urine, and in the stool, 60.9% after 7 days. Rupatadin when used by oral is significantly metabolized before the blood circulation. The unchanged active ingredient found in feces and urine is negligible. Meaning Rupatadin is almost completely metabolized. In general, the metabolic form has desloratadine activity and hydroxylated derivatives, which account for 27% and 48% respectively compared to the total full contact of the pharmaceutical substance, respectively. In vitro metabolic studies on liver cells show that Rupatadin is mainly metabolized by Cytochrom P450 (CYP 3A4).

Before taking 1mg/ml Ha Nam dipatin oral solution for allergic rhinitis and urticaria (20 tubes x 10ml)

How to use

oral medication.

Dosage

Children from 2 to 11 years old:

Dosage in children with weight ≥ 25kg: 5ml (5mg of rupatadin) oral solution/time/day, can be used with food or no food.

Dosage in children weighs ≥ 10kg and

Due to the lack of data on the use of drugs in children under 2 years of age, it is not recommended to use drugs in children under 2 years of age.

In adults and teenagers (over 12 years old):

Lia 10ml (10mg) oral solution/day/day, can be used with food or without food.

Patients with liver or kidney failure:

Due to the lack of clinical experience in taking drugs in patients with impaired liver or kidney function, it is not recommended to use rupatadine for these patients.

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?

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 Rupatadin oral solution have been performed on 626 patients who are children from 2 to 11 years old. In particular, 147 children are treated with 2.5mg Rupatadin, 159 children are treated with Rupatadin 5mg, 249 children use placebo and 71 children using desloratadin.

The following terms are used to classify adverse reactions based on frequency:

Very common: ≥ 1/10;

Common: ≥ 1/100 and classification by agency system rupatadin 2.5 mg rupatadin 5 mg Type (n = 147) (n = 159) (n = 249) (0.63%) 0 (0.68%) 0

0 (0.63%) 0 neutrophilia

0 1 (0.63%) 0 The beginning 2 (1.36%) 4 (2.52%) 4 (1.61%) Surface 0 1 (0.63%) 1 (0.40%) (0.63%) 2 (0.80%) (0.40%) night sweating 0 1 (0.63%) 0 fatigue 0 1 (0.63%) 0
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

Dipatin 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:

Safety of Rupatadin oral solution in children under 2 years of age has not been established.

Avoid using Rupatadin with strong CYP3A4 inhibitors and should be careful when combining rupatadin and medium CYP3A4 inhibitors.

Need to adjust the dose of the drugs is sensitive CYP3A4 substrate (such as simvastatin, lovastatin) and CYP3A4 substrates have a narrow treatment range (such as ciclosporin, tacrolimus, everolimus, cisaprid) because rupatadine can increase the concentration of plasma of these drugs.

Do not use Rupatadin with grapefruit juice (see interactive, cavalry of the drug).

Safety on the heart when using tablets should Rupatadin 10mg has been evaluated in detail in QT/QTC research in adults. When using Rupatadin at a dose of up to 10 times the treatment dose does not cause any changes on the electrocardiogram and therefore, does not affect the safety of the heart. However, it is necessary to be cautious when using Rupata-din for patients who have been determined to have a prolonged QT interval, patients with unsure potassium reduced potassium, patients with arrhythmia progresses with clear clinical manifestations, patients with myocardial infarction.

hypernectic phosphokinase, hyper aminotransferase, increased aspartat aminotransferase as well as abnormalities of liver function testing is a low -level adverse reaction that has been reported with Rupatadin 10mg tablets in adults.

Products containing diameter can be harmful to teeth. Rings have rare genetic problems about fructose intolerance, glucose-galactose absorption or a deficiency of sucrase-isomaltase enzyme without this drug.

The effect of the drug on driving and operating machinery

Rupatadin 10mg does not affect the ability to drive and operate machinery in a clinical trial done. However, it is necessary to be cautious if used before driving or operating machinery until the reactions separately from the patient's Rupatadin are shown.

Use drugs for women during pregnancy and nursing mothers

pregnant women

There are some limited data on rupatadin use for pregnant women. Animal research does not show direct or indirect effects on pregnant women and fetal development, reproductive process or postpartum development. But need to be cautious, avoid using Rupatadin while pregnant.

breastfeeding women

Rupatadin is excreted through animal milk. It is not known whether Rupatadin will be excreted in breast milk. Need to consider the benefits on the mother and the risk on the baby before deciding to stop breastfeeding or stop/avoid rupatadin.

fertility

There is no clinical data on the effects of drugs on fertility.

Interactive drug

There is no study of the interaction of Rupatadin oral solution performed in children.

Interactive studies are only conducted in adults and adolescents (over 12 years old) with Rupatadin 10mg.

The effect of other drugs on Rupatadin

Use Rupatadin with strong CYP3A4 inhibitors (such as Traconazol, Ketoconazol, Voriconazole, Posaconazol, HIV Protase inhibitors, Clarithromycin, Nefazo-Don) should be avoided and should be cautious when combining Rupatadine with CYP3A4 inhibitors medium (Erenthromycin, fluconazol, fluconzol,, fluconzol,, fluconzol,, fluconzol,, fluconzol,, fluconazol,, fluconzol,, fluconzol,, fluconzol,, fluconzole Diltiazem).

Simultaneous use of 20mg simultaneously with ketoconazole or erythromycin increases rupatadin serum levels 10 times and about 2 to 3 times. These changes are not related to the effects on QT intervals or with an increase in adverse reactions when compared to the drugs when used alone.

Interaction with grapefruit: When taken at the same time, Rupatadin and grapefruit juice, rupatadine concentration in serum increases to 3.5 times. Therefore, rupatadin should not be taken with grapefruit juice.

The effect of rupatadin on other drugs

Be careful when taking rupatadin and drugs with narrow treatment because of the information about the effect of rupatadin on other drugs is still limited.

Interaction with alcohol: After drinking alcohol, a 10mg rupatadin dose creates side effects in some dynamic nerve tests but there is no significant difference compared to side effects when using alcohol. A dose of 20mg will increase the harmful effects when drinking alcohol.

Interaction with central analgesics: Like other antihistamines, Confucius eliminates rupatadine interaction with central painkillers.

Interaction with statins: increased creatinine phosphokinase (CPK) is not accompanied by less common symptoms in clinical trials with Rupatadin. It is still unknown about the risk of rupatadine interaction with statin - some drugs in the group are metabolized by isenzyme cytochrom P450 CYP3A4. So be careful when using simultaneously Rupatadin 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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