Rupafin 10mg Hyphens treat allergic rhinitis, urticaria (1 blister x 10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications Rupatadine

Ingredient

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Composition information	Content
Rupatadine	10mg

Uses

Indications

Rupafin 10 mg is indicated in cases of treatment of allergic rhinitis and urticaria in adults and children over 12 years old.

Pharmacokological

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

In Vitro, Rupatadin studies in high concentrations inhibit the collection of mast cells caused by immunity and non-immune stimuli, as well as cause cytokine release, especially TNF-α in Mast cells and monocyte cells. Clinical detection from experimental data is still confirmed. Clinical trials on volunteers (n = 375) and patients (n = 2650) have allergic rhinitis and chronic spontaneous urticaria shows that when using rupatadine at the dose from 2 - 100 mg is not observed significantly the effect on the ECG.

Due to the same basic physiological characteristics, at the same time, chronic patients can easily recover later, people have used chronic spontaneous urticaria as a clinical research model, regardless of the cause of the disease. Because the release of histamine is a urticaria factor, Rupatadin is thought to reduce symptoms in other urticaria conditions as well as chronic spontaneous urticaria according to clinical instructions. In a clinical trial with control in patients with chronic spontaneous urticaria, Rupatadin has the effect of reducing itching after 4 weeks of treatment (reducing itching when using Rupatadin is 57.5%, compared to the placebo use of 44.9%) and reducing the average number of patients with itching, red skin when using Rupatadine is 54.3%and when placebo is 39,794.

pharmacokinetic pharmacokinetics

Rupatadin is quickly absorbed after oral, the time to reach the maximum drug concentration in the blood averages about 0.75 hours after drinking. The maximum amount of drug concentration in the blood averages is 2.6 ng/ml after taking a single dose of 10 mg and 4.6 ng/ml when taking single dose 20 mg.

The pharmacokinetics of Rupatadin ratio is linearly at a dose in a dose of 10 to 40 mg. After taking 10 mg/day/day for 7 days, the maximum amount of drug concentration in CMAX blood is 3.8 ng/ml. The concentration of plasma medication decreases with the second exponent jaw with a semi -exhaust time of 5.9 hours. The ratio of rupatadine linked to plasma proteins is 98.5 - 99%. There is currently no absolute data on Rupatadin due to rupatadin that has not been indicated by intravenously.

Effect of food. Food increases the level of body contact (area under the curve, AUC) with Rupatadine about 23%. The contact level with one of the active metabolites of the drug and with the main metabolites is not active is almost the same (down about 5% for active metabolites and a reduction of about 3% for non -active metabolites). The time it takes to achieve the highest rupatadin concentration in plasma (TMAX) slow down for 1 hour. The highest concentration in plasma (CMAX) is not affected by food. These differences have no clinical significance.

Metabolism and elimination

In a human elimination study (40 mg 14C-rupatadin), 34.6 % of the radioactive markers are found in urine, and the feces are 60.9 % in the samples obtained 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. This means that Rupatadin is almost completely metabolized. In vitro metabolic studies on human liver cells show that Rupatadin is mainly metabolized by cytocrom P450 (CYP 3A4).

Before taking Rupafin 10mg Hyphens treat allergic rhinitis, urticaria (1 blister x 10 tablets)

How to use

Rupafin 10 mg is tablet oral.

Dosage

for adults and children over 12 years old

Dosage is 10 mg (1 tablet)/time/day, can be taken with food or not.

For the elderly (see caution).

used for children

Do not recommend the use of 10 mg Rupatadin tablets for children under 12 years old. Children from 6 to 11 years old are recommended to use Rupatadin 1 mg/ml of oral solution.

Used for patients with liver or renal failure

Due to the lack of clinical experience in using drugs in liver or kidney impaired patients, it is currently not recommended to use Rupatadin 10 mg 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 using overdose? In a study of rupatadin safety, when taking a dose of 100 mg/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.

What to do when forgetting 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

When using Rupafin 10 mg, you may experience unwanted effects (ADR).

Rupatadin 10 mg has been used for over 2025 adults and teenagers in clinical studies, 120 of which have used Rupatadin for at least 1 year.

The most common side effects in clinical studies are controlled as drowsiness (9.5%), headache (6.9%) and fatigue (3.2%).

Most of the side effects are observed in clinical trials that are mild to moderate and often do not need to stop treatment.

The frequency of unwanted effects is reported in patients treated with Rupatadin 10 mg in clinical experiments as follows:

Infections and parasites

Uncommon: Sore throat, rhinitis.

Metabolic and nutrition disorders

Uncommon: Increasing appetite.

Nervous system disorders

Popular: Sleep, headache, dizziness.

Uncommon: distracting.

Respiratory, chest and mediastinum disorders

Uncommon: nosebleeds, dry nose, cough, dry throat, mouth pain - pharyngeal.

Gastrointestinal disorders

popular: dry mouth.

Less: Nausea, upper abdominal pain, diarrhea, indigestion, vomiting, abdominal pain, constipation.

Disorders of skin and subcutaneous tissue

Uncommon: rash.

Less: back pain, arthritis, muscle pain.

Common and local disorders

popular: fatigue, weakness.

Less: thirst, discomfort, fever, easily stimulated.

affect test results

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

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Rupafin 10 mg is contraindicated in cases where patients hypersensitivity to Rupatadine or any ingredient of the drug.

Precautions when using

should not use Rupafin with pressed grapefruit juice (see drug interactions and other types of interactions).

Rupatadin at a dose of up to 10 times the treatment do not cause any changes on the heart electrical and thus, does not affect the safety of the heart. However, it is necessary to be cautious when using Rupatadin for patients who have been determined to have a prolonged QT interval, patients with unsure potassium -reduced potassium, patients with progressive arrhythmia such as clinical bradycardia, patients with myocardial infarction.

Be cautious when using Rupafin 10 mg for the elderly (from 65 years of age). Although there is no overall difference in effectiveness and safety in clinical trials, it is not ruled out the risk of increased sensitivity in some elderly patients because they have only conducted tests on a few patients (see items of pharmacokinetic properties).

Use drugs for children under 12 years old, patients with impaired liver or kidney function: Please see more dose and use.

Because 10 mg Rupatadin tablets contain lactose monohydrates, this drug should not be prescribed for patients with rare galactose intolerance, lactase enzyme deficiency or patients with glucose-galactose intolerance.

The ability to drive and operate machines

Rupatadin 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 separately from the patient's Rupatadin are shown.

Pregnancy

There are some limited data on the use of rupatadin for pregnant women. Animal research does not show direct or indirect effects on pregnant women, up to the development of the fetus, to give birth or the development of babies. But need to be cautious, avoid using Rupatadin while pregnant.

Breastfeeding period

Rupatadin is excreted through animal milk. It is not known whether Rupatadin is excreted through breast milk or not. It is necessary to decide to stop breastfeeding or stop/avoid rupatadin in treatment based on the benefit of breastfeeding and the benefits of the mother's treatment.

Drug interaction

New interactive studies conducted in adults and teenagers (over 12 years old) with 10 mg Rupatadin tablets.

Interact with ketoconazole or erythromycin: simultaneously use Rupatadin 20 mg and ketoconazole or erythromycin, increasing the serum concentration of rupatadin to 10 times and about 2 to 3 times. Rupatadin should not be combined with these drugs as well as other ISOzyme CYP3A4.

Interaction with grapefruit juice: When taking the pills simultaneously with pomelo juice, the serum concentration of rupatadin increases to 3.5 times. Do not drink rupafin simultaneously with grapefruit juice.

Interaction with alcohol: After drinking alcohol, a 10 mg rupatad dose of side effects in a number of trials on motor nerves but there is no significant difference compared to side effects when using alcohol. A dose of 20 mg will increase the harmful effects when drinking alcohol.

Interaction with central analgesics: Like other antihistamine drugs, do not exclude rupatadin interactions with central painkillers.

Interaction with statins: increased creatinine phosphokinase (CPK) without symptoms that are rarely reported in clinical trials with Rupatadin. It is still unknown about the risk of interacting with statins that some drugs are metabolized by isenzyme cytochrome P450 CYP3A4. Therefore, be careful when using simultaneously Rupatadin with statin drugs.

Storage

Store at temperatures below 30 ° C.

Store the drug in the carton box to avoid light.

To be out of reach of children

Expiry date 36 months from the date of manufacture.

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