Bilongen 10mg Menarini medicine for allergic rhinitis, urticaria (1 blister x 10 tablets)
Dosage form Box of 1 blister x 10 tablets
Specifications Bilastine
Ingredient A.Menarini Manufacturing Logistics and Services S.R.I
Ingredient
| Composition information | Content |
| Bilastine | 10mg |
Uses
indications
Bilaxten drug indicated for children from 6 to 11 years old weighing 20kg or more:
ATC code is Ro6AX29.
Mechanism of action
bilastine is a histamine antagonist that does not cause drowsiness, prolonged effect, selective antagonistic on peripheral H1 receptor and has no affinity with Muscarinic receptor.
bilastine inhibits the rashes, rash on the skin due to histamine within 24 hours after using a single seamlessly.
Clinical effectiveness
Bilastine's effectiveness has been studied in adults and adolescents. In principle, this proven effectiveness can be extracurred for children, the body exposure to Bilastine once used for children from 6 to 11 years old has a body weight of at least 20kg equivalent to the body exposure to Bilastine 20mg when used for adults.
The extra data of data from adults and adolescents is completely suitable for this drug because the physiology of allergic rhinitis and urticaria is the same for all ages.
In clinical trials performed on adults and adolescents with allergic rhinitis (seasonal or year -round), Bilastine 20 mg, used once a day within 14-28 days, which is effective in reducing symptoms such as sneezing, runny nose, nasal stuffy, teary -eyed and red eyes. Bilastine effectively controls symptoms within 24 hours.
In two clinical trials performed in patients with chronic primary urticaria, Bilastine 20 mg, taken once/day for 28 days to prove the effect in reducing the level of itching and reducing the number and size of lumpy traces as well as the discomfort of the patient due to urticaria. The patient improves the quality of sleep and thus improves the quality of life.
There is no case that extends the main effect of the main effect or the unwanted effect on the heart is recorded in Bilastine's clinical trials, even at a dose of 200 mg per day (10 times the dose of treatment) within 7 days in 9 patients, or even even in combination with P-GP inhibitors, such as Ketoconazole (24 patients) and Erythromycin (24 patients). In addition, a study monitoring of QT interval has also been conducted over 30 volunteers.
In controlled clinical trials, when using the recommended dose is 20 mg once a day, the data on safety on the central nervous system of Bilastine is equivalent to the placebo and the rate of recording sleep is not different from statistical significance compared to placebo. Clinical trials show that Bilastine at a dose of 40 mg once a day does not affect mental activity as well as the ability to drive is assessed through a standard driving test.
Elderly (≥ 65 years) was selected in phase II and Phase III research, the results showed that there was no difference in efficiency as well as the safety when compared to the younger patient group.
Pharmacokinetics
absorption
Bilastine is absorbed quickly after drinking and reaching the maximum plasma concentration after about 1.3 hours. The drug is not accumulated. The average oral bio -use value of bilastine is 61%.
Distribution
Intro and in vivo research shows that Bilastine is a substrate of P-GP and Oatp's substrate. At the treatment dose, the ratio attached to the plasma protein of the drug is 84 - 90%.
Metabolism
Results of In vitro studies show that bilastine is not touched or inhibited activity of CYP450.
Elimination
In a block of mass balancing under a healthy volunteer, after taking a single dose of 20 mg of C-Bilastine, nearly 95%of the dose found in urine (28.3%) and feces (66.5%) in the form of unchanged bilastine. This shows that bilastine is not much metabolized in the human body. The average selling time on healthy volunteers is 14.5 hours.
linear level
Bilastine manifests linear pharmacokinetic model in the study dose range (5 to 220 mg), with a small level of oscillation between all body.
Patients with renal failure
Bilastine's effectiveness in patients with renal failure is conducted in adult studies.
The process of exporting through urine is almost completed after 48 - 72 hours on all subjects.
These pharmacokinetic changes do not show a clearly clinical impact on the safety of bilastine, due to plasma drug concentration in the case of patients with renal impairment still in the treatment range.
Patients with liver failure
There is no dynamic data on liver failure patients. In humans, bilastine is not metabolized. As a result in the studies in patients with renal impairment shows that the excretion of the kidney is the main elimination line, the process of exit through bile only contributes a very small part to the excretion of bilastine. The change of liver function may not significantly change the pharmacokinetics of bilastine clinically.
Children
Dynamic data in children obtained from a phase -dynamic study of 31 children from 4 - 11 years old with allergic rhinitis or chronic urticaria used tablets should spread in the mouth of Bilastine 10mg 1 time/day. Pharmacokinetic analysis for plasma concentration data in plasma shows that Bilastine dose 10mg 1 time/day for children to create a whole body exposure equivalent to the dose of Bilastine 20mg for adults and young people.
Before taking Bilongen 10mg Menarini medicine for allergic rhinitis, urticaria (1 blister x 10 tablets)
How to use
oral medication.
The drug is used in the form of a dispersed tablet in the mouth, so when it is sucked in the mouth, it will dissolve quickly in saliva, so it will be very easy to swallow.
In addition, the dispersed tablet in the mouth can be dissolved into water before drinking. Do not use grapefruit juice or any other juice to dissolve the pill.Need to take medicine at 1 hour before or 2 hours after eating or drinking juice.
Dosage
Children from 6 to 11 years old weighing 20kg or more:
Treatment length:
In the treatment of allergic rhinitis, the treatment is limited to the time of exposure to the allergic factor. In the treatment of seasonal allergic rhinitis, the drug may stop when the symptoms are gone and reuse when the symptoms rise again. In the treatment of allergic rhinitis all year round, the drug should be used continuously during exposure to allergens. In the treatment of urticaria, the treatment time depends on the urticaria, time and development of symptoms.
Special subjects
Patients with renal failure
The safety and effectiveness of bilastine in children with kidney failure has not been fully studied. Studies performed in adults in a special risk group (patients with renal impairment) show that there is no need to adjust the dose in patients who are adult kidney failure
Patients with liver failure
The safety and effectiveness of bilastine in patients with liver failure have not been fully studied. There is no clinical data on the use of drugs in patients with liver failure in both adults and children. However, because bilastine does not metabolize through the liver but mainly eliminates in the form of unchanged urine and feces, the liver failure may not cause the concentration of drugs in the blood to exceed the safety limit. Therefore, there is no need to adjust the dose in patients who are adults with liver failure.
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?
Information related to the cases of Biasine's overdose collected from clinical test results in the phase of drug development and after -sales data. In clinical studies, after using bilastine at a dose of 10 to 11 times higher than the treatment (220 mg (single dose); or 200 mg/day for 7 days), the frequency of emerging reactions on volunteers is 2 times higher than that of fake. The most unwanted effect is dizzy, headache and nausea. No serious adverse reactions nor significant extension of QT interval on the electrocardiogram. Information collected from after -sales data agreed with reports in clinical trials.
A corrected QT/QT parameters have been conducted on 30 healthy volunteers to assess the impact of the repeated dosage bilastine (100mg x 4 days) on the ventricular polarization. Research has shown that the above -mentioned use regime significantly lasts the value of QT.
In case of overdose, it is necessary to apply symptomatic treatment and support treatment.
There is no specific antagonistic drug for bilastine.
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
Summary of safety properties on children's patients
In clinical trials, frequency, type and severity of unwanted effects on teenagers (from 12 to 17 years old) similar to adults. Information received from these groups of patients (teenagers) in after -sales studies is similar to recorded in clinical studies.
The rate of children (2 to 11 years old) has an undesirable effect after treatment with Bilastine 10mg in allergic rhinitis or chronic spontaneous urticaria in 12 -week clinical research is similar compared to placebo patients (68.5% compared to 67.5%).
The most unwanted effects are reported in clinical trials on 291 children's patients (2 to 11 years old) (260 children participating in the study of safety and 31 children participating in pharmacokinetics research) using bilastine (dispersed tablets in the mouth) are headaches, drowsiness, dizziness and fatigue. These reactions appear at similar frequency of recorded frequency of over 249 patients using fake.
The at least adverse reactions may be related to bilastine and are reported in more than 0.1% of children's patients (from 2 to 11 years old) using Bilastine 20mg during the clinical development of the drug below.
Infections and parasites
Nervous system disorders
General disorders
Describe the adverse reaction in children
Headache, abdominal pain, allergic conjunctivitis and rhinitis have been reported in the group of children treated with Bilastine 10mg or with placebo. The frequency of reported is 2.1% and 1.2% with headaches; 1% and 1.2% have abdominal pain, 1.4% and 2% have allergic conjunctivitis, 1% and 1.2% rhinitis.
Summary of safety characteristics in adults and adolescents
In clinical trials, the number of unwanted effects encountered in adult patients and teenagers with allergic rhinitis or chronic primary urticaria is treated with Bilastine 20 mg similar to the number recorded in the patient using the price (12.7% compared to 12.8%).
Clinical and Pha III clinical trials are conducted in the clinical development phase on 2525 adults & adolescents for different doses of bilastine, including 1697 patients using Bilastine 20mg. In these tests, 1362 patients can use fake.
The adverse reactions of the drug (ADRS) are often recorded in patients using Bilastine 20mg to treat allergic rhinitis and chronic spontaneous urticaria are headaches, drowsiness, dizziness and fatigue. These reactions appear at the same frequency recorded on patients using placebo.
The at least adverse reactions may be related to bilastine and are reported in more than 0.1% of patients using Bilastine 20mg during the clinical development of the drug classified below.
Infections and parasites
Psychological disorders
Nervous system disorders
Gastrointestinal disorders
Skin and soft tissue disorders
General disorder
Testing indicators
Description of adverse reactions in adults and adolescents
Disturbing reactions such as drowsiness, headache, dizziness and fatigue have been reported in the whole group of treatment with Bilastine 20mg or with placebo. For sleepy reactions, the frequency of using bilastine is 3.06% while the placebo is 2.86%; For headache reactions, the frequency of using bilastine is 4.01% while the placebo is 3.38%; For the frequency -dizziness reaction when using bilastine is 0.83% while fake is 0.59%; For fatigue reaction, the frequency of bilastine is 0.83% while the placebo is 1.32%.
The information collected from after -sales data has confirmed the safety characteristics of observation in clinical development studies.
Report cases suspected of unwanted effects
Report cases suspected of unwanted effects after licensing product circulation is very important. It allows to continue monitoring with the risk benefits of the product.
Health workers are required to report any case of undesirable effects through the national reporting system.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Contraindicated bilaxten in the following cases:
Be cautious when using
Children
Information on the effectiveness and safety of bilastine in children under 2 years of age has not been fully studied and has little clinical experience about the use of drugs for children aged 2 to 5, so they should not use bilastine for this age group.
On patients with severe or medium renal impairment, simultaneous use of bilastine with glycoprotein inhibitors such as ketoconazol, erythromycin, cyclosporin, ritonavirin or diliazem may increase bilastine levels in plasma, thus increasing the risk of adverse reactions. Therefore, it is important to avoid using bilastine and glycoprotein p inhibitors on patients with severe or medium renal failure.
Use drugs for women during pregnancy and lactation
Pregnant women: without or have very little data on using bilastine in pregnant women. Animal research does not show direct or indirect effects on fertility, fetal and postpartum development (see section 5.3). However, to ensure safety, avoid using bilongen during pregnancy.
breastfeeding women: There has been no research on whether bilastine viewers whether or not they are exported to breast milk or not. The existing pharmacokinetic data on animals shows that bilastine is exported into milk. In fact, it is necessary to decide to continue/stop breastfeeding or continue/stop using bilongen based on the correlation between the benefits of breastfeeding for babies and mothers' benefits when using bilastine.
Act on fertility: There is no or very little clinical evidence. A mouse study showed no negative impact on reproductive function.
The effect of the drug on driving and operating machinery
A study conducted to assess the impact of bilastine on the ability to driving has shown that the use of doses does not affect the ability to drive. However, patients need to be notified that there are some rare cases that can see drowsiness and affect the ability to operate train machinery.
Drug interaction
The studies on drug interaction are only done in adults and are summarized below:
Interaction with food
Food can reduce the oral bioavailability of Bilastine tablets about 30% and reduce the oral bioavailability of the scattered bilastine tablet in the mouth is about 20%.
Interaction with beam grapefruit juice: Drinking Bilastine 20 mg with grapefruit juice reduces the bioavailability of the drug by 30%. This phenomenon can occur with other juice. The degree of fertility can fluctuate between preparations and different fruits. The mechanism of this interaction is through the inhibition of OATP1A2, a bilastine transportation from the digestive tract into the bloodstream. The drugs are OatP1A2 substrates or inhibitors like ritonavir or rifampicin may reduce bilastine levels in plasma.
Interact with ketoconazole or erythromycin: Take bilastine 20mg simultaneously and ketoconazole 400mg once a day or erythromycin 500mg 3 times/day can increase the AUC of bilastine 2 times, increase CMAX 2-3 times. This can be explained by interacting with the transportation of the drug back to the gastrointestinal tract, because Bilastine is the substrate of P-GP and is not metabolized.
These changes may not affect the safety level of bilastine as well as ketoconazole or erythromycin. Other drugs are also substrates or p-GP inhibitors, such as cyclosporine, which is also at risk of increasing bilastine plasma concentrations.
Interaction with Diltiazem
Take Bilastine 20 mg simultaneously and diltiazem 60 mg once a day, increasing the CMAX concentration of bilastine to 50%. This can be explained by interacting with the transportation of the drug back to the gastrointestinal tract, and may not affect the safety level of bilastine.
Interaction with alcohol
Mental state movement after drinking simultaneously alcohol and 20 mg of bilastine 1 time/day similar to the results recorded after drinking simultaneously alcohol and placebo.
Interaction with Lorazepam
Take Bilastine at the same time 20 mg/day and Lorazepam 3 mg once a day for 8 days does not increase the effect on the central nervous system of Lorazepam.
Group of children's patients
There is no study on drug interaction conducted on children using bilastine pellets dispersed in the mouth. Because there is no clinical experience in bilastine interaction with other drugs, food or juice in children, the results of interactive studies on adults are also considered when prescribing bilastine drugs for children. There is no clinical data in children showing changes in AUC and C ... due to interactions affecting the safety of bilastine.
This drug contains less than 1 mmol sodium (23mg)/tablet, which is basically "no sodium".
Storage
Leave a cool place, avoid light, temperature below 30⁰C.
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