Bilongen 20mg Menarini medicine for allergic rhinitis, urticaria (1 blister x 10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications Bilastine
Ingredient Allergic rhinitis, urticaria, food allergies, rashes

Ingredient

Composition informationContent
Bilastine20mg

Uses

Indications

The effect of Bilaxten 20mg is indicated for symptomatic treatment in case of allergic rhinitis (year -round or seasonal) and urticaria.

Pharmacokology

Pharmacological group: antihistamine drugs using systemic sugar, other antihistamine drugs using systemic sugar.

ATC code is Ronax 29.

Bilastine is a non -drowsy antihistamine, has a long -lasting effect, selectively antagonistic on peripheral H1 receptor and has no affinity to the Muscarinic receptor.

bilastine inhibits the rashes, rash on the skin by histamine within 24 hours after using a single dose.

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, stuffy nose, tearing and redness.

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 adjustment range of qt or unwanted effects on the heart recorded in bilastine clinical trials, even at a dose of 200 mg daily (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 (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 through a standard driving test.

Elderly:

  • Elderly (> 65 years old) were selected in phase II and Phase III research, the results showed that there was no difference in efficiency as well as safety when compared to the younger group of patients.
  • In clinical development studies on teenagers (from 12 to 17 years old), including 128 teenagers using bilastine in clinical studies (81 people participating in blind research, allergic rhinitis). 116 other teenagers were randomly selected to use drugs or placebo, showing no difference in effectiveness and safety between adults and young people. Learning

    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 biological value of bassline is 61%.

    Distribution

    In vitro and in vivo research shows that Bilastine is a substrate of P - GP and CATP's substrate. Bilastine is not the substrate of BCRP transport agents or transport agents at OCT2, OAT1 and OAT3 kidneys. According to In vitro studies, Bilastine is not expected to inhibit the transportation in the whole system, including: P - GP, MRP2, BCRP, BSEP, OATP1B1, CATP1B3, OATP2B1, OAT1, CAT3, OCT1, OCT2, and NTCP, because only low inhibitor recorded with P - GP, OATP2B1 and OCT1, with OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 ICSO value is estimated at> 300 mm, much higher than the maximum concentration of estimated plasma in CMAX plasma. Therefore, these interactions do not have much clinical influence.

    However, according to these studies, it is impossible to eliminate the inhibitory effect of bilastine on the transportation on the intestinal mucosa.

    In 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 equilibrium conducted on a healthy volunteer, after taking a single dose of 20 mg 14C - Bilastine, almost 95%of the dose is found in urine (28.3%) and feces (66.5%) in the form of unchanged blastine.

    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 within the study dose range (5 to 220 mg), with a small level of oscillation between individuals.

    Patients with renal failure

    In a study in patients with renal failure, the average value (SD) of AUC0 increased from 737.4 (+ 260.8) ng 1 hour/ml on normal kidney function patients (glomerular filtration:> 80 ml/min/1.73 m2) to 967.4 (+ 140.2) ng 1 hour/ml on mild kidney impairment patients (glomerular filtration: 50 - 80 mL), 1384.2) 263,23) ng 1 hour/ml on medium renal failure patients (glomerular filtration 30 - 50 ml/min/1.73 m2), and 1708.5 (+ 699.0) ng x hours/ml on patients with severe renal impairment (glomerular filtration:

    The average value (SD) of bilastine's disposal time is 9.3 h (+ 2.8) in normal patients, 15.1 h (+ 7.7) on mild renal impairment patients, 10.5 h (+ 2.3) in patients with average renal insufficiency and 18.4 h (+ 11,4) in patients with severe renal impairment. 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 the plasma drug concentration in the case of patients with renal failure 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 research on patients with renal impairment, the excretion of the kidneys is the main elimination line, the process of the exit through one contributes only a very small contribution to the excretion of bilastine. The change of liver function may not significantly change the pharmacokinetics of bilastine clinically.

    Elderly

    There are very little pharmacokinetic data in people over 65 years old. There is no statistical significance noted between Bilastine's pharmacokinetic properties in the elderly and on young people.

    Children

    There is no pharmacokinetic data in teenagers (from 12-17 years old) because it can be extracted from adult data.

    • Before taking Bilongen 20mg Menarini medicine for allergic rhinitis, urticaria (1 blister x 10 tablets)

    How to use

    Bilaxten recommends oral. Should take the entire dose 1 time a day, at 1 hour before or 2 hours after eating.

    Dosage

    Used for adults and children over 12 years old

    Dosage 20 mg (1 tablet) once a day to treat allergic rhinitis (regular or seasonal) and urticaria.

    Need to take bilongenic medicine at 1 hour ago or 2 hours after eating. Should take the entire dose in 1 single day.

    Elderly: No need to adjust the dose on the elderly.

    Children: Inexperienced in using bilastine for children from 0 - 2 years old for allergic and urticaria indications. Information about the safety and effectiveness of bilastine in children under 12 years old has not been fully studied.

    Patients with renal failure: No dose adjustment on patients with renal failure.

    Patients with hepatic impairment: There is no clinical data on the use of bilaxten 20mg in patients with liver failure. Because bilastine does not metabolize through the liver but mainly eliminates the kidneys, 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 on the patient.

    Treatment length

    In the treatment of allergic rhinitis, the treatment is limited to the time of exposure to the allergic factor. Specifically, in the treatment of seasonal allergic rhinitis, bilongenic medicine may stop 20mg when the symptoms are gone and reuse when symptoms rise again. In the treatment of allergic rhinitis all year round, bilaxten should be used continuously during exposure to allergens.

    in urticaria treatment. Treatment time depends on the urticaria, time and development of symptoms.

    What to do when overdose? 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 unwanted reactions on volunteers is 2 times higher than the placebo.

    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 in 30 healthy volunteers to assess the impact of the repeated dosage bilastine (100 mg 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.

    What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

    Side Effects

    When using Bilaxten 20mg, you may experience unwanted effects (ADR).

    Summary of safety characteristics

    In clinical trials, the number of unwanted effects encountered in patients with allergic rhinitis or chronic primary urticaria is treated with Bilastine 20 mg similar to the number recorded in patients using placebo (12.7% compared to 12.8%).

    Clinical and phase III clinical trials are conducted during clinical development on 2525 patients treated with Bilastine's father, including 1697 patients using list = 2 ng. In these tests, 1362 patients use placebo. The adverse reactions of the drug (ADRS) are usually recorded in patients using Bilastine 20 mg to treat allergic rhinitis and chronic spontaneous urticaritis: headache, drowsiness, dizziness and fatigue. These reactions appear at the same frequency as the recorded frequency in patients using placebo.

    The adverse reaction summary table of the drug

    The at least adverse reactions may be related to bilastine and are reported in more than 0.1% of patients using Bilastine 20 mg during the clinical development of the drug classified below.

    The frequency of records is as follows:

  • Very popular (≥ 1/10).
  • Popular (≥ 1/100 to Description of adverse reactions

    The most common adverse reports are two common reactions (drowsiness, headache) and two non -common reactions (dizziness and fatigue). 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 the placebo 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.

    Children

    During the clinical development period, the frequency, type and severity of adverse reactions in teenagers (from 12 to 17 years old) are similar to adults. The information collected (from teenagers) from after -sales data has confirmed the safety characteristics of observed in clinical development studies.

    • Warnings

    Contraindicated

    Bilaxten 20 mg is contraindicated for patients with hypersensitivity to bilastine or any excipient ingredients in the preparation.

    Precautions when using

    Children

    Information about the effectiveness and safety of bilastine in children under 12 years old has not been fully studied.

    In patients with severe or medium renal failure, simultaneous use of bilastine with glycoprotein inhibitors such as ketoconazol, erythromycin, cyclosporin, ritonavirin or diltiazem may increase bilastine levels in plasma, thus increasing the risk of adverse reactions. Therefore, it is necessary to avoid using Glycoprotein P in patients with severe or medium renal failure.

    The ability to drive and operate machinery

    A study conducted to evaluate the impact of bilastine on the ability to driving has shown that the use of 20mg dose 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.

    Pregnancy

    without or very little data on using bilastine in pregnant women.

    Animal research does not show directly or indirectly harmful effects on fetal fertility, fetal and postpartum development. However, to ensure safety, avoid using bilastine during pregnancy.

    Breastfeeding period

    No research conducted on viewers whether bilastine has been 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 to stop using bilongen based on the correlation between the benefits of breastfeeding for babies and mothers' benefits when using bilastine.

    Medicinal interaction

    Interaction with food: Food can reduce Bilastine's oral bioavailability by about 30%.

    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 juices. The degree of fertility can fluctuate between preparations and different fruits. The mechanism of this interaction is through ATP 1A2 inhibitors, 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.

    Interaction with ketoconazole or erythromycin: Take bilastine and ketoconazole or Erythromycin can increase the AUC of bilastine 2 times, increasing CMAX 2-3 times. This can be explained by interacting with the transport substances to bring 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 inhibitors P - GP, such as cyclosporine, are also at risk of increasing bilastine plasma concentrations.

    Interact with diltiazem: Take Bilastine 20 mg simultaneously and 60 mg diltiazem increases the C concentration of bilastine to 50%. This can be explained by interacting with the transportation to bring the drug back to the gastrointestinal tract, and may not affect the safety level of bilastine.

    Interaction with alcohol: Mental mental state after drinking simultaneously alcohol and 20 mg of bilastine similar to the results recorded after drinking simultaneously alcohol and placebo.

    Interact with Lorazepam: Take Bilastine 20 mg and Lorazepam 3 mg in 8 days without increasing the effect on the central nervous system of Lorazepam.

    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.

    count views

    Popular Keywords