Bilazin 20 Stella Treatment Treatment of allergic rhinitis, urticaria (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Bilastine
Ingredient LD Stellapharm Company Limited

Ingredient

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Composition information	Content
Bilastine	20mg

Uses

indications

Bilazin 20 drugs are indicated for treating symptoms in the case of allergic rhinitis (year -round or seasonal) and urticaria.

Pharmacokology

Pharmacological group: Antihistamine other anti -healing drugs.

ATC code: R06AX29.

bilastine is a antagonist antagonist that does not cause drowsiness, prolonged effect, selective antagonistic on peripheral H1 receptor and has no affinity for Muscarinic receptors. Bilastine inhibits the rashes, rash on the skin due to 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 20mg, used once a day within 14-28 days, which is effective in reducing symptoms such as sneezing, runny nose, stuffy nose, tearing and red eyes. Bilastine effectively controls symptoms within 24 hours.

In two clinical trials performed in patients with chronic primary urticaria, bilastine 20mg, 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, all day 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 control clinical trials, when using the recommended dose is 20 mg x 1 time/day, data on safety on the central nervous system of Bilastine is equivalent to the placebo and the rate of recording drowsiness 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 old) was selected in phase and phase III studies, the results showed no difference in efficiency as well as safety when compared to the younger patient group.

Dynamic pharmacokinetics

absorption

Bilastine is absorbed quickly after drinking and reaching the maximum plasma concentration after about 1.3 hours. The drug is not accumulated. Bilastine's average oral biosling value is 619.

distribution

Intro and in vivo research shows that Bilastine is a substrate of P-GP and Oatp's substrate. Bilastine is not the substrate of BCRP transport agents or transport agents at OCT2, Oati 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, 8SEP, OATP1B1, OATP1B3, OATP2B1, OAT3, OAT3, OAT1, GCT2 and NTCP, because only low inhibitor is recorded with P-GP, OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 and OATP2B1 IC50 value is estimated at> 300 µm, much higher than the maximum concentration estimated in CMAX plasma. Therefore, these interactions do not have much clinical effect. However, according to these studies, it is not possible to exclude the inhibitory effect of bilastine on the transportation on the intestinal mucosa.

In the treatment dose, rules associated with plasma proteins of the drug are 84 - 90%.

transformation

Results of In vitro studies show that bilastine is not touched or inhibited activity of CYP450.

Elimination

In a blocking study study, conducted on a healthy volunteer, after taking a single dose of 20 mg 14C-Bilastine, almost 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 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 impairment, the average value (SD) AUC0 -∞ increased from 737.4 (± 260.8) ng hour/ml on normal kidney function patients (glomerular filtration:> 80 ml/min/1.73 m2) to 967.4 (± 140.2) ng o'clock/ml on patients with mild kidney impairment (glomerular filtration: 50 - minute/minute/minute/minute 1384.2 (± 263.23) ng hour/ml on patients with average renal failure (glomerular filtration: 30 -

Patients with liver failure

There is no dynamic data on liver failure patients. In humans, bilastine is not metabolized. As the results in the studies in patients with renal impairment show that the excretion of the kidney is the main sugar, 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.

Elderly

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

Before taking Bilazin 20 Stella Treatment Treatment of allergic rhinitis, urticaria (2 blisters x 10 tablets)

How to use

bilazin 20 is used by pipes. Used for adults and children over 12 years old.

Dosage

Dosage recommended:

Dosage 20 mg (1 tablet) x 1 time/day to treat allergic rhinitis (regular or seasonal) and urticaria.

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

Dosage in case of treatment:

Elderly: No need to adjust the dose on the elderly, there is not much evidence of the use of drugs in patients over 65 years old. Children under 12 years of age: 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 adjustments on patients with renal impairment.

Patients with liver failure: There is no clinical data on drug use in patients with hepatic impairment. Because bilastine does not metabolize through the liver but mainly eliminates through the kidneys, the liver failure may not cause the drug concentration in the sample to exceed the safety limit. Therefore, there is no need to adjust the dose on patients with liver failure.

Length of treatment: In the treatment of allergic rhinitis, the treatment is limited to the period of exposure to the allergic factor. Specifically, in the treatment of seasonal allergic rhinitis, the drug may stop when the symptoms are gone and use again 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 urticaria, time and development of symptoms.

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? After using bilastine at a dose of 10 to 11 times higher than the treatment (220mg (single dose); or 200 mg/day for 7 days), the frequency of unwanted 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.

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 extends the corrected QT value.

In case of overdose, symptomatic treatment and supportive treatment should be applied.

There is no specific antagonistic drug for bilastine.

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

When using Bilazin 20, you may experience unwanted effects (ADR) such as:

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

The adverse reactions of the drug (ADRS) are usually recorded in patients using Bilastine 20mg in phase clinical trial II and Phase III 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.

The frequency is recorded as follows:

Very popular (≥ 1/10).

Popular (≥ 1/100 and

Agency/frequency system Understanding reaction

bilastine 20 mg

n = 1697

all bilastine doses

n = 2525

placebo

n = 1362

Infection and parasitic infection

Unsatisfactory (0.0%)

Metabolic and nutrition disorders > Psychological disorders

uncompleted Anxiety 6 (0.35%) 8 (0.32%) 0 (0.0%)

insomnia 2 (0.12%) (0.16%) 0 (0.0%) 2 (0.08%) 0 (0.0%) Dizziness 3 (0.18%) 3 (0.12%)

0 (0.0%) Tim

Unsatisfactory Block the right branch 4 (0.24%) 5 (0.20%) 3 (0.22%)

Sinus arrhythmia 5 (0.30%) (0.20%) 1 (0.07%) (0.410%) 11 (0.44%) 2 (0.15%) (3.25%)

39 (2.86%) (0.83%)

23 (0.91%) 8 (0.59%) Unsatisfactory Disgusting breathing 2 (0.12%) 2 (0.08%) 0 (0.0%) (0.08%) 0 (0.0%)

Dry nose 3 (0.18%) 6 (0.24%) 4 (0.29%)

Digestive disorders Variable abdominal pain 11 (0.65%) 14 (0.55%) 6 (0.44%) (0.29%)

nausea 7 (0.41%) 10 (0.40%) 14 (1.03%) (0.0%)

diarrhea 4 (0.24%) 6 (0.24%) 3 (0.22%) (0.24%) 5 (0.37%) (0.16%) 0 (0.0%) (0.15%) General disorder (0.18%) 4 (0.16%) 1 (0.07%) (0.12%) 3 (0.12%) 1 (0.07%) Experiment

Unsatisfactory

Gamma - Gamma - GammaSFerase 7 (0.41%) 8 (0.32%) 15%) increase Alanine AminotransFerase (0.30%) 5 (0.20%) 3 (0.22%) Creatinine in the blood 2 (0.12%) 2 (0.08%) 0 (0.0%) (0.22%)

weight gain 8 (0.47%) 12 (0.48%) 2 (0.1%)

When ADR occurs with the above manifestations, it can be treated as cases of overdose symptoms (see overdose and treatment).

Warnings

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

contraindicated

Bilazin 20 drugs contraindicated in the following cases:

Contraindicated for patients with hypersensitivity to bilastine or any excipient in the preparation.

Be cautious when using

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

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 ketoconazole, erythromycin, cyclosporine, ritonavir or diltiazem may increase blastine 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.

Bilazin 20 contains lactose excipients. This drug should not be used for patients with rare genetic problems galactose intolerance, total lactase enzyme deficiency or poorly absorbed glucose-galactose.

The effect of the drug on driving and operating machinery

A study conducted to evaluate the impact of bilastine on the ability to drive 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.

Use drugs for women during pregnancy and lactation

Pregnant women

No or very little data on the use of 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 women

Information about Bilastine's ability to exit breast milk is not well known.

This feature has not been studied on animals. In fact, it is necessary to decide to continue/stop breastfeeding or continue/stop using bilastine based on the correlation between the benefits of breastfeeding for babies and mothers' benefits when using bilastine.

Interactive drug

Interaction of drugs

Interacting with food: Food can reduce the biochemical bioavailability of bilastine by about 30%.

Interaction with grapefruit juice: Drinking Bilastine 20mg 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 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 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 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 cyclosprorine, which are also at risk of increasing bilastine plasma concentrations.

Interact with Diltiazem: Take Bilastine 20mg simultaneously and 60mg diltiazem increases Bilastine's CMAX concentration 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: Psychiatric psychiatric work after drinking simultaneously alcohol and 20mg of bilastine similar to the results recorded after drinking simultaneously alcohol and placebo.

Interact with Lorazepam: Take Bilastine 20mg 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, temperatures below 30⁰C.

To be out of reach of children, read the instructions carefully before use.

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