Menida 20mg Merap medicine for allergic rhinitis (2 blisters x 10 tablets)
Dosage form Box of 2 blisters x 10 tablets
Specifications Bilastine
Ingredient
| Composition information | Content |
| Bilastine | 20mg |
Uses
Indications
Menida anti -allergy drugs are indicated for symptomatic treatment in case of allergic rhinitis (year -round or seasonal) and urticaria. The drug is indicated for adults and children ≥ 12 years old.
Pharmacokinus
Therapy Pharmacology Group: antihistamine antihistamine Using systemic sugars, other antihistamines using systemic sugars
ATC code: R06AX29
Mechanism of action
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 itchy, rash on the skin due to histamine within 24 hours after using a single dose.
Clinical efficiency and safety
In clinical trials performed on adults and adolescents with allergic rhinitis (seasonal or year -round), using Bilastine 20 mg, 1 time/day for 14-28 days, which is effective in reducing symptoms such as sneezing, runny nose, stuffy nose, tears, tears and red eyes. Bilastine effectively controls symptoms within 24 hours.
In two clinical trials conducted in patients with chronic primary urticaria, taking Bilastine 20 mg, 1 time/day for 28 days has proven the effectiveness reduces the level of itching and reduces the number and size of lumpy traces as well as the discomfort of the patient due to urticaria. Patients improve sleep quality and quality of life.
There is no case that extends the adjustment range of qt or any unwanted effect on the heart recorded in bilastine clinical trials, even at a dose of 200 mg per day (10 times the treatment dose) within 7 days in 9 patients, or even when combined with P-GP inhibitors, such as Ketoconazole (24 patients) and Erythromycin (24 patients). In addition, a careful monitoring of the QT interval has also been conducted over 30 volunteers.
In control clinical trials, when using the recommended dose is 20 mg once a 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 false. 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 evaluated through a standard driving test.
The results obtained in the elderly (≥ 65 years old) were selected in phase II and Phase III research showed that there was no difference in efficiency and safety when compared to the younger group of patients. A study after circulating in 146 elderly patients showed no difference in safety records for adult adults.
Children
128 adolescents (12 - 17 years old) are used bilastine in clinical research showing no differences in efficiency and safety between adults and adolescents.
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 oral average value is 61%.
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, OAT1 and OAT3 kidneys. According to In vitro studies, Bilastine is expected to not inhibit shipping in the whole system, including: P-GP, MRP2, BCRP, BSEP, OATP1B1, OATP1B3, OATP2B1, OAT1, OAT3, OCT1, OCT2, and NTCP, because only low inhibitory levels are 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, 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 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.
Special subjects
Patients with renal failure: In a study in patients with renal impairment, the average value (± sd) of AUC0 -∞ increased from 737.4 (± 260.8) of the hour/ml in normal kidney function patients (glomerular filtration:> 80 ml/min/1.73 m2) to 967.4 (± 140.2) ng x hours/ml in mild kidney failure (mild dialy m2); 1384.2 (± 263.23) ng hour/ml in patients with medium renal failure (glomerular filtration: 30 - The process of urine output is almost completed after 48 - 72 hours on all subjects. These pharmacokinetic changes do not show clinically the clinical impact to 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 the studies in patients with renal impairment, the excretion of the kidneys 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 is expected to significantly change the pharmacokinetics of bilastine clinically.
Elderly: There is very little data on the use of drugs for people over 65 years old. There is no statistical significant difference noted between Bilastine's pharmacokinetic characteristics in the elderly and adults aged 18 - 35 years old.
Children: No pharmacokinetic data in adolescents (12 - 17 years old) because of extrapolation data from adult data is considered suitable for Bilastine 20 mg.
Before taking Menida 20mg Merap medicine for allergic rhinitis (2 blisters x 10 tablets)
How to use
Anti -allergy drugs Menida are used orally. Take medicine at hunger, 1 hour before or 2 hours after eating food or drinking juice.
The drug is taken with water, should take the entire doses once a day.
Dosage
recommended dose:
Adults and children over 12 years: a dose of 20 mg (1 tablet) once a day to treat allergic rhinitis symptoms (year -round or seasonal) and urticaria.
Treatment time:
In the treatment of allergic rhinitis, treatment should be limited to the time of exposure to allergic factors. For seasonal allergic rhinitis, the drug may stop when the symptoms are gone and continue to use when the symptoms rise again. For 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:
Elderly: No need to adjust the dose in the elderly.
Patients with renal failure: The studies conducted in adult groups are at risk (functional impaired patients) show that it is not necessary to adjust the dose on patients with renal impairment.
Patients with liver failure: There is no clinical data on drug use in patients with hepatic impairment. However, because bilastine is not metabolized and eliminated in the form of unchanged urine and feces, the hepatic failure is expected not to increase the concentration of drugs in the blood to exceed the safety limit in adult patients. Therefore, there is no need to adjust the dose in adult patients with liver failure.
Children under 12 years of age: Information about the safety and effectiveness of bilastine in children under 12 years of age has not been fully studied.
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 is the overdose when overdose? In clinical trials, 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) on 26 healthy volunteers, the frequency of unwanted effects 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 in supervision after circulation is in accordance with the report 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.
There is no overdose data in children. In case of overdose, it is necessary to apply symptomatic and supportive treatments.
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
When using Menida anti -allergy drugs often have unwanted effects (ADR) such as:
Summary of safety data records in adults and adolescents (12 - 17 years old)
In clinical trials in adults and adolescents, 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%).
The unwanted effects of the drug (ADRS) are often recorded in patients with allergic rhinitis or chronic primary urticaremia using Bilastine 20 mg in phase clinical trial II and phase III is headache, drowsiness, dizziness and fatigue. These reactions appear at the same frequency recorded on patients using placebo.
Summary of unwanted effects in adults and adolescents
Unwanted effects are at least bilastine and reported on more than 0.1% of patients using Bilastine 20 mg in the clinical development of the drug (1697 patients) classified below:
The frequency of records is as follows: Very common (≥1/10); Common (≥1/100 and
Rare, very rare and unknown reactions are not recorded in the table.
Infections and parasites:
Mental disorders:
Nervous system disorders:
Heart disorders:
Digestive disorders:
Skin and soft tissue disorders:
General disorder:
Testing indicators:
Details of some unwanted effects to be selected in adults and adolescents
Sleep, headache, dizziness and fatigue are recorded in patients treated with bilastine 20 mg or placebo. The reported frequency is 3.06% compared to 2.86% of drowsiness; 4.01% compared to 3.38% of cases of headache; 0.83% compared to 0.59% of cases of dizziness and 0.83% compared to 1.32% of fatigue.
Information collected during the circulation of Bilastine has confirmed the safety record data in the clinical development process Bilastine.
Notice immediately to the doctor or pharmacist the harmful reactions encountered when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
anti -allergic drugs Menida contraindicated in the following cases:
Caution when using
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 impairment, simultaneous use of bilastine with glycoprotein inhibitors such as ketoconazole, erythromycin, cyclosporine, ritonavir or diltiazem may increase bilastine levels in plasma, thus increasing the risk of irregular effects of bilastine. Therefore, it is important to avoid using bilastine and glycoprotein p inhibitors on patients with severe or medium renal failure.
The effect of the drug on the ability to drive and operate machinery
A study conducted in adults to assess the impact of bilastine on the ability to drive has shown that the use of 20 mg dose does not affect driving capabilities. However, because the reaction of each individual for the drug may vary, patients need to check the effects of the drug on themselves before driving or using 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 direct or indirect effects on fetal fertility, fetal development and postpartum. However, to ensure safety, avoid using bilastine during pregnancy.
breastfeeding women
Information about Bilastine's ability to exit breast milk is not well known. Animal pharmacokinetic data shows bilastine's output in breast milk. In fact, the decision to continue/stop breastfeeding or continue/stop using bilastine must be based on the correlation between the benefits of breastfeeding for babies and mothers' benefits when using bilastine.
Drug interaction
Medicine interactive studies are only done in adults and are summarized below:
Interacting with food: Food can reduce the biochemical bioavailability of bilastine 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 OatP1A2 inhibitors, an absorbent transportation that bilastine is the substrate. The drugs are OatP1A2 substrates or inhibitors like ritonavir or rifampicin may reduce bilastine levels in plasma.
Interact with ketoconazole or erythromycin: Take bilastine simultaneously (20 mg, 1 time/day) with ketoconazole (400 mg, 1 time/day) or erythromycin (500 mg, 3 times/day) can increase the AUC of bilastine 2 times and 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 do not seem to affect the safety level of bilastine as well as ketoconazole or erythromycin. Other drugs are P-GP inhibitors or inhibitors, such as cyclosporine, which are also at risk of increasing bilastine plasma concentrations.
Interact with Diltiazem: Take Bilastine 20 mg simultaneously and Diltiazem 60 mg, 1 time/day, increasing 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 does not seem to affect the safety level of bilastine.
Interaction with alcohol: Mental mental state after drinking simultaneously alcohol and 20 mg of bilastine, 1 time/day, similar to the results recorded after drinking simultaneously alcohol and fake.
Interact with Lorazepam: Take Bilastine 20 mg simultaneously and Lorazepam 3 mg, 1 time/day, for 8 days does not increase the effect on the central nervous system of Lorazepam.
Children
Interactive research is only done in adults. Because no clinical data in bilastine's interaction with medicines, food or fruit juice, interactive research data in adults is considered to prescribe drugs for children. No clinical data in children indicates whether AUC or CMAX changes due to interactions affect the safety level of bilastine.
Storage
Store at temperatures below 30 degrees C.
Other drugs
- ALLEGRON TABLETS 10MG
- APRINOX TABLETS 5MG
- ACICLOVIR CREAM 5%
- Daxas
- IMUNOVIR 500MG TABLETS
- PANADOL NIGHT
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.
Popular Keywords
- metformin obat apa
- alahan panjang
- glimepiride obat apa
- takikardia adalah
- erau ernie
- pradiabetes
- besar88
- atrofi adalah
- kutu anjing
- trakeostomi
- mayzent pi
- enbrel auto injector not working
- enbrel interactions
- lenvima life expectancy
- leqvio pi
- what is lenvima
- lenvima pi
- empagliflozin-linagliptin
- encourage foundation for enbrel
- qulipta drug interactions