Pollezin 5mg Egis medicine supports the treatment of allergic rhinitis, urticaria (14 tablets)
Dosage form Film bag tablets
Specifications Box of 2 blisters x 7 tablets
Ingredient Levocetirizine
Ingredient
| Composition information | Content |
| Levocetirizine | 5mg |
Uses
indications
Pollezin drug indicated in cases of treatment of allergic disorders, active ingredients Levocetirizing of the drug is a drug in the group of receptor inhibitors H1.
For adults and children over 6 years old, this drug is used to treat symptoms (sneezing, runny nose, stuffy nose, eye and skin symptoms) of the following allergies:
Mechanism of action
levocetirizine, the same fate (R) of Cetirizine, is a strong and selective antagonistic drug of peripheral H1 receptor.
Combined studies show that levocetirizine has a high affinity for the H1 receptor (ki = 3.2 mmol/l). Levocetirizine has 2 times more affinity than Cetirizine (KI - 6.3 mmol/l). Levocetirizine dissociates from H1 receptors with a selling time of 115 + 38 minutes. After the single dose, Levocetirizine accounts for 90% of the receptor after 4 hours and 57% after 24 hours.
Mobile pharmacokinetic studies in healthy Nguyen loves prove that at only half a dose, levocetirizine has the same activity as Cetirizine, both in the skin and nose.
Pharmaceutical effect
Levocetirizine's pharmacological pharmacology has been studied in controlled random trials.
An effective comparative study of levocetirizine 5 mg, desloratadine 5 mg with placebo on allergens caused by histamine shows that levocetirizine treatment significantly reduces allergens, the best effect in the first 12 hours and lasts for 24 hours (P An hour after taking the medication, Levocetirizine 5 mg begins to show the effect of controlling allergens caused by pollen in placebo -controlled studies with an amenazing test chamber model.
In Vitro studies (Boyden cell and chamber techniques) show that levocetirizine inhibits Eosin, which loves EOSIN caused by Lotaxin moving through endothelial tissue through both skin and lung cells. A pharmacological testing test in vivo shows three main inhibited effects of Levocetirizine 5 mg in the first 6 hours to control the reaction caused by pollen, compared to the placebo in 14 adult patients including: inhibitors of VCAM-1 launch (Vascular cell adhesion molecule-1), regulating vascular permeability and reducing Eosin eucalyptus.
Safety and clinical effectiveness
The effectiveness and safety of levocetirizine has been shown in some of the place where the mesame clinical clinical trials are performed in patients with adults with seasonal allergic rhinitis or year -round allergic rhinitis. Levocetirizine has been shown to significantly improve the symptoms of allergic rhinitis including nasal congestion in some studies.A 6 -month clinical study in 551 adult patients (including 276 patients treated with levocetirizine) suffered from persistent allergic rhinitis (symptoms that appear at least 4 days a week for at least 4 consecutive weeks and sensitive to dust and pollen has proven that levocetirizine 5 mg has a significantly stronger effect on the overall nasal symptoms during the time of nose and nose during the time during the time of nose. Save, do not have any fast immune response.
During the entire research time, levocetirizine significantly improves the quality of life of patients related to health issues. In a placebo clinical clinical trial, there are 166 patients with chronic spontaneous urticaria, 85 patients were given placebo and 81 patients treated with levocetirizine 5 mg once a day for six weeks.
Levocetirizine treatment significantly reduces the level of itching in the first week and in the treatment process compared to placebo. Compared to the placebo, Levocetirizine also significantly improves the quality of life related to health according to the evaluation of the quality of life related to dermatology.The chronic spontaneous urticaria has been studied as a model for urticaria. Because histamine release is a cause of urticaria, levocetirizine is thought to be effective in treating symptoms of other urticaria, in addition to chronic spontaneous urticaria.
Electrical electrocardiogram does not show the relevant effects of levocetirizine on the QT range.
pharmacokinetics
pharmacokinetics of levocetirizine are linear, less changing with individuals. The same pharmacokinetic properties when using Levocetirizine isomers and using Racemic Cetirizine mixture. There is no reversal between optical substances during absorption and elimination.
absorption
levocetirizine is absorbed quickly and after drinking. The peak concentration in plasma is achieved after taking 0.9 hours. Stable state achieved after 2 days.
The peak concentration in the serum corresponds to 270 ng/ml and 308 ng/ml after taking the single dose and the dose repeats 5mg. The level of absorption does not depend on the dose and is not affected by food but the peak concentration in the serum is reduced and the time of reaching the peak concentration is longer.
Distribution
There is no data and drug distribution in human tissue as well as the ability to pass the bloody barrier of levocetirizine. In rats and dogs, the highest level of drug in the liver and kidneys, the lowest in the central nerve cavity.
There are 90% levocetirizine attached to plasma proteins. The distribution of levocetirizine is limited because the distribution volume is 0.4 liters/kg.
Metabolism
The level of metabolism of levocetirizine in humans is 14% of the dose and therefore, the differences due to polymorphism in genetics or use in combination with enzyme inhibitors are not significant. Oxidation pathway in aromatic nucleus, reducing Alkyl N-and O- and conjugated with taurine. The alkyl road is mainly thanks to the catalyst of CYP3A4, while the oxidation in the aromatic nucleus is related to a variety of CYP and/or CYP 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 at concentrations far beyond the peak concentration after drinking the dose of 5mg.
Due to the little metabolic and no metabolic inhibitor, there is no interaction of levocetirizine to other drugs or vice versa.
Elimination
Semi -selling time in adult plasma is 7.9 ± 19 hours. The average clearance in the body is 0.63 ml/min/kg. The main excretion of levocetirizine and metabolites are through water, accounting for about 85.4% of the dose. Eliminating medication in feces only accounts for about 12.9% of the dose. Levocetirizine is eliminated through glomerular filtration and actively eliminated through the renal tubules.
Before taking Pollezin 5mg Egis medicine supports the treatment of allergic rhinitis, urticaria (14 tablets)
How to use
The drug is used by oral, patients need to swallow the tablet with a small amount of drinking water, can be used or not with the same food. Should take medicine once a day.
Dosage
always use this medication as described in the instruction sheet or the doctor has instructed you. Consult your doctor or pharmacist if you are not sure about how to take the drug.
The drug needs to be swallowed whole tablets with drinking water, can be used with or not with food.
Treatment time depends on the type, prolonged time of symptoms. For seasonal allergies, the treatment time is usually 3 - 6 weeks.
recommended dose is as follows:
Adults and children over 12 years old: 1 film tablet 5 mg, 1 time.
Children 6 - 12 years old: 1 film tablet 5 mg, 1 time.
For children 2 - 6 years old: It is not recommended to use this drug due to not guaranteeing the appropriate dose. You should use a levocetirzine preparation for children. Do not use levocetirizine for babies and children under 2 years old.
The elderly: The dose should be adjusted for the elderly to be impaired kidney function at an average or severe level.
Patients with renal failure
Patients with renal failure may be used for lower doses depending on the severity of the kidney disease. In children, the dose is also selected based on the child's weight. The dose mode will be determined by your doctor.
The distance between drug use needs to be determined for each individual, though renal function. Refer to the following table to adjust the dose as instructed. To use this table, the patient's creatinine clearance is estimated (CLCR) is calculated by ml/min. CLCR (ml/min) can be determined from serum creatinine levels (mg/dl) according to the following formula:
CLCR = [140 - Age (year)] x The weight (kg)/72 x Creatine serum (mg/dl) (x 0.85 for women)
Adjust the dose for patients with renal function impairment
Contraindications
Children with renal failure
Dosage must be adjusted for each patient based on kidney clearance and body weight. There is no specific dose data for children with renal failure.
Patients with liver failure
Patients who only have liver failure should take the usual dose.
Patients with impaired liver and kidney function may be given lower doses depending on the severity of the kidney disease. Children, the dose is also chosen based on the weight of children. The dose mode will be determined by your doctor.
No dose adjustment for the elderly if their kidney function is normal.
Treatment time
Non -persistent allergic rhinitis
In the case of persistent allergic rhinitis (symptoms> 4 days/ week or lasting for more than 4 weeks), patients should continue treatment during exposure to allergens. Levocetirizine has been used in clinical for 6 months.
For chronic urticaria and chronic allergic rhinitis, Racemic Cetirizine isomers have been used in clinically used for a year.
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 do
do when overdose? Overdose can cause drowsiness in adults. In children, at first, the four places later were sleepy.
If you have used Pollezin tablets at a higher dose than the recommended dose, notify your doctor. The doctor will decide what to do next.
There is no specific antidote to levocetirizine. If overdose occurs, symptomatic treatment and supportive treatment. Gastric lavage may be considered if you have just used an overdose. The method of hemolysis does not help eliminate levocetirizine.
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
Like other drugs, this drug can cause unwanted effects, although not all patients encounter.
Unwinted effects (can occur in 1 - 10 patients in 100 patients): dry mouth, headache, dizziness, drowsiness/Sleeping chicken.
Unwanted effects are less common (1 - 10 patients may occur in 1000 patients): Exhausted, abdominal pain.
Do not know the frequency (do not estimate the frequency from existing data). Increasing appetite, causing wood, restlessness, hallucinations, depression, insomnia, suicide intentions, convulsions, abnormal (abnormal), dizziness, fainting, tremor, visual disorders, blurred vision, sensation or chest movement, fast heartbeat, shortness of breath, nausea, vomiting, hepatitis, skin pain, skin pain, itchy skin, itchy skin, itchy skin. Pain or difficulty to continue, not urinating urine in the bladder, coverage, weight gain, abnormal results of liver function test results.
As soon as the first signs of a reaction are appeared (swelling of the mouth, tongue, face and/or throat, shortness of breath or difficulty swallowing with urticaria (angioedema), sudden reduction in blood pressure leads to vascular or shocking, can cause death) stop using Pollezin 5 mg film bags immediately and simultaneously contact your doctor.
Notice immediately to your doctor or pharmacist if any unwanted effects occur during the use of the drug, including unwanted effects that have not been listed in this user guide.
Clinical studies
Adults and teenagers over 12 years old
In treatment studies in women and men aged 12 to 71, 15.1% of patients in the group using Levocetirizine 5 mg have at least one harmful reaction compared to 11.3% of patients in the placebo group. 91.6% of these harmful reactions are mild or medium.
In treatment tests, the percentage of treatment due to unwanted effects is 1.0% (9/935 patients) with levocetirizine 5 mg and 1.8% (14/771 patients) with placebo.
Clinical treatment tests with levocetirizing conducted on 935 patients taking drugs at the recommended dose of 5 mg daily. From this synthesis report, the following harmful reactions have been reported with a frequency of 1% or higher (common: ≥ 1/100 to headache Harmful reactions have a sedative effect such as drowsiness, fatigue and weakness that occurs more common (8.1%) in the group using levocetirizine 5 mg compared to the placebo group (3.1%). Children: In two placebo -controlled studies in children 6 - 11 months old and 1 - 6 years old, 159 patients were used levocetirizine with the corresponding dose of 1.25 mg daily for 2 weeks and 125 mg twice a day. The following unwanted effects are preserved at 1% or larger in the group using levocetirizine or placebo. drowsiness Notify the physician the unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Pollezin drugs contraindicated in the following cases:
Be cautious when using
Children: The use of pollezin for children under 6 years of age is not recommended because it is not guaranteed to get the appropriate dose for the form of film tablets. A levocetirzine should be used for children. Do not use levocetirizine for children under 2 years old.
Be cautious when using this medication simultaneously with alcohol.
Patients with rare genetic galactose intolerance, lactase deficiency or malposure-galactose should not be used.
used for pregnant or lactating women
pregnancy and nursing mothers
If you are pregnant or nursing, or you are likely to be pregnant or planning to get pregnant, consult your doctor or pharmacist before taking this medication.
Pregnant women
Data on the use of levocetirizine in pregnant women is not or there is very limited (less than 300 cases of pregnancy). However, for Cetirizine, Levocetirizine's facemic isomers, there are a large amount of data (more than 1,000 cases) in pregnant women, showing no defects or toxicity for fetus/infant.
Animal studies do not show direct or indirect effects on pregnancy, embryo/fetal development, birth or postpartum development. The use of levocetirizine may be considered during pregnancy, if necessary.
breastfeeding women
Cetirizine, racemic isomers of levocetirizine, have been shown to be secreted into breast milk. Therefore, Levocetirizine is likely to be secreted into the mother's milk. Levocetirizine adverse reactions can be observed in breastfed babies. Therefore, be careful when using levocetirizing for breastfeeding women.
affect fertility
There is no clinical data on the fertility of levocetirizine.
The effect of the drug on the ability to drive and operate machinery
Some patients treated with pollezin may be sleepy, tired and exhausted. Be careful when driving or operating machines until you know how the drug affects you. However, special tests show that there is no reduction in alertness, reaction ability or driving ability in healthy test participants after using levocetirizing at the recommended dose.
Therefore, patients plan to drive, participate in activities that can be dangerous or operate carefully.
Drug interaction
Take other drugs
Please inform your doctor or pharmacist if you are taking or new use or can use any other drug.
Use Pollezin 5 mg film tablets with alcohol
Be careful when using alcohol and drugs that affect the central nervous system. In sensitive patients, simultaneously using Cetirizine or Levocetirizine and alcohol or other central neurological inhibitors can reduce alertness and reduce work efficiency.
Pollezin 5 mg film tablets contain lactose monohydrate
Patients with lactose intolerance should be noted this. If the doctor has announced that you are allergic to a few types of sugar, consult your doctor before using this medication.
There is no drug interaction studying conducted with levocetirizine (including no studies with CYP3A4 induction drugs); Studies with racemic cetirizing isomers show that there is no clinical adverse interaction (with antipipyrine, azithromycin, cimetidine, diazepam, erythromycin, glipizide, ketoconazole and pseudoephedrine). The mitigation of cetirizine (10%) is observed in a multi -dose study with theophylline (400 mg once a day) and Cetirizine is used with various materials, while theophylline tends to be not affected when used simultaneously with Cetirizine.
In a multi-dose ritonavir study (600 mg twice a day) and Cetirizine (10 mg daily), the level of contact with Cetirizine increased by about 40% while ritonavi tends to change a bit (-11%) when used simultaneously with Cetirizine. The absorption level of levocetirizine is not affected by food but low -speed autumn speed.
Storage
Leave a cool place, avoid light, temperature below 30⁰C.
To be out of reach of children.
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