Exopadin 60mg medicine for allergic rhinitis, urticaria (3 blisters x 10 tablets)

Dosage form Film bag tablets
Specifications Box of 3 blisters x 10 tablets
Ingredient Fexofenadin hydrochlorid

Ingredient

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Composition information	Content
Fexofenadin hydrochlorid	60mg

Uses

indications

Exopadin drug indications for treatment in the following cases:

Allergic rhinitis: Exopadin is indicated for the treatment of seasonal allergic rhinitis in adults and children aged 12 and older.

Chronic urticaria: Exopadin is indicated to treat unnecessary skin manifestations of chronic urticaria in adults and children aged 12 and older. The drug reduces itching and the amount of urticaria in a significant way.

Pharmacology

Therapy group: System antihistamine

ATC code: R06A x26

Fexofenadin is a second -generation antihistamine drug, which has a specific antagonistic and selective effect on the peripheral H1 histamine receptor. Fexofenadin is a metabolic substance that has the activity of Terfena Dine but is no longer toxic to the heart due to not inhibiting potassium channels associated with myocardial cycles. Fexofenadin does not have a significant effect on cholinergic or dopami - nergic resistance and does not have the effect of inhibiting Alpha - 1 or beta adrenergic receptor. At the treatment dose, Fexofenadin does not cause drowsiness or affects the central nervous system. The drug has a fast and prolonged effect.

pharmacokinetics

absorption:

Fexofenadin is well absorbed when used orally and starts to work after drinking 60 minutes. The peak concentration in plasma is achieved after 2-3 hours. The simultaneous use of Fexofenadin with a high -fat diet reduces AUC and CMAX of Fexofenadin, respectively, 21% and 20% respectively.

Distribution:

About 60 - 70% Fexofenadin binds to plasma proteins mainly with albumin and Alpha -1 Glycoprotein. It is unclear whether the drug will be through the placenta or excreted into breast milk. Fexofenadin does not pass the brain barrier.

Metabolism:

Fexofenadin is very little metabolized (about 5%, mainly in the intestinal mucosa. Only about 0.5 - 1.5% of the dose is metabolized in the liver thanks to the cytochrome P450 enzyme system into non -active substances).

Era:

The average selling time of fexofenadin is about 14.4 hours, lasting longer (31 - 72%) in kidney failure people. The drug is eliminated in a constant form of about 80%, and 11% through urine.

Special subjects

Pharmacokinetics in special subjects (for people with kidney failure, liver and elderly), obtained after a single dose of 80 Mafenadin hydrochloride, compared to healthy volunteers in a separate study of the same design.

Elderly: In the elderly (> 65 years), the peak concentration of fexofenadin in plasma is 99% greater than those younger (

Children: Cross -research comparison shows that the area under the curve (AUC) Fexofenadin after taking a dose of 60 mg fexofenadin hydrochloride in children 7-12 years old has 56% higher allergic rhinitis than a healthy adult volunte for the same dose. Plasma concentration in children when taking 30mg of fexofenadin hydrochloride is equivalent to adults taken 60 mg fexofenadin hydrochloride.

Renal failure: In people with mild to moderate renal failure level (Creatinine clearance 41 - 80 ml/min) and severe renal failure (Creatinine clearance 11 - 40 ml/min), Fexofenadin peak concentration in plasma is 87% and 111% and the average selling time is longer than 59% and 72% compared to healthy volunteers. The peak concentration of plasma in the object of dialysis (Creatinine clearance ≤ 10 ml/min) is greater than 82% and the sale time is 31% longer than observed in healthy primitive lovers. Based on the increase in bioavailability and the sale time, the dose of 60 mg once a day is recommended as the starting dose in patients with renal impairment.

Hepatic failure: Fexofenadin's pharmacokinetics in those with liver disease is not significantly different from observations found in healthy volunteers.

Sex: Through many tests, there is no significant clinical difference related to gender observed in pharmacokinetics of fexofenadin hydrochloride.

Clinical research

Seasonal allergic rhinitis: In randomized, double, multi -center clinical research, lasting 2 weeks in patients from 12 to 65 years old with seasonal allergic rhinitis (n = 863), using Fexofenadin hydrochloride 180mg 1 time a day significantly reduces the total score of symptoms (plus the scores of each symptom of steam, runny nose, iron - Reden eyes - Red eyes - Rose -eyed - Rose - Rush - Rose - Rush - Rose - Rush - Rose - Rose - Rose - Rose - Rose - Rose - Rose - Rose - Rose - Rose - Rose - Rose - Rose - Rose - Rose - Rose - Rose - Rose - Rose - Rose - Rose Eye - Rose Eye) Although the number of patients is small in a few subgroups of patients are divided by gender, age and race.

Chronic urticaria: In a place of placebo, random, double, multicolor, 4 weeks in patients aged 12 years and older with chronic urticaria (n = 259), using Fexofenadin hydrochloride 180 mg once a day significantly reduces the average number of urticaric plaque (MNW), the average score of itching symptoms (MPS) MPS). For MNW and MPS are recorded evenly at the end of the 24 -hour dose. More symptoms in the group using fexofenadin hydrochloride 180mg compared to the placebo group. Improving symptoms proved in one day of treatment with Fexofenadin hydrochloride 180mg and maintained for 4 weeks of treatment. There is no significant difference in the effectiveness of fexofenadin among patients subgroups divided by gender, age and race.

Before taking Exopadin 60mg medicine for allergic rhinitis, urticaria (3 blisters x 10 tablets)

How to use

oral medication with water and before meals. Do not take medicine with fruit juice (such as oranges, grapefruit, apples).

Dosage

Adults and children aged 12 and older: The recommended dose is 60mg x 2 times/day or 180mg/1 time/day

Renal failure: The recommended starting dose is 60mg of fexofenadin hydrochloride per day.

Hepatic failure: No dose adjustment.

Elderly: No dose adjustment, except for renal function impairment.

Note: There is no special requirement on drug treatment after use. 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? However, drowsiness, dizziness, dry mouth have been reported. Dosage Fexofenadin hydrochloride up to 800mg (6 healthy volunteers at this dose) and dose up to 690mg twice a day for 1 month (3 healthy volunteers at this dose) or 240mg once a day for 1 year (234 healthy volunteers at this dose level) have been used without developing clinical significant side effects compared to placebo.

Management: In case of overdose of common measures to remove the drug that has not been absorbed in the digestive tract. Symptomatic treatment and supportive treatment are recommended. Dialysis reduces the concentration of drugs in the blood (1.7%). There is no specific antidote.

There are no deaths that occur with Fexofenadin hydrochloride oral doses up to 5000 mg/kg in mice (110 times the daily recommended dosage daily in adults and 200 times compared to the daily recommended daily dosage in children based on Mg/m2) and up to 5000 mg/kg in mice (230 times the daily oral daily recommendations in adults and 400 times compared to the daily daily dosage of oral recommendations based on oral daily for oral doses mg/m2). In addition, there are no clinical signs of toxicity or general detection of common diseases. In dogs, there is no evidence of toxicity observed at oral dose up to 2000 mg/kg (300 times the daily recommended daily dosage in adults and 530 times the maximum recommended daily dosage in children based on mg/m2).

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

Clinical studies with placeborn in a placebo shows that the unwanted effect rate in the patient group uses Fexofenadin is similar to the placebo group. The unwanted effects of the drug are not affected by the dosage, age, gender and race of the patient.

Common: (> 1/100,

Neurological: Drowsiness (1.3 - 2.2%), Fatigue, headache, insomnia, dizziness.

Neurological: Fear, sleep disorders, nightmares.

Digestive: dry mouth, abdominal pain.

Skin: skin rash, urticaria, itching

Hypersensitivity reactions: Evala, chest tightness, shortness of breath, redness, anaphylaxis.

Cardiovascular: Increased heart rate, suspense.

Digestive: diarrhea

Warnings

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

contraindicated

anti -contraindicated exoadin drugs in the following cases:

Patients with a history of allergies to any ingredients of the drug.

Be cautious when used

Lactose-containing drugs should be cautious when prescribing this drug for patients with rare genetic diseases in galactose tolerance, lapp lactase deficiency or glucose-galactose absorption disorders

Be careful and adjust the appropriate dose when taking drugs for people with impaired renal function because the concentration of drugs in plasma increases due to prolonged sale time.

Be careful when taking drugs for the elderly (over 65 years old) often has renal physiological impairment.

Safety and effectiveness of drugs have not been assessed in children under 12 years old.

Do not arbitrarily use other antihistamines H1 while using exopadin.

It is necessary to stop exoadin at least 24 - 48 hours before conducting injection antigen tests.

Use exoPadin to increase psoriasis.

Use drugs for women during pregnancy and nursing mothers 2>

Pregnant women

The monster effect: Type C. There is no evidence of the likelihood of monitoring in rats or rabbits with oral terfenadine doses of up to 300 mg/kg (leading to fexofenadin exposure about 3 and 30 times, corresponding to the maximum daily exposure level in humans of 180mg FexOfenadin hydrochloride based on AUC comparison)

In the mouse, there is no side effects and teratogenic effects during pregnancy used with a dose of up to 3730 mg/kg (about 15 times the dose of fexofenadin hydrochloride is recommended in daily people of 180 mg fexofenadin hydrochloride based on AUC comparison).

There is no adequate data on the use of fexofenadin hydrochloride in pregnant women. Fexofenadin hydrochloride should not be used during pregnancy, only medication if the benefits are superior to the potential risk to the fetus,

The non -teratogenic effect: Reducing the dose related to weight gain and the survival rate is observed in mice exposed to the dose of 150 mg/kg terfenadine oral (about 3 times the dose of Fexofenadin hydrochloride Maximum recommended daily in humans is 180 mg Fexofenadin hydrochloride based on AUC comparison).

breastfeeding women

There is no data on the composition of breast milk after taking Fexofenadin hydrochloride. However, when using terfenadine during breastfeeding, Fexofenadin hydrochloride is seen in breast milk. So Fexofenadin hydrochloride is recommended not to be used during breastfeeding.

fertility

There is no human data on the effects of fexofenadin hydrochloride on fertility. In mice, there is no effect on fertility with fexofenadin hydrochloride treatment.

The effect of the drug on driving and operating machinery

Based on the pharmacological properties and reports on unwanted effects, Fexofenadin hydrochloride is less likely to affect driving or operating machinery. In objective tests, Fexofenadin Hydrochorid has been shown to have no significant effect on the central nervous system function. This means that patients can drive or perform tasks that require concentration. However, to identify sensitive people with abnormal reactions to the drug, it is advisable to check the personal reaction before driving or perform complex tasks.

Drug interaction

erythromycin and ketoconazole increases the concentration of fexofenadin in plasma but does not change the QT interval. There is no difference in unwanted effects reported when these drugs are used individually or in combination. Aluminum and Magnesi anti -acid drugs if used simultaneously with fexofenadin will reduce the absorption of the drug, so they must use these drugs about 2 hours apart.

There is no interaction between Fexofenadin and Omeprazole. Fexofenadine concentration may be increased by Verapamil, p-Glycoprotein inhibitors.

Fexofenadin may increase alcohol content, central nervous sedatives, cholinergic substances. Avoid using fexofenadin with alcohol because it increases the risk of sedation (sleep).

Fexofenadin may reduce the concentration of acetyl-cholininese inhibitors (in the central nervous system), betahistin.

Fexofenadin may be reduced by concentrations by acetyl - cholinesterase inhibitors (in the central nervous system), amphetamine, antacids, grapefruit juice, rifampicin.

Fruit juice (oranges, grapefruit, apples) can reduce the bioavailability of fexofenadin to 36%.

Cavalry: Due to no studies on the correlation of the drug, do not mix this drug with other drugs.

Storage

In a dry place, temperatures below 30 ° C, avoid light.

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