Oralegic CPC1HN oral fluid is treated with seasonal allergic rhinitis (2 blisters x 5 tubes x 5ml)

Dosage form Drink
Specifications Box of 2 blisters x 5 tubes
Ingredient Fexofenadin HCl

Ingredient

Thành phần cho 1ml

Composition information	Content
Fexofenadin HCl	6mg

Uses

indications

Oralegic drugs are indicated in the following cases:

Allergic rhinitis (symptoms such as continuous sneezing, itchy nose, runny nose and stuffy nose) in adults and children over 2 years old. The drug reduces itching and urticaria. Fexofenadin is an active metabolitus of terfenadin but is no longer toxic to the heart due to not inhibiting potassium channels associated with myocardial cytoplasmic pole. Fexofenadine has no anti-anti-cholinergic or dopaminergic effect and has no effect on inhibiting receptors of Alpha-1 or beta-adrenergic receptors. At the treatment dose, the drug does not cause sleep or affects the central nervous system. The drug has a fast and prolonged effect.

pharmacokinetics

absorption:

Fexofenadin absorbs well when taken orally. After taking a 30 mg dose in healthy adults, the average cmax is 118.0 ng/ml and occurs about 1 hour. Simultaneous use of 30 mg Fexofenadin with high -fat meals reduces AUC and CMAX on average by 30% and 47% for healthy adults.

distribution:

About 60 - 70% Fexofenadin binds to plasma proteins, mainly albumin and alpha 1 - Glycoprotein acid. The distribution volume is 5.4 - 5.8 liters/kg. The drug data through the placenta or excretion into breast milk is not known. Fexofenadin does not pass the brain barrier.

metabolism:

About 5% of the dosage of the drug is metabolized. Fexofenadin is significantly metabolized through the liver (0.5 - 1.5% of the dose) thanks to the cytochrom P450 enzyme system into non -active substances. 3.5% are converted into methyl ester derivatives, mainly thanks to the intestinal bacteria.

excretion:

FEXOFENADIN waste sale time is 11-15 hours in normal people and usually lasts longer in kidney failure. The drug is eliminated in a constant form (about 80%) and about 11% in urine.

Special subjects

Dynamic pharmacokinetics in patients with renal impairment and liver failure and older people, after taking a single dose of 80 mg Fexofenadin hydrochlorid, compared to healthy people in a separate study of similar design:

kidney failure:

For medium -to -average renal failure (Creatinin clearance 47 - 80 ml/min) and severe renal failure (creatinine clearance 11 - 40 ml/min), the peak concentration of Fexofenadin plasma is 87% and 111% and the sale time is 59% and 72%, longer than healthy people. Peak of plasma peaks in dialysis patients (Creatinine clearance ≤ 19 ml/minute) is 82% higher and 31% longer than the selling time than healthy people. Based on the increase in bioavailability and the sale time, the starting dose should be used 60 mg once a day in patients with impaired renal function. For children with impaired renal function, the recommended starting dose of Fexofenadin is 30 mg x 1 time/day for patients from 2 to 11 years old and 15 mg x 1 time/day for patients from 6 months to under 2 years old.

liver failure:

Fexofenadin pharmacokinetics in patients with liver failure is not much different from healthy people.

Elderly:

In older people (≥ 65 years), fexofenadin concentration in plasma is 99% higher than young people ( Children:

A pharmacokinetic analysis is performed in 77 children (6 months old to 12 years old) with allergic rhinitis and 136 adults. Estimated oral clearance of fexofenadin is 44% and 36% in children from 6 to 12 years old (n = 14) and from 2 to 5 years old (n = 21) compared to adults. Use Fexofenadin hydrochlorid dose of 15 mg for children from 5 months to under 2 years old and a dose of 30 mg for children from 2 to 11 years old will give the result equivalent to a dose of 60 mg for adults.

The impact of gender:

In some tests, there is no clinical difference in terms of gender observed in the pharmacokinetics of Fexofenadin Hydrochlorid.

Before taking Oralegic CPC1HN oral fluid is treated with seasonal allergic rhinitis (2 blisters x 5 tubes x 5ml)

How to use

Shake well before use.

Oral drugs, can be taken at full or hungry.

Dosage

allergic rhinitis:

Children from 2 - 11 years old: The recommended dose is 30 mg (5 ml)/time x 2 times/day. For patients with renal function impairment, the recommended starting dose is 30 mg (5 ml)/time x 1 time/day. For patients with renal function impairment, the recommended starting dose is 60 mg (10 ml)/time/day.

Children from 6 months to 2 years: recommended dose is 15 mg (2.5 ml)/time x 2 times/day. For patients with impaired renal function, the recommended starting dose is 15 mg (2.5 ml)/time/day. For patients with renal function, the starting dose is recommended as 30 mg (5 ml) once a day.

Adults and children aged 12 and older: The recommended dose is 60 mg (10 ml)/time x 2 times/day. For patients with impaired renal function, the starting dose is recommended for 60 mg (10 ml) once a day.

Hepatic failure: No dose adjustment.

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

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? Symptoms of drowsiness, dizziness, dry mouth have been reported.

Handling: Use conventional measures to remove unprocessed drugs. Treatment of symptoms and improving physical condition.

In case of 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 doses to compensate for missed dose.

Side Effects

When using the drug, there are common unwanted effects (ADR) such as:

In control clinical trials in children from 6 to 11 years old, the most unwanted side effects are related to Fexofenadin hydrochlorid according to the investigation of a headache. The rate of headache in synthetic data from clinical trials is 1% for patients using 30 mg of fexofenadin hydrochlorid (673 children) and patients to use placebo (700 children). There is no clinical data on the safety of children using fexofenadin hydrochlorid for more than 2 weeks.

In control clinical trials in 845 children from 6 months to 5 years old with allergic rhinitis, 415 children are used Fexofenadin hydrochloride 15 mg or 30 mg and 430 children are placebo. No unexpected adverse reactions in children are treated with fexofenadin and side effects similar to older children and adults.

In adults, the following unwanted side effects have been reported in clinical trials, with the same ratio as placebo.

Nervous system:

Common (≥ 1/100 to

digestive system:

Common (≥ 1/100 to

general:

Not common (≥ 1/1000 to

In adults, the following undesirable reactions have been reported in after -sales monitoring. The frequency they happen is not known (not estimated from the available data):

The immune system: Hypersensitivity reactions to manifestations such as angioedema, shortness of breath, redness and anaphylaxis.

Mental: Insomnia, stress, sleep disorders or nightmares.

Heart: tachycardia, chest drum.

Digestive: diarrhea.

Skin and subcutaneous organization: rash, urticaria, itching.

Instructions on how to handle ADR:

Notify the physician with 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

Oralegic drugs contraindicated in the following cases:

Contraindicated in patients with a history of allergies to any ingredients of the drug.

Be cautious when using

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

Be cautious when using drugs for patients with liver, kidney, elderly.

The effect of the drug on the ability to drive and operate machinery

The drug can cause fatigue, headache, dizziness, so be careful when used for drivers, operating machinery.

Use drugs for women during pregnancy and lactation

pregnancy:

Only use fexofenadin for pregnant women when the benefit of the mother is superior to the risk of the fetus due to the lack of fully studied on pregnant women.

breastfeeding period:

Be careful when using fexofenadin for breastfeeding women due to unknown milk data.

Interactive drug

antacids containing aluminum and magnesi if used simultaneously with fexofenadin will reduce the absorption of the drug, so it must be used by these drugs about 2 hours apart.

Interaction with erythromycin and ketoconazole:

Fexofenadin is low (about 5%). However, fexofenadin shares with ketoconazole or erythromycin has increased the concentration of fexofenadin in plasma. Fexofenadin does not affect the pharmacokinetics of erythromycin or ketoconazole. In two separate studies, Fexofenadin Hydrochlorid 120 mg twice daily (a total dose of 240 mg per day) is used with Erythromycin 500 mg every 8 hours or ketoconazole 400 mg once a day in stable state conditions for healthy objects (n = 24 every research). There is no difference in adverse reactions or the QTC period is observed when the subjects are used for lone Fexofenadin hydrochlorid or in combination with erythromycin or ketoconazole.

Please see more information about research in the user manual attached to the product.

Interaction with fruit juice:

Fruit juice like grapefruit, oranges and apples can reduce the bioavailability of Fexofenadin. This is based on the results of 3 clinical studies using skin stimulants caused by histamine along with pharmacokinetic analysis. Swelling and redness in the skin significantly when using Fexofenadin hydrochlorid with grapefruit or orange juice compared to water. Based on documents, it can be extracted with other juice like apple juice. The clinical significance of these observations is not known. In addition, based on pharmacokinetics analysis combining data from grapefruit and oranges research with data from biological equivalent research, Fexofenadin's biological use has decreased by 36%. Therefore, to maximize the effects of fexofenadin, the drug should be used with water.

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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