Cetirizine Stada 10mg medicine for allergic rhinitis, urticaria (10 blisters x 10 tablets)

Mechanism of impact

Cetirizine, a metabolic substance of hydroxyzine, has a strong antagonistic and selective effect in peripheral receptors. Studies associated with in vitro receptors show that Cetirizine has no affinity for other receptors.

Effectiveness

In addition to the anti -HI effect, Cetirizine has also been shown to have an anti -allergic effect: at a dose of 10 mg, oral 1 or 2 times daily, it inhibits the late stage of using Eosinophil, in the skin and conjunctiva of allergens.

Safety and clinical effectiveness

Studies conducted on healthy volunteers show that Cetirizine at a dose of 5 and 10 mg inhibits strong urticaria and erythema reactions due to the very high hypamine levels in the skin, the correlation with the effect has not been set.

In 6 weeks, the place of restoration in 180 patients with allergic rhinitis and mild to medium asthma, Cetirizine 10 mg dose once a day improves the symptoms of rhinitis and does not change the lung function.

This research shows the safety of the use of cetirizine for allergens with mild to moderate asthma.

In a placebo controlling study, Cetirizine was used at a daily dosage of 60 mg daily in 7 days without causing significant prolonged statistics of the QT interval.

In the recommended dose, Cetirizine has been shown to improve the quality of life of patients with persistent and seasonal allergic rhinitis.

Children

In a 35 -day study in children from 5 to 12 years old, there is no tolerance to antihistamine (urticaria and erythema inhibitors) of Cetirizine's observed. When stopping the new cetirizing after the doses, the skin will recover the normal
reaction with histamine within 3 days.

Dynamic pharmacokinetics

absorption

Peak of plasma peaks in a stable state is about 300 ng/ml and achieved within 1.0 + 0.5 hours.

The distribution of dynamic parameters such as peak plasma concentrations (CMAX) and the area under the curve (ADC) is not homogeneous.

Cetirizine's absorption level does not decrease when using food, although the absorption speed is reduced, similarly used when Cetirizine is used in the form of solution, hard capsules or tablets.

distribution

Expression distribution volume is 0.50 /kg. The ability to bind to plasma proteins of Cetirizine is 93 + 0.3%, Cetirizine does not change the warfarin protein bond.

transformation

Cetirizine does not go through the first transformation process.

Elimination

The final half -life time is about 10 hours. There is no cetirizine accumulation after daily doses of 10 mg in 10 days.

About two -thirds of the dose is excreted in the urine in the form of constant.

linear/non -linear

Cetirizine shows linear dynamics in the dose range from 5 to 60 mg

Patients with renal failure

The pharmacokinetics of the same drug in patients with mild renal impairment (creatinine clearance greater than 40 ml/min) and healthy volunteers. Patients with renal impairment have just had a tripled selling time and 70% decreased by the clearance of healthy volunteers.

Patients with dialysis (Creatinine clearance below 7 ml/minute) Use the only 10 mg Cetirizine 10 mg doses with a tripled half -time and 70% S0 reduction with usual.

Cetirizine is less excluded by hemorrhage. Need to adjust the dose in patients with medium to severe renal impairment.

Patients with liver failure

Patients with chronic liver disease (cirrhosis, bile stasis) use the dose of 10 or 20 mg of Cetirizine the only selling time to increase by 50% and the clearance decreased by 40% compared to healthy volunteers. The adjustment of the dose is only needed in patients with liver and renal failure at the same time.

Elderly

After taking a single dose of 10 mg, the half -life increased by 50% and the clearance decreased by 40% in 16 elderly patients compared to younger people. The reduction of the Cetirizine clearance in these elderly volunteers seems to be related to their impaired renal function.

Pediatric: The half -life of Cetirizine is about 6 hours in children from 6 to 12 years old and 5 hours in children 2-6 years old.

In newborns and children who are only 6 - 24 months old, the half -life is reduced to 3.1 hours.

Teenagers over 12 years: 10 mg x 1 time/day.

Children with renal failure: The dose must be adjusted by individual depending on the clearance of the kidney, age and body weight.

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?

symptoms

Observations of observation, after overdose of Cetirizine, is mainly related to the central nervous system or may suggest to the anti -cholinergic effects.

Symptoms have been reported after taking at least 5 daily dose: Confusion, diarrhea, dizziness, fatigue, headache, difficulty living, dilated pupils, itching, restlessness, sleepy, stunned, fast heartbeat, tremor and urine storage.

Management

There is no specific antidote to Cetirizine.

If the overdose occurs the recommended support treatment. Gastrointestinal lavage should be considered in a short time after overdose.

Hemorrhage does not work in the treatment of overdose of Cetirizine.

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.

Caution when using

in the treatment dose, no clinical interactions have any clinical significance proven with alcohol (for blood alcohol content of 0.5 g /).// P>

However, be careful if drinking alcohol at the same time.

Be cautious in patients with risk factors for urine (such as spinal cord lesions, prostate hyperplasia) because Cetirizine may increase the risk of urine.

Caution should be cautious for epilepsy patients and patients at risk of convulsions.

Antihistamine drugs inhibit reactions with skin allergies, so it takes time to eliminate (3 days) before taking these tests.

Patients with rare genetic problems in tolerance Galactose, Lapp Lactase deficiency or Glucose - Galactose should not use this drug.

Itching and/or urticaria may occur when stopping Cetirizine, even if these symptoms are not available before starting treatment.

In some cases, symptoms may be very intense and may need to start the treatment process. Symptoms will be resolved when re -treatment with drugs.

It is not recommended to use the form of tablet preparation for children under 6 years old because it is not suitable for dosage.

Interactive drug

According to the pharmacokinetics, pharmacoketic and tolerant data of Cetirizine, no interaction is expected to occur with this antihistamine.

In fact, there is no meaning of pharmacokinetic and pharmacokinetics interactions that have been reported in drug interactive studies - drugs that have been done, notably for pseudoephedrine or theophyllline (400 mg/day).

Cetirizine's absorption level does not decrease when using food, although the absorption speed decreases.

In sensitive patients, simultaneous use of alcohol or central neurological inhibitors can reduce alertness, reduce work efficiency, although Cetirizine has no potential to interact with alcohol (at a concentration of 0.5 g/l in blood).