PMS-Cetirizine 10 Imexpharm Treatment of allergic rhinitis, urticaria (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Cetirizine
Ingredient Allergic rhinitis, urticaria, allergic conjunctivitis, rashes

Ingredient

Composition informationContent
Cetirizine10mg

Uses

Indications

The "Cetirizin Imp® 10" drug is indicated in the treatment of persistent allergic rhinitis, seasonal allergic rhinitis, malorganic chronic urticaria, allergic conjunctivitis.

Pharmacokological

cetirizin is a derivative of piperaazin and a metabolic substance of hydroxyzin. Cetirizin has a strong antagonistic and selective effect on peripheral H1 receptors, but has almost no effect on other receptors, so there is almost no antagonistic acetylcholine effect and has no serotonin antagonistic effect.

Cetirizin inhibits the early stage of allergic reactions through histamine intermediaries and also reduces the relocation of inflammatory cells and releases intermediate substances at the late stage of allergic reactions.

The polarization of cetirizine increases compared to hydroxyzin, so the distribution of the drug into the central nervous system decreases and has little impact on the central nervous system compared to the first -generation antihistamine drugs (diphenhydramin, hydroxyzin) so it causes less drowsiness. However, the proportion of patients using Cetirizin has unwanted effects such as sleeping chicken is higher than patients using other second -generation antihistamine drugs such as loratadin.

Clinical effect and safety when used:

When conducting research on healthy volunteers, Cetirizin can strongly inhibit red reactions and skin pain due to high skin hypamine concentration with 5 and 10mg doses, but do not identify effective correlation.

A place to control the placebo for 6 weeks, conducting over 186 patients with allergic rhinitis and mild to moderate, at 10 mg/time/day, Cetirizine helps improve rhinitis symptoms and does not affect lung function. This shows the safety of using cetirizin for patients with allergies and mild to medium asthma.

A restorative study study, using high -dose cetirizin, 60mg/day x 7 days, does not cause significant QT range.

In the recommended dose, Cetirizin helps improve the condition of patients with seasonal and persistent allergic rhinitis.

pharmacokinetics

fast absorption drug after drinking. The concentration of the peak measured at equilibrium at 0.3 micrograms/ml, achieved after 30 minutes - 1.5 hours. Oral bioavailability does not change when taking the drug with food.

Expression distribution volume is 0.5 liters/kg. The associated ratio with plasma protein is 90 - 96%. The drug in breast milk, reaching a concentration of about 25-90% of the drug concentration in plasma, but hardly passes through the bloody barrier.

Small amount of cetirizin is converted into non -active substances.

About 2/3 of the dose is exported in the form of unchanged urine within 96 hours. The sale time of the drug is about 10 hours in adults. Hemolysis only eliminates a small amount of cetirizin.

cetirizin has linear dynamics at a dose of 5 - 60mg.

Special subjects:

Elderly: After taking the single dose of 10mg of Cetirizin, in the elderly, the selling time increased by about 50% and the clearance decreased by 40%.

Children: The sale time of the drug is about 6 hours in children 6 -12 years old; 5 hours in children 2 - 6 years old; About 3 floors in children from 6 - 24 months of age.

Patients with renal failure:

  • mild kidney failure (creatinine clearance is higher than 40 ml/min): pharmacokinetics similar to normal people.
  • medium kidney failure and hemolysis: The sale time is tripled and the drug clearance decreases by 70% compared to normal people. Therefore, the adjustment of cetirizine dose in medium and severe renal failure.

    • Patients with chronic liver failure using Cetirizin single dose 10 or 20mg with a 50% increase in sale time and 40% decreased clearance compared to normal people. The adjustment of the dose in patients with liver failure is only necessary if the patient has more renal failure.

    Before taking PMS-Cetirizine 10 Imexpharm Treatment of allergic rhinitis, urticaria (10 blisters x 10 tablets)

    How to use

    Take oral use. Although food can reduce the peak concentration in the blood and extend the time to reach the peak concentration, it does not affect the absorption level, so it can be taken with food or drinking away from meals.

    Dosage

    The usual dose:

  • Adults and children aged 6 and older: 10mg x 1 time/day.
  • Children from 6 months old - under 6 years old: Do not use Cetirizin IMP 10 due to the inappropriate drug content.

    • Patients with liver failure: No dose adjustment, unless patients have kidney failure.

    Patients with renal impairment: The dose must be adjusted according to creatinine clearance (CLCR) as follows:

    kidney function

    Creatinine clearance (ml/min)

    Dosage

    Normal

    80

    10mg x 1 time/day

    50 - 79

    10mg x 1 time/day

    Moderate kidney failure

    30 - 49

    5mg x 1 time/day

    5mg every 2 days

    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? The symptoms appear after using a number of cetirizin at least 5 times the usual dose: mixed, diarrhea, dizziness, fatigue, discomfort, itching, restlessness, stunning, drowsiness; unconscious and/or stimulating (mainly in children); Loss of air conditioning, tremor, headache, hallucinations, convulsions, dry mouth, flushing, hyperthermia, pupils, urinary retention, tachycardia and in case of overdose, can reduce blood pressure and arrhythmia, vomiting, nausea. Also may appear on the outskirts of the tower.

    Handling: There is no specific antidote in the case of overdose of cetirizin. In serious overdose, it is necessary to cause vomiting and gastric lavage along with supportive methods. Hemorrhage is not effective in treating overdose of Cetirizin.

    What to do when forgetting a dose? Use the drug as soon as you remember and take the next dose as usual. If the drug time is too close to the next dose, you can skip the forgotten dose.

    Side Effects

    When using the "Cetirizin Imp® 10" drug, you may experience unwanted effects (ADR).

    Common, ADR> 1/100

  • System of organs: Central nervous system: Sleeping, fatigue, dizziness, headache.
    • digestive: dry mouth, sore throat, nausea.

    Uncommon, 1/1000

  • Digestive: Anorexia or increased appetite, increased salivation.
  • kidney: urinary retention.
    • Body: flushed.

    Rare, 1/10000

  • Hematology: Hematopathy, thrombocytopenia, severe hypotension.

  • body: Anaphylaxis.
    • liver - bile: hepatitis, stasis. kidney: glomerulonephritis

    Instructions on how to handle ADR

    When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

    Warnings

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

    Contraindicated

    "Cetirizin Imp® 10" drug contraindicated in the following cases:

  • People with a history of allergies to cetirizin, with hydroxyzin or any ingredient of the drug.
  • Children under 6 months old.
  • Patients with end -stage renal impairment (Creatinin Clcr's clearance ratio

    Precautions when using

    Need to adjust the dose in people with liver failure, medium renal failure (CLCR 30 - 49 ml/min) or severe (CLCR 10 - 29 ml/minute).

    Avoid simultaneous use of cetirizin with alcohol and central nervous system inhibitors, because of the effect of these drugs.

    Cetirizin IMP 10 medicine contains lactose excipients. Therefore, patients with rare Galactose genetics, Lapp Lactase or Glucose-Galactose should not be used by this drug.

    The ability to drive and operate machinery

    Cetirizin can cause unwanted effects to sleep in some patients affecting the ability to drive and operate machinery.

    Pregnancy

    Although Cetirizin does not cause teratogenicity in animals, there is no complete studies on pregnant people, so the drug should not be used during pregnancy.

    Breastfeeding period

    Cetirizin is excreted in milk, so avoid breastfeeding when the mother uses medication.

    Drug interaction

    Avoid combined with central nervous system inhibitors such as sedatives and alcohol.

    The calmly reduced cetirizin clearance when taken with 400 mg of theophylin.

    Slow release tablets combine cetirizin hydrochloride and pseudoephedrin contraindicated for patients who are taking or stop taking Monoamine Oxidase inhibitors (IMAO) within 2 weeks. Therefore, be careful when combining Cetirizin Imp 10 with pseudoephedrin.

    • Storage

    not more than 30 ° C, avoid moisture and light.

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