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Cetirizine hydrochloride tablets

Product description
Approval date: August 4, 2010
 
Date of revision: December 1, 2013
 
          November 30, 2015
 
Cetirizine hydrochloride tablets instructions
 
Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
 
Common name: Cetirizine hydrochloride tablets
 
English name: Cetirizine Hydrochloride Tablets
 
Chinese Pinyin: Yansuan Xitiliqin Pian
 
[Ingredients] The main ingredient of this product is: cetirizine hydrochloride. Its chemical name is: (±)-2-{2-[4-[(4-chlorophenyl)benzyl]-1-piperazinyl]ethoxy}acetic acid dihydrochloride.
 
Its chemical structure is:
 
 
 
Molecular formula: C21H25ClN2O3·2HCl
 
Molecular weight: 461.81
 
[Properties] This product is a film-coated tablet, which is white or off-white after removal of the coating.
 
[Indications] Seasonal allergic rhinitis, perennial allergic rhinitis, allergic conjunctivitis and symptomatic treatment of itching and urticaria caused by allergies.
 
[Specification] 10mg
 
[Usage and Dosage] Recommended for adults and children over 2 years old.
 
Adults or children over 6 years old: In most cases, the recommended dose is 10 mg (1 tablet) per day, once orally. If the patient is more sensitive to adverse reactions, take 5mg (1/2 tablet) each morning and evening.
 
Children 2 to 6 years old: 5 mg (1/2 tablet) each time, once a day; or 2.5 mg (1/4 tablet) each time, twice daily.
 
Children 1~2 years old: It is recommended to take 2.5mg (1/4 tablet) in the morning and evening.
 
Children under 1 year of age: Although there are clinical data on the use of cetirizine in infants from 6 months to 1 year old, the relevant assessment has not been completely completed. If you need to use it, please follow the doctor's advice.
 
Elderly patients: elderly patients with normal renal function, refer to the recommended dose for adults.
 
For elderly patients with impaired renal function, see recommended doses for patients with impaired renal function.
 
Patients with impaired renal function:
 
In patients with moderate to severe renal impairment, the dosing interval should be individualized according to renal function. Please use the following formula and chart to calculate the patient's serum creatinine (mg/dl):
 
Creatinine clearance = [140 - age (years)] body weight (kg) (0.85 female patient coefficient)
 
                  72 serum creatinine (mg/dl)
 
Dose adjustment for patients with adult renal impairment:
 
Renal function status creatinine clearance (ml/min) dose and dose
 
Normal ≥80 once daily, 10mg
 
Mild renal insufficiency 50~79 once daily, 10mg
 
Moderate renal insufficiency 30~49 once daily, 5mg
 
Severe renal insufficiency <30 5mg each time, once every other day
 
Late kidney disease - patients taking dialysis therapy <10 disabled
 
For children with impaired renal function, dose adjustments also need to consider children's creatinine clearance and body weight.
 
Patients with impaired liver function: Patients with normal renal function do not need to adjust the dose.
 
[Adverse reactions] Occasionally, patients reported mild and transient adverse reactions such as headache, dizziness, lethargy, arousal, dry mouth, and abdominal discomfort.
 
In an objective experiment to measure psychomotor function, the sedative effect of this product is similar to placebo.
 
Rarely reported allergic reactions.
 
[taboo]
 
It is forbidden to be allergic to any of the ingredients or hydroxyzine of this product.
 
Disabled in patients with severe renal impairment (creatinine clearance less than 10ml/min).
 
【Precautions】
 
1. Avoid using alcohol after drinking: At therapeutic doses, this product will not strengthen alcohol (blood alcohol concentration 0.8g/L), but care must be taken.
 
2. Drivers, operating machines or high-altitude workers should be used with caution: tests on healthy volunteers have shown that taking 20 or 25 mg of this product daily may affect human alertness and reaction time. In a few cases, taking 10 mg of this product may cause agility. reduce.
 
[Pregnant women and lactating women] Animal teratogenicity tests show no teratogenic effects, but for prevention, cetirizine hydrochloride should not be given to pregnant women during the first trimester of pregnancy, nor should it be used by lactating women.
 
[Child medication] See [Usage and Dosage].
 
[Geriatric Use] For elderly patients with normal renal function, refer to [Usage and Dosage] for adult usage and dosage. For elderly patients with impaired renal function, refer to the usage and dosage of patients with renal dysfunction.
 
[Drug interactions] There is no data to interact with other drugs so far, but be careful when taking sedatives (hypnotics) or theophylline.
 
[Drug overdose] Symptoms of overdose can be expressed as drowsiness in adults and as excitement in children. Oral administration of 50 mg can cause drowsiness. So far, there is no specific antidote, and in a large amount of excess, the stomach should be washed as soon as possible. In addition to general first aid supportive care, all vital signs must be regularly monitored.
 
【Pharmacology and Toxicology】
 
Pharmacological action This product is an oral selective histamine H1 receptor antagonist. No significant anticholinergic and anti-serotonin effects, less central inhibition.
 
Toxicological research
 
Genotoxicity: The results of this product Ames test, human lymphocyte chromosome aberration test, mouse lymphoma test and rat micronucleus test were negative.
 
Reproductive toxicity: The results of mouse fertility and general reproductive toxicity test indicate that cetirizine is administered orally at a dose of 64 mg/kg (according to body surface area, approximately equivalent to 25 times the maximum daily oral dose recommended by adults). No damage to fertility.
 
Mice, rats and rabbits were administered orally at doses of 96, 225 and 135 mg/kg, respectively, based on body surface area, approximately 40, 180 and 220 times the maximum daily oral dose recommended by adults. No teratogenic effects were observed. However, there is currently no adequate and strictly controlled clinical research data for pregnant women. Since animal reproduction studies do not always predict the effects of drugs on humans, this product can only be taken during pregnancy if it is really needed.
 
Lactation mice (mother) oral dose of 96 mg / kg (converted by body surface area, about 40 times the maximum daily oral dose recommended for adult clinical) can cause delay in weight gain in the pups. Studies in Beagle dogs have shown that approximately 3% of the administered dose is excreted by the milk. Cetirizine has been reported to be excreted from human milk, so it is not recommended for lactating women to use this product.
 
Carcinogenicity: The rat carcinogenicity test for oral administration for 2 consecutive years, the dose is up to 20 mg / kg (according to body surface area, about 15 times the maximum daily oral dose recommended for adult clinical, or the maximum recommended clinical recommendation for children) At 10 times the dose, no carcinogenicity was observed. In the carcinogenicity test of mice administered orally for 2 consecutive years, the dose is up to 16 mg/kg (according to body surface area, about 6 times the maximum daily oral dose recommended by adults, or the maximum daily dose recommended by children. At times, it can cause an increase in the incidence of benign liver tumors in male animals; the dose is up to 4 mg/kg (according to body surface area, about twice the maximum daily oral dose recommended by adults, or equivalent to the maximum recommended clinical recommendation for children) At the dose, no increase in the incidence of liver tumors was observed. The clinical significance of the above findings is unclear.
 
[Pharmacokinetics] Oral cetirizine hydrochloride is linear in the dose range of 5~60mg, and the plasma concentration level is linear. The plasma elimination half-life is approximately 10 hours and the apparent volume of distribution is 0.5 L/kg. After taking 10 mg per day and taking 10 days of cetirizine hydrochloride continuously, no accumulation was found. The steady-state plasma concentration peaked at approximately 300 ng/ml and peaked within 10.5 hours after administration. Cetirizine binds strongly to plasma proteins with a plasma protein binding rate of 93 ± 0.3%. The metabolism of cetirizine has no first-pass effect, and 2/3 of the administered dose is excreted from the urine by the prototype drug. The absorption of cetirizine is not affected by eating. The bioavailability of cetirizine solutions, capsules and tablets is similar, and the absorption between individuals is very consistent.
 
Pharmacokinetics of special populations:
 
Elderly: The trial data showed that the mean plasma half-life of elderly subjects was 11.8 hours after oral administration of a single dose of 10 mg of cetirizine hydrochloride; 16 elderly subjects with a 40% reduction in creatinine clearance had a lower plasma half-life than creatinine clearance. Older patients with a normal rate increase by about 50%; elderly patients with normal renal function do not need to reduce the dose.
 
Children: children aged 6 to 12 years, the plasma half-life of cetirizine is about 6 hours;
 
The plasma half-life of cetirizine in children aged 2-6 years is about 5 hours;
 
The plasma half-life of cetirizine in infants aged 6 to 24 months is approximately 3.1 hours.
 
Patients with impaired renal function: Patients with mild renal impairment (creatinine clearance greater than 40 ml/min) have similar pharmacokinetic parameters to cetirizine compared to healthy volunteers. The plasma half-life of cetirizine in patients with moderate renal impairment increased three-fold compared with those with normal renal function, and the drug clearance rate was 70% lower than that in patients with normal renal function. Cetirizine is difficult to remove by hemodialysis, so patients with moderate or severe renal impairment must adjust the dose.
 
Patients with impaired liver function: Patients with chronic liver disease (hepatocytes, cholestasis, biliary cirrhosis) have a longer plasma half-life compared with healthy subjects after a single dose of 10 mg or 20 mg of cetirizine 50%, the drug clearance rate decreased by 40%. For patients with liver damage, the dosage should be adjusted only when the patient has symptoms of renal insufficiency.
 
[Storage] shading, sealing, and storing in a dry place (10~30 °C).
 
[Packing] Aluminum-plastic packaging, 4 pieces per box; 6 pieces per box; 8 pieces per box; 12 pieces per box; 16 pieces per box; 18 pieces per box.
 
[Validity Period] 36 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
 
[Approval No.] National Drug Standard H20103387
 
【manufacturer】
 
Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
 
  Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
 
  Postal code: 529331
 
  Phone number: (0750) 2789348 2783621
 
            400-8899-328 (National Service Phone)
 
  Fax number: (0750) 2789348
 
Website: http://www.pdpharm.com
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