Class A
Cetirizine Hydrochloride Tablets InstructionsPlease read the instructions carefully and use as directed or purchase and use under the guidance of your pharmacist.
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[Drug Name]
Generic Name: Cetirizine Hydrochloride Tablets
English name: Cetirizine Hydrochloride Tablets
Hanyu Pinyin:Yansuan Xitiliqin Pian
[Ingredients]
This product contains cetirizine hydrochloride per tablet. span>10mg. The excipients are: microcrystalline cellulose, low substituted hydroxypropyl cellulose, silicon dioxide, magnesium stearate and film-coated premix (gastric soluble).
[Properties]This product is a film-coated tablet, which appears white or off-white after removing the coating.
[Category of action
This product is an over-the-counter drug in the anti-allergy category.
[Indications
Symptomatic treatment of seasonal rhinitis, perennial allergic rhinitis, allergic conjunctivitis and allergy-induced pruritus and urticaria.
[Specification]10mg.
[dosage]
Orally. Recommended for adults and children 6 years of age and older. Adults: 1 tablet once with a small amount of liquid at dinner, or half a tablet once a day in the morning and once in the evening if sensitive to adverse reactions. children 6 to 12 years of age: 1 tablet once a day; or half a tablet twice a day.
[Adverse Reactions]
Mild and transient adverse reactions have occasionally been reported in patients. Such as headache, dizziness, drowsiness, agitation, dry mouth, and abdominal discomfort. In objective tests measuring psychomotor function, the sedative effect of this product was similar to that of placebo. Rarely, allergic reactions have been reported.
Compared to first-generation H1 receptor antagonists, cetirizine enters the central nervous system more weakly. Clinical studies have shown mild CNS adverse effects with recommended doses of cetirizine, including drowsiness, fatigue, numbness, impaired concentration, dizziness, and headache. Central nervous system excitation has also been reported in some cases.
Although cetirizine is a selective peripheral H1receptor antagonist. without significant anticholinergic activity, there have been isolated reports of impaired urination, dysregulation, and dry mouth.
Individual patients have experienced impaired liver function with elevated liver enzyme levels and bilirubin levels. Usually, liver enzyme levels and bilirubin levels return to normal after discontinuation of the drug.
Safety data from clinical studies of the original product:
The following safety data were derived from the original product clinical study. In this clinical study comparing cetirizine (3260 cases) (taken at the recommended dose of 10 mg/day) with placebo or other antihistamines, the following side effects were observed with an incidence of at least 1%: drowsiness (9.63%), headache (7.42%), dizziness (1.10 %), pharyngitis (1.29 %), dry mouth (2.09 %), nausea (1.07 %), and abdominal pain (0.98 %), and fatigue (1.63 %).
The following adverse reactions were observed with cetirizine (1656 cases) in a placebo-controlled clinical study of the original product in children (6 months to 12 years of age): drowsiness (1.8%), rhinitis (1.4%), diarrhea (1.0%), and fatigue (1.0%).
Safety data from post-marketing studies (PMS) of the original product.
In addition to the adverse reactions listed in the reports during clinical trials, the following adverse reactions were reported in post-marketing studies of the original investigational product.
According to the MedDRA system organ classification and by frequency based on post-marketing Frequency description of adverse events based on report estimates:
Frequencies were defined as follows: very common (≥1/10); common (≥1/100 – <1/10); occasional (≥1/1,000 – <1/100); rare (≥1/10,000 – <1/1, 000); very rare (<1/10,000); unknown (not estimable from available data).
– Cardiac symptoms:
Rare: Tachycardia
– Blood and lymphatic symptoms:
Very rare: thrombocytopenia
– Neurological symptoms:
Sometimes: sensory abnormalities
Rare: convulsions
Very rare: taste disturbance, dyskinesia, dystonia, syncope, tremor
Unknown: deafness, amnesia, memory impairment
– Eye symptoms:
Very rare: visual dysregulation, blurred vision, eye spinning
Unknown: vasculitis
-ear and vagal symptoms:
Unspecified: vertigo
– Gastrointestinal symptoms:
Sometimes: diarrhea
– Renal and urinary symptoms:
Very rare: difficulty urinating, enuresis
Unknown: urinary retention
– Skin and subcutaneous tissue symptoms:
Sometimes: pruritus, rash
Rare: urticaria
Very rare: angioneurotic edema, fixed drug rash
– Systemic symptoms as well as drug site symptoms:
Sometimes: weakness, discomfort
Rare: edema
– Immune system symptoms:
Rare: hypersensitivity reactions
Very rare: anaphylaxis
– Hepatobiliary symptoms:
Rare: abnormal liver function (transaminases, alkaline phosphatase, gamma-GTand elevated bilirubin)
– Metabolic and nutritional disorders:
Unknown: increased appetite
– Psychiatric symptoms:
Sometimes: agitation
Rare: aggression, confusion, depression, hallucinations, insomnia
Very rare: tics
Unknown: suicidal ideation
-Lab Tests:
Rare: weight gain
The following adverse reactions were observed after the original product received marketing authorization: pruritus after discontinuation of cetirizine and/ or urticaria after discontinuation of cetirizine.
[Contraindicated]
1. Hypersensitivity to the ingredients of this product, hydroxyzine or any other piperazine derivatives is contraindicated.
2. Contraindicated in patients with severe renal impairment.
[Precautions]
1. At therapeutic doses, no clinically significant interactions with alcohol have been demonstrated (blood alcohol level of 0.5 g/l). Despite this, alcohol should be consumed with caution when taking this product.
2. Cetirizine should be used with caution in patients with susceptibility factors for urinary retention (eg, spinal cord damage, prostatic hypertrophy), as it may increase the risk of urinary retention.
3. Caution is advised in patients with epilepsy and in those at risk for convulsions.
4. It should be used under medical supervision in patients with renal insufficiency.
5. Special care should be taken when administering to pregnant women. It is not recommended for women in the first trimester of pregnancy. Cetirizine should not be administered to women who are breastfeeding because the drug passes into breast milk.
6. Do not drive aircraft, vehicles, boats, work at heights, work with machinery, or operate precision instruments while taking the drug.
7. This product is contraindicated in allergic persons and should be used with caution in allergic persons.
8. Antihistamines can reduce the sensitivity of skin allergy test results, so the drug should be discontinued for 3 days before undergoing such tests.
9. This product is contraindicated in the event of a change in properties.
10. Keep this product out of the reach of children.
11. Children must be used under adult supervision. cetirizine hydrochloride drops are recommended for children 2-6 years of age. This product is not recommended for children under 6 years of age, as the coated tablets do not allow for accurate dose adjustment.
12. If you are using other drugs, consult your physician or pharmacist before using this product.
[Drug Interactions]
1.This product should be taken with caution with sedatives (sleeping pills) or theophylline.
2.Drug interactions may occur if used with other drugs, consult your physician or pharmacist for details.
[Storage]Sheltered, sealed, below 25℃Dry place to store
Please keep in a place that is not easily touched by children. where it is not easily touched.
[Package]Oral solid PharmaceuticalHigh Density Polyethylenebottles and Polypropylene for Oral Solids/Low-density polyethylene child-safe moisture-proof combination capbottle Package,30tablets/bottle, 1 bottle/box.
[Expiration date]24months.
[Executive Standard]
[Approval No.]State Drug Administration H19980059
[Marketing authorization holder
Company name: Yangtze River Pharmaceutical Group Co.
Registered Address: No. 1 South Yangzijiang Road, Taizhou City
Postal code: 225321
Contact: 400-988-1999
Fax number: (0523) 86976161
[Manufacturer
Company name: Yangtze River Pharmaceutical Group Co.
Production Address: No.1 South Yangzijiang Road, Taizhou, Jiangsu Province
Postal code: 225321
Phone number: 400-988-1999
Fax number: (0523) 86976161
Website: www.yangzijiang.com
Contact the manufacturer if you have any questions.