Product Overview
【Drug Name】
Generic Name: Cetirizine Hydrochloride Tablets
Brand Name: Shidi Cetirizine Hydrochloride Tablets 10mg*12 tablets
Pinyin Code: ShiDi YanSuanXiTiLiZuoPian 10mg*12Pian
【Main Ingredients】
The main ingredient of this product is cetirizine hydrochloride. Excipients include lactose, microcrystalline cellulose, starch, magnesium stearate, etc.
【Appearance】
This product is a film-coated tablet. After removing the coating, the tablet is white or off-white.
【Indications/Main Functions】
Symptomatic treatment of seasonal rhinitis, perennial allergic rhinitis, allergic conjunctivitis, and itching and urticaria caused by allergies.
【Specifications】
10mg*12 tablets (Shidi)
【Dosage and Administration】
Oral administration. Recommended for adults and children over 2 years of age.
Adults: Take one tablet once a day with a small amount of liquid at dinner. If sensitive to adverse reactions, take half a tablet twice a day, morning and evening.
Children aged 6-12 years: Take one tablet once a day; or half a tablet twice a day.
Children aged 2-6 years: Take half a tablet once a day; or 1/4 tablet twice a day.
【Adverse Reactions】
Mild and transient adverse reactions include drowsiness, lethargy, headache, dizziness, agitation, dry mouth, and gastrointestinal discomfort. Occasionally, a slight increase in aspartate aminotransferase may occur.
【Contraindications】
1. Contraindicated in patients with known hypersensitivity to this product.
2. Contraindicated in patients with severe renal impairment.
【Precautions】
1. Dosage should be halved in patients with renal impairment.
2. Avoid use after drinking alcohol.
3. Use with caution if you are a driver, operator of machinery, or working at heights.
【Drug Interactions】
No drug interactions have been reported, but caution should be exercised when taking sedatives concurrently.
【Pediatric Use】
Not yet clear.
【Use in Elderly Patients】
Dosage adjustments for elderly patients should be made based on liver and kidney function.
【Use in Pregnant and Lactating Women】
Contraindicated in pregnant and lactating women.
【Overdosage】
There is no specific antagonist for this drug. Patients with severe overdosage should undergo immediate gastric lavage, supportive therapy, and close long-term monitoring of their condition.
【Pharmacology and Toxicology】
This product is a selective histamine H1 receptor antagonist. Animal studies have shown that this product has no significant anticholinergic or anti-serotonin effects and does not readily cross the blood-brain barrier to act on central H1 receptors. In clinical use, the central nervous system depressant effect is relatively mild.
【Pharmacokinetics】
According to reports, it is absorbed from the gastrointestinal tract after oral administration. In healthy adults, a single oral dose of 10 mg cetirizine results in a peak plasma concentration (tmax) of 30–60 minutes and a peak plasma concentration of 300 ng/ml. Cetirizine has a high plasma protein binding rate. Its plasma half-life is approximately 10 hours, with about 70% excreted unchanged in the urine and a small amount excreted in the feces.
【Storage】
Protect from light and keep tightly closed. Store in a dry place.
【Packaging】
Aluminum-aluminum blister packaging
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H19990321
【Manufacturer】
Qilu Pharmaceutical Co., Ltd.
