Celecoxib Capsules

Based on routine studies on multiple-dose toxicity, reproduction, teratogenicity, mutagenicity or carcinogenicity, preclinical data indicate that this drug poses no special hazard to humans.

The main ingredients of this product and their chemical names are: Celecoxib, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1-hydrogen-1-pyrazol-1-yl]benzenesulfonamide

For the treatment of the symptoms and signs of acute or chronic osteoarthritis and rheumatoid arthritis.

Adult osteoarthritis: The recommended dose is 200 mg, taken orally once or twice a day. Doses up to 400 mg per day have also been used in clinical studies. Arthritis Rheumatoid arthritis: The recommended dose is 100 mg or 200 mg twice a day. Doses up to 800 mg per day have been used in clinical studies. Elderly: No dose adjustment is required. Patients with hepatic impairment: No dose adjustment is required for patients with mild to moderate hepatic impairment, and there is no clinical experience in patients with severe hepatic impairment. Patients with renal impairment: No dose adjustment is required for patients with mild to moderate renal impairment, and there is no clinical experience in patients with severe renal impairment. Children: Celecoxib has not been clinically studied in people under 18 years of age.

Adverse reactions reported in controlled clinical trials are classified by incidence as follows: 1%, but equal to or less than placebo: Central nervous system: headache. Gastrointestinal: constipation, nausea. Others: arthralgia, back pain, insomnia, myalgia, peripheral pain, pruritus. 1%, incidence higher than placebo (% in brackets is the percentage higher than placebo): Central nervous system: dizziness (0.4%). Gastrointestinal: abdominal pain (1.8%), diarrhea (2.3%), indigestion (2.2%), flatulence (1.2%), dental disease (0.1%), vomiting (0.6%). Respiratory: bronchitis (0.2%), cough (0.7%), pharyngitis (1.2%), rhinitis (0.6%), sinusitis (0.1%), upper respiratory tract infection (0.2%). Others: accidental injury (0.4%), aggravated allergy (0.2%), flu-like symptoms (0.4%), peripheral edema (0.4%), rash (0.1%), urinary tract infection (0.2%). In clinical studies with more than 3,000 patient-years, no causal relationship between this product and fatal, serious or rare adverse reactions has been confirmed.

Allergic to any ingredient in this product. Known allergic to sulfonamide.

Precautions for children: Celecoxib has not been clinically studied in people under 18 years of age. Precautions for pregnancy and lactation: There is no information on the use of this product during pregnancy. Pregnant women can only consider using this product for treatment when the potential benefits outweigh the harm to the fetus. The effects on early embryos observed in animal experiments are mainly related to the inhibition of COX-2, such as miscarriage before and after embryo implantation, but have no effect on long-term reproductive function. Teratogenic studies have found that celecoxib has no teratogenic effect on rabbits. In one of the two experiments conducted in rats, it was found that when the dosage was 7 times the highest dose (i.e., 400 mg per day), diaphragmatic hernia related to the dose of celecoxib could be found. Celecoxib has no adverse effects on delivery and does not cause dystocia. Preclinical studies have confirmed that celecoxib can pass through the placenta. Studies conducted in rats have shown that celecoxib can be secreted through breast milk at concentrations similar to plasma concentrations. Since similar studies have not been conducted in humans, this product should not be used in lactating women. Precautions for the elderly: No dosage adjustment is required.

In vitro and in vivo tests have confirmed that celecoxib is mainly metabolized by cytochrome P450-CYP2C9. In tests on healthy male volunteers, fluconazole (a CYP2C9 inhibitor) can inhibit the metabolism of celecoxib, thereby approximately doubling its plasma concentration, while Tmax and half-life have no significant changes. Because celecoxib has a wide therapeutic window, there is no need to adjust the dose of celecoxib when these two drugs are used together. There is no obvious interaction between ketoconazole (a CYP3A4 inhibitor) and celecoxib. In the interaction study of this product with other substances metabolized by CPY2C9 conducted in healthy volunteers, it was confirmed that when this product was used in combination with phenytoin or tolbutamide, its pharmacokinetics did not produce clinically significant changes. In addition, this product did not affect the pharmacodynamics or pharmacokinetics of warfarin. In patients with rheumatoid arthritis who had received stable doses of methotrexate for at least 3 months, there was no significant effect on the bioavailability and renal elimination rate of methotrexate after 7 days of co-administration with this product. In healthy volunteers, this product has no clinically significant pharmacokinetic effect on lithium cleared by the kidneys. This product shows non-concentration-dependent protein binding and has no interaction with highly protein-bound drugs such as warfarin and glibenclamide. Antacids (aluminum and magnesium) can reduce the absorption of celecoxib by 10%, but do not affect its clinical effect.

Sealed and stored at room temperature.

24 months