Cefaclor Dispersible Tablets

Toxic symptoms after taking an overdose of cefaclor include nausea, vomiting, upper abdominal discomfort and diarrhea, the severity of which is dose-related. If other symptoms are present, they may be secondary to the original disease, allergic reaction or other toxic effects. When treating drug overdose, the possibility of multiple drug overdose, drug interactions and individual differences in patient pharmacokinetics should be considered. Unless five times the normal dose of cefaclor is taken, it is not necessary to clear the excess drug from the gastrointestinal tract. Pay attention to protecting the patient's airway and maintaining ventilation and perfusion. Closely monitor and maintain the patient's vital signs, blood gas and serum electrolytes within an acceptable range. Giving activated carbon can reduce the absorption of drugs through the gastrointestinal tract. Activated carbon is more effective than vomiting and lavage in many cases. Consider using activated carbon instead of gastric emptying, or in addition to gastric emptying. Multiple administrations of activated carbon may accelerate the elimination of some absorbed drugs. When performing gastric emptying or giving activated carbon, pay attention to protecting the patient's airway. Forced catheterization, peritoneal dialysis, hemodialysis, or carbon hemoperfusion have not been shown to be beneficial in the setting of cefaclor overdose.

The main ingredient is cefaclor: (6R,7R)-7-[(R)-2-amino-2-phenylacetylamino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate

This product is off-white to slightly yellow tablets

This product is mainly suitable for respiratory system, urinary system, ENT, skin and soft tissue infections caused by sensitive bacteria.

This product is suitable for oral administration on an empty stomach. The usual dosage for adults is 0.25g once, 3 times a day. The dosage for patients with severe infection can be doubled, but the total daily dosage should not exceed 4g. For children, the dosage is 20mg/kg per day, divided into 3 times. For severe infection, the dosage can be increased to 40mg/kg, but the total daily dosage should not exceed 1g.

Allergic reactions: According to reports, about 1.5% of patients, including urticarial rash (1/100). Itching, urticaria and positive Coombs test, the incidence is less than 1/200. Serum sickness-like reactions have been reported with the use of cefaclor. This reaction is characterized by the appearance of erythema multiforme, rash and other skin manifestations accompanied by arthritis/arthralgia, fever or no fever. It differs from typical serum sickness in that it is rarely associated with lymphadenopathy and proteinuria, there is no immune complex entering the circulation, and there is no sign of sequelae of the reaction. People are conducting in-depth research. Serum sickness-like reactions seem to be due to allergy and often occur during or when entering the second course of cefaclor. Such reactions have been reported more frequently in children than in adults, with an overall incidence of 1 in 200 cases (0.5%) in a centralized trial and 2 in 8346 cases (0.024%) in total clinical trials [0.055% in children in individual clinical trials and 1 in 38,000 cases (0.003%) in reports of adverse events]. Signs and symptoms appear within a few days of starting treatment and resolve within a few days of stopping treatment. Such reactions occasionally lead to hospitalization, but hospitalization is usually brief (average length of stay based on postmarketing surveillance studies is 2 to 3 days). Among those patients who require hospitalization, symptoms range from mild to severe at the time of admission, with a greater incidence of severe reactions in children. Antihistamines and glucocorticoids appear to be useful for symptom relief, and no serious sequelae have been reported. More severe allergic reactions (including Stevens-Johnson syndrome, toxic epithelial necrolysis, and anaphylaxis) have been reported rarely and may occur more frequently in patients with a history of penicillin allergy. Gastrointestinal symptoms: Approximately 2.5% of cases, soft stools, stomach discomfort, loss of appetite, nausea, vomiting, belching, including diarrhea (1 in 70 cases). Pseudomembranous colitis: May occur during or after antibiotic treatment. Transient hepatitis and cholestatic jaundice are rarely reported. Other treatment-related side effects include: eosinophilia (1 in 50 cases). Genital itching or vaginitis (less than 1 in 100 cases), thrombocytopenia or reversible interstitial nephritis are rarely reported.

1. People who are allergic to this product and other cephalosporins; 2. Pregnant and lactating women should use with caution.

Precautions for children: The efficacy and safety of this product for infants under one month have not been established. Precautions for pregnancy and lactation: Pregnant women: Multiple reproductive studies have been conducted on mice and rats, with doses as high as 12 times the human dose, and the dose of ferret studies was three times the maximum human dose. The results showed no evidence that cefaclor impairs fertility or endangers the fetus. However, there are no adequate and strictly controlled clinical studies on pregnant women. Because animal reproductive studies cannot fully predict human responses, pregnant women should not use this product unless it is necessary. Delivery: The effect of cefaclor on delivery is unclear. Lactating women: After a lactating woman takes a single oral dose of cefaclor 500 mg, a small amount of cefaclor can be detected in breast milk, with average levels of 0.18, 0.20, 0.21 and 0.16 mg/L at 2, 3, 4 and 5 hours after taking it, respectively, and trace amounts of the drug are detected in the first hour. The effect of this product on infants is unknown. Be cautious when using cefaclor in lactating women. Precautions for the elderly: According to literature reports, compared with healthy adult subjects under 45 years old, 40-45% of healthy elderly subjects (over 65 years old) who took 750 mg of cefaclor alone had high AUC and 20% had low renal clearance. These differences are mainly caused by age-related functional kidney diseases. In clinical studies, when elderly patients take the recommended adult dose, the clinical effect and safety are similar to those of adult patients, and there is no difference in the dose taken by elderly patients. Therefore, unless the elderly patient is weak, malnourished or has severe renal impairment, there is generally no need to adjust the dose.

1. Antacids: If this product is taken within 1 hour of using aluminum hydroxide or magnesium hydroxide, the absorption of this product will be reduced. H2 receptor antagonists will not change the absorption degree and rate of this product. 2. Probenecid: Probenecid can reduce the renal excretion rate of this product. 3. Warfarin: When this product is used in combination with warfarin, there are few clinical reports that the prothrombin time will be prolonged, with or without bleeding. At present, there is no special research to explore the role in this regard. 4. Furosemide, ethacrynic acid, bumetanide and other strong diuretics, carmustine, streptozocin and other anti-tumor drugs and aminoglycoside antibiotics and other nephrotoxic drugs used in combination with this product may increase nephrotoxicity. 5. Clavulanic acid can enhance the antibacterial activity of this product against certain Gram-negative bacteria that are resistant to this product due to the production of β-lactamase. Laboratory test: The use of this product will cause a false positive reaction of glucose in the urine. This phenomenon has also been observed in patients taking cephalosporins when the test was performed with Benedict's and Fehling's solutions, and also with Clinitest tablets.

Keep away from light, seal tightly, and store in a cool, dark and dry place.

0.25 g in terms of C15H14ClN3O4 flakes.

24 months

Kinhoo Pharmaceutical Co., Ltd.

• Founded in:

  2005-04-18

• Address:

  Zhuhai Golden Coast Bio-Industrial Zone

• Tax NO.:

  914404007740042759

• Registered Funds:

  65.6 million yuan

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