Cefixime Dispersible Tablets

1. Pharmacological action: This product is a third-generation cephalosporin with a broad antibacterial spectrum. It has antibacterial activity against both Gram-positive and Gram-negative bacteria, especially against Streptococcus (except Enterococcus) and Pneumococcus among Gram-positive bacteria, and gonococci, Branhamella, Escherichia coli, Klebsiella, Serratia, Proteus, and Haemophilus influenzae among Gram-negative bacteria. Its mechanism of action is to prevent the synthesis of bacterial cell walls. Its action point varies with the type of bacteria. It has a high affinity with PBP1 (1a, 1b, 1c) and PBP3 among penicillin-binding proteins (PBP). This product has strong stability against beta-lactamase produced by various bacteria. 2. Reproductive toxicity: SD rats were orally administered 100-1000 mg/kg before pregnancy and in the early stages of pregnancy, and 320-3200 mg/kg during the period of organogenesis, perinatal period, and lactation. There was no effect on the fertility of the rats, no teratogenic effects were observed, and no abnormalities were found in the growth, development, and reproductive ability of the newborn rats.

The main ingredient of this product is cefixime.

This product is a film-coated tablet, which appears white or slightly yellow after removing the coating.

This product is effective for the following infections caused by streptococci (except enterococci) that are sensitive to cefixime, pneumococci, gonococci, catarrhalis, Escherichia coli, Klebsiella, Serratia, Proteus, influenza bacilli, etc. Acute exacerbation of chronic bronchitis, acute bronchitis with bacterial infection, bronchial tube dilatation with infection, pneumonia, pyelonephritis, cystitis, gonococcal urethritis, acute bacterial infection of the biliary system (cholecystitis, cholangitis), scarlet fever; otitis media, sinusitis.

Oral administration: can be taken directly with water, or add this product to an appropriate amount of warm boiled water and wait for dispersion and dissolution (can be stirred) before taking. 1. Adults and children weighing more than 30 kg: 50-100 mg (titer) each time, twice a day. In addition, it can be appropriately increased or decreased according to age, weight, and symptoms. For critically ill patients, 200 mg (titer) can be taken orally each time, twice a day. 2. Children: 1.5-3 mg (titer)/kg (body weight) each time, twice a day. In addition, it can be appropriately increased or decreased according to symptoms. For critically ill patients, 6 mg (titer)/kg (body weight) can be taken orally each time, twice a day.

Among the total 12,879 cases, adverse reactions including abnormal clinical examination values were found in 294 cases (2.58%). These adverse reactions included digestive tract symptoms such as diarrhea in 112 cases (0.87%), skin symptoms such as rash in 29 cases (0.23%), and abnormal clinical examination values including increased GPT in 78 cases (0.61%), increased GOT in 58 cases (0.45%), and increased eosinophilia in 26 cases (0.20%). 1. Serious adverse reactions: (1) Shock: Due to the possibility of shock (0.1%), close observation should be made. If discomfort, abnormal sensation in the mouth, asthma, dizziness, urge to defecate, tinnitus, sweating, etc. occur, the drug should be discontinued and appropriate measures should be taken. (2) Allergic-like symptoms: There is a possibility of allergic-like symptoms (including dyspnea, systemic flushing, angioedema, urticaria, etc.) (0.1%). Close observation should be made. If abnormalities occur, the drug should be discontinued and appropriate measures should be taken. (3) Skin lesions: There is a possibility of skin mucosal eye syndrome (Stevens-Johnson syndrome, (0.1%), toxic epidermal necrolysis (Lyell syndrome, 0.1%). Close observation is required. If fever, headache, joint pain, skin or mucosal erythema, blisters, skin tension, burning sensation, pain and other symptoms occur, the drug should be stopped and appropriate treatment should be taken. 2. Other adverse reactions with an incidence of 0.1-5% are common, and those below 0.1% are rare. (1) Allergy: Common rash, urticaria, erythema, rare itching, fever, edema, (2) Blood: Common (0.1-5%) eosinophilia, rare neutropenia. (3) Liver: Common elevation of alanine aminotransferase (ALP/GPT), elevated alanine aminotransferase (ALP/GOT), rare jaundice, etc.

Patients with a history of allergy to this product or cephalosporin antibiotics are contraindicated.

Precautions for children: The safety and efficacy of cefotaxime for children under 6 months of age have not been determined. Precautions for pregnancy and lactation: The safety and efficacy of this product for pregnant women have not been established. Use this product only when it is really necessary. It is not clear whether this product is secreted from breast milk. Breastfeeding should be suspended when it is necessary. Precautions for the elderly: The peak blood concentration and AUC of this product in the elderly can be 26% and 20% higher than those in young people, respectively. Elderly patients can use this product.

1. Carbamazepine: When used in combination with this product, it may cause an increase in carbamazepine levels. When used in combination, the plasma carbamazepine concentration should be monitored. 2. Warfarin and anticoagulant drugs: When used in combination with this product, the prothrombin time will increase.

Light-proof and sealed.

Calculated as C16H15N5O7S2 50mg

24 months

NCPC Hebei HUAMIN Pharmaceutical Co., Ltd.

• Founded in:

  2010-04-28

• Address:

  No. 98, Hainan Road, Shijiazhuang Economic and Technological Development Zone

• Tax NO.:

  91130182554463533P

• Registered Funds:

  1.450139 million yuan

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