Cefixime Capsules

1. This product is an oral third-generation cephalosporin with a broad antibacterial spectrum. It has antibacterial activity against some 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 influenza bacilli among Gram-negative bacteria. Its mechanism of action is bactericidal. 2. This product has strong stability against beta-lactamase produced by various bacteria, and shows superior antibacterial activity against bacteria that produce beta-lactamase. 3. The mechanism of action of this product is to prevent the synthesis of bacterial cell walls. Its action point varies depending on the type of bacteria. It has a high affinity with 1 (1a, 1b, 1c) and 3 in penicillin binding protein (PBP).

The main ingredient of this product is cefixime.

Hard capsule, the contents are white to light yellow powder.

This product is suitable for the following bacterial infectious diseases caused by streptococci (except enterococci) that are sensitive to cefixime, pneumococci, gonococci, Branhamella catarrhalis, Escherichia coli, Klebsiella, Serratia, Proteus and influenza bacilli: 1. Bronchitis, bronchiectasis (when infected), secondary infection of chronic respiratory system infections, pneumonia; 2. Pyelonephritis, cystitis, gonococcal urethritis; 3. Cholecystitis, cholangitis; 4. Scarlet fever; 5. Otitis media, sinusitis.

1. Adults and children weighing more than 30 kg: Oral, 50~100 mg (titer) each time, twice a day. In addition, it can be 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, oral, 1.5~3 mg (titer)/kg (body weight) each time, twice a day. In addition, it can be 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.

Clinical research data show that the main adverse reactions of this product include digestive tract reactions such as diarrhea (0.87%), skin symptoms such as rash (0.23%), and abnormal clinical examination values (including increased GPT (0.61%), increased GOT (0.45%), and eosinophilia (0.20%)). The details are as follows: 1. Serious adverse reactions: (1) Shock: There is a possibility of causing 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 stopped and appropriate measures should be taken. (2) Allergic 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 stopped and appropriate measures should be taken. (3) Skin lesions: There is a possibility of developing skin, mucosal and ocular syndrome (Stevens Johnson syndrome (0.1%), toxic epidermal necrolysis (i.e. Lyell syndrome, 0.1%). Close observation is required. If fever, headache, joint pain, skin or mucosal erythema, blisters, skin tension, burning sensation, pain, etc. occur, the drug should be stopped and appropriate measures should be taken. (4) Blood disorders: There is a possibility of developing agranulocytosis (0.1%, early symptoms: fever, sore throat, headache, fatigue, etc.), hemolytic anemia (0.1%, early symptoms: fever, hemoglobinuria, anemia, etc.), blood There is a possibility of cytopenia (0.1%, early symptoms: punctate hemorrhage, purpura, etc.), and there are also reports of pancytopenia like other cephalosporin antibiotics, so close observation is required, such as regular examinations, etc. If any abnormality occurs, the drug should be discontinued and appropriate measures should be taken. (5) Renal dysfunction: There is a possibility of causing severe renal dysfunction such as acute renal insufficiency (0.1%), so close observation is required, such as regular examinations, etc. If any abnormality occurs, the drug should be discontinued and appropriate measures should be taken. (6) Colitis: It may cause severe colitis with bloody stools such as pseudomembranous colitis (0.1%). If there is If abdominal pain or recurrent diarrhea occurs, the drug should be stopped immediately and appropriate measures should be taken. (7) There is a possibility of interstitial pneumonia (with symptoms such as fever, cough, dyspnea, abnormal chest X-ray, eosinophilia, etc.) and PIE syndrome (both 0.1%). If the above symptoms occur, the drug should be stopped and appropriate measures such as glucocorticoids should be taken. 2. Other adverse reactions (1) Allergic reactions: rash, urticaria, erythema (0.1-5%); itching, fever, edema (0.1%) (2) Blood: eosinophilia (0.1-5%); granulocytopenia (0.1%) (3) Liver: GOT increase , GPT increased, AL-P increased (0.1-5%); jaundice (0.1%) (4) Kidney: BUN increased (0.1%) (5) Digestive system: diarrhea, stomach discomfort (0.1-5%); nausea, vomiting, abdominal pain, chest burning sensation, loss of appetite, abdominal fullness, constipation (0.1%) (6) Dysbacteriosis: stomatitis, oral candidiasis (0.1%) (7) Vitamin deficiency: Vitamin K deficiency (hypoprothrombinemia, bleeding tendency, etc.), vitamin B deficiency (glossitis, stomatitis, loss of appetite, neuritis, etc.) (0.1%) (8) Others: headache, dizziness (0.1%)

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

Precautions for children: The safety and efficacy of cefixime for children under 6 months of age have not been determined. Precautions for pregnancy and lactation: Reproductive studies in mice and rats at doses up to 400 times the human dose showed no evidence of damage to fetal mice. The safety of the drug during pregnancy has not been determined, so when using the drug for pregnant women or women who may become pregnant, the pros and cons must be weighed, and the drug can only be used when the benefits outweigh the cons. The effect of cefixime on delivery has not been studied, and it can only be used when it is clearly needed. It is unclear whether cefixime is excreted in human milk. When using this product, consider suspending breastfeeding. Precautions for the elderly: 1. The peak blood concentration and AUC of this product in the elderly can be 26% and 20% higher than those in young people, respectively, and the elderly can use this product. 2. Patients with renal insufficiency should adjust the dosage, and patients with a creatinine clearance of ge; 60ml/min can use it according to the normal dose and course of treatment. Patients with a creatinine clearance of 21~60ml/min or hemodialysis can be given at 75% of the standard dose (standard dosing interval). Patients with creatinine clearance of 20 ml/min or long-term bedridden peritoneal dialysis can be given half the standard dose (standard dosing interval).

When used with warfarin, there is a possibility that the effect of warfarin may be enhanced. However, there are no case reports on this preparation. Mechanism: Intestinal bacteria cause inhibition of vitamin K synthesis.

Keep in a dark, sealed container, and stored in a cool, dark (no more than 20°C) dry place.

0.1g (calculated as C16H15N5O7S2)

24 months

Yunnan HAOPY Pharmaceutical Co., Ltd.

• Founded in:

  2000-08-30

• Address:

  No. 555, Dengzhanhua Street, Kunming New Town High-tech Industrial Base, Kunming City, Yunnan Province

• Tax NO.:

  91530000725282180K

• Registered Funds:

  58.761772 million yuan

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