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Cefixime dry suspension

Product description
Approved date: March 16, 2007
 
Cefixime dry suspension instructions
 
 Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
 
  Common name: Cefixime dry suspension
 
  English name: Cefixime for Suspension
 
  Pinyin: Toubaokewo Ganhunxuanji
 
[Ingredients] The main component of this product is cefixime, the chemical name is (6R,7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-(carboxymethoxyimine Acetylamino-3-ethene-8-oxo-5-thia-l-azabicyclo[4.2.0]oct-2-en-2-carboxylic acid trihydrate.
 
  Molecular formula: C16H15N507S2·3H2O
 
  Molecular weight: 507.49
 
【Properties】 This product is white or white-like particles, which is aromatic and sweet.
 
[indications]
 
    Caused by cephalosporin-sensitive bacteria in Streptococcus (except Enterococcus), pneumococcus, Neisseria gonorrhoeae, catarrhalis, Escherichia coli, Klebsiella, Serratia, Proteus, and Influenza The following infections are valid:
 
    ● acute exacerbation of chronic bronchitis, acute bronchitis complicated with bacterial infection, bronchiectasis, infection, pneumonia;
 
    ●Pyelonephritis, cystitis, gonococcal urethritis;
 
    ● bacterial infection of the acute biliary system (cholecystitis, cholangitis);
 
    ● Scarlet fever;
 
    ● otitis media, sinusitis.
 
[Specification] 50mg (according to C16H15N507S2)
 
[Usage and Dosage] Add 20ml of water when taking it.
 
    Adults and children weighing more than 30 kg: Oral, 50 ~ 100mg each time (1 ~ 2 bags), twice a day; adult severe infection can be increased to 200mg (4 bags) each time, twice a day.
 
   Children: Oral, the dosage is reduced by half for adults, or 1.5 to 3.0 mg per kilogram, calculated twice daily, or as directed by a physician.
 
【Adverse reactions】
 
    Of the 12,879 cases, a total of 294 (2.58%) adverse events including abnormal clinical findings were found. These adverse reactions included 112 cases (0.87%) of gastrointestinal symptoms such as diarrhea and 29 cases (0.23%) of skin symptoms such as rash. In addition, abnormal clinical examination values ​​included 78 cases of GPT (0.61%) and 58 cases of GOT ( 0.45%), 26 cases (0.20%) of eosinophilia.
 
  (1) Serious adverse reactions:
 
    1 shock: due to the possibility of shock (<0.1%), should be closely observed, if there is discomfort, abnormal mouth, asthma, dizziness, constipation, tinnitus, sweating, etc., should stop dosing, take appropriate treatment ;
 
    2 allergic symptoms: there are allergic symptoms (including difficulty breathing, systemic flushing, angioedema, urticaria)
 
The possibility of () 0.1% (<0.1%) should be closely observed, if there is an abnormality, stop the administration and take appropriate treatment;
 
    3 skin lesions: the possibility of skin and mucous membrane eye syndrome (Stevens-Johnson syndrome, <0.1%), toxic epidermal necrosis (Lyell syndrome, <0.1%), should be closely observed, if there is fever, headache, joints Symptoms such as pain, skin or mucous membrane erythema, blisters, skin tension, burning sensation, pain, etc. should be stopped and appropriate treatment should be taken;
 
    4 blood disorders: there is agranulocytosis (<0.l%, early symptoms: fever, sore throat, headache, burnout, etc.), hemolytic anemia (<0.1%, early symptoms: fever, hemoglobinuria, anemia, etc. Symptoms), thrombocytopenia (<0.1%, early symptoms: punctiform hemorrhage, purple spot, etc.), and other cephalosporin antibiotics cause a report of complete cytopenia, so should be closely observed, such as regular inspections, etc., abnormal Do not stop the administration when it occurs, and take appropriate treatment;
 
    5 renal dysfunction: due to the possibility of acute renal dysfunction such as acute renal insufficiency (<0.l%), so should be closely observed, such as regular inspections, etc., if abnormalities occur, should stop taking, take Proper disposal;
 
    6 colitis: may cause severe colitis with bloody stools, such as pseudomembranous colitis (<0.1%). If abdominal pain or repeated diarrhea occurs, the drug should be stopped immediately and appropriate treatment should be taken;
 
  7 interstitial pneumonia, PIE syndrome: the possibility of interstitial pneumonia with symptoms of fever, cough, dyspnea, chest X-ray abnormalities, eosinophilia, PIE syndrome (<0.1%, respectively), If the above symptoms occur, the administration should be stopped, and appropriate treatment such as glucocorticoid administration should be taken.
 
  (2) Other adverse reactions
 
   The incidence of adverse reactions is 0.1 to 5%, and it is rare to be below 0.1%.
 
   Allergies: common rash, urticaria, erythema, rare itching, fever, edema;
 
   Blood: common (0.1 to 5%) eosinophilia, rare neutropenia;
 
   Liver: common alanine aminotransferase (ALP/GPT) increased, alanine aminotransferase (AST/GOT) increased, rare jaundice;
 
  Kidney: Rarely elevated urea nitrogen (BUN);
 
  Digestive system: common diarrhea, stomach discomfort, rare nausea, vomiting, abdominal pain, chest burning, loss of appetite, fullness of the abdomen, constipation;
 
  Flora disorders: rare stomatitis, oral candidiasis;
 
  Vitamin deficiency: rare vitamin K deficiency (low prothrombinemia, bleeding tendency, etc.), vitamin B deficiency (tongueitis, stomatitis, loss of appetite, neuritis, etc.);
 
  Other: headache, dizziness.
 
[Contraindications] Those who are allergic to this product or other cephalosporin antibiotics.
 
【Precautions】
 
  (1) In order to prevent the emergence of drug-resistant strains, sensitivity should be confirmed in principle before using this product, and the dose should be controlled to the minimum dose required to control the disease.
 
  (2) For patients with severe renal dysfunction, since the drug can maintain the concentration in the blood, it should be appropriately reduced according to the renal function, and the interval of administration should be appropriately increased.
 
  (3) The following patients are carefully administered:
 
    1 patient with a history of allergies to penicillins.
 
    2 I, a parent or a brother, have a constitution that is susceptible to bronchial asthma, rash, urticaria and other allergic symptoms.
 
    3 patients with severe renal dysfunction.
 
    4 patients with difficult oral or non-oral nutrition, patients with systemic dyscrasia. (Because there are symptoms of vitamin K deficiency, you should pay attention to observation).
 
  (4) Due to the possibility of shock, a full medical history should be asked before administration.
 
  (5) Do not mix milk, juice, etc. with the medicine.
 
  (6) Impact on clinical test results:
 
    1 In addition to the test paper reaction, Benedict reagent, Fehling reagent, urine glucose test pellet (Clinitest)
 
For urine sugar tests, the possibility of false positives should be noted.
 
    2 There is a possibility that the direct Coombs test is positive and should be noted.
 
[Pregnant women and lactating women] The safety and effectiveness of this product in pregnant women has not been established. Use this product only when it is really needed. It is not clear whether this product is secreted from milk. .
 
[Children's medication] The safety of premature infants and neonatal medications has not been established (no experience).
 
[Geriatric medication] elderly patients with medication to reduce.
 
【medicine interactions】
 
Carbamazepine: When combined with this product, it can cause the level of carbamazepine to rise. When combined, the concentration of carbamazepine in plasma should be monitored.
 
Warfarin and anticoagulant drugs: increase prothrombin time when used in combination with this product.
 
[Drug overdose] gastric lavage, no special detoxification drugs, hemodialysis and peritoneal dialysis can not effectively remove this product.
 
【Pharmacology and Toxicology】
 
  Pharmacological action
 
    This product is oral third-generation cephalosporin with broad antibacterial spectrum and antibacterial activity against some Gram-positive and negative bacteria.
 
Especially for Streptococcus (except Enterococcus), pneumococcal, Gram-negative bacteria in Gram-positive bacteria,
 
Branham's cocci, coliform, Klebsi, Serratia, Proteus, Influenza, etc. have strong antibacterial properties
 
Use, its mechanism of action is to prevent the synthesis of bacterial cell walls, the role of which varies with the type of bacteria, and penicillin binding protein
 
PBP1 (la, 1b, 1c) and PBP3 have higher affinity in (PBP). This product has strong stability to β-lactamase produced by various bacteria.
 
  Toxicological research
 
    Reproductive toxicity: SD rats were orally administered 100-1000 mg/kg before and during the first trimester of pregnancy. Oral administration of 320-3200 mg/kg during organogenesis, perinatal period, and lactation did not affect fertility in rats. No teratogenic effects were observed, and no abnormalities were found in the growth, development and reproductive capacity of newborn rats.
 
【Pharmacokinetics】
 
    According to PDR57 version: after oral administration of cefixime, its absolute bioavailability is 40-50%, which is not affected by diet. The cefixime tablet 200mg was administered orally in a single dose, and the peak plasma concentration was 3.7 μg/ml. The peak concentration of the oral dose of the oral cefixime suspension was 25% to 50% higher than that of the tablet. The average peak concentration of cefixime 200mg suspension and 400mg suspension was 3 μg/ml and 4.6μg/ml, oral cefixime suspension 100mg to 400mg, time-concentration curve area ratio oral oral dose The agent is 10% to 25% higher, and the suspension dosage form should be considered for its increased absorption. The peak time of a single oral 200 mg tablet, 400 mg tablet, and 400 mg suspension is 2 to 6 hours, and the peak time of a single oral 200 mg suspension is 2 to 5 hours. 50% of the absorbed drug within 24 hours is excreted from the urine in its original form. The serum protein binding rate was 65%, and the drug was administered for 14 days. No accumulation of cefixime was found in the body. The plasma half-life of cefixime is 3 to 4 hours, but it can be up to 9 hours in some volunteers, regardless of the dosage form.
 
    Special population pharmacokinetics
 
    Elderly patients: The mean AUCs at steady state are about 40% higher than normal adults.
 
    Subjects with renal insufficiency: When the creatinine clearance rate was 20-50 ml/min, the average serum half-life of cefixime was extended to 6.4 hours; when the creatinine clearance rate was 5-20 ml/min, the average serum half-life of cefixime was extended to 11.5 hours.
 
    Hemodialysis and peritoneal dialysis: Cefixime cannot be effectively removed from the blood. But there are also literature tips for hemodialysis.
 
The patient, taking a 400 mg dose of cefixime, had similar changes in blood and subjects with a creatinine clearance level of 21 to 60 ml/min.
 
[Storage] shading, sealed, and stored in a cool place (not more than 20 ° C).
 
[Packing] aluminum-plastic composite bag, 6 bags per box; 8 bags per box; 10 bags per box; 12 bags per box.
 
[Validity Period] tentatively 24 months
 
[Executive Standards] National Food and Drug Administration Standards (Trial) YBH07912004
 
[Approval No.] National Drug Standard H20040810
 
【manufacturer】
 
  Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
 
  Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
 
  Postal code: 529331
 
  Phone number: (0750) 2787017
 
  Fax number: (0750) 2787017
 
  Website: http://www.pdpharm.com
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