Cefpirome Sulfate for Injection

This product has a broad spectrum of antibacterial activity against Gram-positive and Gram-negative bacteria, especially against Escherichia coli, Klebsiella, Haemophilus influenzae, Proteus and Bacteroides fragilis. Its mechanism of action is to show a strong affinity for penicillin-binding protein, which is the usual site of action of β-lactam antibiotics, inhibit cell wall synthesis, bind to peptidoglycan, inhibit the binding of peptidoglycan to lipoprotein to promote bacteriolysis, and show a strong bactericidal effect in a short time. This product shows antibacterial effect on bacteria during the proliferation period and the early stage of the stable period, and has a bactericidal effect at concentrations lower than the MIC, and lyses bacteria in a short time. The in vivo antibacterial effect is stronger than the prediction of the MIC. This product has no effect on the reproductive capacity of rat mothers, the development and differentiation of offspring, and the reproductive capacity when injected with 200-1600 mg/kg/day. Rabbits were injected with 400-1600 mg/kg/day for 5 days. In the group with more than 800 mg/kg/day, the nephrotoxicity was observed to be weaker than cefazolin, but slightly stronger than cephalothin. There is almost no antigenicity to mice, rats, guinea pigs and rabbits. There is no immunological cross-reactivity with cefmetazole, cefazolin, penicillin G and ampicillin, and no positive Coombs' reaction is observed.

The main ingredient of this product is cefpirome sulfate. Its chemical name is: (6R,7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-methoxyiminoacetylamino]-3-(6,7-dihydro-5H-cyclopenta[b]pyridin-1-ylmethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxy monosulfate.

This product is white to slightly yellow crystalline powder.

This product can be used to treat the following infections caused by the above-mentioned sensitive bacteria: 1. Respiratory system infections: tonsillitis, peritonsillar abscess, bronchitis, bronchiolitis, bronchiectasis (infection), secondary infection of chronic respiratory diseases, pneumonia, pulmonary suppuration. 2. Urinary system infections: pyelonephritis, cystitis. 3. Abdominal infections: cholecystitis, cholangitis, peritonitis. 4. Pelvic infections: pelvic peritonitis, adnexitis, intrauterine infection, pelvic dead cavity inflammation, parametrial tissue inflammation. 5. Sepsis.

This product is only for intravenous injection or intravenous drip. Intravenous injection: During intravenous injection, each 1g (titer) of the drug can be dissolved with 20ml of water for injection, 5%-10% glucose injection or 0.9% sodium chloride injection. Intravenous drip: During intravenous drip, each 1g (titer) of the drug can be dissolved with 100-500ml of 5%-10% glucose injection or 0.9% sodium chloride injection, and drip for 1-2 hours. The recommended common dose is: 1g (titer) each time for adults, twice a day, which can be increased or decreased appropriately with age and symptoms. For sepsis, refractory or severe infections, it can be increased to 6g (titer) per day, divided into 3-4 doses; children are measured by weight 20mg (titer)/kg each time, 3-4 times a day. This product should be prepared temporarily and used as soon as possible after dissolution.

The following adverse reactions have been observed after this product was put on the market: Incidence: Occasionally: less than 0.1%, sometimes: 0.1-5%, common: more than 5% or unknown frequency. 1) Serious side effects ① Shock Occasionally shock occurs, so you should observe carefully. If you experience discomfort, foreign body sensation in the mouth, wheezing, dizziness, urge to defecate, tinnitus, sweating, etc., you should stop the drug and deal with it appropriately. ② Pancytopenia Occasionally pancytopenia occurs, so you should check regularly and observe carefully. If abnormalities occur, you should stop the drug and deal with it appropriately. ③ Pseudomembranous colitis Occasionally severe colitis such as pseudomembranous colitis accompanied by bloody stools occurs, so you should observe carefully. If you experience abdominal pain or frequent diarrhea, you should stop the drug and deal with it appropriately. 2) Serious side effects observed with similar drugs ① Skin mucosal eye syndrome (Stevens-Johnson syndrome), toxic epidermal necrosis (Lyell syndrome) Other cephem antibiotics have occasional reports of skin mucosal eye syndrome (Stevens-Johnson syndrome) and toxic epidermal necrosis (Lyell syndrome), so pay attention to observation. If abnormalities occur, the drug should be discontinued and appropriate treatment should be given. ② Acute renal failure Other cephem antibiotics have occasional reports of severe renal damage such as acute renal failure, so the drug should be discontinued and appropriate treatment should be given when abnormalities occur. ③ Hemolytic anemia Other cephem antibiotics have reports of hemolytic anemia, so regular examinations should be conducted, pay attention to observation, and if abnormalities occur, the drug should be discontinued and appropriate treatment should be given. ④ Interstitial pneumonia, PIE syndrome Other cephem antibiotics have occasional reports of interstitial pneumonia, PIE syndrome, etc. accompanied by fever, cough, dyspnea, abnormal chest X-ray, eosinophilia, etc. If such symptoms occur, the drug should be discontinued and adrenocortical hormone preparations should be given for appropriate treatment. 3) Other side effects ① Allergic reactions may cause skin rashes, and occasionally skin redness, itching, fever, etc. If such symptoms occur, the drug should be discontinued and treated appropriately. ② Kidneys may occasionally show signs of kidney damage such as increased BUN, increased blood creatinine, oliguria, and proteinuria, so regular examinations should be performed and careful observation should be observed. If oliguria, hematuria, urine protein, increased BUN, and increased blood creatinine occur, the drug should be discontinued and treated appropriately. ③ Blood may sometimes show signs of granulocytopenia and eosinophilia, and occasionally signs of erythropenia, decreased hematocrit, decreased hemoglobin, thrombocytopenia, and prolonged prothrombin time, so regular examinations should be performed and careful observation should be observed. If abnormalities occur, the drug should be discontinued and treated appropriately. ④ Liver may sometimes show signs of increased GOT, GPT, and AL-P, and occasionally signs of increased γ-GTP, LAP, LDH, and bilirubin, as well as jaundice. Careful observation should be performed. If abnormalities occur, the drug should be discontinued and treated appropriately. ⑤ Sometimes diarrhea occurs in the digestive tract, and nausea, vomiting, loss of appetite, etc. may occur occasionally, so pay attention to observation. If abnormalities occur, the drug should be discontinued and appropriate treatment should be given. ⑥ Occasionally, stomatitis and candidiasis may occur in alternating flora. ⑦ Occasionally, symptoms of vitamin K deficiency (hypoprothrombinemia, bleeding tendency, etc.) and vitamin B deficiency (glossitis, stomatitis, loss of appetite, neuritis, etc.) may occur in vitamin deficiency. ⑧ Others Occasionally, a feeling of general fatigue may occur.

This product is contraindicated for patients who are allergic to cephalosporins and should be used with caution by patients who are allergic to penicillin antibiotics.

This product cannot be used in combination with aminophylline or pyridoxal phosphate because it will reduce potency or color. It should not be used in combination with fursultiamine, lipoic acid, hydrocortisone sodium succinate and adenosylcobalamin because it will change color after a while. It should be used as soon as possible after combination. It may increase renal toxicity when used in combination with diuretics (such as furanilamide). Animal experiments have confirmed that this product affects alcohol metabolism, increases blood acetaldehyde concentration, and shows a disulfiram-like effect. Therefore, alcohol should be avoided during or after medication.

Keep away from light and in a cool place.

Calculated as C22H22N6O5S2, 1.0g

24 months

Hainan Lingkang Pharmaceutical Co., Ltd.

• Founded in:

  2013-04-22

• Address:

  No. 16, Yaogu Erheng Road, Yaogu Industrial Park, Haikou National High-tech Industrial Development Zone, Hainan Province

• Tax NO.:

  91460000062331438Q

• Registered Funds:

  200 million yuan

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