Cefmenoxime Hydrochloride for Injection Instructions
Release time:
2020-07-31
Approval Date: March 29, 2007
First Amendment Date: September 16, 2009
Second Amendment Date: December 01, 2013
Third Amendment Date: October 31, 2014
Fourth Amendment Date: December 01, 2015
Fifth Amendment Date: december 03, 2015
Cefmenoxime Hydrochloride for Injection Instructions
Please read the instructions carefully and use
[Drug Name]
General Name: Cefmenoxime Hydrochloride for Injection
English Name: Cofmenoxime Hydrochloride for Injection
Chinese Pinyin: Zhusheyong Yansuan Toubaojiawo
[Ingredients] The main ingredient of this product is Cefmenoxime Hydrochloride, whose chemical name is:(6R,7R) -7-[(Z)-2-(2-amino-4-thiazolyl)-2-methoxyiminoacetamido]-3-[[(1-methyl-1H-tetrazol-5-yl)-thio] methyl]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-Formic acid hydrochloride (2:1).
chemical structural formula:
molecular formula:(C16H17N9O5S3)2 · HCl molecular weight: 1059.58 auxiliary material: anhydrous sodium carbonate
[properties] this product is white to light yellow crystal or crystalline powder.
[Indications] This product is applicable to cefmenoxime-sensitive Streptococcus (except Enterococcus), Streptococcus pneumoniae, Digestococcus, Digestococcus, Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Serratia, Proteus, Haemophilus influenzae, Bacteroides, etc. caused by the following infections:
1, pneumonia, bronchitis, bronchiectasis complicated with infection, secondary infection of chronic respiratory diseases; Lung abscess, empyema;
2, pyelonephritis, cystitis; Bartholin's adenitis, endometritis, uterine adnexitis, pelvic inflammation, parauterine tissue inflammation;
3, cholangitis, cholecystitis, liver abscess; Peritonitis;
4, secondary infection of burns and surgical trauma;
5;
6. Cerebrospinal meningitis.
[Specifications] 0.25g, 0.5g, 1.0g, 2.0g (by C16H17N9O5S3)
[Usage and Dosage] Usage: This product is dissolved in 0.9 sodium chloride injection or glucose injection for intravenous drip.
In addition, for adults, 0.5g-2g of this product can also be added to the rehydration of sugar solution, electrolyte solution or amino acid preparation for intravenous drip within 30 minutes to 2 hours. For children, one dose can also be considered to be added to the fluid infusion, and intravenous drip is carried out within 30 minutes to 1 hour. For static injection, inject about 5ml of dissolved solution into the bottle for dissolution when using 1g, and inject not less than 100ml of dissolved solution into the bottle for drip.
Dosage: 1. Adults: mild infection: 1-2g a day, divided into 2 intravenous drips; Moderate and severe infection: it can be increased to 4g a day, divided into 2-4 intravenous drips. The dose can also be adjusted according to the clinical situation. 2. Children: mild infection: 40-80mg per kilogram of body weight per day, divided into 3-4 times of intravenous drip; Moderate and severe infection: it can be increased to 160mg per kilogram of body weight per day, divided into 3-4 times of intravenous drip; Cerebrospinal meningitis: it can be increased to 200mg per kilogram of body weight per day, divided into 3-4 times of intravenous drip.
[Adverse Reactions] 1. Serious Adverse Reactions:
⑴ Sometimes Shock (less than 0.1%) is caused. Therefore, careful observation should be made. In case of abnormal symptoms such as discomfort, abnormal feeling in mouth, wheezing, vertigo, defecation, tinnitus, sweating, etc., administration should be stopped and appropriate treatment should be carried out.
(2) Occasionally, severe renal dysfunction such as acute renal insufficiency (less than 0.1%), so renal function should be checked regularly and carefully observed. If abnormal, drug administration should be stopped and appropriate treatment should be carried out.
(3) Sometimes granulocytopenia (less than 0.1-5%) or no granulocytosis (less than 0.1). In addition, other cephalosporin antibiotics have been reported to cause hemolytic anemia. In case of abnormality, administration should be stopped and appropriate management should be carried out. Severe colitis with bloody stool, such as pseudomembranous colitis, sometimes occurs (less than 0.1 percent), such as abdominal pain and repeated diarrhea, should be stopped immediately and managed appropriately.
(5) Interstitial pneumonia and PIE syndrome (less than 0.1 percent) with fever, cough, dyspnea, chest X-ray abnormalities, eosinophilia, etc., should be discontinued and managed appropriately.
(6) In patients with renal insufficiency, spasticity and the like are sometimes caused when a large amount of drugs are administered.
2, Other Adverse Reactions
⑴ Allergy: Rash, Urticaria, Erythema, Pruritus, Fever, Lymphadenopathy, Arthralgia;
⑵ Blood: Anemia, Eosinophilia, Thrombocytopenia;
(3) Liver: ALT, AST, ALP, LDH Elevation, Jaundice, γ-GTP Elevation;
(4) Digestive Tract);
(5) Flora disorder: stomatitis, candidiasis;
(6) Vitamin deficiency: vitamin K deficiency symptoms (hypocoagulinemia, bleeding tendency, etc.), vitamin B deficiency symptoms (glossitis, stomatitis, loss of appetite, neuritis, etc.);
(7) Others: burnout, staggering, headache.
[Taboo] The product and cephalosporins have a history of allergic reactions are prohibited.
[Precautions] 1. The following patients take drugs carefully
(1) Patients with a history of allergy to penicillin antibiotics;
(2) I or my parents and brothers have patients who are prone to allergic symptoms such as bronchial asthma, rash, urticaria, etc.
(3) Patients with severe renal dysfunction (continuous increase of blood drug concentration may occur);
(4) Elderly Patients (Decline in Physiological Function, side effects are easy to occur; Sometimes vitamin K deficiency and bleeding tendency);
(5) people with poor oral feeding or intravenous nutrition, and people with poor general state (sometimes vitamin K deficiency can be caused, so careful observation should be made);
2, because shock reaction may occur, so detailed consultation is required. It is recommended to do skin allergy test before injection. First aid should be done in advance in the event of shock.
3, the use of this product, the best regular liver function, kidney function, blood and other tests.
4. Interference to diagnostic reagents: In addition to the reaction of urine sugar test strip (TES-tape), false positive reaction may occur when urine sugar test is carried out with Banns reagent, Flynn reagent and Clinitest (sheet reagent containing copper sulfate), and direct antiglobulin (Coombs) test is positive, please pay attention.
[Medication for pregnant and lactating women] The safety of medication for pregnancy has not been established, and the use of this product by pregnant and lactating women should be weighed.
[Use in children] The safety of use in preterm infants and newborns is uncertain.
[Elderly medication] Most elderly patients have decreased physiological functions and are prone to side effects. Sometimes vitamin K deficiency and bleeding tendency.
[Drug Interactions]
1. Furananilic Acid Diuretics: It has been reported that renal dysfunction can be aggravated when combined with other cephalosporins. Therefore, renal function should be paid attention to when combined.
2. Ethanol (drinking): alcohol intake due to drinking, sometimes flushing, nausea, tachycardia, hyperhidrosis, headache, etc., so alcohol intake should be avoided during and at least one week after medication.
[Drug Overdose] Unclear
[Pharmacology and Toxicology] Pharmacological Effects
Cefmenoxime is a semi-synthetic cephalosporin broad-spectrum antibiotic that achieves bactericidal effects by inhibiting the biosynthesis of bacterial cell walls. This product has a strong antibacterial effect on gram-negative bacteria due to its good extracellular membrane permeability, stability to β-lactamase, and strong affinity to penicillin binding proteins (PBPs)1A, 1B and 3, which has a strong barrier to the formation of cell wall mucin cross-linking.
In vitro tests show that this product has an effect on both gram-positive and gram-negative bacteria. The antibacterial activity of Gram-positive bacteria was stronger than that of cefotiam (CTM) and cefazolin (CEZ) in terms of Streptococcus pyogenes and Streptococcus pneumoniae. It has strong antibacterial power against digestive cocci and digestive streptococcus. The antibacterial power to Gram-negative bacteria was slightly stronger than CTM and much stronger than CEZ in terms of E. coli and pneumoniae. The antibacterial force against influenza bacilli, Proteus, Serratia marcescens, Citrobacter, and intestinal bacteria was stronger than CTM, and much stronger than CEZ. In addition, it also shows strong antibacterial power to Bacteroides.
Toxicology study Reproductive toxicity: Animal experiments showed that in rats, rabbits and monkeys during the organ formation period of administration, each administration group of rabbits had female rabbit death or abortion, but all kinds of animals had no teratogenic effect. There was no obvious abnormality in general reproductive toxicity test and perinatal reproductive toxicity test in rats. [Pharmacokinetics] According to literature data, the peak blood drug concentration can reach 50.9mg/L and 135.7mg/L respectively after a single intravenous infusion of 0.5g and 1g of this drug in adults with normal renal function, and 75mg/L and 125mg/L respectively after a single intravenous infusion of 0.5g and 1g of cefmenoxime. The serum elimination half-life of this product is about 1 hour. It is well distributed in various tissues and body fluids after administration. It can also cross the blood-brain barrier. The drug is mainly excreted through the kidney. After an intravenous injection or intravenous drip of 0.5g, 1g and 2g of the drug in adults (with normal renal function), the excretion rate in urine within 6 hours is 60-82%. In addition, the urine drug concentration after 1g of intravenous drip was about 4400 μg/L for 0-2 hours, about 750 μg/L for 2-4 hours, and about 120 μg/L for 4-6 hours. Children (with normal renal function) had the same urinary excretion rate at 6 hours after a single intravenous injection or intravenous drip of 10, 20, and 40 mg/kg as adults.
[Storage] Shaded, airtight, and stored in a cool and dry place (not more than 20 ℃).
[Package] Antibiotic Glass Bottle, 0.25g × 2 Bottle/Box, 0.25g × 1 Bottle/Box; 0.5g × 1 bottle/box, 0.5g × 2 bottle/box; 1.0g × 1 bottle/box; 2.0g × 2 bottles/box, 2.0g × 1 bottle/box; 0.25g × 5 bottles/box, 0.5g × 5 bottles/box, 1.0g × 5 bottles/box.
[Validity Period] 24 Months
[Implementation Standard] "Chinese Pharmacopoeia" 2015 Edition II
[Approval Document No.] Chinese Medicine Standard H20041145( 0.25g), Chinese Medicine Standard H20041146( 0.5g), Chinese Medicine Standard H20041147(1.0g), Chinese Medicine Standard H20093940( 2.0g)
[Production Enterprise] Enterprise Name: Zhejiang Jianfeng Pharmaceutical Co., Ltd. Address: no. 58, Gaofan Section, Baitang Downline, Wucheng District, Jinhua City, Zhejiang Province Tel: 0579-82661998 (Consultation) 0579-82131973 (Sales)
Fax: 0579-82661998 Postal Code: 321075
Website:
www.zjjfyy.com.cn
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