Amoxicillin Sodium and Clavulanate Potassium for Injection

The following infections caused by sensitive bacteria producing β-lactamase: 1. Upper respiratory tract infection: sinusitis, tonsillitis, pharyngitis. 2, lower respiratory tract infection: acute bronchitis, acute exacerbation of chronic bronchitis, pneumonia, lung abscess and bronchiectasis combined infection. 3, urinary tract infections: cystitis, urethritis, pyelonephritis, prostatitis, pelvic inflammatory disease, Neisseria gonorrhoeae urinary tract infection. 4, skin and soft tissue infections: sputum, abscess, cellulitis, wound infections, etc. 5, other infections: otitis media, osteomyelitis, sepsis, peritonitis and post-operative infection.

Product Details

Indication

The following infections caused by sensitive bacteria producing β-lactamase: 1. Upper respiratory tract infection: sinusitis, tonsillitis, pharyngitis. 2, lower respiratory tract infection: acute bronchitis, acute exacerbation of chronic bronchitis, pneumonia, lung abscess and bronchiectasis combined infection. 3, urinary tract infections: cystitis, urethritis, pyelonephritis, prostatitis, pelvic inflammatory disease, Neisseria gonorrhoeae urinary tract infection. 4, skin and soft tissue infections: sputum, abscess, cellulitis, wound infections, etc. 5, other infections: otitis media, osteomyelitis, sepsis, peritonitis and post-operative infection.

Clinical pharmacology

This product is a combination of amoxicillin sodium and potassium clavulanate. Amoxicillin is a broad-spectrum penicillin antibiotic. Potassium clavulanate itself has only weak antibacterial activity, but it has a strong broad-spectrum β-lactamase inhibitory effect. Together, it can protect amoxicillin from β-lactam. Enzymatic hydrolysis. The antibacterial spectrum of this product is the same as that of amoxicillin. It has good effects on the production of Staphylococcus aureus, Staphylococcus epidermidis, coagulase-negative staphylococcus and enterococci. For certain Enterobacteriaceae producing β-lactamase Haemophilus influenzae, Moraxella catarrhalis, Bacteroides fragilis, etc. also have good antibacterial activity. This product has no effect on Enterobacteriaceae and Pseudomonas which are chromosomally-mediated type I enzymes such as methicillin-resistant Staphylococcus and Enterobacter.

Dosage

Intravenous injection. This product is 1.2g for adults and children over 12 years old, 30mg for each child from 3 months to 12 years old, dissolved in 50~100ml normal saline (need to reduce the newborn), intravenous infusion for 30 minutes, daily 2 ~3 times. The course of treatment is generally 7 to 14 days.

Formulation

Powder needle

specification

1.2g (amoxicillin 1g and clavulanic acid 0.2g)

Instruction manual

Approved date: May 8, 2007

Date of revision: March 03, 2008 July 1, 2009

October 01, 2010 October 01, 2012 December 01, 2015

Amoxicillin sodium clavulanate potassium injection instructions

Please read the instructions carefully and use them under the guidance of a physician.

【Drug Name】

Generic name: Amoxicillin sodium for injection, potassium clavulanate

English name: Amoxicillin Sodium and Clavulanate Potassium for Injection

Pinyin: Zhusheyong Amoxilinna Kelaweisuanjia

【Ingredients】This product is a compound preparation, and its composition is amoxicillin 1g and clavulanic acid 0.2g.

【Properties】 This product is white or off-white powder.

【Indications】 The following infections caused by sensitive bacteria producing β-lactamase:

1, upper respiratory tract infection: sinusitis, tonsillitis, pharyngitis.

2, lower respiratory tract infection: acute bronchitis, acute exacerbation of chronic bronchitis, pneumonia, lung abscess and bronchiectasis combined infection.

3, urinary tract infections: cystitis, urethritis, pyelonephritis, prostatitis, pelvic inflammatory disease, Neisseria gonorrhoeae urinary tract infection.

4, skin and soft tissue infections: sputum, abscess, cellulitis, wound infections, etc.

5, other infections: otitis media, osteomyelitis, sepsis, peritonitis and post-operative infection.

【Specification】  1.2g (amoxicillin 1g and clavulanic acid 0.2g)

【Usage and dosage】  intravenous injection.

This product is 1.2g for adults and children over 12 years old, 30mg for each child from 3 months to 12 years old, dissolved in 50~100ml normal saline (need to reduce the newborn), intravenous infusion for 30 minutes, daily 2 ~3 times. The course of treatment is generally 7 to 14 days.

【Adverse reactions】 The incidence of adverse reactions is similar to that of amoxicillin. The observed adverse reactions are:

1, a small number of patients can be seen nausea, vomiting, diarrhea, soft stools, loss of appetite, flatulence and other gastrointestinal reactions, can continue to be administered after symptomatic treatment.

2, occasionally urticaria and rash (especially prone to infectious mononucleosis), if it occurs, should stop using this product, and treat the disease.

3, visible anaphylactic shock, angioedema, drug fever and asthma.

4, occasionally elevated serum aminotransferase, elevated urea nitrogen, transient obstructive jaundice, low prothrombinemia, eosinophilia, leukopenia and double infection caused by Candida or drug-resistant bacteria .

5, the literature reported that individual patients with phlebitis at the injection site.

【taboo】 

Penicillin skin test positive responders, those who are allergic to this product and other penicillin drugs and patients with infectious mononucleosis are banned.

【Precautions】

1. The penicillin skin test must be performed before the patient starts using the product.

2, those who are allergic to cephalosporins, severe liver dysfunction, moderate and severe renal dysfunction and those with history of allergic diseases such as asthma, eczema, hay fever, urticaria and so on.

3. There is cross-allergy between this product and other penicillins and cephalosporins. If an allergic reaction occurs, the product should be discontinued immediately and appropriate measures taken.

4. This product and ampicillin have complete cross-resistance and cross-resistance with other penicillins and cephalosporins.

5, renal dysfunction should be adjusted according to plasma creatinine clearance or dosing period; hemodialysis can affect the blood concentration of amoxicillin in this product, so this product should be added during and at the end of hemodialysis 1 Times.

6. For patients with gonorrhea suspected of having syphilis damage, a dark-field examination should be performed before using this product, and a serum test should be performed once a month for at least 4 months.

7, long-term or high-dose use of this product, should regularly check the liver, kidney, hematopoietic system function and test serum potassium or sodium.

8, interference with laboratory test indicators: 1 copper sulfate method urine test can be false positive, but the glucose enzyme test method is not affected; 2 can determine serum alanine aminotransferase or aspartate aminotransferase The value rises.

9. This product should be administered immediately after dissolution. The remaining liquid should be discarded and can not be reused. The prepared solution of this product cannot be stored frozen.

10, this product is not suitable for intramuscular injection.

11. This product will reduce the stability in the solution containing glucose, dextran or acidic carbonate, so this product can not be mixed with the solution containing the above substances.

12. This product solution should not be mixed with blood products, protein-containing liquids (such as hydrolyzed proteins), or mixed with intravenous lipid emulsions.

13, this product can not be mixed with aminoglycoside antibiotics in vitro, because this product can make the latter lose activity.

【Pregnant women and lactating women】

1, this product can pass through the placenta, the concentration of blood in the cord is 1/4 to 1/3 of the maternal blood concentration, so pregnant women are prohibited.

2, this product can be secreted into breast milk, may cause sensitization of the baby and cause diarrhea, rash, Candida infection, etc., so lactating women with caution or medication during the suspension of breastfeeding.

【Child medication】See 【Usage and dosage】.

【Geriatric Use】Elderly patients should adjust the dose or medication interval according to the renal function.

【medicine interactions】

1, aspirin, indomethacin, phenylbutazone, sulfa drugs can reduce the excretion of this product in the renal tubules, thus increasing the blood concentration of this product, blood elimination half-life (t1/2β) prolonged, toxicity may also increase .

2. When this product is combined with allopurinol, the incidence of rash is significantly increased, so it should be avoided.

3. This product should not be combined with acetaldehyde dehydrogenase inhibitors such as disulfiram.

4. When this product is combined with chloramphenicol for bacterial meningitis, the incidence of long-term sequelae is higher than when the two are used alone.

5, this product can stimulate estrogen metabolism or reduce its intestinal hepatic circulation, thus reducing the effectiveness of oral contraceptives.

6, chloramphenicol, erythromycin, tetracyclines and other antibiotics and sulfa drugs and other antibacterial drugs can interfere with the bactericidal activity of this product, so it should not be combined with this product, especially in the treatment of meningitis or severely needed bactericidal drugs.

7, this product can strengthen the role of warfarin.

8. Aminoglycoside antibiotics generally enhance the in vitro bactericidal effect of this product on Enterococcus faecalis at sub-inhibitory concentrations.

【Drug overdose】This experiment was not performed and there is no reliable reference.

【Pharmacology and Toxicology】

This product is a combination of amoxicillin sodium and potassium clavulanate. Amoxicillin is a broad-spectrum penicillin antibiotic. Potassium clavulanate itself has only weak antibacterial activity, but it has a strong broad-spectrum β-lactamase inhibitory effect. Together, it can protect amoxicillin from β-lactam. Enzymatic hydrolysis.

The antibacterial spectrum of this product is the same as that of amoxicillin. It has good effects on the production of Staphylococcus aureus, Staphylococcus epidermidis, coagulase-negative staphylococcus and enterococci. For certain Enterobacteriaceae producing β-lactamase Haemophilus influenzae, Moraxella catarrhalis, Bacteroides fragilis, etc. also have good antibacterial activity. This product has no effect on Enterobacteriaceae and Pseudomonas which are chromosomally-mediated type I enzymes such as methicillin-resistant Staphylococcus and Enterobacter.

【Pharmacokinetics】

1.2 g of this product (containing amoxicillin 1.0 g and clavulanic acid 0.2 g) was administered intravenously, and amoxicillin and clavulanic acid immediately reached peak plasma concentration (Cmax). The pharmacokinetics were consistent with the two-compartment open model. The blood elimination half-life (t1/2β) of amoxicillin was 1.03±0.11 hours, and the blood elimination half-life (t1/2β) of clavulanic acid was 0.838±0.04 hours. Both drugs have a low serum protein binding rate, about 70% of the free state of the product is present in the serum, amoxicillin and clavulanic acid are discharged from the urine at a high concentration, 8 hours urine excretion rate Amoxicillin is about 60% and clavulanic acid is about 50%.

【Storage】Sealed and stored in a cool place (cool and dark (not exceeding 20 ° C).

【Package】 antibiotic glass bottle. 10 bottles / box.

【Validity Period】 24 months

【Executive Standards】 "Chinese Pharmacopoeia" 2015 Edition 2

【Approval No.】 National Drug Standard H20054159

【manufacturer】

Company Name: Lunan Beite Pharmaceutical Co., Ltd.

Production address: No. 243, Yinqueshan Road, Linyi City, Shandong Province

Postal code: 276006

Phone number: 0539-8336336 (Sales) 8336337 (Quality Management Department)

Fax number: 0539-8336029 (Sales) 8336338 (Quality Management Department)

Website: www.LUNAN.com.cn

24-hour customer service hotline: 400-0539-310