Amoxicillin and Clavulanate Potassium Tablets

1, upper respiratory tract infection: sinusitis, tonsillitis, pharyngitis and so on.

2, lower respiratory tract infections: 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 and soft sputum.

4, skin and soft tissue infections: sputum, abscess, cellulitis, wound infection, intra-abdominal sepsis.

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

Product Details

Indication

1, upper respiratory tract infection: sinusitis, tonsillitis, pharyngitis and so on.

2, lower respiratory tract infections: 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 and soft sputum.

4, skin and soft tissue infections: sputum, abscess, cellulitis, wound infection, intra-abdominal sepsis.

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

Clinical pharmacology

This product is a combination of amoxicillin and clavulanate potassium. Amoxicillin is a broad-spectrum antibacterial penicillin antibiotic. Potassium clavulanate itself has only weak antibacterial activity, but it has strong broad-spectrum β-lactamase inhibition. The combination of the two can protect amoxicillin from β-lactamase hydrolysis. The antibacterial spectrum of this product is the same as that of amoxicillin and has been expanded. It has a good effect on the production of Staphylococcus aureus, Staphylococcus epidermidis, coagulase-negative staphylococci and enterococci. It also has good antibacterial activity against certain Enterobacteriaceae bacteria producing β-lactamase, Haemophilus influenzae, Moraxella catarrhalis, Bacteroides fragilis and the like.

Dosage

oral. Adults and children over 12 years old are 1 tablet at a time, 3 times a day. The dose can be doubled in case of severe infection. The continuous treatment period does not exceed 14 days without re-examination.

Formulation

tablet

specification

0.375 g (amoxicillin 0.25 g and clavulanic acid 0.125 g).

Instruction manual

Approval date:

Date of revision: October 1, 2012

August 14, 2015 (Supplemental application approval)

December 01, 2015 (2015 Pharmacopoeia)

Amoxicillin Clavulanate Potassium Tablet Instructions

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

【Drug Name】

Common name: Amoxicillin Clavulanate potassium tablets

English name: Amoxicillin and Clavulanate Potassium Tablets

Pinyin: Amoxilin Kelaweisuanjia Pian

【Ingredients】This product is a compound preparation, and its components are: 0.25 g of amoxicillin and 0.125 g of clavulanic acid per tablet.

【Properties】 This product is a film-coated tablet, which is white to pale yellow after removal of the coating.

【indications】 

This product is suitable for various infections caused by sensitive bacteria, such as:

1, upper respiratory tract infection: sinusitis, tonsillitis, pharyngitis and so on.

2, lower respiratory tract infections: 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 and soft sputum.

4, skin and soft tissue infections: sputum, abscess, cellulitis, wound infection, intra-abdominal sepsis.

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

【Specifications】 0.375 g (amoxicillin 0.25 g and clavulanic acid 0.125 g).

【Dosage】

oral. Adults and children over 12 years old are 1 tablet at a time, 3 times a day. The dose can be doubled in case of severe infection. The continuous treatment period does not exceed 14 days without re-examination.

【Adverse reactions】

1, common gastrointestinal reactions such as diarrhea, nausea and vomiting.

2, rash, especially prone to infectious mononucleosis.

3, visible anaphylactic shock, drug fever and asthma.

4, occasionally elevated serum aminotransferase, eosinophilia, leukopenia and double infection caused by Candida or drug-resistant bacteria.

【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 patient must first perform a penicillin skin test before starting the product.

2, those who are allergic to cephalosporins and those with history of allergic diseases such as asthma, eczema, hay fever, urticaria and severe liver dysfunction should be used with caution.

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

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

5, renal dysfunction should be based on plasma creatinine clearance rate adjustment or dosing period; hemodialysis can affect the blood concentration of amoxicillin in this product, so in the hemodialysis process and at the end should be added this product 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, severe liver function decline should be used with caution. Long-term or large doses of this product should be regularly checked for liver, kidney, hematopoietic system function and serum potassium or sodium.

8. Interference with laboratory test indicators: 

(1) The copper sulfate method urine test can be false positive, but the glucose enzyme test method is not affected; 

(2) the serum alanine aminotransferase or aspartate can be made. The aminotransferase assay is elevated.

【Pregnant women and lactating women】

1. This product can pass through the placenta, and the blood concentration of the cord is 1/4 to 1/3 of the maternal blood concentration, so the pregnant woman is 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.

【Children's medication】 For children over 12 years old, see [Usage and Dosage]. The safety and effectiveness of children under the age of 12 have not been established.

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

【medicine interactions】

1. Aspirin, indomethacin, phenylbutazone and sulfa drugs can reduce the excretion of this product in the renal tubules, thus increasing the blood concentration of this product, prolonging the blood elimination half-life (t1/2b), and increasing toxicity. .

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.

9, because the absorption of this product in the gastrointestinal tract is not affected by food, it can be taken on an empty stomach or after meals, and can be served with milk and other foods; with food can reduce gastrointestinal reactions.

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

【Pharmacology and Toxicology】

This product is a combination of amoxicillin and clavulanate potassium. Amoxicillin is a broad-spectrum antibacterial penicillin antibiotic. Potassium clavulanate itself has only weak antibacterial activity, but it has strong broad-spectrum β-lactamase inhibition. The combination of the two can protect amoxicillin from β-lactamase hydrolysis.

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

【Pharmacokinetics】

This product is stable to gastric acid, good oral absorption, and food has no obvious effect on the absorption of this product. Oral administration of 375mg (amoxicillin 250 mg, and clavulanic acid 125mg), amoxicillin peak plasma concentration (Cmax) at 1.5 hours, about 5.6mg / L. The blood elimination half-life (t1/2b) is about 1 hour. The 8-hour urine discharge rate was 50% to 78%. The pharmacokinetic parameters of clavulanic acid are the same as those of single use. The peak concentration (Cmax) of Clavulanic acid in a normal person after oral administration of 125 mg of clavulanic acid is about 3.4 mg/L. The protein binding rate is 22% to 30%. The blood elimination half-life (t1/2b) was 0.76 to 1.4 hours, and the 8-hour urine discharge rate was about 46%. The bioavailability of both oral administration was 97% and 75%, respectively.

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

【Packing】plastic bottle, 10 pieces / bottle; 14 pieces / bottle; 15 pieces / bottle; 21 pieces / bottle.

【Validity period】24 months.

【Executive Standards】"Chinese Pharmacopoeia" 2015 Edition 2

【Approval No.】 National Medicine Zhunzi H20053424.

【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) 0539-8336337 (Quality Management Department)

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

Website: www.LUNAN.com.cn

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