Amoxicillin Sodium and Clavulanate Potassium for Injection

This product is a compound preparation of amoxicillin sodium and clavulanate potassium. Amoxicillin is a broad-spectrum penicillin antibiotic. Clavulanate potassium itself has only weak antibacterial activity, but has a strong broad-spectrum β-lactamase inhibitory effect. 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 enzyme-producing Staphylococcus aureus, Staphylococcus epidermidis, coagulase-negative Staphylococci and enterococci. It also has good antibacterial activity against some β-lactamase-producing Enterobacteriaceae, Haemophilus influenzae, Moraxella catarrhalis, Bacteroides fragilis, etc. This product has no effect on methicillin-resistant Staphylococcus aureus and Enterobacter, which produce chromosome-mediated type I enzymes, and Pseudomonas.

This product is a compound preparation, and its components are: each 0.6g contains 0.5g of amoxicillin sodium as amoxicillin and 0.1g of clavulanate potassium as clavulanic acid.

This product is white or off-white powder.

1. Upper respiratory tract infections: sinusitis, tonsillitis, pharyngitis. 2. Lower respiratory tract infections: acute bronchitis, acute exacerbation of chronic bronchitis, pneumonia, lung abscess and bronchiectasis combined with infection. 3. Urinary tract infections: cystitis, urethritis, pyelonephritis, prostatitis, pelvic inflammatory disease, urinary tract infection caused by Neisseria gonorrhoeae. 4. Skin and soft tissue infections: furunculosis, abscess, cellulitis, wound infection, intra-abdominal sepsis, etc. 5. Other infections: otitis media, osteomyelitis, sepsis, peritonitis and postoperative infection.

Intravenous drip. Adults take 1.2g at a time, 3 to 4 times a day, and the course of treatment is 10 to 14 days. Dissolve the single dose of this product in 50 to 100 ml of sodium chloride injection and drip intravenously for 30 minutes.

1. A few patients may experience gastrointestinal reactions such as nausea, vomiting, and diarrhea. After symptomatic treatment, the drug can be continued. 2. Urticaria and rash may occur occasionally (especially in patients with infectious mononucleosis). If they occur, the drug should be discontinued and symptomatic treatment should be given. 3. Anaphylactic shock, drug fever, and asthma may occur. 4. Elevated serum aminotransferase, eosinophilia, leukopenia, and superinfection caused by Candida or drug-resistant bacteria may occur occasionally. 5. Literature reports that some patients developed phlebitis at the injection site.

It is contraindicated for patients with positive penicillin skin test reaction, those who are allergic to this product and other penicillins, and those with infectious mononucleosis.

Precautions during pregnancy and lactation: 1. This product can pass through the placenta, and the concentration in umbilical cord blood is 1/4~1/3 of the maternal blood concentration, so pregnant women are prohibited from using it. 2. This product can be secreted into breast milk, which may sensitize infants and cause diarrhea, rash, Candida infection, etc., so lactating women should use it with caution or stop breastfeeding during medication. Precautions for the elderly: Elderly patients should adjust the dosage or medication interval according to their renal function.

1. Aspirin, indomethacin, phenylbutazone, and sulfonamides can reduce the excretion of this product in the renal tubules, thereby increasing the blood concentration of this product, prolonging the blood elimination half-life (t1/2β), and the toxicity may also increase. 2. When this product is used in combination with allopurinol, the incidence of rash increases significantly, so the combination should be avoided. 3. This product should not be used in combination with acetaldehyde dehydrogenase inhibitors such as disulfiram. 4. When this product is used in combination with chloramphenicol for bacterial meningitis, the incidence of long-term sequelae is higher than when either is used alone. 5. This product can stimulate estrogen metabolism or reduce its enterohepatic circulation, thereby reducing the effectiveness of oral contraceptives. 6. Antibiotics such as chloramphenicol, erythromycin, tetracyclines and antibacterial drugs such as sulfonamides can interfere with the bactericidal activity of this product, so it is not suitable to be used in combination with this product, especially in the treatment of meningitis.

Keep tightly closed in a dark, cool and dry place.

1.2g (1.0g C16H19N3O5 flakes and 0.2g C8H9NO5)