Amoxicillin and Clavulanate Potassium Tablets

1. This product is a compound preparation of amoxicillin and potassium clavulanate. Amoxicillin is a broad-spectrum penicillin antibiotic. Potassium clavulanate itself has only weak antibacterial activity, but has a strong broad-spectrum b-lactamase inhibitory effect. The combination of the two can protect amoxicillin from b-lactamase hydrolysis. 2. 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 b-lactamase-producing Enterobacteriaceae, Haemophilus influenzae, Moraxella catarrhalis, Bacteroides fragilis, etc. This product has no effect on methicillin-resistant Staphylococcus aureus and Enterobacter, etc., which produce chromosome-mediated type I enzymes and Pseudomonas.

Amoxicillin, Clavulanic Acid

This product is a film-coated tablet, which appears off-white or light yellow after removing the coating.

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

Oral. Adults and children over 12 years old, 1 tablet at a time, 3 times a day. The dose can be doubled in case of severe infection. Continuous treatment period shall not exceed 14 days without reexamination.

Amoxicillin and clavulanate potassium dispersible tablets are well tolerated, and most of the side effects observed clinically are mild and transient. Less than 3% of patients discontinue treatment due to drug-related side effects. The main side effects reported are diarrhea/loose stools (9%), nausea (3%), hives and urticaria (3%), vomiting (1%), and vaginitis (1%). The occurrence of adverse reactions, especially diarrhea, is related to the larger dosage of the drug. Other rare side effects include: abdominal discomfort, bloating, and headache.

Contraindicated in patients allergic to penicillins or with impaired liver function

Precautions for children: For children weighing less than 40kg, it is recommended to use a suspension. Due to the imperfect renal function of newborns and infants, the metabolism of amoxicillin will be delayed. In pediatric treatment, the dose should be reduced for infants less than three months old. Precautions for pregnancy and lactation: 1. This product can pass through the placenta, and the concentration in umbilical cord blood is 1/4 to 1/3 of the maternal blood concentration, so it is contraindicated for pregnant women. 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 suspend 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 (t1/2b), and possibly increasing the toxicity. 2. When this product is used in combination with allopurinol, the incidence of rash increases significantly, so it 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, thus reducing the effectiveness of oral contraceptives. 6. Chloramphenicol, erythromycin, tetracyclines and other antibiotics and sulfonamides and other antibacterial drugs can interfere with the bactericidal activity of this product, so it should not be used in combination with this product, especially in the treatment of meningitis or severe infections that urgently require bactericidal drugs. 7. This product can enhance the effect of warfarin. 8. Aminoglycoside antibiotics can generally enhance the in vitro bactericidal effect of this product on Enterococcus faecalis at sub-inhibitory concentrations. 9. Since the absorption of this product in the gastrointestinal tract is not affected by food, it can be taken on an empty stomach or after a meal, and can be taken with milk and other foods; taking it with food can reduce gastrointestinal reactions.

Keep in a dark, sealed place and store in a cool, dry place

0.457 g (0.4 g of C16H19N3O5 flakes and 0.057 g of C8H9NO5)

24 months