Amoxicillin and Clavulanate Potassium Chewable Tablets (14:1)

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 beta-lactamase inhibitory effect. The combination of the two can protect amoxicillin from beta-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 beta-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, its components are amoxicillin and clavulanate potassium.

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

1. This product is suitable for lower respiratory tract infections, otitis media, and sinusitis caused by enzyme-producing Haemophilus influenzae and Moraxella catarrhalis; respiratory tract, urinary tract, and skin and soft tissue infections caused by enzyme-producing Staphylococcus aureus and enzyme-producing Enterobacteriaceae such as Escherichia coli and Klebsiella; it can also be used for mild to moderate infections caused by enterococci. 2. This product can also be used for the above-mentioned infections caused by sensitive non-enzyme-producing bacteria.

Take this product and chew it in your mouth and swallow it. Adult pneumonia and other moderate and severe infections: 625 mg once, once every 8 hours, for a course of 7 to 10 days. Other infections: 375 mg once, once every 8 hours, for a course of 7 to 10 days. Children (weight ≤40kg) are calculated according to amoxicillin. General infections: 25 mg/kg per body weight, once every 12 hours; or 20 mg/kg per body weight, once every 8 hours. Severe infections: 45 mg/kg per body weight, once every 12 hours; or 40 mg/kg per body weight, once every 8 hours. The course of treatment is 7 to 10 days. For other infections, the dose is halved. Children over 40kg can be given the adult dose. Patients with impaired renal function and creatinine clearance of 30 ml/min do not need to reduce the dosage; patients with creatinine clearance of 10-30 ml/min should take 250-500 mg (in amoxicillin) of this product orally every 12 hours; patients with creatinine clearance of <10 ml/min should take 250-500 mg (in amoxicillin) of this product orally every 24 hours. Patients on hemodialysis should take 250-500 mg (in amoxicillin) of this product orally every 24 hours according to the severity of the disease; take one more dose during and at the end of hemodialysis.

1. Common gastrointestinal reactions such as diarrhea, nausea and vomiting. 2. Skin rash, especially in patients with infectious mononucleosis. 3. Anaphylactic shock, drug fever and asthma may occur. 4. Occasionally, serum aminotransferase elevation, eosinophilia, leukocytosis and superinfection caused by Candida or drug-resistant bacteria may occur.

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.

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 toxicity. 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 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. 8Aminoglycoside antibiotics can generally enhance the in vitro bactericidal effect of this product on Enterococcus faecalis at sub-inhibitory concentrations. 9Since 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 away from light and store in sealed container.

Amoxicillin 0.6g and potassium clavulanate (calculated as clavulanic acid) 0.043g

Simcere Pharmaceutical Co., Ltd.

• Founded in:

  1998-09-10

• Address:

  No. 99, Huakang Road, Jiangbei New District, Nanjing, Jiangsu Province

• Tax NO.:

  91320100135665907G

• Registered Funds:

  1.60281382 million yuan

• Website:

  Log in to view

• Email:

  Log in to view