Amoxicillin and Clavulanate Potassium Tablets (14:1)

This product is a compound preparation composed of amoxicillin and potassium clavulanate, in which amoxicillin is a semi-synthetic broad-spectrum penicillin antibiotic that mainly acts on the bacterial reproduction stage by inhibiting the biosynthesis of its cell wall mucopolypeptide. It is effective against many Gram-positive and Gram-negative bacteria. Potassium clavulanate has a β-lactam structure similar to penicillin. It has only weak antibacterial activity itself, but it can inactivate enzymes produced by many bacteria by blocking the active site of β-lactamase, especially for clinically important, plasmid-mediated β-lactamases (these enzymes are usually related to changes in resistance to penicillins and cephalosporins). The combination of the two can protect amoxicillin from hydrolysis and destruction by β-lactamase, so that it is still effective against resistant bacteria that produce β-lactamase.

This product is a compound preparation, its components are amoxicillin and clavulanate potassium (4:1).

This product is a film-coated tablet, which is off-white to light yellow after removing the coating; it tastes slightly bitter and is hygroscopic.

This product is suitable for various infections caused by sensitive bacteria, such as: 1. Upper respiratory tract infections: sinusitis, tonsillitis, pharyngitis, otitis media, etc. 2. Lower respiratory tract infections: acute bronchitis, acute exacerbation of chronic bronchitis, pneumonia, lung abscess and bronchiectasis combined with infection, etc. 3. Urinary system infections: cystitis, urethritis, pyelonephritis, prostatitis, pelvic inflammatory disease, gonococcal urinary tract infection and soft chancroid, etc. 4. Skin and soft tissue infections: furuncle, abscess, cellulitis, wound infection, intra-abdominal sepsis, etc. 5. Other infections: osteomyelitis, sepsis, peritonitis and postoperative infection, etc.

Adults and children over 12 years old, generally 1 tablet each time, three times a day; in case of severe infection, the dose can be doubled or as directed by the doctor. Without re-examination, the continuous treatment period shall not exceed 14 days. For patients with impaired renal function: patients with impaired renal function (creatinine elimination rate> 30ml/min) generally do not require a dose reduction; patients with severe renal impairment, creatinine elimination rate <30ml/min, should appropriately reduce the dose and extend the dosing interval. Patients on hemodialysis should take an additional dose after the end of dialysis.

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. 5. Central nervous system: Occasionally, headache may occur, and insomnia, anxiety and abnormal behavior may occur rarely. Attention should be paid to possible adverse reactions to ampicillin antibiotics.

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 for children: This experiment has not been conducted and there are no reliable references. Precautions for pregnancy and lactation: This product can pass through the placenta, and the concentration in umbilical cord blood is 1/4 to 1/3 of the mother's, so pregnant women are prohibited from using it. This product can be secreted into breast milk, which may sensitize infants and cause rashes, Candida infections, 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 dosing 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 (t1/2()), 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. Chloramphenicol, erythromycin

Seal and store in a cool, dark and dry place. Validity period: 24 months

0.643g (amoxicillin 0.6g and potassium clavulanate 0.043g)

24 months

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