Amoxicillin and clavulanate potassium dispersible tablets (4:1)

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.

Amoxicillin trihydrate and clavulanate potassium.

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

Upper and lower respiratory tract infections: sinusitis, tonsillitis, pharyngitis, etc. Urinary tract infections Skin and soft tissue infections.

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.

Precautions for children: For children weighing less than 40kg, it is recommended to use a suspension. If this product is used, the recommended dose should be followed (see Dosage and Administration). 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 1/4~1/3 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 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.

Sealed, store in a cool, dark and dry place.

156.25 mg (C16H19N3O5S125 mg and C8H9NO531.25 mg)

24 months

SANTA(Zhangjiakou)PHARMACEUTICAL Co., Ltd.

• Founded in:

  2002-08-15

• Address:

  No. 6, Tengfei Road, Dongshan High-tech Industrial Development Zone, Zhangjiakou, Hebei Province

• Tax NO.:

  91130700741518034N

• Registered Funds:

  9.93252 million yuan

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