Amoxicillin and clavulanate potassium dispersible tablets

This product is a compound preparation composed of amoxicillin and potassium clavulanate in a ratio of 7:1. Amoxicillin and ampicillin have similar anti-sensitive microbial effects, mainly acting in the reproduction stage of microorganisms by inhibiting the biosynthesis of cell wall mucopolypeptides. Potassium clavulanate has a β-lactam structure similar to penicillin, which can inactivate most of the enzymes produced by bacteria by blocking the active site of β-lactamase, especially for clinically important plasmid-mediated β-lactamase (these enzymes are usually related to changes in resistance to penicillins and cephalosporins). In vitro tests and clinical use results have shown that this compound preparation is effective against most of the following microorganisms: Gram-positive aerobic microorganisms: Staphylococcus aureus (strains that produce β-lactamase and those that do not produce β-lactamase); Staphylococci resistant to methicillin/oxacillin are also resistant to this product. Gram-negative aerobic microorganisms: Escherichia coli (strains producing β-lactamase and those not producing β-lactamase); Haemophilus influenzae (strains producing β-lactamase and those not producing β-lactamase); Klebsiella (all known strains are β-lactamase producing strains); Moraxella catarrhalis (strains producing β-lactamase and those not producing β-lactamase). Most of the following microorganisms have in vitro research results, but their clinical significance is still unclear: most Streptococcus pneumoniae, Neisseria gonorrhoeae, most Staphylococci and anaerobic bacteria. These bacteria are sensitive to amoxicillin, but there are no sufficient and strictly controlled research results on the clinical efficacy of this compound against these bacteria.

This product is a compound preparation, and its components are: each tablet contains 0.2g amoxicillin and 0.0285g clavulanic acid.

This product is off-white to light yellow tablets.

This product can be used to treat infections caused by sensitive strains of microorganisms specified in the following conditions: 1. Lower respiratory system infections: caused by β-lactamase-producing bacteria Haemophilus or Moraxella. 2. Otitis media: caused by β-lactamase-producing bacteria Haemophilus or Moraxella. 3. Sinusitis: caused by β-lactamase-producing bacteria Haemophilus or Moraxella. 4. Skin and skin soft tissue infections: caused by β-lactamase-producing bacteria Staphylococcus, Escherichia coli or Klebsiella. 5. Urinary tract infections: caused by Escherichia coli, Klebsiella or Enterobacter. Although this product is effective for the above infections, infections caused by ampicillin-sensitive bacteria can also be treated with this product because it contains amoxicillin. Therefore, this product is effective for complex infections caused by ampicillin-sensitive microorganisms and β-lactamase-producing microorganisms, and no other antibiotics are needed. Because amoxicillin is more effective than ampicillin and penicillin against Streptococcus pneumoniae in vitro, the vast majority of Streptococcus pneumoniae that are sensitive to ampicillin or penicillin are completely sensitive to amoxicillin and this product. In order to detect the pathogenic bacteria and their sensitivity to this product, bacteriological tests should be performed together with surgical operations. When the infection may involve the above-mentioned microorganisms that produce β-lactamases, treatment must be started before the results of bacteriological and sensitive tests are obtained in order to measure the pathogenic bacteria and their sensitivity to this product. Once the results are known, the treatment plan should be adjusted in a timely manner if necessary.

This product can be taken directly orally, or placed in an appropriate amount of warm water, stirred until completely dissolved before taking. This product can also be placed in milk or juice, stirred until completely dissolved before taking. 　　For adults and children weighing more than 40kg (or over 12 years old), take 2 to 4 tablets each time (each tablet contains 200mg amoxicillin and 28.5mg clavulanic acid), once every 12 hours, according to the needs of the condition. Or follow the doctor's advice. 　　For children weighing less than 40kg (or under 12 years old), it is recommended to use a suspension. If this product is used, the recommended dose is as follows: 　　1) For children aged 7 to 12, take 1.5 tablets each time (each tablet contains 200mg amoxicillin and 28.5mg clavulanic acid), once every 12 hours. Or follow the doctor's advice. 　　2) For children aged 2 to 7, take 1 tablet each time (each tablet contains 200mg amoxicillin and 28.5mg clavulanic acid), once every 12 hours. Or follow the doctor's advice. 3) For children aged 9 months to 2 years, take 1/2 tablet each time (each tablet contains 200mg amoxicillin and 28.5mg clavulanic acid), once every 12 hours. Or follow the doctor's advice. For patients with impaired renal function: patients with impaired renal function generally do not require a dose reduction; patients with severe renal impairment and creatinine clearance <30ml/min should not take this product. For patients with impaired liver function: this product should be used with caution, and liver function should be checked regularly.

This product is generally 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 high dose of the drug. Other rare side effects include: abdominal discomfort, bloating and headache. The following side effects have been reported for ampicillin antibiotics: Gastrointestinal: diarrhea, nausea, vomiting, dyspepsia, gastritis, stomatitis, glossitis, black tongue, mucosal candidiasis, colitis and bleeding/pseudomembranous colitis. Symptoms of pseudomembranous colitis may occur during or after antibiotic treatment. Allergic reactions: skin hives, itching, urticaria, angioedema, serum-like illness reactions (urticaria or skin hives accompanied by arthritis, arthralgia, myalgia and frequent fever). Erythema multiforme (rarely Stevens-Johnson syndrome) and exfoliative dermatitis (including toxic skin necrosis) have been reported. These symptoms can be controlled with antihistamines. Take corticosteroids if necessary. If any of the above symptoms occur, discontinue the drug immediately unless otherwise advised. Severe occasional allergic reactions have occurred with other beta-lactam antibiotics. Liver: Patients treated with amoxicillin antibiotics have mild increases in AST (SGOT) and/or ALT (SGPT), but the significance of these results is not clear. Occasional reports of liver damage, including increased AST and/or ALT, blood bilirubin and alkaline phosphatase, have been reported in patients taking this product. Such reports are more common in elderly patients, male patients or patients treated for a long time. Signs or symptoms of liver damage may occur during treatment or within a few weeks after stopping treatment. Severe liver damage is usually reversible, and deaths have been reported very rarely and are usually related to serious underlying diseases or concomitant treatment. Kidney: Rare interstitial nephritis and hematuria. Blood and lymphatic system: Anemia including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis. Once treatment is stopped, these symptoms will disappear and are considered to be allergic phenomena. Less than 1% of patients experience mild thrombocytosis after taking this product. There are reports that the coagulation time of patients taking this product in combination with anticoagulants will be prolonged. Central nervous system: Rarely, there are excitement, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia and reversible hyperfunction.

It is contraindicated in patients who are allergic to penicillins or have liver impairment.

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 [Usage and Dosage]). 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: Use with caution in pregnant women. Ampicillin antibiotics can be secreted through breast milk, so lactating women should use this product with caution. Precautions for the elderly: When elderly patients use this product, there is no need to adjust the dose. The specific dosage is the same as that for adults.

1. Benzenesulfonamide (uric acid drug) can reduce the secretion of amoxicillin from the renal tubules. When used in combination with this product, the blood concentration of amoxicillin will increase. It is recommended not to use it in combination with uric acid drugs: Allopurinol (gout drug) and ampicillin combined will increase the incidence of rash in patients. It is not clear whether the rash caused by ampicillin is caused by allopurinol in the patient's body or by increased blood uric acid. There is no data on the combination of this product with allopurinol; similar to other broad-spectrum antibiotics, this product may reduce the efficacy of contraceptives. 2. Drug/laboratory test interactions: Oral administration of this product will cause an increase in the urine concentration of amoxicillin, and an increase in the urine concentration of ampicillin may cause a false positive reaction. When using Clinitest, Benedict reagent or Fehling reagent to check glucose in urine, because amoxicillin will have this effect, when taking this product, glucose should be detected by glucose oxidase reaction method. After pregnant women take ampicillin, estriol, estriol-glucuronide, and progesterone in the body will temporarily decrease. Amoxicillin and this product can also cause this effect.

Seal tightly and store in a cool, dark (avoid light and not exceeding 20°C) dry place.

0.2285 g (amoxicillin 0.2 g and clavulanic acid 0.0285 g)

24 months

Lunan BETTER Pharmaceutical Co., Ltd.

• Founded in:

  2003-12-16

• Address:

  No. 209, Hongqi Road, Linyi City

• Tax NO.:

  91371300756399007K

• Registered Funds:

  115 million yuan

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