Amoxicillin and clavulanate potassium dry suspension
Function and Efficacy
Clavulanic acid combined with amoxicillin can inhibit Staphylococcus aureus, Haemophilus influenzae, and Catarrhalis. β-lactamase produced by microorganisms such as Escherichia coli, Klebsiella, Proteus mirabilis, Proteus vulgaris, gonococci, Legionella, and Bacteroides fragilis destroys amoxicillin, so it is effective against enzyme-producing or non-enzyme-producing strains of the above pathogens. This product also has antibacterial effects on Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Clostridium, Peptococcus, and Peptostreptococcus, which do not produce β-lactamase.
Ingredients
Potassium clavulanate and amoxicillin. Chemical name: potassium (Z)-(2S,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate and (2S,5R,6R)-3,3-dimethyl-6-[(R)-(-)-2-amino-2-(4-hydroxyphenyl)acetylamino]-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate trihydrate.
| Name | Description | Content | CAS NO. | Manufacturer |
|---|---|---|---|---|
| Potassium clavulanateIngredients |
By inhibiting β-lactamase, it protects amoxicillin from destruction and enhances its antibacterial effect; it is effective against β-lactamase produced by Staphylococcus aureus, Haemophilus influenzae, Catarrhalis, Escherichia coli, Klebsiella, Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, Legionella, Bacteroides fragilis, etc. More |
61177-45-5 | 27 | |
| AmoxicillinIngredients |
When used in combination with clavulanic acid, it has antibacterial effects on enzyme-producing or non-enzyme-producing Staphylococci, Haemophilus influenzae, Catarrhalis, Escherichia coli, Klebsiella, Proteus mirabilis, Proteus vulgaris, gonococci, Legionella, Bacteroides fragilis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Clostridium difficile, Peptococcus, and Streptococcus pyogenes. More |
26787-78-0 | 30 |
Appearance
This product is off-white to light yellow in color and tastes sweet.
Indication
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 b-lactamase-producing bacteria Haemophilus or Moraxella. 2. Otitis media: caused by b-lactamase-producing bacteria Haemophilus or Moraxella. 3. Sinusitis: caused by b-lactamase-producing bacteria Haemophilus or Moraxella. 4. Skin and skin soft tissue infections: caused by b-lactamase-producing bacteria Staphylococcus aureus, 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 not effective for ampicillin-sensitive microorganisms and b-lactamase-producing bacteria.
Usage and Dosage
This product can be taken directly orally, or placed in an appropriate amount of warm water, stirred until completely dissolved and then taken. This product can also be placed in milk or juice, stirred until completely dissolved and then taken. For adults and children weighing more than 40kg (or over 12 years old), according to the needs of the condition, take 2-4 tablets each time (each tablet contains 200mg amoxicillin and 28.5mg clavulanic acid), once every 12 hours. 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 selected, the recommended dose is as follows: 1). For children aged 7-12 years, 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 2-7 years, 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 <30hl/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.
Adverse Reactions
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 hemorrhagic/pseudomembranous colitis. Symptoms of pseudomembranous colitis may occur during or after antibiotic treatment. Allergic reactions: skin hives, cramps, 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 by antihistamines. Take corticosteroids if necessary. If any of the above symptoms occur, the drug should be discontinued immediately unless otherwise advised by the doctor. Serious occasional allergic reactions have occurred with other b-lactam antibiotics. Liver: Patients treated with amoxicillin antibiotics have a slight increase in AST (SGOT) and/or ALT (SGPT), but the significance of these results has not been determined. Patients taking this product have occasionally reported liver damage, including increased AST and/or ALT, increased blood bilirubin and alkaline phosphatase. 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. Death has been reported very rarely and is 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, leukocytopenia 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.
Precautions
It is contraindicated in patients who are allergic to penicillins or have liver impairment.
Special Population Medication
Precautions for children: For children weighing less than 40 kg, 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: Animal experiments have shown that this product has teratogenic effects on the fetus, so pregnant women should use it with caution. 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.
Drug Interactions
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. The combination of allopurinol (gout drug) and ampicillin will increase the incidence of skin 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. The 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, there will be a temporary decrease in estriol, estriol-glucuronide, and progesterone in the body. Amoxicillin and this product can also cause this effect.
Storage
Keep away from light, seal tightly, and store in a cool, dark and dry place.
Packaging Specification
Amoxicillin 0.2 g with clavulanic acid 28.5 mg
Validity Period
24 months
Manufacturer
Nanjing Cuccess Pharmaceutical Co., Ltd.
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Founded in:
2002-03-20 -
Address:
No. 20, Xingang Avenue, Nanjing Economic and Technological Development Zone -
Tax NO.:
913201926089285606 -
Registered Funds:
60 million yuan -
Website:
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Email: