What Factors Affect Amoxicillin Pediatric Dosage?

Amoxicillin and potassium clavulanate chewable tablets, the indication is that this product can be used to treat infections caused by sensitive strains of microorganisms specified in the following conditions: 1. Lower respiratory infections: -lactamase-producing bacteria Haemophilus or Caused by Moraxella. 2. Otitis media: caused by -lactamase-producing bacteria Haemophilus or Moraxella. 3. Sinusitis: caused by -lactamase-producing bacteria Haemophilus or Moraxella. 4. Skin and skin soft tissue infections: caused by -lactamase production of Staphylococcus, E. coli or Klebsiella. 5. Urinary tract infection: caused by E. coli, Klebsiella or Enterobacter. Although this product is effective against the above various infections, infections caused by ampicillin-sensitive bacteria can also be treated with this product because the product contains amoxicillin. Therefore, the complex infection caused by ampicillin-sensitive microorganisms and -lactamase-producing microorganisms is sensitive to this product, and no other antibiotics are needed. Because amoxicillin is more effective against Streptococcus pneumoniae than ampicillin and penicillin in vitro, the vast majority of Streptococcus pneumoniae that is neutrally sensitive to ampicillin or penicillin is completely sensitive to amoxicillin and this product. In order to detect pathogenic bacteria and their sensitivity to this product, bacteriological tests should be performed together with surgery. When the infection may involve the above-mentioned -lactamase-producing microorganisms, treatment must be started before the results of bacteriological and sensitivity tests, in order to determine the pathogenic bacteria and their sensitivity to the product. Once the results are known, the treatment plan should be adjusted immediately if needed.

Drug Name: Amoxicillin clavulanate potassium chewable tablet

Drug type: prescription

Warnings for amoxicillin and clavulanate potassium chewable tablets

Patients who are allergic to penicillins or patients with liver dysfunction are contraindicated.

Amoxicillin clavulanate potassium chewable tablet ingredients

This product is a compound preparation, and its components are: each tablet containing amoxicillin (based on C ₁₆ H ₁₉ N ₃ O ₅ S) and potassium clavulanate (based on C ₈ H ₉ NO ₅ ) are 0.2g and 0.0285g.

Amoxicillin and Clavulanate Potassium Chewable Tablets

This product is a film-coated tablet. After removing the film coating, it is white or light yellow.

Indications of amoxicillin and clavulanate potassium chewable tablets

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

Amoxicillin clavulanate potassium chewable tablet specifications

0.2285g (C ₁₆ H ₁₉ N ₃ O ₅ S 0.2g and C ₈ H ₉ NO ₅ 0.0285g)

Amoxicillin and clavulanate potassium chewable tablets

After chewing, swallow it with warm water, or swallow directly after chewing.
Adults and children weighing more than 40kg (or older than 12 years old), according to the needs of the disease, 2-4 tablets each time (each tablet contains 200mg amoxicillin and 28.5mg potassium clavulanate), once every 12 hours. Or as directed by your doctor.
For children weighing less than 40 kg (or under 12 years of age), suspensions are recommended.
If using this product, the recommended dosage is as follows:
(1) For children 7-12 years old, take 1.5 tablets each time (each tablet contains 200 mg of amoxicillin and 28.5 mg of potassium clavulanate), once every 12 hours. Or as directed by your doctor.
(2) For children 2 to 7 years old, take 1 tablet each time (each tablet contains 200 mg of amoxicillin and 28.5 mg of potassium clavulanate), once every 12 hours. Or as directed by your doctor.
(3) For children from 9 months to 2 years old, each half tablet (each tablet contains 200 mg amoxicillin and 28.5 mg potassium clavulanate), once every 12 hours. Or as directed by your doctor.
For patients with impaired renal function: Patients with impaired renal function generally do not require dose reduction; patients with severe impaired renal function, those with 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.

Adverse reactions of amoxicillin and clavulanate potassium chewable tablets

This product is generally well tolerated, and most of the side effects observed clinically are mild and transient. Less than 3% of patients discontinued treatment due to drug-related side effects. The main side effects reported were diarrhea / thinning of stool (9%), nausea (3%), measles and urticaria (3%), vomiting (1%), and myocarditis (1%). The occurrence of adverse reactions, especially diarrhea, is associated with higher doses. Other rare side effects include: abdominal discomfort, bloating, and headache.
The following side effects have been reported for ampicillin antibiotics.
Gastrointestinal tract: diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, dark tongue coating, mucosal candidiasis, colitis, and bleeding / pseudomembrane colitis. Symptoms of pseudomembranous colitis occur during or after antibiotic treatment.
Allergic reactions: skin measles, pruritus, urticaria, angioedema, serum sickness-like reactions (urticaria or skin measles with arthritis, joint pain, myalgia, and frequent fever). Polytype erythema (rare Stevens-Johnson syndrome) and exfoliative dermatitis (including toxic skin necrosis) have been reported. These symptoms can be controlled with antihistamines. If necessary, take corticosteroids. If any of the above symptoms occur, the drug should be discontinued immediately unless otherwise prescribed.
With other beta-lactam antibiotics, severe occasional allergic reactions will occur.
Liver: Patients treated with ampicillin antibiotics have slightly elevated AST (SGOT) and / or ALT (SGPT), but the significance of these results has not been clarified. Patients taking this product have occasionally reported liver damage, including elevated AST and / or ALT, elevated bilirubin and / or alkaline phosphatase. Such reports are more common in elderly patients, male patients, or long-term patients.
At the time of treatment or within a few weeks after stopping treatment, there may be signs or symptoms of liver damage. Hepatic impairment may be severe but is usually reversible. There are very few reports of death, but it usually occurs in cases with severe underlying disease or in combination with other medications.
Kidney: Rare interstitial nephritis and hematuria.
Blood and Lymphatic System: Anemia includes hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis. Once treatment is stopped, these symptoms will disappear and they are considered to be allergic. Less than 1% of patients develop mild thrombocythemia after taking Ametine. There have been reports of prolonged coagulation time in patients taking this product in combination with anticoagulants.
Central nervous system: Rarely hyperactivity including agitation, anxiety, behavioral changes, confusion, dizziness, insomnia, and reversibility.

Amoxicillin clavulanate potassium chewable taboo

Patients who are allergic to penicillins or patients with liver dysfunction are contraindicated.

Precautions for amoxicillin and clavulanate potassium chewable tablets

1. general:
Although this product has the low toxicity of ampicillin antibiotics, it is still recommended to regularly check some organ functions during extended treatment, including kidney, liver or hematopoietic support.
Patients with mononucleosis are more likely to develop erythema after taking ampicillin. Therefore, patients with mononucleosis should disable ampicillin antibiotics.
During treatment, there is a possibility of double infection caused by mold or bacteria. If dual infection occurs, the drug should be discontinued or appropriate treatment should be continued.
2. Information for patients:
Take this product with meals to reduce gastrointestinal side effects. Many antibiotics can cause diarrhea. If you have severe diarrhea or persistent diarrhea for more than 2 to 3 days, consult your doctor.
3 caveat:
Serious and common allergic reactions have been reported in patients during penicillin treatment. This reaction is prone to patients with a history of penicillin allergy or sensitivity to multiple allergens. There have been reports of individual patients allergic to penicillin responding to cephalosporins. Before starting the treatment of this product, the patient's allergy history must be carefully investigated. If any allergic reaction occurs, the drug must be stopped immediately.
Severe allergic reactions need to be immediately treated with epinephrine, oxygen therapy, intravenous steroids, and throat airway treatment.
Pseudomucosal colitis has been reported in all antibiotics and may progress from mild to life-threatening, so patients with diarrhea after taking this product should be treated with caution.
Antibiotics change the common flora that causes diarrhea, and may cause Clostridium to grow in large numbers. Studies have shown that toxins produced by Clostridium may be the main cause of diarrhea.
After determining a treatment plan for pseudomucosal colitis, appropriate therapies can begin. Mild holiday mucosal colitis may be caused by intermittent medication. For more severe cases, treatments that supplement electrolytes, proteins, and other clinically effective antibiotics for Clostridium should be taken. Patients with liver dysfunction should be cautious in taking the drug, and abnormal liver function caused by taking the drug is recoverable. The probability of causing death in the clinic is very low, less than one in four million, and it is usually caused by some hidden disease or concomitant medication.
4 other:
1) Carcinogenicity, mutagenicity and damage to fertility: Long-term animal studies have not been conducted to evaluate the carcinogenic effects of this product.
2) Mutagenicity: Ames test, human lymphocyte genetic test, yeast test, and mouse lymphocyte were used to study the mutagenic effect of this product in vitro. The mouse nucleoli test and the dominant lethal test were used in vivo. Except the mouse in vivo lymphoma test, other tests were negative.
3) Damage to fertility: the oral dose of this product was increased to 1200 mg / kg / day (517 times the maximum human dose) and no effect on fertility and fertility in rats was found (amoxicillin and clavulanic acid ratio was 2: 1).
4) Teratogenic effect: administered orally to pregnant rats and mice at a dose of 1200 mg / Kg / day, equivalent to 7200 and 4080 mg / m2 / day, respectively (according to body surface area, 4.9 and 2.8 times the maximum human dose ) Have not shown that this product has teratogenic effects on the fetus, but there are no adequate and well controlled trials in pregnant women. Because animal reproductive research does not always predict human response, unless doctors consider it necessary. Avoid using it for pregnant women.
5) Delivery: Oral ampicillin is rarely absorbed during delivery. Studies in guinea pigs have shown that intravenous injection of ampicillin reduces uterine tension, frequency of contraction, intensity of contraction, and duration of contraction. However, it is not clear whether the pregnant women used by Ametine for delivery have immediate or delayed side effects on the fetus, prolong the delivery time or increase the possibility of high-force delivery or other surgery.
5. Compound formulations consisting of amoxicillin and potassium clavulanate in different proportions cannot be replaced with each other.

Amoxicillin clavulanate potassium chewable tablets for pregnant and lactating women

Animal tests have shown that this product has teratogenic effects on the fetus, pregnant women should be used with caution.
Ampicillin antibiotics can be secreted through milk, so lactating women should use this product with caution.

Amoxicillin and clavulanate potassium chewable tablets for children

For children weighing less than 40kg, suspensions are recommended.
Due to the impaired renal function of newborns and infants, the metabolism of amoxicillin may be delayed. In pediatric treatment, doses should be reduced for infants less than three months old.

Amoxicillin clavulanate potassium chewable tablets for elderly

Elderly patients do not need to adjust the dosage when using this product, the specific dosage is the same as that of adults.

Amoxicillin clavulanate potassium chewable tablet drug interactions

1. Probenecid reduces the secretion of amoxicillin from the renal tubules. When used with this product, it will increase the blood concentration of amoxicillin. It is recommended not to use it with diuretic drugs; allopurinol (gout medicine) and ampicillin Combined use will increase the incidence of rash in patients. It is not clear whether ampicillin caused the rash due to allopurinol or elevated urinary acid in patients. There is no data on the combination of this product with allopurinol; and other broad-spectrum antibiotics Similarly, this product may reduce the effectiveness of contraceptives.
2. Drug / laboratory interactions: Oral Augmentin causes an increase in urine concentration of amoxicillin, and an increase in urine concentration of ampicillin may cause a false positive reaction. For example, when using Clinitest, Benedict reagent or Fehling reagent to check glucose in urine, because amoxicillin can produce this effect, glucose should be detected by glucose oxidase reaction method when taking this product. After taking ampicillin in pregnant women, estriol, estriol-glucuronide, estrone and estriol are temporarily reduced in the body. Amoxicillin and this product also cause this effect.

Clinical trial of amoxicillin and clavulanate potassium chewable tablets

Excessive medication will not cause adverse symptoms for most patients or mainly cause gastrointestinal discomfort such as stomach pain, abdominal pain, vomiting, and diarrhea. In a small number of patients, it can cause symptoms such as rash, hyperfunction, or lethargy. If you take too much medicine, you should stop taking this product immediately and take support or symptomatic treatment according to your symptoms. If it is overdose for a short period of time and the patient has no contraindications, he should take vomiting or gastric lavage.

Pharmacology and toxicology of amoxicillin and clavulanate potassium chewable tablets

This agent is composed of amoxicillin trihydrate and potassium clavulanate. Amoxicillin is a bactericidal broad-spectrum antibiotic and potassium clavulanate is an irreversible broad-spectrum -lactamase inhibitor, which can effectively inhibit -lactamase produced by drug-resistant bacteria. Clinically, many Gram-positive and Gram-negative bacteria produce -lactamase, which can cause amoxicillin to lose its antibacterial activity. The presence of potassium clavulanate protects amoxicillin from beta-lactamase, so that bacteria that are resistant to amoxicillin and produce beta-lactamase are still sensitive to amoxicillin.
This product is a bactericidal antibiotic, which can clinically kill a variety of Gram-positive and Gram-negative bacteria, and has a special curative effect on -lactamase-resistant bacteria. These bacteria include:
Gram-positive bacteria:
Aerobic bacteria: Staphylococcus aureus, Streptococcus faecalis, Staphylococcus epidermidis, Listeria monocytogenes, Streptococcus pyogenes, Corynebacterium, Streptococcus green, Streptococcus pneumoniae;
Anaerobic: Clostridium, Digestive Streptococcus, Digestive Streptococcus
Gram-negative bacteria:
Aerobic bacteria: Escherichia coli, Brucella, mirabilis, Haemophilus influenzae, common degenerative bacteria, meningococcus, Klebsiella, Neisseria gonorrhoeae, Salmonella, Haemophilus ducrei, Chi Hemophilus, Branhamella, Pertussis, Pasteurella haemorrhagic;
Anaerobic: Bacteroides include Bacteroides fragile.

Pharmacokinetics of amoxicillin and clavulanate potassium chewable tablets

Detailed and comprehensive human pharmacokinetic data of amoxicillin and clavulazone potassium (7: 1) dry suspension (each containing 200 mg of amoxicillin and 28.5 mg of clavulanate potassium) are not available in China. However, research data on human bioavailability of 20 healthy male volunteers in China showed that a single oral administration of 4 packets of this product (containing 80 mg of amoxicillin and 114.0 mg of clavulanic acid) was measured by HPLC. Cmax of amoxicillin, The Tmax and AUC were 12959 ± 3163ng / ml, 1.487 ± 0.681h, 31963 ± 8136ng.h / ml, and the Cmax, Tmax, and AUC of potassium clavulanate were 1822.4 ± 507.5ug / 1, 1.19 ± 0.72h, and 4452.1 ± 856.9ug.h / l.
According to foreign countries, potassium amoxicillin clavulanate 125mg / 5ml (4: 1) dry suspension (containing amoxicillin 125mg and potassium clavulanate 31.25mg), ) Dry suspension (containing amoxicillin 250mg and potassium clavulanate 62.5mg), amoxicillin and clavulanate potassium 200mg / 5ml (7: 1) dry suspension (containing amoxicillin 200mg and potassium clavulanate) 28.5mg), amoxicillin potassium clavulanate 400mg / 5ml (7: 1) dry suspension (containing amoxicillin 400mg and potassium clavulanate 57mg) and amoxicillin potassium clavulanate 125mg (4: 1) Chewable tablets (containing amoxicillin 125mg and clavulanate potassium 31.25mg), amoxicillin potassium clavulanate 250mg (4: 1) chewable tablets (containing amoxicillin 250mg and potassium clavulanate 62.5mg), amoxicillin Clavulanate potassium 200mg (7: 1) chewable tablets (containing amoxicillin 200mg and clavulanate potassium 28.5mg), amoxicillin potassium clavulanate 400mg (7: 1) chewable tablets (containing amoxicillin 400mg and carat Potassium retinoic acid 57mg) study data, amoxicillin / clavulanate potassium gastrointestinal absorption is good. Food has little effect on the pharmacokinetic parameters of amoxicillin. This product can be taken on an empty stomach or after a meal, but in a relatively fasting state, potassium clavulanate is absorbed more when taken with food. In one study, taking this product within 30 to 150 minutes after taking a high-fat breakfast reduced the relative bioavailability of potassium clavulanate.
Comparison of pharmacokinetic parameters of 28 adult volunteers after taking a single dose of amoxicillin and clavulanate potassium 400mg (7: 1) and amoxicillin and clavulanate potassium 400mg / 5ml (7: 1) as follows:

Amoxicillin potassium clavulanate 250mg / 5ml (4: 1) dry suspension for oral administration 5ml or equivalent dose Amoxicillin potassium clavulanate 125mg / 5m1 (4: 1) dry suspension for oral administration 10ml, available after 1 hour At the peak of average blood concentration, Cmax of amoxicillin is equivalent to 6.9 g / ml, Cmax of clavulanic acid is equivalent to 1.6 g / ml, and adult volunteers take 5 ml of amoxicillin and clavulanate potassium 250 mg / 5 ml suspension or 10 ml. Amoxicillin potassium clavulanate 125mg / 5ml suspension, 4 hours after taking the drug, the AUC of amoxicillin was 12.6 g.hr. / ml, and the AUC of clavulanic acid was 2.9 g.hr. / ml. One amoxicillin potassium clavulanate 250mg (4: 1) chewable tablet or two amoxicillin potassium clavulanate 125mg (4: 1) chewable tablets and 5ml amoxicillin potassium clavulanate 250mg / 5ml suspension, Its blood levels of amoxicillin and clavulanic acid are similar.
After taking amoxicillin and potassium clavulanate, the blood concentration achieved by amoxicillin was similar to that achieved by taking the same dose of amoxicillin alone. After taking amoxicillin and clavulanate potassium, the half-lives of amoxicillin and clavulanic acid were 1.3 hours and 1.0 hours, respectively. Adults and children take this product according to the corresponding q12h and q8h dosage regimens. The time above the minimum inhibitory concentration of amoxicillin 1.0 g / ml is similar.
Amoxicillin potassium clavulanate 250mg / 5ml (4: 1) dry-mixed dose of 10 rml, about 50% -70% of amoxicillin and 25% -40% of clavulanic acid are excreted through the urine as a prototype. Taking probenecid at the same time delays excretion of amoxicillin but does not affect renal excretion of clavulanic acid.
The protein binding rate of any component in amoxicillin and clavulanate potassium was low. In human serum, the binding rate of amoxicillin is approximately 18%, and the binding rate of clavulanic acid is approximately 25%.
Amoxicillin gradually enters most tissues and fluids of the human body except the brain and spinal cord. The experimental results of clavulanic acid administered to animals show that clavulanic acid is as easily distributed throughout the body as amoxicillin.
Children take potassium amoxicillin clavulanate at a dose of 35mg / kg on an empty stomach. Two hours later, the average concentration of amoxicillin measured in the middle ear secretion is 3.0 g / ml, and the average concentration of clavulanic acid is 0.5. g / ml.

Storage of amoxicillin and clavulanate potassium chewable tablets

Store in a cool, dark, dry place (protected from light not exceeding 20 ° C).

Amoxicillin clavulanate potassium chewable tablet packaging

Double-layer aluminum foil packaging. 6 tablets / board / box; 6 tablets / board × 2 boards / box.

Validity of Amoxicillin and Clavulanate Potassium Chewable Tablets

Tentative 24 months.

Amoxicillin clavulanate potassium chewable tablet

WS-740 (X-587) -2001 ^[1]