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Amoxicillin and clavulanate potassium injection is a compound antibiotic formulation composed of amoxicillin and Clavulinate Potassium in a specific ratio. Amoxicillin belongs to the penicillin class of β - lactam antibiotics and exerts bactericidal effects by inhibiting bacterial cell wall synthesis; Potassium clavulanate is a β - lactase inhibitor that can protect amoxicillin from degradation by β - lactase, thereby expanding its antibacterial spectrum and enhancing therapeutic efficacy. This drug is administered intravenously and is suitable for treating severe or systemic infections caused by sensitive bacteria.
Additional information of chemical compound:
| Product Name | Amoxicillin And Clavulanate Potassium Injection | Amoxicillin And Clavulanate Potassium Tablets | Amoxicillin And Clavulanate Potassium Suspension |
| Product Type | Injection | Tablet | Liquid |
| Product Purity | ≥99% | ≥99% | ≥99% |
| Product Specifications | Customizable | Customizable | Customizable |
| Product Package | Customizable | Customizable | Customizable |
Our product
It is an antibiotic that kills bacteria. The main components of amoxicillin and clavulanic acid potassium injection are amoxicillin and clavulanic acid. Amoxicillin belongs to the penicillin class of drugs and also belongs to the β - lactam class of antibiotics. Its function is to kill bacteria by inhibiting the synthesis of bacterial cell walls. Clavulanic acid belongs to β - lactase inhibitors, and its antibacterial effect is relatively weak. It can firmly bind with the β - lactase produced by bacteria to prevent the hydrolysis and destruction of amoxicillin by β - lactase, thereby protecting the bactericidal effect of amoxicillin.
This drug is mainly used to treat the following infections caused by sensitive bacteria:
Lower respiratory tract infections: such as community-acquired pneumonia, acute exacerbation of chronic bronchitis, and concurrent infections with bronchiectasis.
Upper respiratory tract infections: such as sinusitis, tonsillitis, otitis media (especially recurrent or chronic otitis media).
Urinary tract infections: such as complex urinary tract infections and pyelonephritis.
Skin and soft tissue infection: such as cellulitis, animal bite infection, diabetes foot infection.
Bone and joint infections, such as osteomyelitis and arthritis.
Abdominal infection: such as peritonitis and liver abscess.
Other: such as prevention of sepsis and infective endocarditis (for specific high-risk populations).
Amoxicillin and clavulanic acid potassium injections are mainly used clinically to treat respiratory infections, such as pharyngitis, tonsillitis, sinusitis, acute and chronic bronchitis, pneumonia, lung abscess, bronchiectasis complicated with infection, etc; Urinary tract infections, such as cystitis, pyelonephritis, prostatitis, pelvic inflammatory disease, urethritis, etc; Skin and soft tissue infections, such as boils, abscesses, cellulitis, wound infections, as well as osteomyelitis, otitis media, peritonitis, sepsis, postoperative infections, and other infections.
Amoxicillin and Clavulinate Potassium Injection is a broad-spectrum compound antibiotic formulation administered intravenously for the treatment of severe or systemic infections caused by sensitive bacteria. Its core chemical composition and dosage form specification design balance antibacterial activity, stability, and precision of clinical medication.
Chemical composition: synergistic effect of dual active ingredients
Chemical essence: Amoxicillin belongs to the penicillin class of beta lactam antibiotics, and its sodium salt form (C16H19N3NaO5S) is soluble in water and easy to administer intravenously.
Mechanism of action: By inhibiting bacterial cell wall synthases (penicillin binding proteins, PBPs), the cross-linking of cell wall peptidoglycans is blocked, leading to bacterial expansion and lysis. It has a strong bactericidal effect on Gram positive bacteria (such as Staphylococcus aureus and Streptococcus) and some Gram negative bacteria (such as Haemophilus influenzae and Moraxella catarrhalis).
Pharmacokinetic optimization: The sodium salt form enhances the water solubility of amoxicillin, allowing it to rapidly distribute to systemic tissues (such as cerebrospinal fluid, lungs, prostate) after intravenous injection, with an apparent distribution volume (Vd) of 0.3-0.4 L/kg and a half-life (t ₁/₂) of approximately 1-1.3 hours.
Chemical essence: Clavulanic acid is a β - lactase inhibitor, and its potassium salt form (C8H8KNO5) is also soluble in water, complexed with amoxicillin in a fixed ratio.
Mechanism of action: By irreversibly binding to β - lactases produced by bacteria (such as TEM-1 and SHV-1 enzymes), amoxicillin is protected from enzymatic hydrolysis, thereby restoring its antibacterial activity against enzyme producing bacteria (such as ESBL producing Escherichia coli and Klebsiella pneumoniae). Clavulanic acid itself has only a weak antibacterial effect, but its enzyme inhibitory activity is the core value.
Pharmacokinetic synergy: The Vd of clavulanic acid is 0.2-0.3 L/kg, and t ₁/₂ is about 0.7-1.2 hours, which highly matches the metabolic cycle of amoxicillin, ensuring that the two exert synergistic effects synchronously in vivo.
Clinical studies have shown that when amoxicillin is combined with clavulanic acid in a 5:1 (mass ratio) ratio, it can maximize the protection of amoxicillin from enzymatic hydrolysis and avoid liver toxicity (such as elevated transaminase) caused by excessive clavulanic acid. For example:
1000 mg/200 mg specification: Contains 1000 mg amoxicillin (based on the matrix) and 200 mg clavulanic acid, with a strict ratio of 5:1.
2000 mg/200 mg specification: Although the dose of amoxicillin is doubled, the dose of clavulanic acid remains unchanged, suitable for scenarios requiring higher concentrations of amoxicillin in severe infections, while controlling the total amount of clavulanic acid to reduce risk.
Formulation specification: Accurately match clinical needs
1000 mg/200 mg specification:
Ingredients: Sodium amoxicillin (equivalent to 1000 mg amoxicillin)+potassium clavulanate (equivalent to 200 mg clavulanic acid).
Additional ingredients: Each bottle contains 2.7 mmol/L sodium (62.9 mg) and 1.0 mmol/L potassium (39.3 mg), and attention should be paid to electrolyte balance (especially for those with renal dysfunction).
Packaging: Sterile powder is packaged in a 20 mL Type II glass bottle with a bromobutyl rubber stopper to ensure sealing and stability.
2000 mg/200 mg specification:
Ingredients: Sodium amoxicillin (2000 mg)+potassium clavulanate (200 mg).
Additional ingredients: The sodium content increased to 5.5 mmol (125.9 mg), while the potassium content remained unchanged.
Applicable scenarios: Priority should be given to severe infections (such as sepsis, complex urinary tract infections) that require rapid attainment of high blood drug concentrations.
1.2 g specification:
Ingredients: Amoxicillin 1000 mg+clavulanic acid 200 mg (based on matrix), some products may adjust the proportion of excipients to optimize solubility.
Advantages: More concentrated single dose administration, reduced infusion frequency, and improved patient compliance.
Appearance: White to off white sterile powder, dissolved into a clear solution (pH 4.5-7.0), with no visible particles.
Stability:
Storage conditions: Store in a sealed place below 30 ℃, away from light and dry, to prevent the decomposition of potassium clavulanate (which is sensitive to light and heat).
Validity period: Usually 36 months, it should be used immediately after opening to avoid contamination.
Dissolution and dilution:
Dissolve: Dissolve the powder in 10-20 mL of injection water and shake gently until completely clear.
Dilution: Further dilute the solution to 20-100 mL (such as 0.9% sodium chloride injection or 5% glucose injection), with an infusion time of ≥ 30 minutes to reduce venous irritation.
3. Design considerations for special dosage forms
Sodium/potassium content control: The sodium content significantly increases in high-dose specifications, and it is necessary to monitor the electrolyte balance of patients with renal insufficiency to avoid hypernatremia.
Accessory selection: Using bromobutyl rubber stoppers can reduce the interaction between drugs and packaging materials, and prevent dose loss caused by potassium clavulanate adsorption.
Pediatric applicability: Although the safety of infants under 3 months old has not been established, the safety of pediatric formulations (such as oral suspensions) is optimized by adjusting the amoxicillin/clavulanic acid ratio (such as 125 mg/31.25 mg per 5 mL), while injections require strict calculation of dosage based on body weight.
The logic of specification selection in clinical applications
Mild to moderate infection: Priority should be given to the 1000 mg/200 mg dosage, administered every 8 hours (q8h), to balance efficacy and safety.
Severe infection: Use the 2000 mg/200 mg specification, q8h or q12h (adjusted according to pharmacokinetic models), to quickly control bacteremia.
Renal insufficiency: Adjust the dosage according to creatinine clearance rate. For example, when CrCl is 10-30 mL/min, the 1000 mg/200 mg specification can be extended to q12h administration.
Liver dysfunction: Mild to moderate liver damage does not require dose adjustment, but transaminase monitoring is necessary; Be cautious or contraindicated with severe liver damage.
For ESBL strain infection, it is necessary to ensure that the concentration of clavulanic acid is sufficient to inhibit enzyme activity, and usually choose a high-dose specification with a standard ratio (5:1).
The chemical composition and formulation specification design of Amoxicillin and Clavulinate Potassium Injection embody the dual goals of "precise antibacterial" and "safe and controllable". Its 5:1 golden ratio, diverse specification selection, and strict stability control provide an efficient and flexible solution for clinical treatment of severe bacterial infections.
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