GMP Certified / Amoxicillin Sodium and Sulbactam Sodium for Injection

• Quality Standard: USP, Bp
• Usage Mode: Injection
• Factory Certified: GMP
• Transport Package: Carton
• Specification: 1.5g
• Trademark: Sinolead
• Model NO.: injection
• Origin: China
• Production Capacity: 100000ctns Per Month

Product Description

Generic Name	Amoxicillin Sodium and Sulbactam Sodium for Injection
Strength	1.5 g
Packing	10 vials /box
Origin	China

 

 

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 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Amoxicillin Sodium and Sulbactam Sodium for Injection

Character:
This product is white or white powder.

Indications:
This product contains beta-lactamase inhibitor Sulbactam and is suitable for the following infectious diseases caused by enzyme-resistant bacteria, including:
1. Upper respiratory tract infection: such as ear, nose and throat infection, namely otitis media, sinusitis, tonsillitis and pharyngitis;
2. Lower respiratory tract infections: such as pneumonia, acute bronchitis and acute episodes of chronic bronchitis, bronchiectasis, empyema, lung abscess;
3. Genitourinary system infection; Such as pyelonephritis, cystitis and urethritis;
4. Skin and soft tissue infections: such as cellulitis, wound infection, furunculosis, purulent dermatitis and impetigo, venereal diseases; Gonorrhea, etc.
5. Pelvic infection: gynecological infection, postpartum infection, etc.;
6. Oral abscess: such as surgical drugs;
7. Serious system infection: such as meningitis, bacterial endocarditis, peritonitis, osteomyelitis, typhoid and paratyphoid, prevention of endocarditis, etc.

Adverse reactions:
This product is generally well tolerated, and common adverse reactions are:
1. Gastrointestinal reactions: such as diarrhea, nausea, vomiting, etc.
2. Skin reaction: erythematous maculopapular injury, urticaria, etc.
3. Allergic reactions: such as rash, swelling of lips and ulceration of oral mucosa;
4. Others: transient elevated SGPT, etc.;
The above gastrointestinal reactions and skin reactions are more common in hypersensitive patients, generally mild and brief, and will disappear on their own or after stopping the drug.
In people who are allergic to penicillin, severe allergic reactions may occur.

Pharmacology and toxicology:
1. Pharmacological action: This product is a compound preparation composed of amoxicillin sodium and sulbactam sodium in a 2:1 ratio, among which amoxicillin has similar anti-sensitive microbial action to ampicillin, mainly in its reproductive stage. It acts by inhibiting the biosynthesis of cell wall mucopeptides. Sulbactam sodium can inhibit β-lactamase produced by most bacteria (type II to type IV), its stability is better than other β-lactamase inhibitors, it can quickly penetrate the bacterial cell wall and reversibly destroy β-lactamase, so that bacteria can restore the sensitivity to amoxicillin.
Results of both in vitro trials and clinical use indicate that amoxicillin is effective against most of the following microorganisms:
Gram-positive aerobic organisms: Streptococcus faecalis, Staphylococcus genus (factory beta-lactamase-negative strains only), Streptococcus pneumoniae, Streptococcus genus (alpha and beta hemolytic strains only).
Gram-negative aerobic microorganisms: Escherichia coli (limited to β-lactamase-negative strains), Haemophilus influenzae (limited to β-lactamase-negative strains), Neisseria gonorrhoeae (limited to β-lactamase-negative strains), Proteus miris (limited to β-lactamase-negative strains).
2. Toxicological studies: At present, there is no research data on genotoxicity, reproductive toxicity and carcinogenicity of this compound. For toxicological studies of each single drug, please refer to the following relevant data.
Amoxicillin
Genotoxicity: There is no single drug genotoxicity research information, but the results of 4:1 mixing of this product with potassium clavulanate show that Ames test and yeast gene reverting mutation test results have not found mutagenicity. Tests on mouse lymphoma cells were weakly positive, however, in this test. At the dose where the mutation rate tended to increase, the survival of cells also decreased. The results of micronucleus test and dominant lethal test in mice were negative.
Reproductive toxicity: In multi-generation reproductive studies in rats, no damage to fertility and no adverse effects on reproductive function were observed at doses up to 500mg/kg/ day (calculated by body surface area, about 3 times the human dose). Reproductive studies in mice and rats have shown that no damage to fertility or to the fetus has been observed at doses up to 10 times the normal dose. However, full and rigorously controlled trials have not been conducted in pregnant women. Because the results of animal reproductive studies are not always predictive of human conditions, pregnant women should only use this product when it is confirmed to be necessary. Uptake of oral ampicillin antibiotics during delivery is low. Studies in guinea pigs have shown that intravenous administration of ampicillin can slightly reduce uterine tension and frequency of contractions, but can somewhat increase the magnitude and duration of contractions; however, the effect of clinical use of amoxicillin on delivery is unknown.
Carcinogenicity: There have been no studies on the carcinogenicity of this product for long-term use in animals.
sulbactam
Genotoxicity: No studies have been reported.
Reproductive toxicity: When administered to mice, rats and other dosing agents at 10 times the dose, no fertility impairment and fetal toxicity were found. However, without sufficient and rigorous data on pregnant women, the correlation between animals and humans is unclear.
Carcinogenicity: No studies have been reported.

Storage:
Keep in a dry place below 25ºC. Use immediately after preparation and do not refrigerate.