GMP Certified / Piperacillin Sodium and Sulbactam Sodium for Injection 1.5g

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

Product Description

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

 

 

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Product name:
Piperacillin Sodium and Sulbactam Sodium for Injection 1.5g

Character:
 This product is white or white like loose mass or powder, odorless, bitter taste, very wet.

Indications:
It is suitable for the following infections caused by β-lactamase producing bacteria that are resistant to piperacillin and sensitive to this product. Additional antibiotics are not necessary for the treatment of mixed infections caused by piperacillin monotherapy-sensitive bacteria and β-lactamase producing bacteria that are resistant to piperacillin monotherapy-sensitive bacteria.
1. Respiratory system infection: including acute bronchitis, acute attack of chronic bronchitis, bronchiectasis combined with infection, pneumonia and suppurative tonsillitis.
2. Urinary system infection: including simple urinary system infection and complex urinary system infection.

Adverse reactions:
In general, this product is well tolerated by patients, and only a few patients may occur: 1. Gastrointestinal reactions: As with other antibiotics, the use of this product may produce diarrhea, loose stools, occasional nausea, vomiting, and flatulence. Pseudomembranous enteritis is rare. 2. Skin reaction: Like penicillin and cephalosporins, this product can cause rash and itchy skin. 3. Allergic reaction: Like penicillin and cephalosporins, this product can cause allergic reactions, so it is necessary to ask the allergy history before taking the drug, and those who have a history of penicillin allergy are prohibited. 4. Local reaction: Like other β-lactam antibiotics, this product can cause local irritation reaction at the injection site, pain, phlebitis, thrombophlebitis, edema, etc. 5. Abnormal laboratory examination: Liver function: transient elevation of alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase. 6. Other reactions: headache, dizziness, irritability, anxiety.

Pharmacology and toxicology:
Pharmacological action This product is a compound preparation composed of piperacillin sodium and sulbactam sodium in a ratio of 4:1. Piperacillin is a broad spectrum antibiotic of penicillin class. It plays a bactericidal role by interfering with the synthesis of bacterial cell walls. It is mainly used for infection caused by Pseudomonas aeruginosa and various sensitive gram-negative bacilli, but it is easy to be hydrolyzed by β-lactamase produced by bacteria, resulting in resistance. Sulbactam has no antibacterial activity against other bacteria except Neisseraceae and acinetobacter, but sulbactam irreversibly inhibits most important β-lactam enzymes produced by β-lactam antibiotic resistant strains. Sulbactam can prevent the destruction of penicillin and cephalosporin antibiotics by drug-resistant bacteria, and sulbactam has obvious synergistic effect with penicillin and cephalosporin antibiotics. In vitro tests showed that compared with piperacillin alone, this product has a synergistic effect on the enzyme-producing strains of the following common pathogenic bacteria (MIC value can be reduced by more than 4 times) : Methicillin-resistant Staphylococcus aureus, methicillin-resistant Staphylococcus epidermidis, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Enterobacter cloacae, Pseudomonas aeruginosa, Proteus, Morganella, dysentery and Shigella, Citrobacter, Acinetobacter, Yersinia, Vibrio. In vitro tests also showed that this product has bactericidal effect on the following common clinical pathogens: 1. Gram-negative bacteria: It has strong antibacterial activity against Escherichia coli, Proteus, Klebsiella and Pseudomonas aeruginosa that produce and do not produce β-lactamase; It has good antibacterial activity against Haemophilus (influenzae and Haemophilus parainfluenza), Salmonella, Shigella, Serratia, Citrobacter, Proventeobacteria, Acinetobacter, Morganella, Arc Bacillus, Yersinia, gonococcus and Neisseria meningitidis. 2. Gram-positive bacteria: Streptococcus (Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactis), Staphylococcus (Staphylococcus aureus, MSSA, MRSA, coagulase negative staphylococcus) and Enterococcus have good antibacterial activity against both β-lactamase producing and non-producing streptococcus. 3. Anaerobic bacteria: fragile bacilli, other bacilli, Clostridium, peptostreptococcus, etc. Toxicity of repeated administration: rats were injected intraperitoneally for 8 weeks with a non-toxic dose of 1g/kg; In 2g/kg group, loose stools, diarrhea and slight enlargement of liver and spleen were occasionally observed. In 4g/kg group, dilute stools, diarrhea, ASpartate aminotransferase and urea nitrogen were found to be increased. Reversible pathological changes were also observed. Hepatosplenomegaly, hepatocyte swelling degeneration, splenic sinus expansion, congestion, renal tubular epithelial cell swelling degeneration, 2 weeks after withdrawal of the drug recovery. At present, there are no studies on genotoxicity, reproductive toxicity and carcinogenicity of this product. In animal experiments, no reproductive toxicity was observed with piperacillin or sulbactam alone.

Storage:
Store in a cool and dry place (no more than 20ºC)