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

• Quality Standard: USP, Bp
• Packing: 1 Vial+1 AMP/Box
• Packing 2: 10 Vials / Box
• Transport Package: Carton
• Specification: 1.5g
• Trademark: Sinolead
• Model NO.: injection
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Generic Name	Ampicillin Sodium and Sulbactam Sodium for Injection 1.5g
Strength	1.5g
Packing	1 vial+1 amp / box ; 10 vials / box
Origin	China

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Ampicillin Sodium and Sulbactam Sodium for Injection 1.5g

Character:
 This product is white or white powder.

Indications:
This product is suitable for the treatment of infections caused by sensitive bacteria. Typical indications include sinusitis, otitis media, epiglottitis, bacterial pneumonia and other upper and lower respiratory tract infections; Urinary tract infection, pyelonephritis; Peritonitis, cholecystitis, endometritis, pelvic cellulitis and other intraperitoneal infections; Bacterial bacteremia; Skin, soft tissue, bone, joint infection; Gonococcal infection.
In the perioperative period, it can also be injected to reduce the incidence of wound infection in patients after abdominal and pelvic surgery. Wound infection can be secondary to peritoneal infection. During pregnancy termination or caesarean section, sulbactam sodium for injection and ampicillin sodium can be used prophylactically to reduce the risk of post-operative sepsis.

Adverse reactions:
As with other antibiotics administered parenterally, the main side effect observed was pain at the injection site, especially intramuscular. A few patients may develop phlebitis or injection site reaction after intravenous injection.
Immune system allergic reaction and anaphylactic shock.
Convulsions in the nervous system have rarely been reported.
Gastrointestinal nausea, vomiting, diarrhea, enterocolitis and pseudomembranous enteritis.
In the blood and lymphatic system, anemia, hemolytic anemia, thrombocytopenia, eosinophilia, and leukopenia have been reported during treatment with sulbactam sodium and ampicillin. It can return to normal after stopping the drug, and it has been confirmed that the above condition is caused by allergic reaction.
Transient elevation of ALT (SGPT) and AST (SGOT) was examined in the laboratory.
Hepatobiliary bilirubinemia, abnormal liver function and jaundice.
Skin and subcutaneous tissue rashes, pruritus, and other skin reactions, Stevens-Johnson syndrome, epidermal necrosis, and erythema multiforme are rarely reported.
Interstitial nephritis of the kidney and urinary tract has rarely been reported.
The adverse reactions that occur with ampicillin alone can also be observed with the administration of ampicillin with sulbactam sodium for injection.

Drug interaction:
Allopurinol: It has been reported that patients taking ampicillin combined with allopurinol have a significantly higher incidence of rashes than those taking ampicillin alone.
Aminoglycoside antibiotics: In vitro test results showed that ampicillin mixed with aminoglycoside antibiotics could inactivate the effects of both; When the two antimicrobials are used together, they should be injected separately in different parts of the patient and at least 1 hour apart.
Anticoagulants: Penicillin-based antibiotics administered outside the gastrointestinal tract can alter the results of platelet aggregation and agglutination tests. Anticoagulants may be added to counteract this effect.
Bacteriostatic drugs (chloramphenicol, erythromycin, sulfonamides and tetracycline) : The bactericidal action of penicillin antibiotics can affect bacteriostatic drugs. It is best to avoid its concurrence.
Estrogen-containing oral contraceptives: There have been case reports of reduced contraceptive effectiveness in women taking ampicillin oral contraceptives, resulting in unplanned pregnancies. Although the likelihood of this happening is small, patients taking ampicillin should be given the option to take another form of birth control or augment it with their original form of birth control.
Methotrexate: Combined with penicillin antibiotics can reduce the clearance of methotrexate, thereby increasing the toxicity of methotrexate. Patients should be closely monitored. It may be necessary to increase the dose of leucovorin and extend the interval of administration.
Prosulfanilamide: When prosulfanilamide is combined with this product, the former can reduce the secretion of ampicillin and sulbactam in the renal tubules, resulting in the increase and extension of the serum peak concentration of the latter, and at the same time, the elimination of half reduction period is prolonged, increasing the risk of poisoning.
Drug interactions in laboratory tests:
When urinalysis was performed with Benedict, Fehling, and ClinitestTM reagents, false positive results for urine sugar were observed. After the injection of ampicillin in pregnant women, it was found that the plasma total bound estradiol, glucoside-estradiol, bound estrone and estradiol were transient decreased. This phenomenon can also occur in patients treated with injectable sulbactam sodium and ampicillin sodium.

Pharmacology and toxicology
Biochemical studies of bacterial free cell systems have shown that sulbactam is an irreversible inhibitor of most important beta-lactamases produced by penicillin-resistant strains. Sulbactam had obvious antibacterial activity only against Neisseraceae, Acinetobacter calc acetate, Bacillus, Moraxella kataxella and Pseudomonas ceponiae. Overall bacterial studies with drug-resistant strains confirmed that sulbactam was effective in preventing the destruction of penicillin and cephalosporin antibiotics by drug-resistant bacteria, and that sulbactam sodium showed obvious synergistic effects when combined with penicillin and cephalosporin antibiotics. Because sulbactam also binds to certain penicillin-binding proteins, some strains that are sensitive to beta-lactam antibiotics alone become more sensitive to sulbactam combinations.
The bactericidal ingredient of this compound preparation is ampicillin. Like other benzylpenicillins, ampicillin works by inhibiting cell wall mucopeptide biosynthesis in sensitive bacteria during their active breeding period.
Sulbactam sodium for injection and ampicillin sodium are effective against a variety of gram-positive and gram-negative bacteria, including Staphylococcus aureus and Staphylococcus epidermidis (including penicillin-resistant and certain methicillin-resistant strains); Streptococcus pneumoniae, Streptococcus faecalis and other streptococcus genera; Haemophilus influenzae and Haemophilus parainfluenzae (including β-lactamase positive and negative strains); Moraxella catarrata; Anaerobic bacteria, including fragile bacilli and related bacteria; E. coli, Klebsiella, Proteus (indole-positive and negative strains), Morganella, Citrate, Enterobacter, meningococcus, and Gonococcus.

Storage:
Sealed and stored below 30ºC.