Aztreonam for injection

Aztreonam has high antibacterial activity against most aerobic Gram-negative bacteria, including Escherichia coli, Klebsiella pneumoniae and Oxytobacter, aerogenes, Cloacae, Proteus, Serratia, Citrobacter, Shigella and other Enterobacteriaceae, as well as influenza bacilli, gonococci, meningococci, etc. It also has good antibacterial effect against Pseudomonas aeruginosa, but has poor antibacterial effect against some Pseudomonas and Acinetobacter other than Pseudomonas aeruginosa, and has no antibacterial activity against aerobic Gram-positive bacteria such as Staphylococcus and Streptococcus, as well as anaerobic bacteria. Aztreonam inhibits the synthesis of cell walls by highly binding to penicillin-binding protein 3 (PBP3) on the cell membrane of sensitive aerobic Gram-negative bacteria. Unlike most beta-lactam antibiotics, it does not induce bacteria to produce beta-lactamase and is highly stable to most beta-lactamases produced by bacteria.

The main ingredient of this product is aztreonam. Chemical name: [2S-[2alpha;,3beta;(z)]]-2-[[[1-(2-amino-4-thiazolyl)-2-[(2-methyl-4-oxo-1-sulfo-3-azetidinyl)amino]-2-oxoethylidene]amino]oxy]-2-methylpropionic acid. Molecular formula: C13H17N5O8S2 Molecular weight: 435.43 Excipients: L-arginine.

Powder for injection is white or off-white powder.

It is suitable for treating various infections caused by sensitive aerobic Gram-negative bacteria, such as urinary tract infection, lower respiratory tract infection, sepsis, intra-abdominal infection, gynecological infection, postoperative wounds and burns, ulcers and other skin and soft tissue infections, etc. It is also used to treat the above-mentioned types of infections in hospital infections (such as hospital infections in immunodeficient patients).

1 Intravenous drip: Dissolve at least 3 ml of water for injection per 1 g of aztreonam, and then dilute with appropriate infusion fluid (0.9% sodium chloride injection, 5% or 10% glucose injection or Ringer's injection). The concentration of aztreonam should not exceed 2%. The drip time is 20 to 60 minutes. 2 Intravenous push: Dissolve each bottle with 6 to 10 ml of water for injection and slowly inject into the vein within 3 to 5 minutes. 3 Intramuscular injection: (1) Adults: Dissolve at least 3 ml of water for injection or 0.9% sodium chloride injection per 1 g of aztreonam and inject deep into the muscle. Dosage: Infection type Dose (g) Interval (hours) Urinary tract infection 0.5 or 18 or 12 Moderate to severe infection 1 or 28 or 12 Life-threatening or severe infection with Pseudomonas aeruginosa 26 or 8 Patients with a single dose greater than 1 g or suffering from sepsis, other severe systemic infection or life-threatening infection should be given intravenously, with the maximum dose being 8 g per day. (2) When the patient has transient or persistent renal impairment: the dosage should be reduced according to the renal function. For patients with renal impairment whose creatinine clearance is less than 10-30 ml/(min.1.73 m2), the initial dosage is 1 g or 2 g, and the dosage is halved thereafter; for patients with severe renal failure whose creatinine clearance is less than 10 ml/(min.1.73 m2), such as those who rely on hemodialysis, the initial dosage is 0.5 g, 1 g or 2 g, and the maintenance dosage is 1/4 of the initial dosage, with an interval of 6, 8 or 12 hours; for patients with severe or life-threatening infections, after each hemodialysis, add 1/8 of the initial dosage to the original maintenance dosage.

Adverse reactions are rare, with a systemic adverse reaction rate of about 1-1.3% or slightly lower, including gastrointestinal reactions, most commonly nausea, vomiting, diarrhea, and skin allergic reactions. Decreased white blood cell count, thrombocytopenia, Clostridium difficile diarrhea, gastrointestinal bleeding, exfoliative dermatitis, hypotension, transient electrocardiogram changes, hepatobiliary system damage, central nervous system reactions, and muscle pain are rare.

Patients with a history of allergy to aztreonam are contraindicated.

Precautions for children: The safety of infants and young children has not been established, so it should be used with caution. Precautions for pregnancy and lactation: 1. This product can enter the fetal circulation through the placenta. Although animal experiments show that it has no effect on the fetus, is non-toxic and non-teratogenic, pregnant women should still use it only when necessary. 2. It can be secreted through breast milk, and the concentration is less than 1% of the maternal blood drug concentration. When breastfeeding women use it, breastfeeding should be suspended. Precautions for the elderly: The dosage for the elderly should be reduced as appropriate according to their renal function impairment.

1. This product is combined with aminoglycosides (gentamicin, tobramycin, amikacin, etc.) to have a synergistic antibacterial effect against Pseudomonas aeruginosa, Acinetobacter, Serratia, Klebsiella, Providencia, Enterobacter, Escherichia coli, Morganella, etc. 2. This product and cefoxitin have antagonistic effects in vitro and in vivo: it does not interfere with the efficacy of naphthiocylin, cloxacillin, erythromycin, vancomycin, etc.

Keep away from light and store in a sealed container.

0.5g

STAR Pharmaceutical Pte.ltd

• Founded in:

  1993-08-28

• Address:

  3rd Floor, Office Building, No. 6 Shunda Road, Jiangdong New District, Haikou City, Hainan Province

• Tax NO.:

  91469002620007633W

• Registered Funds:

  HK$50 million

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