Meropenem for injection

Meropenem is a synthetic broad-spectrum carbapenem antibiotic that produces antibacterial effects by inhibiting the synthesis of bacterial cell walls. Meropenem easily penetrates the cell walls of most Gram-positive and Gram-negative bacteria to reach its target penicillin-binding proteins (PBPs). It has strong stability to the hydrolysis of most β-lactamases (including penicillinase and cephalosporinase produced by Gram-positive and Gram-negative bacteria) except metallo-β-lactamase. Meropenem is not suitable for the treatment of methicillin-resistant Staphylococcus aureus infections, and sometimes shows cross-resistance to other carbapenem-resistant strains. In vitro tests have shown that meropenem and aminoglycoside antibiotics can produce synergistic effects against some isolated strains of Pseudomonas aeruginosa. Both in vitro tests and clinical infection applications have shown that meropenem is active against most of the following microorganisms: (1) Gram-positive aerobic bacteria: Streptococcus pneumoniae (excluding penicillin-resistant strains) and Streptococcus viridans. (2) Gram-negative aerobic bacteria: Escherichia coli, Haemophilus influenzae (β-lactamase-positive strains and β-lactamase-negative strains), Klebsiella pneumoniae, Pseudomonas aeruginosa, Neisseria meningitidis. (3) Anaerobic bacteria: Bacteroides fragilis, Bacteroides thetaiotaomicron, Peptostreptococcus. Meropenem exhibits in vitro antibacterial activity against the following microorganisms, but its clinical significance is unclear: (1) Gram-positive aerobic bacteria: Staphylococcus aureus (β-lactamase-positive strains and β-lactamase-negative strains), Staphylococcus epidermidis (β-lactamase-positive strains and β-lactamase-negative strains). (Note: Staphylococci that are resistant to methicillin/oxacillin should also be considered to be resistant to meropenem) (2) Gram-negative aerobic bacteria: Acinetobacter, Aeromonas hydrophila, Campylobacter jejuni, Citrobacter heteromorphis, Citrobacter freundii, Enterobacter cloacae, Haemophilus influenzae (ampicillin-resistant strains and β-lactamase-negative strains), Moraxella catarrhalis (β-lactamase-positive strains and β-lactamase-negative strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris, Salmonella, Serratia marcescens, Shigella, etc. (3) Anaerobic bacteria: Bacteroides gibbsii, Bacteroides ovale, Bacteroides monomorpha, Bacteroides urealyticum, Bacteroides vulgaris, Clostridium difficile, Clostridium perfringens, Eubacterium tarda, Fusobacterium, Porphyromonas aglycolyticus, Propionibacterium acnes, etc. Toxicological studies: Genetic toxicity: No potential mutagenic effects were found in bacterial reverse mutagenicity test, Chinese hamster ovary cell HGPMT test, human lymphocyte gene culture test, and mouse micronucleus test. Reproductive toxicity: Rats were given meropenem at a dose of 1000 mg/kg per day, and macaques at a dose of 360 mg/kg per day (compared with AUC, equivalent to 1.8 and 3.7 times the exposure of humans at a dose of 1 gram every 8 hours, respectively). No reproductive toxicity was observed, and no damage to fertility and the fetus was found. However, when the rat dose was ≥250 mg/kg per day (compared with AUC, equivalent to 0.4 times the exposure of humans at a dose of 1 gram every 8 hours, respectively), the fetal weight showed slight abnormal changes.

The main ingredient of this product is meropenem. Its chemical name is (-)-(4R,5S,6S)-3-{[(3S,5S)-5-(dimethylaminoformyl)-3-pyrrolidinyl]sulfur}-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3,2,0]hept-2-ene-2-carboxylic acid trihydrate. [Molecular formula] C12H25N3O5S·3H2O [Molecular weight] 437.51

Meropenem is clinically applicable to the following infections caused by sensitive bacteria: 1. Respiratory system infections, such as chronic bronchitis, pneumonia, lung abscess, empyema, etc.; 2. Intra-abdominal infections, such as cholecystitis, cholangitis, liver abscess, peritonitis, etc.; 3. Urinary and reproductive system infections, such as pyelonephritis, complicated cystitis, adnexitis, intrauterine infection, pelvic inflammatory disease, uterine connective tissue inflammation, etc.; 4. Bone, joint, skin and soft tissue infections, such as cellulitis, perianal abscess, osteomyelitis, arthritis, traumatic wound infection, burn wound infection, surgical incision infection, jaw and peri-jaw cellulitis, etc.; 5. Eye and ear, nose and throat infections; 6. Other serious infections, such as meningitis, sepsis, etc.

Usage: The intravenous injection time of meropenem should be greater than 5 minutes, and the intravenous drip time should be greater than 15-30 minutes. When meropenem is injected, it should be prepared with sterile water for injection (250 mg of this product per 5 ml), with a concentration of about 50 mg/ml. Meropenem can be dissolved in the following infusions: 0.9% sodium chloride solution, 5% or 10% glucose solution, 5% glucose solution (sodium bicarbonate concentration 0.02%), 0.9% sodium chloride solution and 5% glucose solution, 5% glucose solution (sodium chloride concentration 0.225%), 5% glucose solution (potassium chloride concentration 0.15%) 25% or 10% mannitol solution. Dosage: Adults: The dosage and time interval should be determined according to the type and severity of the infection and the specific conditions of the patient. The recommended dose is as follows: Pneumonia, urinary tract infection, gynecological infection (such as endometritis), skin or soft tissue infection, once every 8 hours, 500 mg each time, intravenous drip. For the treatment of hospital-acquired pneumonia, peritonitis, concurrent infection and sepsis in patients with neutropenia, the drug is administered once every 8 hours, 1g each time, by intravenous drip. For patients with meningitis, it is recommended to administer the drug once every 8 hours, 2g each time. For patients with renal insufficiency, the daily dose adjustment is as follows: For patients with creatinine clearance <51ml/min, the dose is reduced as follows. Creatinine clearance (ml/min) Dose (unit dose 500mg, 1g, 2g) Time interval 26-50 1 unit dose every 12 hours 10-25 1/2 unit dose every 12 hours 10 1/2 unit dose every 24 hours [Overdose] If an overdose occurs during treatment, especially for patients with renal impairment, the symptoms should be promptly treated. Usually, the drug is rapidly excreted through the kidneys; patients with renal insufficiency can remove meropenem and its metabolites through hemodialysis.

Main adverse reactions: rash, diarrhea, soft stools, nausea, vomiting. In addition, the main abnormalities of laboratory test values include increased GOT, increased GPT, increased ALP, and increased eosinophilia. 1. Serious adverse reactions in patients using meropenem: anaphylactic shock, severe renal dysfunction such as acute renal failure, severe colitis with bloody stools such as pseudomembranous colitis, interstitial pneumonia, PZF syndrome, central nervous system symptoms such as spasm and impaired consciousness, toxic epidermal necrosis (LYELL syndrome), Stevens-Johnson syndrome, pancytopenia, agranulocytosis, leukopenia, liver dysfunction, jaundice, and reports of hemolysis and thrombophlebitis in similar drugs. 2. Other adverse reactions in patients using meropenem: ① Allergic reactions: urticaria, fever, erythema, itching, fever, redness. ② Blood system: granulocytopenia, thrombocytopenia or thrombocytopenia, lymphocytosis, eosinophilia, decreased red blood cells, leukoglobin and hematocrit, etc. ③ Neuropsychiatric: headache, fatigue. ④ Liver: increased LDH, γ-GTP, bilirubin, urobilinogen and jaundice. ⑤ Kidney: increased β2-microglobulin, BUN, Cr. ⑥ Digestive system: abdominal pain, loss of appetite, stomatitis, candida infection, vitamin K deficiency symptoms, vitamin B deficiency symptoms.

1. Those who are allergic to this product are prohibited from using. 2. Pregnant and lactating women should use with caution.

Precautions during pregnancy and lactation: Use with caution in pregnant and lactating women.

When meropenem is used in combination with potentially nephrotoxic drugs, it should be noted that the combination of probenecid and meropenem can competitively activate renal tubular secretion, inhibit renal excretion, and lead to a prolonged elimination half-life of meropenem and an increase in blood drug concentration. Therefore, the combination of meropenem and probenecid is not recommended. When this product is used simultaneously with valproic acid, the blood drug concentration of valproic acid will be reduced, leading to epileptic seizures. Meropenem cannot be used simultaneously with valerate glyceride. Meropenem should not be used in combination with other drugs.

Store tightly closed in a cool, dark and dry place.

Calculated as C17H25N3O5S 0.25g

Zhuhai UNITED Laboratories Co., Ltd.

• Founded in:

  1993-07-03

• Address:

  No. 2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai City

• Tax NO.:

  91440400618249510X

• Registered Funds:

  1.7623158 million yuan

• Website:

  Log in to view

• Email:

  Log in to view