CEFOTAXIME injection, powder, for solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

CEFOTAXIME SODIUM (UNII: 258J72S7TZ) (CEFOTAXIME - UNII:N2GI8B1GK7)

Dostępny od:

Hikma Pharmaceuticals USA Inc.

INN (International Nazwa):

CEFOTAXIME SODIUM

Skład:

CEFOTAXIME 1 g

Droga podania:

INTRAMUSCULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Cefotaxime for Injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae ), Streptococcus pyogenes* (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis ), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli , Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae , Proteus mirabilis , Serratia marcescens* , Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa ). (2) Genitourinary infections . Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis , Staphylococcus aureus* , (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli , Klebsiella species, Proteus mirabilis , Proteus vulgaris* , Providencia stuartii , Morganella morganii* , Providencia rettgeri* , Serratia marcescens and Pseudomonas species (including P. aeruginosa ). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae , including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis , Streptococcus species, Enterococcus species, Enterobacter species*, Klebsiella species*, Escherichia coli , Proteus mirabilis , Bacteroides species (including Bacteroides fragilis* ), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum* ). Cefotaxime for Injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis . Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli , Klebsiella species, and Serratia marcescens , Staphylococcus aureus and Streptococcus species (including S. pneumoniae ). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis , Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species*, Escherichia coli , Citrobacter species (including C. freundii* ), Enterobacter species, Klebsiella species, Proteus mirabilis , Proteus vulgaris* , Morganella morganii , Providencia rettgeri* , Pseudomonas species, Serratia marcescens , Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species*, Escherichia coli , Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus* species) Proteus mirabilis* , and Clostridium species*. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes* ), Pseudomonas species (including P. aeruginosa* ), and Proteus mirabilis* . (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis , Haemophilus influenzae , Streptococcus pneumoniae , Klebsiella pneumoniae* and Escherichia coli* . (*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections. Although many strains of enterococci (e.g., S. faecalis ) and Pseudomonas species are resistant to cefotaxime sodium in vitro , Cefotaxime for Injection, USP has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, Cefotaxime for Injection, USP may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if Cefotaxime for Injection, USP is used concomitantly with an aminoglycoside. The administration of Cefotaxime for Injection, USP preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of Cefotaxime for Injection, USP may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, Cefotaxime for Injection, USP should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section. For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefotaxime for Injection, USP and other antibacterial drugs, Cefotaxime for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime sodium, or the cephalosporin group of antibiotics.

Podsumowanie produktu:

Sterile Cefotaxime for Injection, USP, is a dry off-white to pale yellow crystalline powder supplied in vials and bottles containing cefotaxime sodium as follows: 500 mg cefotaxime (free acid equivalent) vials in packages of 10 (NDC 0143-9930-10) 1 g cefotaxime (free acid equivalent) vials in packages of 25 (NDC 0143-9931-25) 2 g cefotaxime (free acid equivalent) vials in packages of 25 (NDC 0143-9933-25) NOTE: Cefotaxime for Injection, USP in the dry state should be stored at 20º to 25°C (68º to 77°F) [See USP Controlled Room Temperature]. The dry material as well as solutions tend to darken depending on storage conditions and should be protected from elevated temperatures and excessive light.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CEFOTAXIME- CEFOTAXIME INJECTION, POWDER, FOR SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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CEFOTAXIME FOR INJECTION, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Cefotaxime for Injection, USP (cefotaxime sodium) and other
antibacterial drugs,
Cefotaxime for Injection, USP should be used only to treat or prevent
infections that are
proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Sterile cefotaxime sodium is a semisynthetic, broad spectrum
cephalosporin antibiotic
for parenteral administration. It is the sodium salt of
7-[2-(2-amino-4-thiazolyl)
glyoxylamido]-3(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0]
oct-2-ene-2-
carboxylate 72 (Z)-(o-methyloxime), acetate (ester). Cefotaxime for
Injection, USP
contains approximately 50.5 mg (2.2 mEq) of sodium per gram of
cefotaxime activity.
Solutions of Cefotaxime for Injection, USP range from very pale yellow
to light amber
depending on the concentration and the diluent used. The pH of the
injectable solutions
usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4.
C
H
N NaO S
MW 477.45
Cefotaxime for Injection, USP is supplied as a dry powder in vials.
Each vial contains
cefotaxime sodium, equivalent to 500 mg, 1 gram or 2 grams of
cefotaxime.
CLINICAL PHARMACOLOGY
Following IM administration of a single 500 mg or 1 g dose of
cefotaxime to normal
volunteers, mean peak serum concentrations of 11.7 and 20.5 mcg/mL
respectively
were attained within 30 minutes and declined with an elimination
half-life of
approximately 1 hour. There was a dose-dependent increase in serum
levels after the IV
administration of 500 mg, 1 g, and 2 g of cefotaxime (38.9, 101.7, and
214.4 mcg/mL
respectively) without alteration in the elimination half-life. There
is no evidence of
accumulation following repetitive IV infusion of 1 g doses every 6
hours for 14 days as
there are no alterations of serum or renal clearance. About 60% of the
administered
16
16
5
7 2
dose was recovered from urine during the