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Basic Drug Info
Drug Name:Cefotaxime and Dextrose
Manufacturer:B. Braun Medical Inc.
Other Info:

DUPLEX® is a registered trademark of B.

Braun Medical Inc.U.S.

Patent Nos.

D388,168, D397,789, D402,366, D407,816, 5,944,709, and 6,165,161; additional patents pending.Made in USAB.

Braun Medical Inc.Irvine, CA USA 92614-5895©2007 B.

Braun Medical Inc.Y36-002-588



Clinical Trials:


Indications and Usage

Cefotaxime for Injection USP and Dextrose Injection 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, Streptococcus pyogenesEfficacy for this organism, in this organ system, has been studied in fewer than 10 infections.

(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).(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, 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.Although many strains of enterococci (e.g., E.

faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, cefotaxime 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 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 is used concomitantly with an aminoglycoside.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Lower respiratory tract infection --

Pneumonia -- Inflammation of any part, segment or lobe, of the lung parenchyma.

Proteus Infections -- Infections with bacteria of the genus PROTEUS.

Urinary tract infection -- Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.

Pelvic Inflammatory Disease -- A spectrum of inflammation involving the female upper genital tract and the supporting tissues. It is usually caused by an ascending infection of organisms from the endocervix. Infection may be confined to the uterus (ENDOMETRITIS), the FALLOPIAN TUBES; (SALPINGITIS); the ovaries (OOPHORITIS), the supporting ligaments (PARAMETRITIS), or may involve several of the above uterine appendages. Such inflammation can lead to functional impairment and infertility.

Endometritis -- Inflammation of the ENDOMETRIUM, usually caused by intrauterine infections. Endometritis is the most common cause of postpartum fever.

Parametritis -- Inflammation of the parametrium, the connective tissue of the pelvic floor, extending from the subserous coat of the uterus laterally between the layers of the BROAD LIGAMENT.

Septicemia -- systemic disease associated with presence and persistance of pathogenic microorganisms or their toxins in the blood.

skin infection -- Skin diseases caused by bacteria, fungi, parasites, or viruses.

Abdominal Infection --

Peritonitis -- INFLAMMATION of the PERITONEUM lining the ABDOMINAL CAVITY as the result of infectious, autoimmune, or chemical processes. Primary peritonitis is due to infection of the PERITONEAL CAVITY via hematogenous or lymphatic spread and without intra-abdominal source. Secondary peritonitis arises from the ABDOMINAL CAVITY itself through RUPTURE or ABSCESS of intra-abdominal organs.

Arthropathy associated with infection --

Infections of the central nervous system -- Pathogenic infections of the brain, spinal cord, and meninges. DNA VIRUS INFECTIONS; RNA VIRUS INFECTIONS; BACTERIAL INFECTIONS; MYCOPLASMA INFECTIONS; SPIROCHAETALES INFECTIONS; fungal infections; PROTOZOAN INFECTIONS; HELMINTHIASIS; and PRION DISEASES may involve the central nervous system as a primary or secondary process.

Meningitis -- Inflammation of the coverings of the brain and/or spinal cord, which consist of the PIA MATER; ARACHNOID; and DURA MATER. Infections (viral, bacterial, and fungal) are the most common causes of this condition, but subarachnoid hemorrhage (HEMORRHAGES, SUBARACHNOID), chemical irritation (chemical MENINGITIS), granulomatous conditions, neoplastic conditions (CARCINOMATOUS MENINGITIS), and other inflammatory conditions may produce this syndrome. (From Joynt, Clinical Neurology, 1994, Ch24, p6)

Avian ventriculitis --

Neurological ventriculitis --

Septicemia due to gram-negative organism, unspecified --

Communicable Diseases -- broad class of diseases whose causative agents may be passed between individuals in many different ways.

Contraindications
Cefotaxime for Injection USP and Dextrose Injection is contraindicated in patients who have shown hypersensitivity to cefotaxime sodium or the cephalosporin group of antibiotics.Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

BEFORE THERAPY WITH CEFOTAXIME FOR INJECTION USP AND DEXTROSE INJECTION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOTAXIME SODIUM, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS.

THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PATIENTS WITH TYPE I HYPERSENSITIVITY REACTIONS TO PENICILLIN.

ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS.

IF AN ALLERGIC REACTION TO CEFOTAXIME FOR INJECTION USP AND DEXTROSE INJECTION OCCURS, DISCONTINUE TREATMENT WITH THE DRUG.

SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.During post-marketing surveillance, a potentially life-threatening arrhythmia was reported in each of six patients who received a rapid (less than 60 seconds) bolus injection of cefotaxime through a central venous catheter.

Therefore, cefotaxime should only be administered as instructed in the DOSAGE AND ADMINISTRATION section.Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefotaxime for Injection USP and Dextrose Injection, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.

difficile.C.

difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of C.

difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.

difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.

difficile, and surgical evaluation should be instituted as clinically indicated.

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