CEFOBID- cefoperazone_powder, for solution

CLINICAL PHARMACOLOGY
High serum and bile levels of CEFOBID are attained after a single dose of the drug. Table 1 demonstrates the serum concentrations of CEFOBID in normal volunteers following either a single 15-minute constant rate intravenous infusion of 1, 2, 3 or 4 g of the drug, or a single intramuscular injection of 1 or 2 g of the drug. Cefoperazone Serum Concentrations Mean Serum Concentrations (mcg/mL) Dose/Route 0 Hours post-administration, with 0 time being the end of the infusion. 5 hr 1 hr 2 hr 4 hr 8 hr 12 hr 1 g IV 153 114 73 38 16 4 0. 5 2 g IV 252 153 114 70 32 8 2 3 g IV 340 210 142 89 41 9 2 4 g IV 506 325 251 161 71 19 6 1 g IM 32 Values obtained 15 minutes post-injection. 52 65 57 33 7 1 2 g IM 40 69 93 97 58 14 4 The mean serum half-life of CEFOBID is approximately 2. 0 hours, independent of the route of administration. In a pharmacokinetic study, a total daily dose of 16 g was administered to severely immunocompromised patients by constant infusion without complications. Steady state serum concentrations were approximately 150 mcg/mL in these patients. In vitro CEFOBID achieves therapeutic concentrations in the following body tissues and fluids: Table 2. Tissue or Fluid Dose Concentration Ascitic Fluid 2 g 64 mcg/mL Cerebrospinal Fluid (in patients with inflamed meninges) 50 mg/kg 1. 8 mcg/mL to 8. 0 mcg/mL Urine 2 g 3,286 mcg/mL Sputum 3 g 6. 0 mcg/mL Endometrium 2 g 74 mcg/g Myometrium 2 g 54 mcg/g Palatine Tonsil 1 g 8 mcg/g Sinus Mucous Membrane 1 g 8 mcg/g Umbilical Cord Blood 1 g 25 mcg/mL Amniotic Fluid 1 g 4. 8 mcg/mL Lung 1 g 28 mcg/g Bone 2 g 40 mcg/g CEFOBID is excreted mainly in the bile. Maximum bile concentrations are generally obtained between one and three hours following drug administration and exceed concurrent serum concentrations by up to 100 times. Reported biliary concentrations of CEFOBID range from 66 mcg/mL at 30 minutes to as high as 6000 mcg/mL at 3 hours after an intravenous bolus injection of 2 g. Following a single intramuscular or intravenous dose, the urinary recovery of CEFOBID over a 12-hour period averages 20en dash30%. No significant quantity of metabolites has been found in the urine. Urinary concentrations greater than 2200 mcg/mL have been obtained following a 15-minute infusion of a 2 g dose. After an IM injection of 2 g, peak urine concentrations of almost 1000 mcg/mL have been obtained, and therapeutic levels are maintained for 12 hours. Repeated administration of CEFOBID at 12-hour intervals does not result in accumulation of the drug in normal subjects. Peak serum concentrations, areas under the curve (AUC''s), and serum half-lives in patients with severe renal insufficiency are not significantly different from those in normal volunteers. In patients with hepatic dysfunction, the serum half-life is prolonged and urinary excretion is increased. In patients with combined renal and hepatic insufficiencies, CEFOBID may accumulate in the serum. CEFOBID has been used in pediatrics, but the safety and effectiveness in children have not been established. The half-life of CEFOBID in serum is 6en dash10 hours in low birth-weight neonates. Cefoperazone, a third-generation cephalosporin, interferes with cell wall synthesis by binding to the penicillin-binding proteins (PBPs), thus preventing cross-linking of nascent peptidoglycan. There are 3 principal mechanisms of resistance to cefoperazone: mutations in the target PBPs, which occur primarily in gram-positive bacteria; production of extended spectrum beta-lactamases or over-expression of chromosomally determined beta-lactamases in gram-negative bacteria; reduced uptake or active efflux in certain gram-negative bacteria. When tested in vitro in vitro Cefoperazone has been shown to be active against most isolates of the following microorganisms, both in vitro INDICATIONS AND USAGE Gram-positive bacteria Staphylococcus aureus Staphylococcus epidermidis Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes Gram-negative bacteria Citrobacter Enterobacter Escherichia coli Haemophilus influenzae Klebsiella Morganella morganii Neisseria gonorrhoeae Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas Serratia marcescens Peptococcus Peptostreptococcus Clostridioides Bacteroides The following in vitro in vitro Gram-negative bacteria Bordetella pertussis Neisseria meningitidis Salmonella Serratia liquefaciens Shigella Yersinia enterocolytica Eubacterium Fusobacterium For specific information regarding susceptibility test interpretive criteria, and associated test methods and quality control standards recognized by FDA for this drug, please see https://www.
Microbiology
Cefoperazone, a third-generation cephalosporin, interferes with cell wall synthesis by binding to the penicillin-binding proteins (PBPs), thus preventing cross-linking of nascent peptidoglycan. There are 3 principal mechanisms of resistance to cefoperazone: mutations in the target PBPs, which occur primarily in gram-positive bacteria; production of extended spectrum beta-lactamases or over-expression of chromosomally determined beta-lactamases in gram-negative bacteria; reduced uptake or active efflux in certain gram-negative bacteria. When tested in vitro in vitro Cefoperazone has been shown to be active against most isolates of the following microorganisms, both in vitro INDICATIONS AND USAGE Gram-positive bacteria Staphylococcus aureus Staphylococcus epidermidis Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes Gram-negative bacteria Citrobacter Enterobacter Escherichia coli Haemophilus influenzae Klebsiella Morganella morganii Neisseria gonorrhoeae Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas Serratia marcescens Peptococcus Peptostreptococcus Clostridioides Bacteroides The following in vitro in vitro Gram-negative bacteria Bordetella pertussis Neisseria meningitidis Salmonella Serratia liquefaciens Shigella Yersinia enterocolytica Eubacterium Fusobacterium For specific information regarding susceptibility test interpretive criteria, and associated test methods and quality control standards recognized by FDA for this drug, please see https://www.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFOBID and other antibacterial drugs. CEFOBID should be used only to treat 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. CEFOBID is indicated for the treatment of the following infections when caused by susceptible organisms: Respiratory Tract Infections S. pneumoniae H. influenzae S. pyogenes Efficacy against this organism in this organ system was studied in fewer than 10 infections. aeruginosa Klebsiella pneumoniae E. coli Proteus mirabilis Enterobacter Peritonitis and Other Intra-abdominal Infections E. aeruginosa, Bacteroides fragilis Bacterial Septicemia S. pneumoniae S. agalactiae S. aureus Pseudomonas aeruginosa E. coli Klebsiella Klebsiella pneumoniae Proteus Clostridioides Infections of the Skin and Skin Structures S. aeruginosa Pelvic Inflammatory Disease, Endometritis, and Other Infections of the Female Genital Tract N. gonorrhoeae S. epidermidis S. agalactiae E. coli Clostridioides Bacteroides Bacteroides fragilis Cefobid registered Chlamydia trachomatis C. trachomatis Urinary Tract Infections Escherichia coli Pseudomonas aeruginosa Enterococcal Infections: peritonitis and other intra-abdominal infections, infections of the skin and skin structures, pelvic inflammatory disease, endometritis and other infections of the female genital tract, and urinary tract infections in vitro in vivo Synergy between CEFOBID and aminoglycosides has been demonstrated with many gram-negative bacilli. However, such enhanced activity of these combinations is not predictable. If such therapy is considered, in vitro PRECAUTIONS DOSAGE AND ADMINISTRATION.

DOSAGE AND ADMINISTRATION
The usual adult daily dose of CEFOBID (sterile cefoperazone) is 2 to 4 g per day administered in equally divided doses every 12 hours. In severe infections or infections caused by less sensitive organisms, the total daily dose and/or frequency may be increased. Patients have been successfully treated with a total daily dosage of 6en dash12 g divided into 2, 3 or 4 administrations ranging from 1. 5 to 4 g per dose. When treating infections caused by Streptococcus pyogenes If C. trachomatis Solutions of CEFOBID and aminoglycoside should not be directly mixed, since there is a physical incompatibility between them. If combination therapy with CEFOBID and an aminoglycoside is contemplated (see INDICATIONS AND USAGE In vitro The following solutions may be used for the initial reconstitution of CEFOBID (sterile cefoperazone). Solutions for Initial Reconstitution 5% Dextrose Injection (USP) 0. 9% Sodium Chloride Injection (USP) 5% Dextrose and 0. 9% Sodium Chloride Injection (USP) Normosolregistered M and 5% Dextrose Injection 5% Dextrose and 0. 2% Sodium Chloride Injection (USP) Normosolregistered R 10% Dextrose Injection (USP) Sterile Water for Injection Not to be used as a vehicle for intravenous infusion. Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens] (USP) Preparations containing Benzyl Alcohol should not be used in neonates. CEFOBID (sterile cefoperazone) for intravenous or intramuscular use may be initially reconstituted with any compatible solution mentioned above in Table 3. Solutions should be allowed to stand after reconstitution to allow any foaming to dissipate to permit visual inspection for complete solubilization. Vigorous and prolonged agitation may be necessary to solubilize CEFOBID in higher concentrations (above 333 mg cefoperazone/mL). The maximum solubility of CEFOBID (sterile cefoperazone) is approximately 475 mg cefoperazone/mL of compatible diluent. CEFOBID (sterile cefoperazone) concentrations between 2 mg/mL and 50 mg/mL are recommended for intravenous administration. Vials of CEFOBID (sterile cefoperazone) may be initially reconstituted with a minimum of 2. 8 mL per g of cefoperazone of any compatible reconstituting solution appropriate for intravenous administration listed above in Table 3. For ease of reconstitution the use of 5 mL of compatible solution per g of CEFOBID is recommended. The entire quantity of the resulting solution should then be withdrawn for further dilution and administration using any of the following vehicles for intravenous infusion: Table 4. Vehicles for Intravenous Infusion 5% Dextrose Injection (USP) Lactated Ringer''s Injection (USP) 5% Dextrose and Lactated Ringer''s Injection 0. 9% Sodium Chloride Injection (USP) Normosol registered 5% Dextrose and 0. 2% Sodium Chloride Injection (USP) Normosol registered 10% Dextrose Injection (USP) The resulting intravenous solution should be administered in one of the following manners: Solutions of CEFOBID should be administered over a 15en dash30 minute time period. CEFOBID can be used for continuous infusion after dilution to a final concentration of between 2 and 25 mg cefoperazone per mL. Any suitable solution listed above may be used to prepare CEFOBID (sterile cefoperazone) for intramuscular injection. When concentrations of 250 mg/mL or more are to be administered, a lidocaine solution should be used. These solutions should be prepared using a combination of Sterile Water for Injection and 2% Lidocaine Hydrochloride Injection (USP) that approximates a 0. 5% Lidocaine Hydrochloride Solution. A two-step dilution process as follows is recommended: First, add the required amount of Sterile Water for Injection and agitate until CEFOBID powder is completely dissolved. Second, add the required amount of 2% lidocaine and mix. Final Step 1 Step 2 There is sufficient excess present to allow for withdrawal of the stated volume. Final lidocaine concentration will approximate that obtained if a 0. 5% Lidocaine Hydrochloride Solution is used as diluent. 1 g vial 333 mg/mL 2. 6 mL 3 mL 250 mg/mL 2. 0 mL 4 mL 2 g vial 333 mg/mL 3. 2 mL 6 mL 250 mg/mL 5. 8 mL 8 mL When a diluent other than Lidocaine HCl Injection (USP) is used reconstitute as follows: Cefoperazone Concentration Volume of Diluent to be Added Withdrawable There is sufficient excess present to allow for withdrawal of the stated volume. 6 mL 3 mL 250 mg/mL 3. 8 mL 4 mL 2 g vial 333 mg/mL 5. 0 mL 6 mL 250 mg/mL 7.
RECONSTITUTION
The following solutions may be used for the initial reconstitution of CEFOBID (sterile cefoperazone). Solutions for Initial Reconstitution 5% Dextrose Injection (USP) 0. 9% Sodium Chloride Injection (USP) 5% Dextrose and 0. 9% Sodium Chloride Injection (USP) Normosolregistered M and 5% Dextrose Injection 5% Dextrose and 0. 2% Sodium Chloride Injection (USP) Normosolregistered R 10% Dextrose Injection (USP) Sterile Water for Injection Not to be used as a vehicle for intravenous infusion. Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens] (USP) Preparations containing Benzyl Alcohol should not be used in neonates. CEFOBID (sterile cefoperazone) for intravenous or intramuscular use may be initially reconstituted with any compatible solution mentioned above in Table 3. Solutions should be allowed to stand after reconstitution to allow any foaming to dissipate to permit visual inspection for complete solubilization. Vigorous and prolonged agitation may be necessary to solubilize CEFOBID in higher concentrations (above 333 mg cefoperazone/mL). The maximum solubility of CEFOBID (sterile cefoperazone) is approximately 475 mg cefoperazone/mL of compatible diluent. CEFOBID (sterile cefoperazone) concentrations between 2 mg/mL and 50 mg/mL are recommended for intravenous administration. Vials of CEFOBID (sterile cefoperazone) may be initially reconstituted with a minimum of 2. 8 mL per g of cefoperazone of any compatible reconstituting solution appropriate for intravenous administration listed above in Table 3. For ease of reconstitution the use of 5 mL of compatible solution per g of CEFOBID is recommended. The entire quantity of the resulting solution should then be withdrawn for further dilution and administration using any of the following vehicles for intravenous infusion: Table 4. Vehicles for Intravenous Infusion 5% Dextrose Injection (USP) Lactated Ringer''s Injection (USP) 5% Dextrose and Lactated Ringer''s Injection 0. 9% Sodium Chloride Injection (USP) Normosol registered 5% Dextrose and 0. 2% Sodium Chloride Injection (USP) Normosol registered 10% Dextrose Injection (USP) The resulting intravenous solution should be administered in one of the following manners: Solutions of CEFOBID should be administered over a 15en dash30 minute time period. CEFOBID can be used for continuous infusion after dilution to a final concentration of between 2 and 25 mg cefoperazone per mL. Any suitable solution listed above may be used to prepare CEFOBID (sterile cefoperazone) for intramuscular injection. When concentrations of 250 mg/mL or more are to be administered, a lidocaine solution should be used. These solutions should be prepared using a combination of Sterile Water for Injection and 2% Lidocaine Hydrochloride Injection (USP) that approximates a 0. 5% Lidocaine Hydrochloride Solution. A two-step dilution process as follows is recommended: First, add the required amount of Sterile Water for Injection and agitate until CEFOBID powder is completely dissolved. Second, add the required amount of 2% lidocaine and mix. Final Step 1 Step 2 There is sufficient excess present to allow for withdrawal of the stated volume. Final lidocaine concentration will approximate that obtained if a 0. 5% Lidocaine Hydrochloride Solution is used as diluent. 1 g vial 333 mg/mL 2. 6 mL 3 mL 250 mg/mL 2. 0 mL 4 mL 2 g vial 333 mg/mL 3. 2 mL 6 mL 250 mg/mL 5. 8 mL 8 mL When a diluent other than Lidocaine HCl Injection (USP) is used reconstitute as follows: Cefoperazone Concentration Volume of Diluent to be Added Withdrawable There is sufficient excess present to allow for withdrawal of the stated volume. 6 mL 3 mL 250 mg/mL 3. 8 mL 4 mL 2 g vial 333 mg/mL 5. 0 mL 6 mL 250 mg/mL 7.

Encephalopathy
Encephalopathy (including decreased consciousness, delirium, seizures) has been reported with the use of CEFOBID. Most cases occurred in patients with renal impairment. The adverse reactions resolved after discontinuation of CEFOBID and/or hemodialysis/continuous veno‑venous hemofiltration. If encephalopathy occurs, consider discontinuing CEFOBID and institute supportive measures.
ADVERSE REACTIONS
In clinical studies the following adverse effects were observed and were considered to be related to CEFOBID therapy or of uncertain etiology: As with all cephalosporins, hypersensitivity manifested by skin reactions (1 patient in 45), drug fever (1 in 260), or a change in Coombs'' test (1 in 60) has been reported. These reactions are more likely to occur in patients with a history of allergies, particularly to penicillin. As with other beta-lactam antibacterial drugs, reversible neutropenia may occur with prolonged administration. Slight decreases in neutrophil count (1 patient in 50) have been reported. Decreased hemoglobins (1 in 20) or hematocrits (1 in 20) have been reported, which is consistent with published literature on other cephalosporins. Transient eosinophilia has occurred in 1 patient in 10. Of 1285 patients treated with cefoperazone in clinical trials, one patient with a history of liver disease developed significantly elevated liver function enzymes during CEFOBID therapy. Clinical signs and symptoms of nonspecific hepatitis accompanied these increases. After CEFOBID therapy was discontinued, the patient''s enzymes returned to pre-treatment levels and the symptomatology resolved. As with other antibacterial drugs that achieve high bile levels, mild transient elevations of liver function enzymes have been observed in 5en dash10% of the patients receiving CEFOBID therapy. The relevance of these findings, which were not accompanied by overt signs or symptoms of hepatic dysfunction, has not been established. Diarrhea or loose stools has been reported in 1 in 30 patients. Most of these experiences have been mild or moderate in severity and self-limiting in nature. In all cases, these symptoms responded to symptomatic therapy or ceased when cefoperazone therapy was stopped. Nausea and vomiting have been reported rarely. Symptoms of pseudomembranous colitis can appear during or for several weeks subsequent to antibacterial therapy (see WARNINGS Transient elevations of the BUN (1 in 16) and serum creatinine (1 in 48) have been noted. CEFOBID is well tolerated following intramuscular administration. Occasionally, transient pain (1 in 140) may follow administration by this route. When CEFOBID is administered by intravenous infusion some patients may develop phlebitis (1 in 120) at the infusion site. The following adverse reactions have been identified during post-approval use of CEFOBID. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders: Coagulopathy, thrombocytopenia, hypoprothrombinaemia (see PRECAUTIONS Immune System disorders: Anaphylactic reaction including shock and fatal cases (see WARNINGS Hepatobiliary Disorders: Jaundice, hepatic dysfunction Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, pruritus Vascular Disorders: Hemorrhage (see WARNINGS Nervous System Disorders: Encephalopathy (including decreased consciousness, delirium, seizures) (see WARNINGS.
Clinical Trials Experience
In clinical studies the following adverse effects were observed and were considered to be related to CEFOBID therapy or of uncertain etiology: As with all cephalosporins, hypersensitivity manifested by skin reactions (1 patient in 45), drug fever (1 in 260), or a change in Coombs'' test (1 in 60) has been reported. These reactions are more likely to occur in patients with a history of allergies, particularly to penicillin. As with other beta-lactam antibacterial drugs, reversible neutropenia may occur with prolonged administration. Slight decreases in neutrophil count (1 patient in 50) have been reported. Decreased hemoglobins (1 in 20) or hematocrits (1 in 20) have been reported, which is consistent with published literature on other cephalosporins. Transient eosinophilia has occurred in 1 patient in 10. Of 1285 patients treated with cefoperazone in clinical trials, one patient with a history of liver disease developed significantly elevated liver function enzymes during CEFOBID therapy. Clinical signs and symptoms of nonspecific hepatitis accompanied these increases. After CEFOBID therapy was discontinued, the patient''s enzymes returned to pre-treatment levels and the symptomatology resolved. As with other antibacterial drugs that achieve high bile levels, mild transient elevations of liver function enzymes have been observed in 5en dash10% of the patients receiving CEFOBID therapy. The relevance of these findings, which were not accompanied by overt signs or symptoms of hepatic dysfunction, has not been established. Diarrhea or loose stools has been reported in 1 in 30 patients. Most of these experiences have been mild or moderate in severity and self-limiting in nature. In all cases, these symptoms responded to symptomatic therapy or ceased when cefoperazone therapy was stopped. Nausea and vomiting have been reported rarely. Symptoms of pseudomembranous colitis can appear during or for several weeks subsequent to antibacterial therapy (see WARNINGS Transient elevations of the BUN (1 in 16) and serum creatinine (1 in 48) have been noted. CEFOBID is well tolerated following intramuscular administration. Occasionally, transient pain (1 in 140) may follow administration by this route. When CEFOBID is administered by intravenous infusion some patients may develop phlebitis (1 in 120) at the infusion site.
Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of CEFOBID. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders: Coagulopathy, thrombocytopenia, hypoprothrombinaemia (see PRECAUTIONS Immune System disorders: Anaphylactic reaction including shock and fatal cases (see WARNINGS Hepatobiliary Disorders: Jaundice, hepatic dysfunction Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, pruritus Vascular Disorders: Hemorrhage (see WARNINGS Nervous System Disorders: Encephalopathy (including decreased consciousness, delirium, seizures) (see WARNINGS

CEFOBID is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated severe hypersensitivity to beta-lactams (see WARNINGS

Usage in Pregnancy
Reproduction studies have been performed in mice, rats, and monkeys at doses up to 10 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to CEFOBID. Cefoperazone crosses the placental barrier. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Usage in Nursing Mothers
Only low concentrations of CEFOBID are excreted in human milk. Although CEFOBID passes poorly into breast milk of nursing mothers, caution should be exercised when CEFOBID is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in children have not been established. For information concerning testicular changes in prepubertal rats (see Carcinogenesis, Mutagenesis, Impairment of Fertility
Geriatric Use
Clinical studies of CEFOBID registered

Combination Therapy
Synergy between CEFOBID and aminoglycosides has been demonstrated with many gram-negative bacilli. However, such enhanced activity of these combinations is not predictable. If such therapy is considered, in vitro PRECAUTIONS DOSAGE AND ADMINISTRATION
Drug/Laboratory Test Interactions
A false-positive reaction for glucose in the urine may occur with Benedict''s or Fehling''s solution.

CEFOBID (sterile cefoperazone) is to be stored at or below 25°C (77°F) and protected from light prior to reconstitution. After reconstitution, protection from light is not necessary. The following parenteral diluents and approximate concentrations of CEFOBID provide stable solutions under the following conditions for the indicated time periods. (After the indicated time periods, unused portions of solutions should be discarded.) Room Temperature (15°en dash25°C/59°en dash77°F) Approximate Concentrations Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens] (USP) 300 mg/mL 5% Dextrose Injection (USP) 2 mg to 50 mg/mL 5% Dextrose and Lactated Ringer's Injection 2 mg to 50 mg/mL 5% Dextrose and 0.9% Sodium Chloride Injection (USP) 2 mg to 50 mg/mL 5% Dextrose and 0.2% Sodium Chloride Injection (USP) 2 mg to 50 mg/mL 10% Dextrose Injection (USP) 2 mg to 50 mg/mL Lactated Ringer's Injection (USP) 2 mg/mL 0.5% Lidocaine Hydrochloride Injection (USP) 300 mg/mL 0.9% Sodium Chloride Injection (USP) 2 mg to 300 mg/mL Normosol registered 2 mg to 50 mg/mL Normosol registered 2 mg to 50 mg/mL Sterile Water for Injection 300 mg/mL Reconstituted CEFOBID solutions may be stored in glass or plastic syringes, or in glass or flexible plastic parenteral solution containers. Refrigerator Temperature (2°en dash8°C/36°en dash46°F) Approximate Concentrations Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens] (USP) 300 mg/mL 5% Dextrose Injection (USP) 2 mg to 50 mg/mL 5% Dextrose and 0.9% Sodium Chloride Injection (USP) 2 mg to 50 mg/mL 5% Dextrose and 0.2% Sodium Chloride Injection (USP) 2 mg to 50 mg/mL Lactated Ringer's Injection (USP) 2 mg/mL 0.5% Lidocaine Hydrochloride Injection (USP) 300 mg/mL 0.9% Sodium Chloride Injection (USP) 2 mg to 300 mg/mL Normosol registered 2 mg to 50 mg/mL Normosol registered 2 mg to 50 mg/mL Sterile Water for Injection 300 mg/mL Reconstituted CEFOBID solutions may be stored in glass or plastic syringes, or in glass or flexible plastic parenteral solution containers. Freezer Temperature (en dash20° to en dash10°C/en dash4° to 14°F) Approximate Concentrations 5% Dextrose Injection (USP) 50 mg/mL 5% Dextrose and 0.9% Sodium Chloride Injection (USP) 2 mg/mL 5% Dextrose and 0.2% Sodium Chloride Injection (USP) 2 mg/mL 0.9% Sodium Chloride Injection (USP) 300 mg/mL Sterile Water for Injection 300 mg/mL Reconstituted CEFOBID solutions may be stored in plastic syringes, or in flexible plastic parenteral solution containers. Frozen samples should be thawed at room temperature before use. After thawing, unused portions should be discarded. Do not refreeze.

WARNINGS
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING BETA-LACTAM ANTIBACTERIALS, INCLUDING CEFOPERAZONE. THESE REACTIONS ARE MORE APT TO OCCUR IN INDIVIDUALS WITH A HISTORY OF HYPERSENSITIVITY REACTIONS TO MULTIPLE ALLERGENS. BEFORE THERAPY WITH CEFOBID IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS, PENICILLINS, CARBAPENEMS OR OTHER DRUGS. IF AN ALLERGIC REACTION OCCURS, CEFOPERAZONE SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. Severe and occasionally fatal skin reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and exfoliative dermatitis have been reported in patients on CEFOBID therapy. If a severe skin reaction occurs CEFOBID should be discontinued and appropriate therapy should be initiated (see ADVERSE REACTIONS Clostridioides difficile C. difficile C. difficile If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile Serious hemorrhage cases, including fatalities, have been reported with cefoperazone. Monitor for signs of bleeding, thrombocytopenia, and coagulopathy. Discontinue CEFOBID if there is persistent bleeding and no alternative explanations are identified. Encephalopathy (including decreased consciousness, delirium, seizures) has been reported with the use of CEFOBID. Most cases occurred in patients with renal impairment. The adverse reactions resolved after discontinuation of CEFOBID and/or hemodialysis/continuous veno‑venous hemofiltration. If encephalopathy occurs, consider discontinuing CEFOBID and institute supportive measures.
Carcinogenesis,Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential. The maximum duration of CEFOBID animal toxicity studies is six months. In none of the in vivo in vitro
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CEFOBID- cefoperazone_powder, for solution Product manual source documgent