"The U.S. Food and Drug Administration today approved Clinolipid (lipid injectable emulsion, USP) for intravenous feeding (parenteral nutrition) in adult patients, providing a source of calories and essential fatty acids for adult patients who are"...
(Generic versions may still be available.)
Mandol (cefamandole) is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below:
Lower respiratory infections, including pneumonia, caused by S. pneumoniae, H. influenzae, Klebsiella spp., S. aureus (penicillinase- and non-penicillinase-producing), (beta)-hemolytic streptococci, and P. mirabilis
Urinary tract infections caused by E. coli, Proteus spp. (both indole-negative and indole-positive), Enterobacter spp., Klebsiella spp., group D streptococci (Note: Most enterococci, eg, E. faecalis, are resistant), and S. epidermidis
Peritonitis caused by E. coli and Enterobacter spp.
Septicemia caused by E. coli, S. aureus (penicillinase- and non-penicillinase-producing), S. pneumoniae, S. pyogenes (group A (beta)-hemolytic streptococci), H. influenzae, and Klebsiella spp.
Skin and skin structure infections caused by S. aureus (penicillinase- and non-penicillinase-producing), S. pyogenes (group A (beta)-hemolytic streptococci), H. influenzae, E. coli, Enterobacter spp., and P. mirabilis
Clinical microbiologic studies in nongonococcal pelvic inflammatory disease in females, lower respiratory infections, and skin infections frequently reveal the growth of susceptible strains of both aerobic and anaerobic organisms. Mandol (cefamandole) has been used successfully in those infections in which several organisms have been isolated. Most strains of B. fragilis are resistant in vitro; however, infections caused by susceptible strains have been treated successfully.
Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to cefamandol (cefamandole) e. 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, Mandol (cefamandole) may be used concomitantly with an aminoglycoside ( see Precautions ). The recommended doses of both antibiotics may be given, depending on the severity of the infection and the patient's condition. The renal function of the patient should be carefully monitored, especially if higher dosages of the antibiotics are to be administered.
Antibiotic therapy of (beta)-hemolytic streptococcal infections should continue for at least 10 days.
Preventive Therapy The administration of Mandol (cefamandole) preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated (eg, gastrointestinal surgery, cesarean section, vaginal hysterectomy, or cholecystectomy in high-risk patients such as those with acute cholecystitis, obstructive jaundice, or common-bile-duct stones).
In major surgery in which the risk of postoperative infection is low but serious (cardiovascular surgery, neurosurgery, or prosthetic arthroplasty), Mandol (cefamandole) may be effective in preventing such infections.
If signs of infection occur, specimens for culture should be obtained for identification of the causative organism so that appropriate antibiotic therapy may be instituted.
DOSAGE AND ADMINISTRATION
Dosage Adults: The usual dosage range for cefamandol (cefamandole) e is 500 mg to 1 g every 4 to 8 hours.
In infections of skin structures and in uncomplicated pneumonia, a dosage of 500 mg every 6 hours is adequate.
In uncomplicated urinary tract infections, a dosage of 500 mg every 8 hours is sufficient. In more serious urinary tract infections, a dosage of 1 g every 8 hours may be needed.
In severe infections, 1-g doses may be given at 4 to 6-hour intervals.
In life-threatening infections or infections due to less susceptible organisms, doses up to 2 g every 4 hours (ie, 12 g/day) may be needed.
Infants and Children: Administration of 50 to 100 mg/kg/ day in equally divided doses every 4 to 8 hours has been effective for most infections susceptible to Mandol (cefamandole) . This may be increased to a total daily dose of 150 mg/kg (not to exceed the maximum adult dose) for severe infections. ( See recommendations regarding this age group in WARNINGS and Precautions.)
Note: As with antibiotic therapy in general, administration of Mandol (cefamandole) should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by group A (beta)-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment for several weeks; and doses smaller than those indicated above should not be used.
For perioperative use of Mandol (cefamandole) , the following dosages are recommended:
Adults 1 or 2 g intravenously or intramuscularly 1 / 2 to 1 hour prior to the surgical incision followed by 1 or 2 g every 6 hours for 24 to 48 hours.
Pediatric Patients (3 months of age and older) 50 to 100 mg/kg/day in equally divided doses by the routes and schedule designated above.
Note: In patients undergoing prosthetic arthroplasty, administration is recommended for as long as 72 hours.
In patients undergoing cesarean section, the initial dose may be administered just prior to surgery or immediately after the cord has been clamped.
Impaired Renal Function When renal function is impaired, a reduced dosage must be employed and the serum levels closely monitored. After an initial dose of 1 to 2 g (depending on the severity of infection), a maintenance dosage schedule should be followed (see chart). Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism.
|Creatinine Clearance |
(mL/min/1.73 m 2 )
|Renal Function ||Life-Threatening |
|Less Severe |
|>80||Normal||2 g q4h||1-2 g q6h|
|80-50||Mild Impairment||1.5 g q4h |
2 g q6h
|0.75-1.5 g q6h|
|50-25||Moderate Impairment||1.5 g q6h |
2 g q8h
|0.75-1.5 g q8h|
|25-10||Severe Impairment||1 g q6h |
1.25 g q8h
|0.5-1 g q8h|
|10-2||Marked Impairment||0.67 g q8h |
1 g q12h
|0.5-0.75 g q12h|
|<2||None||0.5 g q8h |
0.75 g q12h
|0.25-0.5 g q12h|
When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.
Males: Weight (kg) x (140 - age)
72 x serum creatinine
Females: 0.9 x above value
Modes of Administration Mandol (cefamandole) may be given intravenously or by deep intramuscular injection into a large muscle mass (such as the gluteus or lateral part of the thigh) to minimize pain.
Intramuscular Administration Each g of Mandol (cefamandole) should be diluted with 3 mL of 1 of the following diluents: Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9% Sodium Chloride Injection, or Bacteriostatic Sodium Chloride Injection. Shake well until dissolved.
Intravenous Administration The intravenous route may be preferable for patients with bacterial septicemia, localized parenchymal abscesses (such as intra-abdominal abscess), peritonitis, or other severe or life-threatening infections when they may be poor risks because of lowered resistance. In those with normal renal function, the intravenous dosage for such infections is 3 to 12 g of Mandol (cefamandole) daily. In conditions such as bacterial septicemia, 6 to 12 g/day may be given initially by the intravenous route for several days, and dosage may then be gradually reduced according to clinical response and laboratory findings.
If combination therapy with Mandol (cefamandole) and an aminoglycoside is indicated, each of these antibiotics should be administered in different sites. Do not mix an aminoglycoside with Mandol (cefamandole) in the same intravenous fluid container.
A SOLUTION OF 1 G OF MANDOL (cefamandole) IN 22 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.
For direct intermittent intravenous administration, each g of cefamandol (cefamandole) e should be reconstituted with 10 mL of Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection. Slowly inject the solution into the vein over a period of 3 to 5 minutes, or give it through the tubing of an administration set while the patient is also receiving 1 of the following intravenous fluids:
0.9% Sodium Chloride Injection; 5% Dextrose Injection; 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; or Sodium Lactate Injection (M/6).
Intermittent intravenous infusion with a Y-type administration set or volume control set can also be accomplished while any of the above-mentioned intravenous fluids are being infused. However, during infusion of the solution containing Mandol (cefamandole) , it is desirable to discontinue the other solution. When this technique is employed, careful attention should be paid to the volume of the solution containing Mandol (cefamandole) so that the calculated dose will be infused. If Sterile Water for Injection is used as the diluent, reconstitute with approximately 20 mL/g to avoid a hypotonic solution.
For continuous intravenous infusion, each g of cefamandol (cefamandole) e should be diluted with 10 mL of Sterile Water for Injection. An appropriate quantity of the resulting solution may be added to an IV bottle containing 1 of the following fluids: 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; or Sodium Lactate Injection (M/6).
Reconstituted Mandol (cefamandole) is stable for 24 hours at room temperature (25°C) and for 96 hours if stored under refrigeration (5°C). During storage at room temperature, carbon dioxide develops inside the vial after reconstitution. This pressure may be dissipated prior to withdrawal of the vial contents, or it may be used to aid withdrawal if the vial is inverted over the syringe needle and the contents are allowed to flow into the syringe.
Solutions of Mandol (cefamandole) in Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection that are frozen immediately after reconstitution in the conventional vials in which the drugs are supplied are stable for 6 months when stored at -20°C. If the product is warmed (to a maximum of 37°C), care should be taken to avoid heating it after the thawing is complete. Once thawed, the solution should not be refrozen.
Vials (Dry Powder):
1 g. * 10-mL size (No. 7061) (Traypak ** of 25) NDC 0002-7061-25
2 g, * 20-mL size (No. 7064) (Traypak of 10) NDC 0002-7064-10
*Equivalent to cefamandol (cefamandole) e activity.
** Traypak TM (multivial carton, Lilly).
- Bauer AW, Kirby WMM, et al: Antibiotic susceptibility testing by a standardized single disk method. Am J Clin Pathol 1966;45:493. Standardized disk susceptibility test. Federal Register 1974;39:19182-19184. National Committee for Clinical Laboratory Standards. Approved Standard: M2-A3 Performance standards for antimicrobial disk susceptibility tests Fourth Edition, December, 1988.
- Determined by the ICS agar-dilution method (Ericsson HM, Sherris JC: Acta Pathol Microbiol Scand 1971;[suppl 217]:B), or any other method that has been shown to give equivalent results.
This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Mandol Information
- Mandol Drug Interactions Center: cefamandole inj
- Mandol Side Effects Center
- Mandol FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.