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Mandol® (Cefamandol (cefamandole) e Nafate for Injection, USP) is a semisynthetic broad-spectrum cephalosporin antibiotic for parenteral administration. It is 5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(formyloxy)phenylacetyl]amino]-3-[[(1-methyl-1 H -tetrazol-5-yl)thio]methyl]-8-oxo-, monosodium salt, [6 R- [6(alpha),7(beta)( R *)]]. Cefamandol (cefamandole) e has the empirical formula C 19 H 17 N 6 NaO 6 S 2 representing a molecular weight of 512.49.
Mandol (cefamandole) also contains 63 mg sodium carbonate/g of cefamandol (cefamandole) e activity. The total sodium content is approximately 77 mg (3.3 mEq sodium ion) per g of cefamandole activity. After addition of diluent, cefamandole nafate rapidly hydrolyzes to cefamandol (cefamandole) e, and both compounds have microbiologic activity in vivo. Solutions of Mandol (cefamandole) range from light-yellow to amber, depending on concentration and diluent used. The pH of freshly reconstituted solutions usually ranges from 6.0 to 8.5.
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
Bone and joint infections caused by S. aureus (penicillinase- and non-penicillinase-producing)
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 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 Infections Maximum Dosage | Less Severe Infections |
| >80 | Normal | 2 g q4h | 1-2 g q6h |
| 80-50 | Mild Impairment | 1.5 g q4h OR 2 g q6h | 0.75-1.5 g q6h |
| 50-25 | Moderate Impairment | 1.5 g q6h OR 2 g q8h | 0.75-1.5 g q8h |
| 25-10 | Severe Impairment | 1 g q6h OR 1.25 g q8h | 0.5-1 g q8h |
| 10-2 | Marked Impairment | 0.67 g q8h OR 1 g q12h | 0.5-0.75 g q12h |
