Cefamandole dosage and administration

Cefamandole
MANDOL® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Dosage and Administration

Dosage

Adults

• The usual dosage range for cefamandol (cefamandole) 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.

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.

The choice of saline, dextrose, or electrolyte solution and the volume to be employed are dictated by fluid and electrolyte management.

For direct intermittent intravenous administration, each g of cefamandol (cefamandole) 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) 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).

Stability

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.

References

Adapted from the FDA Package Insert.