Cefotetan

FDA label, PAI Holdings, LLC dba PAI Pharma, intramuscular, effective 2024-04-08. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

In patients undergoing cesarean section, the dose should be administered as soon as the umbilical cord is clamped. Impaired Renal Function When renal function is impaired, a reduced dosage schedule must be employed. The following dosage guidelines may be used. [See table below.] * Dose determined by the type and severity of infection, and susceptibility of the causative organism.

Alternatively, the dosing interval may remain constant at 12 hour intervals, but the dose reduced to one-half the usual recommended dose for patients with a creatinine clearance of 10 to 30 mL/min, and one-quarter the usual recommended dose for patients with a creatinine clearance of less than 10 mL/min. When only serum creatinine levels are available, creatinine clearance may be calculated from the following formula.

The serum creatinine level should represent a steady state of renal function. Males: Weight (kg) x (140 - age) 72 x serum creatinine (mg/100 mL) Females: 0.85 x value for males Cefotetan is dialyzable and it is recommended that for patients undergoing intermittent hemodialysis, one-quarter of the usual recommended dose be given every 24 hours on days between dialysis and one-half the usual recommended dose on the day of dialysis.

In patients undergoing cesarean section, the dose should be administered as soon as the umbilical cord is clamped. Impaired Renal Function When renal function is impaired, a reduced dosage schedule must be employed. The following dosage guidelines may be used. [See table below.] * Dose determined by the type and severity of infection, and susceptibility of the causative organism.

Alternatively, the dosing interval may remain constant at 12 hour intervals, but the dose reduced to one-half the usual recommended dose for patients with a creatinine clearance of 10 to 30 mL/min, and one-quarter the usual recommended dose for patients with a creatinine clearance of less than 10 mL/min. When only serum creatinine levels are available, creatinine clearance may be calculated from the following formula.

The serum creatinine level should represent a steady state of renal function. Males: Weight (kg) x (140 - age) 72 x serum creatinine (mg/100 mL) Females: 0.85 x value for males Cefotetan is dialyzable and it is recommended that for patients undergoing intermittent hemodialysis, one-quarter of the usual recommended dose be given every 24 hours on days between dialysis and one-half the usual recommended dose on the day of dialysis.

DOSAGE GUIDELINES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
Creatinine ClearancemL/min Dose Frequency
Greater than 30Usual Recommended Dosage*Every 12 hours
10 to 30Usual Recommended Dosage*Every 24 hours
Less than 10Usual Recommended Dosage*Every 48 hours
DOSAGE GUIDELINES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
Creatinine ClearancemL/min Dose Frequency
Greater than 30Usual Recommended Dosage*Every 12 hours
10 to 30Usual Recommended Dosage*Every 24 hours
Less than 10Usual Recommended Dosage*Every 48 hours

Preparation and administration

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Preparation of Solution For Intravenous Use Reconstitute with Sterile Water for Injection. Shake to dissolve and let stand until clear. [See table below.] For Intramuscular Use Reconstitute with Sterile Water for Injection; Bacteriostatic Water for Injection; Sodium Chloride Injection 0.9%, USP; 0.5% Lidocaine HCl; or 1% Lidocaine HCl.

For intermittent intravenous administration, a solution containing 1 gram or 2 grams of CEFOTAN® (Cefotetan for Injection, USP) in Sterile Water for Injection can be injected over a period of three to five minutes. Using an infusion system, the solution may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions.

Butterfly® or scalp vein-type needles are preferred for this type of infusion. However, during infusion of the solution containing CEFOTAN® (Cefotetan for Injection, USP), it is advisable to discontinue temporarily the administration of other solutions at the same site. NOTE: Solutions of cefotetan must not be admixed with solutions containing aminoglycosides.

Compatibility and Stability Frozen samples should be thawed at room temperature before use. After the periods mentioned below, any unused solutions or frozen material should be discarded. DO NOT REFREEZE . NOTE: Solutions of CEFOTAN® (Cefotetan for Injection, USP) must not be admixed with solutions containing aminoglycosides.

If CEFOTAN® (Cefotetan for Injection, USP) and aminoglycosides are to be administered to the same patient, they must be administered separately and not as a mixed injection. DO NOT ADD SUPPLEMENTARY MEDICATION . CEFOTAN® (Cefotetan for Injection, USP) reconstituted as described above (see DOSAGE AND ADMINISTRATION, Preparation of Solution ) maintains satisfactory potency for 24 hours at room temperature (25°C/77°F), for 96 hours under refrigeration (5°C/41°F), and for at least 1 week in the frozen state (-20°C/-4°F).

After reconstitution and subsequent storage in disposable glass or plastic syringes, CEFOTAN® (Cefotetan for Injection, USP) is stable for 24 hours at room temperature and 96 hours under refrigeration. NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Preparation of Solution For Intravenous Use Reconstitute with Sterile Water for Injection. Shake to dissolve and let stand until clear. [See table below.] For Intramuscular Use Reconstitute with Sterile Water for Injection; Bacteriostatic Water for Injection; Sodium Chloride Injection 0.9%, USP; 0.5% Lidocaine HCl; or 1% Lidocaine HCl.

For intermittent intravenous administration, a solution containing 1 gram or 2 grams of CEFOTAN® (Cefotetan for Injection, USP) in Sterile Water for Injection can be injected over a period of three to five minutes. Using an infusion system, the solution may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions.

Butterfly® or scalp vein-type needles are preferred for this type of infusion. However, during infusion of the solution containing CEFOTAN® (Cefotetan for Injection, USP), it is advisable to discontinue temporarily the administration of other solutions at the same site. NOTE: Solutions of cefotetan must not be admixed with solutions containing aminoglycosides.

Compatibility and Stability Frozen samples should be thawed at room temperature before use. After the periods mentioned below, any unused solutions or frozen material should be discarded. DO NOT REFREEZE . NOTE: Solutions of CEFOTAN® (Cefotetan for Injection, USP) must not be admixed with solutions containing aminoglycosides.

If CEFOTAN® (Cefotetan for Injection, USP) and aminoglycosides are to be administered to the same patient, they must be administered separately and not as a mixed injection. DO NOT ADD SUPPLEMENTARY MEDICATION . CEFOTAN® (Cefotetan for Injection, USP) reconstituted as described above (see DOSAGE AND ADMINISTRATION, Preparation of Solution ) maintains satisfactory potency for 24 hours at room temperature (25°C/77°F), for 96 hours under refrigeration (5°C/41°F), and for at least 1 week in the frozen state (-20°C/-4°F).

After reconstitution and subsequent storage in disposable glass or plastic syringes, CEFOTAN® (Cefotetan for Injection, USP) is stable for 24 hours at room temperature and 96 hours under refrigeration. NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Vial SizeAmount of Diluent Added (mL)Approximate Withdrawable Vol (mL)Approximate Average Concentration (mg/mL)
1 gram1010.595
2 gram10 to 2011 to 21182 to 95
Vial SizeAmount of Diluent Added (mL)Approximate Withdrawable Vol (mL)Approximate Average Concentration(mg/mL)
1 gram22.5400
2 gram34500
Vial SizeAmount of Diluent Added (mL)Approximate Withdrawable Vol (mL)Approximate Average Concentration (mg/mL)
1 gram1010.595
2 gram10 to 2011 to 21182 to 95

Drug interactions

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Label text (2 paragraphs)

Drug Interactions Increases in serum creatinine have occurred when CEFOTAN® was given alone. If CEFOTAN® and an aminoglycoside are used concomitantly, renal function should be carefully monitored, because nephrotoxicity may be potentiated. Drug/Laboratory Test Interactions The administration of CEFOTAN ® may result in a false positive reaction for glucose in the urine using Clinitest® ‡ , Benedict’s solution, or Fehling’s solution. It is recommended that glucose tests based on enzymatic glucose oxidase be used.

As with other cephalosporins, high concentrations of cefotetan may interfere with measurement of serum and urine creatinine levels by Jaffé reaction and produce false increases in the levels of creatinine reported.

Contraindications

CONTRAINDICATIONS CEFOTAN® is contraindicated in patients with a known allergy to the cephalosporin group of antibiotics and in those individuals who have experienced a cephalosporin associated hemolytic anemia.

Pregnancy and lactation

Pregnancy

Pregnancy Teratogenic Effects. 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. Reproduction studies have been performed in rats and monkeys at doses up to 2000 and 600 mg/kg/day (3 and 2 times the maximum recommended human dose on a body surface area basis, respectively), and have revealed no evidence of impaired fertility or harm to the fetus due to cefotetan.

Lactation

Nursing Mothers Cefotetan is excreted in human milk in very low concentrations. Caution should be exercised when cefotetan is administered to a nursing woman.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

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