Cefotan

Information on overdosage with CEFOTAN™ in humans is not available. If overdosage should occur, it should be treated sympto matically and he modialysis considered, particularly if renal function is compromised.

Cefotan is a prescription medication used to treat infections of the urinary tract, respiratory tract, skin, female reproductive organs, bones, joints, and stomach. Cefotan is also used before surgery to prevent infections. Cefotan belongs to a group of drugs called cephalosporin antibiotics. These work to kill bacteria.

This medication comes in an injectable form to be given directly into a vein (IV) or can be injected into the muscle (IM).

Common side effects of Cefotan include nausea and diarrhea.

Drinking alcohol within 72 hours after using cefotetan can cause unpleasant side effects such as headache, sweating, fast heart rate, and flushing (warmth, redness, or tingly feeling).

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop using cefotetan and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Cefotetan is a cephalosporin (SEF a low spor in) antibiotic. It works by fighting bacteria in your body.

Cefotetan is used to treat many different types of infections caused by bacteria.

Cefotetan may also be used for purposes not listed in this medication guide.

Drinking alcohol within 72 hours after using cefotetan can cause unpleasant side effects such as headache, sweating, fast heart rate, and flushing (warmth, redness, or tingly feeling).

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Hemolytic anemia may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you have back, leg, or stomach pains; bleeding gums; chills; dark urine; difficulty with breathing; fever; general body swelling; headache; loss of appetite; nausea or vomiting; nosebleeds; pale skin; sore throat; unusual tiredness or weakness; or yellowing of the eyes or skin.

Cefotetan injection may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Do not drink alcohol while you are receiving cefotetan injection and for 3 days (72 hours) after your last dose. Drinking alcohol during this period may cause flushing; headache; sweating; and fast, pounding, or irregular heartbeat.

Before you have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

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.

In clinical studies, the following adverse effects were considered related to Cefotan therapy.  Those appearing in italics have been reported during postmarketing experience.

Gastrointestinal: symptoms occurred in 1.5% of patients, the most frequent were diarrhea (1 in 80) and nausea (1 in 700); pseudomembranous colitis.  Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment or surgical prophylaxis (see WARNINGS).

Hematologic: laboratory abnormalities occurred in 1.4% of patients and included eosinophilia (1 in 200), positive direct Coombs test (1 in 250), and thrombocytosis (1 in 300); agranulocytosis, hemolytic anemia, leukopenia, thrombocytopenia, and prolonged prothrombin time with or without bleeding.

Hepatic: enzyme elevations occurred in 1.2% of patients and included a rise in ALT (SGPT) (1 in 150), AST (SGOT) (1 in 300), alkaline phosphatase (1 in 700), and LDH (1 in 700).

Hypersensitivity: reactions were reported in 1.2% of patients and included rash (1 in 150) and itching (1 in 700); anaphylactic reactions and urticaria.

Local: effects were reported in less than 1% of patients and included phlebitis at the site of injection (1 in 300), and discomfort (1 in 500).

Renal: Elevations in BUN and serum creatinine have been reported.

Urogenital: Nephrotoxicity has rarely been reported.

Miscellaneous: Fever

In addition to the adverse reactions listed above which have been observed in patients treated with cefotetan, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: pruritus, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, vomiting, abdominal pain, colitis, superinfection, vaginitis including vaginal candidiasis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, elevated bilirubin, pancytopenia, and neutropenia.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE).  If seizures associated with drug therapy occur, the drug should be discontinued.  Anticonvulsant therapy can be given if clinically indicated.

To report SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Information on overdosage with Cefotan® in humans is not available.  If overdosage should occur, it should be treated symptomatically and hemodialysis considered, particularly if renal function is compromised.

Treatment

The usual adult dosage is 1 or 2 grams of Cefotan® (cefotetan for Injection, USP) administered intravenously or intramuscularly.  Proper dosage and route of administration should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organism.

aKlebsiella pneumoniae skin and skin structure infections should be treated with 1 or 2 grams every 12 hours IV or IM.

b Maximum daily dosage should not exceed 6 grams.

If Chlamydia trachomatis is a suspected pathogen in gynecologic infections, appropriate antichlamydial coverage should be added, since cefotetan has no activity against this organism.

Prophylaxis

To prevent postoperative infection in clean contaminated or potentially contaminated surgery in adults, the recommended dosage is 1 or 2 g of Cefotan® (cefotetan for Injection, USP) administered once, intravenously, 30 to 60 minutes prior to surgery.  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.

* 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.

Preparation of Solution

For Intravenous Use

Reconstitute with Sterile Water for Injection.  Shake to dissolve and let stand until clear.

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.  Shake to dissolve and let stand until clear.

Intravenous Administration

The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

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.  If Cefotan® and aminoglycosides are to be administered to the same patient, they must be administered separately and not as a mixed injection.

Intramuscular Administration

As with all intramuscular preparations, Cefotan® (cefotetan for Injection, USP) should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel.

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 (25ºC/77ºF), for 96 hours under refrigeration (5ºC/41ºF), and for at least 1 week in the frozen state (-20ºC/-4ºF).  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.