Data from FDA - Curated by EPG Health - Last updated 20 December 2016

Indication(s)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefotetan for Injection USP and Dextrose Injection USP and other antibacterial drugs, Cefotetan for Injection USP and Dextrose Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy.

In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Treatment Cefotetan for Injection USP and Dextrose Injection USP is indicated for the therapeutic treatment of the following infections when caused by susceptible strains of the designated organisms: Urinary Tract Infections caused by E. coli, Klebsiella spp (including K. pneumoniae), Proteus mirabilis and Proteus spp (which may include the organisms now called Proteus vulgaris, Providencia rettgeri, and Morganella morganii).

Lower Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase - and nonpenicillinase-producing strains), Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella species (including K. pneumoniae), E. coli, Proteus mirabilis, and Serratia marcescens Efficacy for this organism in this organ system was studied in fewer than ten infections..

Skin and Skin Structure Infections due to Staphylococcus aureus (penicillinase - and nonpenicillinase-producing strains), Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus species (excluding enterococci), Escherichia coli, Klebsiella pneumoniae, Peptococcus niger, Peptostreptococcus species.

Gynecologic Infections caused by Staphylococcus aureus (including penicillinase - and nonpenicillinase-producing strains), Staphylococcus epidermidis, Streptococcus species (excluding enterococci), Streptococcus agalactiae, E. coli, Proteus mirabilis, Neisseria gonorrhoeae, Bacteroides species (excluding B. distasonis, B. ovatus, B. thetaiotaomicron), Fusobacterium species, and gram-positive anaerobic cocci (including Peptococcus niger and Peptostreptococcus species).

Cefotetan, like other cephalosporins, has no activity against Chlamydia trachomatis.

Therefore, when cephalosporins are used in the treatment of pelvic inflammatory disease, and C. trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added.

Intra-abdominal Infections caused by E. coli, Klebsiella species (including K. pneumoniae), Streptococcus species (excluding enterococci), Bacteroides species (excluding B. distasonis, B. ovatus, B. thetaiotaomicron) and Clostridium species.

Bone and Joint Infections caused by Staphylococcus aureus.

Specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to cefotetan.

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 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, it is possible to use Cefotetan for Injection USP and Dextrose Injection USP concomitantly with an aminoglycoside.

Cefotetan combinations with aminoglycosides have been shown to be synergistic in_vitro against many Enterobacteriaceae and also some other gram-negative bacteria.

The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient 's condition.

NOTE: Increases in serum creatinine have occurred when cefotetan was given alone.

If Cefotetan for Injection USP and Dextrose Injection USP and an aminoglycoside are used concomitantly, renal function should be carefully monitored, because nephrotoxicity may be potentiated.

Prophylaxis The preoperative administration of Cefotetan for Injection USP and Dextrose Injection USP may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures that are classified as clean, contaminated or potentially contaminated (e.g., cesarean section, abdominal or vaginal hysterectomy, transurethral surgery, biliary tract surgery, and gastrointestinal surgery).

If there are signs and symptoms of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapeutic measures may be initiated.

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Advisory information

contraindications
CONTRAINDICATIONS Cefotetan for Injection USP and Dextrose Injection USP 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. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.
Special warnings and precautions

PRECAUTIONS General Prescribing Cefotetan for Injection USP and Dextrose Injection USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

As with other broad-spectrum antibiotics, prolonged use of Cefotetan for Injection USP and Dextrose Injection USP may result in overgrowth of nonsusceptible organisms.

Careful observation of the patient is essential.

If superinfection does occur during therapy, appropriate measures should be taken.

Cefotetan for Injection USP and Dextrose Injection USP should be used with caution in individuals with a history of gastrointestinal disease, particularly colitis.

As with other dextrose-containing solutions, Cefotetan for Injection USP and Dextrose Injection USP should be prescribed with caution in patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

Use only if solution is clear and container and seals are intact.

Information for Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.

Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic.

If this occurs, patients should contact their physician as soon as possible.

Patients should be counseled that antibacterial drugs, including Cefotetan for Injection USP and Dextrose Injection USP, should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold).

When Cefotetan for Injection USP and Dextrose Injection USP is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefotetan for Injection USP and Dextrose Injection USP or other antibacterial drugs in the future.

As with some other cephalosporins, a disulfiram-like reaction characterized by flushing, sweating, headache, and tachycardia may occur when alcohol (beer, wine, etc.) is ingested within 72 hours after Cefotetan for Injection USP and Dextrose Injection USP administration.

Patients should be cautioned about the ingestion of alcoholic beverages following the administration of Cefotetan for Injection USP and Dextrose Injection USP. Drug Interactions Increases in serum creatinine have occurred when

Cefotetan for

Injection USP and Dextrose Injection USP was given alone.

If Cefotetan for Injection USP and Dextrose Injection USP and an aminoglycoside are used concomitantly, renal function should be carefully monitored, because nephrotoxicity may be potentiated.

Drug/Laboratory Test Interactions The administration of Cefotetan for Injection USP and Dextrose Injection USP 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 Jaff?

reaction and produce false increases in the levels of creatinine reported.

Carcinogenesis, Mutagenesis, Impairment of Fertility Although long-term studies in animals have not been performed to evaluate carcinogenic potential, no mutagenic potential of cefotetan was found in standard laboratory tests.

Cefotetan has adverse effects on the testes of prepubertal rats.

Subcutaneous administration of 500 mg/kg/day (approximately 8-16 times the usual adult human dose) on days 6-35 of life (thought to be developmentally analogous to late childhood and prepuberty in humans) resulted in reduced testicular weight and seminiferous tubule degeneration in 10 of 10 animals.

Affected cells included spermatogonia and spermatocytes; Sertoli and Leydig cells were unaffected.

Incidence and severity of lesions were dose-dependent; at 120 mg/kg/day (approximately 2-4 times the usual human dose) only 1 of 10 treated animals was affected, and the degree of degeneration was mild.

Similar lesions have been observed in experiments of comparable design with other methylthiotetrazole-containing antibiotics and impaired fertility has been reported, particularly at high dose levels.

No testicular effects were observed in 7-week-old rats treated with up to 1000 mg/kg/day SC for 5 weeks, or in infant dogs (3 weeks old) that received up to 300 mg/kg/day IV for 5 weeks.

The relevance of these findings in humans is unknown.

Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in rats and monkeys at doses up to 20 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefotetan.

There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers Cefotetan is excreted in human milk in very low concentrations.

Caution should be exercised when cefotetan is administered to a nursing woman.

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Geriatric Use Of the 925 subjects who received cefotetan in clinical studies, 492 (53 %) were 60 years and older, while 76 (8 %) were 80 years and older.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals can not be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

(See DOSAGE AND ADMINISTRATION - Impaired Renal Function.

)

Adverse reactions

ADVERSE REACTIONS In clinical studies, the following adverse effects were considered related to Cefotetan for Injection USP and Dextrose Injection USP 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.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION Cefotetan for Injection USP and Dextrose Injection USP in the DUPLEX® Container is intended for intravenous use only.

Treatment The usual adult dosage is 1 or 2 grams of Cefotetan for Injection USP and Dextrose Injection USP administered intravenously every 12 hours for 5 to 10 days.

Proper dosage should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organism.

General Guidelines for Dosage of Cefotetan for Injection USP and Dextrose Injection USP Type of Infection Daily Dose Frequency and Route Urinary Tract 1-4 grams 500 mg every 12 hours IV 1 or 2 g every 24 hours IV 1 or 2 g every 12 hours IV Skin & Skin Structure Mild - Moderate Klebsiella pneumoniae skin and skin structure infections should be treated with 1 or 2 grams every 12 hours IV. 2 grams 2 g every 24 hours IV 1 g every 12 hours IV Severe 4 grams 2 g every 12 hours IV Other Sites 2-4 grams 1 or 2 g every 12 hours IV Severe 4 grams 2 g

every 12 hours IV Life-Threatening 6 gramsMaximum daily dosage should not exceed 6 grams.

3 g every 12 hours IV 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 Cefotetan for Injection USP and Dextrose 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.

DOSAGE GUIDELINES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance mL/min Dose Frequency > 30 Usual Recommended DosageDose determined by the type and severity of infection, and susceptibility of the causative organism.

Every 12 hours 10 - 30 Usual Recommended Dosage Every 24 hours < 10 Usual Recommended Dosage Every 48 hours 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 10-30 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)?

(140 - age) 72?

serum creatinine (mg/100 mL) Females: 0.9?

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.

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.

Using an infusion system, Cefotetan for Injection USP and Dextrose Injection USP may 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 Cefotetan for Injection USP and Dextrose Injection USP, it is advisable to discontinue temporarily the administration of other solutions at the same site.

NOTE: Solutions of Cefotetan for Injection

USP and Dextrose

Injection USP must not be admixed with solutions containing aminoglycosides.

If Cefotetan for Injection USP and Dextrose Injection USP and aminoglycosides are to be administered to the same patient, they must be administered separately and not as a mixed injection.

Caution: Do not use plastic containers in series connections.

Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

DUPLEX® Drug Delivery System Directions for Use To avoid inadvertent activation, DUPLEX® Container should remain in the folded position until activation is intended.

Patient Labeling and Drug Powder/Diluent Inspection Apply patient-specific label on foil side of container.

USE CARE to avoid activation.

Do not cover any portion of foil strip with patient label.

Unlatch side tab and unfold DUPLEX® Container.

(See Diagram 1.)

Visually inspect diluent chamber for particulate matter.

Use only if container and seals are intact.

To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber.

(See Diagram 2.)

Protect from light after removal of foil strip.

Note:

If foil strip is removed, product must be used within 7 days, but not beyond the labeled expiration date.

The product should be re-folded and the side tab latched until ready to activate.

Reconstitution (Activation) Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use.

Unfold the DUPLEX® Container and point the set port in a downward direction.

Starting at the hanger tab end, fold the DUPLEX® Container just below the diluent meniscus trapping all air above the fold.

To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber.

(See Diagram 3.)

Agitate the liquid-powder mixture until the drug powder is completely dissolved.

Note:

Following reconstitution (activation), product must be used within 12 hours if stored at room temperature or within 5 days if stored under refrigeration.

Administration Visually inspect the reconstituted solution for particulate matter.

Point the set port in a downwards direction.

Starting at the hanger tab end, fold the DUPLEX® Container just below the solution meniscus trapping all air above the fold.

Squeeze the folded DUPLEX® Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port.

(See Diagram 4.)

Prior to attaching the IV set, check for minute leaks by squeezing container firmly.

If leaks are found, discard container and solution as sterility may be impaired.

Using aseptic technique, peel foil cover from the set port and attach sterile administration set.

(See Diagram 5.)

Refer to Directions for Use accompanying the administration set.

Precautions As with other cephalosporins, reconstituted Cefotetan for Injection USP and Dextrose Injection USP tends to darken depending on storage conditions, within the stated recommendations.

However, product potency is not adversely affected.

Use only if prepared solution is clear and free from particulate matter.

Do not use in series connection.

Do not introduce additives into the DUPLEX® Container.

Do not freeze.

Figure Figure Figure Figure Figure

Pregnancy and 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.

Interactions

Drug Interactions Increases in serum creatinine have occurred when Cefotetan for Injection USP and Dextrose Injection USP was given alone. If Cefotetan for Injection USP and Dextrose Injection USP and an aminoglycoside are used concomitantly, renal function should be carefully monitored, because nephrotoxicity may be potentiated.

More information

Category Value
Authorisation number NDA065430
Orphan designation No
Product NDC 0264-3175,0264-3173
Date Last Revised 14-02-2013
Type HUMAN PRESCRIPTION DRUG
RXCUI 1722919
Storage and handling Store the unactivated unit at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.]
Marketing authorisation holder B. Braun Medical Inc.