Cefotetan

What is Cefotetan?

• Cefotetan (Cefotan) as cefotetan disodium, is a sterile, semisynthetic, broad-spectrum, beta-lactamase resistant, cephalosporin (cephamycin) antibacterial for parenteral administration is used to treat infections of the lungs, skin, bones, joints, stomach area, blood, female reproductive organs, and urinary tract.
• Cefotetan injection is also used before surgery to prevent infections.

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Cefotetan

What are the uses of this medicine?

Cefotetan (Cefotan) is indicated for the therapeutic treatment of the following infections:

• Urinary Tract Infections caused by E. coli, Klebsiella spp (including K. pneumoniae), Proteus mirabilis, Proteusvulgaris, Providencia rettgeri, and Morganella morganii).
• Lower Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible), Haemophilus influenzae, Klebsiella species (including K. pneumoniae), E. coli, Proteus mirabilis, and Serratia marcescens.
• Skin and Skin Structure Infections due to Staphylococcus aureus (methicillin-susceptible), Staphylococcus epidermidis (methicillin susceptible), Streptococcus pyogenes, Streptococcus species, Escherichia coli, Klebsiella pneumoniae, Peptococcus niger*, Peptostreptococcus species.
• Gynecologic Infections caused by Staphylococcus aureus (methicillin susceptible), Staphylococcus epidermidis (methicillin susceptible), Streptococcus species, Streptococcus agalactiae, E. coli, Proteus mirabilis, Neisseria gonorrhoeae, Bacteroidesfragilis, Prevotella melaninogenica, Bacteroides vulgatus, Fusobacterium species*, and gram-positive anaerobic cocci (including Peptococcus niger and Peptostreptococcus species).
• Intra-abdominal lnfections caused by E. coli, Klebsiella species (including K. pneumoniae), Streptococcus species, Bacteroidesfragilis, Prevotella melaninogenica, Bacteroidesvulgatus and Clostridium species
• Bone and Joint Infections caused by Staphylococcus aureus (methicillin susceptible).

Prophylaxis:

• The preoperative administration of cefotetan may reduce the incidence of certain postoperative infections.

Limitations of use: 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.

How does this medicine work?

• Cefotetan is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis.
• Cefotetan has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria.

Cefotetan has been shown to be active against most isolates of the following microorganisms:

Gram-Negative Bacteria:

• Escherichia coli
• Haemophilus influenza
• Klebsiella species (including K. pneumoniae)
• Morganella morganii
• Neisseria gonorrhoeae
• Proteus mirabilis
• Proteus vulgaris
• Providencia rettgeri
• Serratia marcescens

Gram-Positive Bacteria:

• Staphylococcus aureus (methicillin-susceptible isolates only)
• Staphylococcus epidermidis (methicillin-susceptible isolates only)
• Streptococcus agalactiae
• Streptococcus pneumoniae
• Streptococcus pyogenes
• Streptococcus species

Anaerobes:

• Prevotella bivia
• Prevotella disiens
• Bacteroides fragilis
• Prevotella melaninogenica
• Bacteroides vulgatus
• Fusobacterium species
• Clostridium species
• Peptococcus niger
• Peptostreptococcus species

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known allergy to the cephalosporin group of antibiotics
• who have experienced a cephalosporin associated hemolytic anemia.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• aminoglycoside antibiotics such as amikacin, gentamicin, kanamycin, neomycin, streptomycin, and tobramycin.
• anticoagulants ('blood thinners') such as warfarin (Coumadin).

Is this medicine FDA approved?

• Yes, it was FDA approved.
• Cefotetan was developed by Yamanouchi. It is marketed outside Japan by AstraZeneca with the brand names Apatef and Cefotan.

How should this medicine be used?

Recommended dosage:

• The usual adult dosage is 1 gram (g) or 2 grams of Cefotetan for Injection, USP administered intravenously or intramuscularly.
• Klebsiella pneumoniae skin and skin structure infections should be treated with 1 or 2 grams every 12 hours intravenous or intramuscular.
• 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 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.

Administration:

• Cefotetan injection comes as a powder to be added to fluid and injected intravenously (into a vein) or it can be injected into a large muscle.
• Cefotetan injection is also available as a premixed product to be injected intravenously.
• It is usually given every 12 or 24 hours.
• You may receive cefotetan injection in a hospital or you may administer the medication at home.
• If you will be receiving cefotetan injection at home, your healthcare provider will show you how to use the medication.
• Use cefotetan injection until you finish the prescription, even if you feel better.
• If you stop using cefotetan injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cefotetan for Injection, USP is supplied in vials containing 80 mg (3.5 mEq) of sodium per gram of cefotetan activity.

This medicine is available in fallowing brand namesː

• Cefotan

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• nausea
• pseudomembranous colitis
• eosinophilia
• positive direct Coombs test
• thrombocytosis
• agranulocytosis
• hemolytic anemia
• leukopenia
• thrombocytopenia
• prolonged prothrombin time with or without bleeding
• rise in ALT (SGPT) ,AST (SGOT), alkaline phosphatase, and LDH
• Hypersensitivity
• phlebitis at the site of injection
• Elevations in BUN and serum creatinine
• Nephrotoxicity
• Fever

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.

What special precautions should I follow?

• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefotetan, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
• If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
• In common with many other broad-spectrum antibiotics, cefotetan may be associated with a fall in prothrombin activity and, possibly, subsequent bleeding. Prothrombin time should be monitored and exogenous vitamin K administered as indicated.
• Tell your doctor if you have or have ever had hemolytic anemia (condition where a low number of red blood cells occurs because the cells are being destroyed in the body). Your doctor may tell you not to use cefotetan injection.
• Prescribing cefotetan in the absence of 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.
• Cefotetan should be used with caution in individuals with a history of gastrointestinal disease, particularly colitis.
• 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 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, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
• 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 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 administration. Patients should be cautioned about the ingestion of alcoholic beverages following the administration of cefotetan.
• Cefotetan is excreted in human milk in very low concentrations. Caution should be exercised when cefotetan is administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Information on overdosage with cefotetan in humans is not available.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• If overdosage should occur, it should be treated symptomatically and hemodialysis considered, particularly if renal function is compromised.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• 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.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CEFOTETAN DISODIUM

Inactive ingredients:

• none

Who manufactures and distributes this medicine?

Manufactured for:

• fresenius-kabi
• Lake Zurich, IL
• Made in Italy

What should I know about storage and disposal of this medication?

• The vials should be stored at 20° to 25°C (68° to 77°F).
• PROTECT FROM LIGHT.
• The container closure is not made with natural rubber latex.

• Dailymed label info on Cefotetan
• FDA Cefotetan

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