cefotan
Pharmaranks rates Cefotan 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Cefotan (Cefotetan Disodium) is a cephalosporin antibacterial used to treat Abscess, Bacteroides Infections, Human Bites, Infectious Bone Diseases.
Cefotetan Disodium · by Pai Holdings Pharm
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Cefotetan Disodium
- Drug class
- Cephalosporin Antibacterial
- Form
- Injectable
- Strength
- Cefotetan Disodium EQ 10GM BASE/VIAL **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Cefotetan Disodium EQ 1GM BASE/VIAL · Cefotetan Disodium EQ 2GM BASE/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- abscess, bacteroides infections, human bites
- Manufacturer
- Pai Holdings Pharm
- FDA application
- NDA050588
What is Cefotan?
From the FDA label:CEFOTAN ® (Cefotetan for Injection, USP), as cefotetan disodium, is a sterile, semisynthetic, broad-spectrum, beta-lactamase resistant, cephalosporin (cephamycin) antibiotic for parenteral administration. It is the disodium salt of [6 R -(6α,7α)]-7-[[[4-(2-amino-1-carboxy-2-oxoethylidene)-1,3-dithietan-2-yl]carbonyl]amino]-7-methoxy-3-[[(1-methyl-1 H -tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Structural formula: CEFOTAN ® (Cefotetan for Injection, USP) is supplied in vials containing 80 mg (3.5 mEq) of sodium per gram of cefotetan activity. It is a white to pale yellow powder which is very soluble in water. Reconstituted solutions of CEFOTAN ® (cefotetan for Injection, USP) are intended for intravenous and intramuscular administration. The solution varies from colorless to yellow depending on the concentration. The pH of freshly reconstituted solutions is usually between 4.5 to 6.5. CEFOTAN ® (Cefotetan for Injection, USP) is available in two vial strengths. Each 1 gram vial contains cefotetan disodium equivalent to 1 gram cefotetan activity. Each 2 gram vial contains cefotetan disodium equivalent to 2 grams cefotetan activity. Cefotetan Chemical Structure
How to use
Treatment The usual adult dosage is 1 gram (g) 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. General Guidelines for Dosage of CEFOTAN ® (Cefotetan for Injection, USP) Type of Infection Daily Dose Frequency and Route Urinary Tract 1 g to 4 g 500 mg every 12 hours intravenous or intramuscular 1 or 2 g every 24 hours intravenous or intramuscular 1 or 2 g every 12 hours intravenous or intramuscular Skin & Skin Structure Mild - Moderate a 2 g 2 g every 24 hours intravenous 1 g every 12 hours intravenous or intramuscular Severe 4 g 2 g every 12 hours intravenous Other Sites 2 g to 4 g 1 g or 2 g every 12 hours intravenous or intramuscular Severe 4 g 2 g every 12 hours intravenous Life-Threatening 6 g b 3 g every 12 hours intravenous General Guidelines for Dosage of CEFOTAN ® (Cefotetan for Injection, USP) Type of Infection Daily Dose Frequency and Route Urinary Tract 1 to 4 grams 500 mg every 12 hours IV or IM 1 or 2 g every 24 hours IV or IM 1 or 2 g every 12 hours IV or IM Skin & Skin Structure Mild - Moderate a Severe 2 grams 2 g every 24 hours IV 1 g every 12 hours IV or IM 4 grams 2 g every 12 hours IV Other Sites 2 to 4 grams 1 or 2 g every 12 hours IV or…
Side effects
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…
Warnings
Important safety information
BEFORE THERAPY WITH CEFOTAN® IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOTETAN DISODIUM, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFOTAN® OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. AN IMMUNE MEDIATED HEMOLYTIC ANEMIA HAS BEEN OBSERVED IN PATIENTS RECEIVING CEPHALOSPORIN CLASS ANTIBIOTICS. SEVERE CASES OF HEMOLYTIC ANEMIA, INCLUDING FATALITIES, HAVE BEEN REPORTED IN ASSOCIATION WITH THE ADMINISTRATION OF CEFOTETAN. SUCH REPORTS ARE UNCOMMON. THERE APPEARS TO BE AN INCREASED RISK OF DEVELOPING HEMOLYTIC ANEMIA ON CEFOTETAN RELATIVE TO OTHER CEPHALOSPORINS OF AT LEAST 3 FOLD. IF A PATIENT DEVELOPS ANEMIA ANYTIME WITHIN 2 TO 3 WEEKS SUBSEQUENT TO THE ADMINISTRATION OF CEFOTETAN, THE DIAGNOSIS OF A CEPHALOSPORIN ASSOCIATED ANEMIA SHOULD BE CONSIDERED AND THE DRUG STOPPED UNTIL THE ETIOLOGY IS DETERMINED WITH CERTAINTY. BLOOD TRANSFUSIONS MAY BE CONSIDERED AS NEEDED (see CONTRAINDICATIONS ). PATIENTS WHO RECEIVE COURSES OF CEFOTETAN FOR TREATMENT OR PROPHYLAXIS OF INFECTIONS SHOULD HAVE PERIODIC MONITORING FOR SIGNS AND SYMPTOMS OF HEMOLYTIC ANEMIA INCLUDING A MEASUREMENT OF HEMATOLOGICAL PARAMETERS WHERE APPROPRIATE. 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 . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. 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, CEFOTAN® may be associated with a fall in prothrombin activity and, possibly, subsequent bleeding. Those at increased risk include patients with renal or hepatobiliary impairment or poor nutritional state, the elderly, and patients with cancer. Prothrombin time should be monitored and exogenous vitamin K administered as indicated.
Who should not take Cefotan
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.
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
How this class works, per Cephalosporins - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- abscess
- bacteroides infections
- human bites
- infectious bone diseases
- clostridium infections
- escherichia coli infections
See how Cefotan ranks — best-rated cephalosporin antibacterial for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Cefotan treat?
- Cefotan (Cefotetan Disodium) may be used to treat abscess, bacteroides infections, human bites, infectious bone diseases, clostridium infections, escherichia coli infections, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Cefotan work?
- Cefotan is a cephalosporin antibacterial. Cephalosporins kill bacteria by blocking the proteins they use to build their cell walls. Without an intact wall, the bacterium cannot hold its shape and dies, which clears the infection.
- How is Cefotan rated?
- pharmaranks gives Cefotan a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Cefotan?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cefotan. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cefotan?
- Cefotan is marketed by Pai Holdings Pharm. You can see Pai Holdings Pharm's full profile, rating, and other products on pharmaranks.
- Is Cefotan a brand-name or generic drug?
- Cefotan is a brand-name product with the active ingredient Cefotetan Disodium.
- Is Cefotan available over the counter?
- No. Cefotan is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cefotan come in?
- Cefotan is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Cefotan?
- Cefotan is classified as cephalosporin antibacterial, per the FDA's Established Pharmacologic Class.
- Is Cefotan FDA-registered?
- Cefotan is on record with the U.S. FDA under application number NDA050588. You can verify this on its official FDA label.
- Has Cefotan been recalled by the FDA?
- Cefotan has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Cefotan safe?
- There's no single safe-or-not verdict. pharmaranks gives Cefotan a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Cefotan?
- Cefotan's side effects are taken directly from its FDA label. From the label: 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);… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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cefotan
70/100