Cefotetan 2 g/20mL
CEFOTETAN DISODIUM · INJECTION, POWDER, FOR SOLUTION · Fresenius Kabi USA, LLC
Cefotetan is a injection, powder, for solution containing cefotetan disodium at 2 g/20mL, taken intramuscular. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Cefotetan
- Generic Name
- CEFOTETAN DISODIUM
- NDC Code (Product)
63323-386- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 2 g/20mL
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA065374
- Marketing Start
- 11/18/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotetan and other antibacterial drugs, cefotetan 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 antibacterial 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 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 (includ…
Dosage & Administration
DOSAGE AND ADMINISTRATION Treatment The usual adult dosage is 1 or 2 grams of Cefotetan for Injection 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 Cefotetan for Injection 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 4 grams 2 g every 24 hours IV 1 g every 12 hours IV or IM 2 g every 12 hours IV Other Sites 2 to 4 grams 1 or 2 g every 12 hours IV or IM Severe 4 grams 2 g every 12 hours IV Life-Threatening 6 grams b 3 g every 12 hours IV a Klebsiella pneumoniae skin and skin structure infections should be treated with 1 or2 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 preve…
Warnings
WARNINGS BEFORE THERAPY WITH CEFOTETAN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOTETAN, 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 CEFOTETAN 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 FOL…
Contraindications
CONTRAINDICATIONS Cefotetan 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.
Drug Interactions
Drug Interactions Increases in serum creatinine have occurred when cefotetan was given alone. If cefotetan and an aminoglycoside are used concomitantly, renal function should be carefully monitored, because nephrotoxicity may be potentiated.
Adverse Reactions
ADVERSE REACTIONS In clinical studies, the following adverse effects were considered related to cefotetan 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 o…
Frequently Asked Questions
What is Cefotetan used for?
Cefotetan contains CEFOTETAN DISODIUM. It is a injection, powder, for solution taken intramuscular. Consult your doctor for specific uses.
Is Cefotetan a controlled substance?
Cefotetan is not classified as a controlled substance by the DEA.
What is the generic name for Cefotetan?
The generic name for Cefotetan is CEFOTETAN DISODIUM. There are no other listed brand versions of CEFOTETAN DISODIUM.
What is the NDC code for Cefotetan 2 g/20mL?
The NDC (National Drug Code) for Cefotetan 2 g/20mL is 63323-386, listed by Fresenius Kabi USA, LLC.
Other Cefotetan Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)