Cefotetan

Contraindications (additional)

Documented hypersensitivity

Coagulation disorders

Cautions (additional)

Reduce dosage by 1/2 if <10-30 mL/min creatinine clearance and by 1/4 if <10 mL/min; (high doses may cause CNS toxicity); bacterial or fungal overgrowth of nonsusceptible organisms may occur with prolonged or repeated therapy

Associated with rare but potentially fatal hemolytic anemia - monitor as needed

Current US formulation does not allow direct IV or IM administration

Inappropriate for pediatric mild-moderate infections (AAP)

IV Incompatibilities

Additive: aminoglycosides, heparin, tetracyclines

Syringe: doxapram, promethazine

Y-site: cisatracurium(?), promethazine, vancomycin, vinorelbine

IV Compatibilities

Solution: D5W, NS

Y-site: allopurinol, amifostine, aztreonam, bivalirudin, dexmedetomidine, diltiazem, docetaxel, etoposide PO4, famotidine, fenoldopam, filgrastim, fluconazole, fludarabine, gatifloxacin, gemcitabine, granisetron, heparin, Hextend, reg insulin, linezolid, melphalan, meperidine, morphine SO4, paclitaxel, propofol, remifentanil, sargramostim, tacrolimus, teniposide, theophylline, thiotepa

IV Preparation (for powder)

Solution: add 10 mL diluent to 1 g vial; withdraw 10.5 mL (95 mg/mL)

IV Administration

Intermittent infusion over 20-60 min

Do not administer with other drugs

Canadian (but not US) formulations allow for IV inj or deep IM

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• diarrhea that is watery or bloody;
• chest pain;
• fever, chills, body aches, flu symptoms;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• severe tingling, numbness, pain, muscle weakness;
• seizure (convulsions);
• pale skin, dark colored urine, fever, confusion or weakness;
• jaundice (yellowing of the skin or eyes);
• increased thirst, loss of appetite, swelling, weight gain, feeling short of breath, urinating less than usual or not at all; or
• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

• nausea, vomiting;
• stomach pain;
• mild diarrhea;
• vaginal itching or discharge; or
• pain, swelling, redness, or bruising where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

CEFOTAN™ (cefotetan for Injection, USP) is a dry, white to pale yellow powder supplied in vials containing cefotetan disodium equivalent to 1 g and 2 g cefotetan activity for intravenous and intramuscular administration. The vials should be stored at 20°C to 25° C (68° to 77° F) [see USP Controlled Room Temperature] and should be protected from light.

The following packages are available:

Vial stoppers do not contain natural rubber latex.

Manufactured for: Teligent Pharma, Inc. Buena, NJ 08310 Made in Italy. Revised: March 2017.

Serious side effects have been reported with cefotetan. See the "Cefotetan Precautions" section.

Common side effects of cefotetan include:

• nausea
• diarrhea
• rash
• itching
• redness, pain, or swelling at the injection site

This is not a complete list of cefotetan side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.

You should not use this medication if you are allergic to cefotetan, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, and others.

Before using this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have kidney disease or a history of intestinal problems.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Cefotetan will not treat a viral infection such as the common cold or flu.

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.

Your pharmacist can provide more information about cefotetan.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.01. Revision date: 4/12/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Cefotetan for Injection, USP is a dry, white to pale yellow powder supplied in vials containing Cefotetan disodium equivalent to 1 g and 2 g Cefotetan activity for intravenous and intramuscular administration. 

The following packages are available:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  PROTECT FROM LIGHT.
Vials stoppers do not contain natural rubber latex.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Injection:

Cefotan: 1 g (1 ea); 2 g (1 ea)

Generic: 1 g (1 ea); 2 g (1 ea); 10 g (1 ea)

Solution Reconstituted, Intravenous:

Generic: 1 g (1 ea); 2 g (1 ea)

Refer to adult dosing.

Moderate: 1 to 2 g IV or IM every 12 hours
Severe: 2 g IV every 12 hours
Life-threatening: 3 g IV every 12 hours
Duration: Therapy should be continued for approximately 3 to 4 weeks, depending on the nature and severity of the infection. Longer therapy, 6 weeks or more, may be required for prosthetic joint infections. In addition, removal of the involved prosthesis is usually required.

No adjustment recommended

Hemodialysis: One-fourth of the usual dose every 24 hours on days between dialysis and one-half the usual dose on the day of dialysis.

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 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.

Read the entire FDA prescribing information for Cefotetan (Cefotetan for Injection)