Dosing & Uses
Dosage Forms & Strengths
solution, reconstituted
- 1g
- 2g
Skin & Skin Structure (Mild to Moderate)
2 g IV q24hr
Skin & Skin Structure (Severe)
2 g IV q12hr
Urinary Tract
500 mg IV/IM q12hr; 1-2 g IV/IM q24hr; 1-2 g IV/IM q12hr
Other Infection Sites
1-2 g IV/IM q12hr
Severe Infection
2 g IV q12hr
Life-Threatening Infection
3 g IV q12hr
Surgery Infection Prophylaxis
Colorectal, non-perforated appendectomy, hysterectomy: 1-2 g IV
Ruptured viscus: 1-2 g IV q12hr
Renal Impairment
CrCl 10-30 mL/min: Give qDay
CrCl <10 mL/min: Give q48hr
Other Indications & Uses
Dosage and route of administration depends on condition of patient, severity of infection, and susceptibility of causative organism
Bacteroides spp., C. perfringens, E. coli, H. influenzae, Klebsiella spp., M. morganii, N. gonorrhoeae, P. mirabilis, Peptococcus spp., Peptostreptococcus spp., Serratia spp., Staphylococci, group A beta-hemolytic Streptococcus, S. agalactiae, S. epidermidis, S. pyogenes
Dosage Forms & Strengths
solution, reconstituted
- 1g
- 2g
Severe Infection (Off-label)
Skin & skin structure (mild to moderate)
2 g IV q24hr
Skin & skin structure (severe)
2 g IV q12hr
Urinary tract
500 mg IV/IM q12hr; 1-2 g IV/IM q24hr; 1-2 g IV/IM q12hr
Other infection sites
1-2 g IV/IM q12hr
Severe infection
2 g IV q12hr
Life-threatening infection
3 g IV q12hr
Surgery infection prophylaxis
Colorectal, non-perforated appendectomy, hysterectomy: 1-2 g IV
Ruptured viscus: 1-2 g IV q12hr
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- dronabinol
cefotetan increases toxicity of dronabinol by aldehyde dehydrogenase inhibition. Contraindicated. Dronabinol oral solution (Syndros) contains 50% (w/w) dehydrated alcohol 5.5% (w/w) propylene glycol, which can produce disulfiramlike reactions if coadministered with cefotetan. Discontinue cefotetan at least 14 days before starting dronabinol solution and do not administer cefotetan within 7 days of completing treatment with dronabinol solution.
Serious - Use Alternative (9)
- argatroban
cefotetan increases effects of argatroban by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity.
- BCG vaccine live
cefotetan decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.
- bivalirudin
cefotetan increases effects of bivalirudin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity.
- cholera vaccine
cefotetan, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.
- dalteparin
cefotetan increases effects of dalteparin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity.
- enoxaparin
cefotetan increases effects of enoxaparin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity.
- fondaparinux
cefotetan increases effects of fondaparinux by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity.
- heparin
cefotetan increases effects of heparin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity.
- microbiota oral
cefotetan decreases effects of microbiota oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Microbiota oral contains bacterial spores. Antibacterial agents may decrease efficacy if coadministered. Complete antibiotic regimens 2-4 days before initiating microbiota oral. .
Monitor Closely (7)
- bazedoxifene/conjugated estrogens
cefotetan will decrease the level or effect of bazedoxifene/conjugated estrogens by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- dienogest/estradiol valerate
cefotetan will decrease the level or effect of dienogest/estradiol valerate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. An alternate or additional form of birth control may be advisable during concomitant use.
- ethanol
cefotetan, ethanol. Mechanism: decreasing metabolism. Use Caution/Monitor. Risk of disulfiram like reaction; avoid EtOH during and for 2 days following Rx.
- probenecid
probenecid will increase the level or effect of cefotetan by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.
- sodium picosulfate/magnesium oxide/anhydrous citric acid
cefotetan decreases effects of sodium picosulfate/magnesium oxide/anhydrous citric acid by altering metabolism. Use Caution/Monitor. Coadministration with antibiotics decreases efficacy by altering colonic bacterial flora needed to convert sodium picosulfate to active drug.
- voclosporin
voclosporin, cefotetan. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.
- warfarin
cefotetan increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.
Minor (9)
- chloramphenicol
chloramphenicol decreases effects of cefotetan by pharmacodynamic antagonism. Minor/Significance Unknown. bacteriostatic agents may inhibit the effects of bactericidal agents.
- chlorpropamide
cefotetan will increase the level or effect of chlorpropamide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- choline magnesium trisalicylate
cefotetan will increase the level or effect of choline magnesium trisalicylate by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- fenoprofen
cefotetan will increase the level or effect of fenoprofen by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- furosemide
cefotetan increases toxicity of furosemide by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of nephrotoxicity.
- meclofenamate
cefotetan will increase the level or effect of meclofenamate by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- pyridoxine
cefotetan will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
- rose hips
rose hips will increase the level or effect of cefotetan by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- willow bark
cefotetan will increase the level or effect of willow bark by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
Adverse Effects
1-10%
Diarrhea (1%)
Hepatic enzyme elevation (1%)
Hypersensitivity reaction (1%)
<1%
Prolongation of bleeding time
Neutropenia
Thrombocytopenia
Immune-mediated hemolytic anemia
Warnings
Contraindications
Hypersensitivity to drug or excipients
Previously experienced cephalosporin-associated hemolytic anemia
Cautions
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
Inappropriate for pediatric mild-moderate infections (AAP)
Before initiating therapy, make careful inquiry to determine whether patient has had previous cross-hypersensitivity reaction to beta-lactams; if allergic reaction to this drug occurs, discontinue drug; serious hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, antihistamines corticosteroids, pressor amines, and airway management
In common with many other broad-spectrum antibiotics, this drug 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
Prescribing this antibiotic 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
As with other broad-spectrum antibiotics, prolonged use may result in overgrowth of nonsusceptible organisms; careful observation of the patient is essential; if superinfection occurs during therapy, appropriate measures should be taken
This antibiotic should be used with caution in individuals with a history of gastrointestinal disease, particularly colitis
Immune hemolytic anemia
- Immune hemolytic anemia has been reported in patients receiving cephalosporins; severe cases of hemolytic anemia, including fatalities, reported in association with the administration of this drug; reports are uncommon
- Consider diagnosis of cephalosporin-associated anemia and stop therapy until etiology determined with certainty if patient develops anemia anytime within 2-3 weeks subsequent to administration of this drug; may consider blood transfusion as needed
- Patients receiving courses of this drug for treatment or prophylaxis of infections should have periodic monitoring for signs and symptoms of hemolytic anemia, including measurement of hematological parameters where appropriate
Clostridium difficile-associated diarrhea
- Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents 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 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 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
Pregnancy & Lactation
Pregnancy
Available data from published observational studies and case reports over several decades with drug use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
Animal data
- In animal reproduction studies, no adverse developmental effects were observed when pregnant rats and monkeys were treated, during period of organogenesis, at doses up to approximately 3 and 2 times maximum recommended human dose (MRHD), respectively
- Maternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age and premature rupture of membranes; perinatal transmission of gonorrhea to offspring can result in infant blindness, joint infections and bloodstream infections
Lactation
Published literature reports that drug is present in human milk at low levels following intravenous administration; there is no information regarding effects of cefotetan on milk production or the breastfed infant; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Second-generation cephalosporin used as single-drug therapy to provide broad gram-negative coverage and anaerobic coverage. Also provides some coverage of gram-positive bacteria. Half-life is 3.5 h. Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins; inhibits final transpeptidation step of peptidoglycan synthesis, resulting in cell wall death
Pharmacokinetics
Half-Life: 2.8-4.6 hr
Peak Plasma Time: 1.5-3 hr (IM)
Protein Bound: 76-90%
Distribution: Body fluids & tissue, including bile, sputum, prostatic & peritoneal fluids, low in CSF
Metabolism: Liver
Excretion: urine primarily unchanged; feces (20%)
Administration
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| cefotetan injection - | 2 gram vial |  | |
| cefotetan injection - | 1 gram vial |  | |
| Cefotan injection - | 2 gram vial |  | |
| Cefotan injection - | 1 gram vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
cefotetan injection
CEFOTETAN - INJECTION
(sef-oh-TEE-tan)
COMMON BRAND NAME(S): Cefotan
USES: Cefotetan is an antibiotic used to treat a wide variety of bacterial infections. It may also be used before and during certain surgeries to help prevent infection. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria.This antibiotic treats only bacterial infections. It will not work for virus infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
HOW TO USE: Read and learn all preparation and usage instructions supplied by the manufacturer. Follow all instructions for proper mixing with the correct IV fluids. Consult your pharmacist for details. Before using, check the product visually for particles or discoloration. If either is present, do not use the liquid.If you are using the frozen pre-mixed solution, thaw the container at room temperature or in the refrigerator. If the bag is thawed in the refrigerator, let it sit at room temperature at least 1 hour before using. Do not thaw by putting in a water bath or microwaving. After thawing, shake well and squeeze the container to check for leaks. Discard solution if the container leaks. Do not re-freeze the solution after thawing.This medication is given by injection into a muscle or vein as directed by your doctor.For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same time(s) every day. The dosage is based on your medical condition and response to treatment.Continue to use this medication until the full prescribed treatment period is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for details.
SIDE EFFECTS: Swelling, redness, pain, or soreness at the injection site may occur. This medication may also rarely cause loss of appetite, nausea, vomiting, diarrhea, or headache. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: dark urine, easy bruising/bleeding, fast/pounding/irregular heartbeat, seizures, unusual weakness, yellowing eyes/skin, mental/mood changes (such as confusion).This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool.If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using cefotetan, tell your doctor or pharmacist if you are allergic to it; or to other cephalosporins; or to penicillins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, stomach/intestinal diseases (such as colitis), use/abuse of alcohol.Avoid alcoholic beverages while taking this medication and for at least 3 days after finishing this medicine. Drinking alcohol may result in severe stomach upset/cramps, nausea, vomiting, headache, and flushing.Cefotetan may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using cefotetan before having any immunizations/vaccinations.Tell your doctor if you are pregnant before using this medication.This medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with these drugs are: aminoglycoside antibiotics (such as tobramycin, gentamicin), "blood thinners" (such as warfarin), chloramphenicol.This medication may interfere with certain lab tests (such as as urine glucose tests, serum or urine creatinine tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: trouble breathing, seizures.
NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.Lab and/or medical tests (such as complete blood count, kidney function) may be done while you are using this product. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Before mixing, store at room temperature away from light and moisture. Do not refrigerate or freeze the dry powder. Different brands/packaging of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements before and after mixing for the product you are using. Do not store in the bathroom.Store the pre-mixed solution containers in the freezer at or below -4 degrees F (-20 degrees C). (For thawing instructions, see How to Use section.) If stored at room temperature, use/discard the thawed solution within 24 hours.Consult the package instructions or your pharmacist for other storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised July 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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