Cefotetan

Cefotetan is a prescription medication used for prophylaxis and treatment of a wide variety of bacterial infections.

• Cefotetan is available under various brand names: Cefotan

Common side effects of Cefotetan include:

• nausea,
• vomiting,
• mild diarrhea,
• vaginal itching or discharge, and
• abnormal liver function tests.

Serious side effects of Cefotetan include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe stomach pain,
• watery or bloody diarrhea,
• pale or yellowed skin,
• dark colored urine,
• fever,
• confusion,
• weakness,
• seizure,
• little or no urination,
• painful or difficult urination,
• swelling in your feet or ankles,
• tiredness,
• shortness of breath,
• sudden weakness,
• ill feeling,
• chills,
• sore throat,
• mouth sores,
• red or swollen gums,
• trouble swallowing,
• easy bruising,
• unusual bleeding (nose, mouth, vagina, or rectum),
• purple or red pinpoint spots under the skin,
• sore throat,
• burning in the eyes, and
• skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling

Rare side effects of Cefotetan include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Solution reconstituted

• 1 g
• 2 g

Skin & Skin Structure

Adult and geriatric dosage

• 2 g IV every 24 hours

Urinary Tract

Adult and geriatric dosage

• 500 mg IV/IM every 12 hours; 1-2 g IV/IM every 24 hours; 1-2 g IV/IM every 12 hours

Other infection sites

Adult and geriatric dosage

• 1-2 g IV/IM every 12 hours

Severe infection

Adult and geriatric dosage

• 2 g IV every 12 hours

Life-threatening infection

Adult and geriatric dosage

• 3 g IV every 12 hours

Surgery infection prophylaxis

Adult and geriatric dosage

• Colorectal, non-perforated appendectomy, hysterectomy: 1-2 g IV
• Ruptured viscus: 1-2 g IV every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Cefotetan has severe interactions with the following drug:
  • dronabinol
• Cefotetan has serious interactions with the following drugs:
  • argatroban
  • BCG vaccine live
  • bivalirudin
  • cholera vaccine
  • dalteparin
  • enoxaparin
  • fondaparinux
  • heparin
• Cefotetan has moderate interactions with the following drugs:
  • bazedoxifene/conjugated estrogens
  • dienogest/estradiol valerate
  • ethanol
  • probenecid
  • sodium picosulfate/magnesium oxide/anhydrous citric acid
  • voclosporin
  • warfarin
• Cefotetan has minor interactions with the following drugs:
  • chloramphenicol
  • chlorpropamide
  • choline magnesium trisalicylate
  • fenoprofen
  • furosemide
  • meclofenamate
  • pyridoxine
  • rose hips
  • willow bark

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to the drug or excipients
• Previously experienced cephalosporin-associated hemolytic anemia

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Cefotetan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Cefotetan?”

Cautions

• Reduce dosage by 1/2 if less than 10-30 mL/min creatinine clearance and by 1/4 if less than 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 a careful inquiry to determine whether the patient has had a previous cross-hypersensitivity reaction to beta-lactams; if an allergic reaction to this drug occurs, discontinue the 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 the 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, are reported in association with the administration of this drug; reports are uncommon
  • Consider a diagnosis of cephalosporin-associated anemia and stop therapy until etiology is determined with certainty if a patient develops anemia anytime within 2-3 weeks after 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 the 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 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

Pregnancy & Lactation

• 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
• Lactation
  • Published literature reports that the drug is present in human milk at low levels following intravenous administration; there is no information regarding the effects of cefotetan on milk production or the breastfed infant; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from the drug or an underlying maternal condition