cefotetan

REMS

Treatment of the following infections caused by susceptible organisms:
- Lower respiratory tract infections,
- Skin and skin structure infections,
- Bone and joint infections,
- Urinary tract infections,
- Gynecological infections,
- Intra-abdominal infections.
Perioperative prophylaxis.

Action ⬆ ⬇

Binds to bacterial cell wall membrane, causing cell death.

Therapeutic effects:

Bactericidal action against susceptible bacteria.

Spectrum:

Similar to that of first-generation cephalosporins but has increased activity against several other gram-negative pathogens including:
- Haemophilus influenzae(including β-lactamase-producing strains),
- Escherichia coli,
- Klebsiella pneumoniae,
- Morganella morganii,
- Neisseria gonorrhoeae,
- Proteus mirabilis,
- Proteus vulgaris,
- Providencia rettgeri,
- Serratia marcescens,
Also has activity against Bacteroides fragilis.
Not active against methicillin-resistant staphylococci or enterococci.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following IM administration; IV administration results in complete bioavailability.

Distribution: Widely distributed. Penetration into CSF is poor. Crosses the placenta and enters breast milk in low concentrations.

Metabolism/Excretion: Excreted primarily unchanged by the kidneys.

Protein Binding: 88%.

Half-Life: 3–4.6 hr.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
IM	rapid	1–3 hr	12 hr
IV	rapid	end of infusion	12 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to cephalosporins;
Serious hypersensitivity to penicillins.

Use Cautiously in:

Renal impairment (dose ↓/↑ dosing interval recommended if CCr ≤30 mL/min);
History of GI disease, especially colitis;
Patients with hepatic impairment, poor nutritional state, or cancer (may be at ↑ risk of bleeding);
Pedi: Safety and effectiveness not established in children;
Geri: Dose adjustment due to age-related in renal function may be necessary in older adults; also may be at risk of bleeding.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash, urticaria

GI: CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), diarrhea, nausea

Hemat: bleeding, eosinophilia, hemolytic anemia, leukopenia, thrombocytopenia

Local: pain at IM site, phlebitis at IV site

Neuro: SEIZURES (HIGH DOSES)

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS) , superinfection

Interactions ⬆ ⬇

Drug-drug:

Probenecid↓ excretion and ↑ levels.
If alcohol is ingested within 48–72 hr of cefotetan, a disulfiram-like reaction may occur.
May potentiate the effects of anticoagulants and ↑ the risk of bleeding.
Concurrent use of aminoglycosides may ↑ the risk of nephrotoxicity.

Route/Dosage ⬆ ⬇

IM IV (Adults ): Most infections: 1–2 g every 12 hr. Severe/life-threatening infections: 2–3 g every 12 hr. Urinary tract infections: 500 mg–2 g every 12 hr or 1–2 g every 24 hr. Perioperative prophylaxis: 1–2 g 30–60 min before initial incision (one-time dose).

Renal Impairment

IM IV (Adults ): CCr 10–30 mL/min: Usual adult dose every 24 hr or 50% of usual adult dose every 12 hr;<CCr 10 mL/min: Usual adult dose every 48 hr or 25% of usual adult dose every 12 hr.

Availability ⬆ ⬇

(Generic available)

Powder for injection: 1 g/vial; 2 g/vial

Assessment ⬆ ⬇

Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and throughout therapy.
Before initiating therapy, obtain a history to determine previous use of and reactions to penicillins or cephalosporins. Persons with a negative history of penicillin sensitivity may still have an allergic response.
Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
Observe patient for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Discontinue the drug and notify health care professional immediately if these symptoms occur. Keep epinephrine, an antihistamine, and resuscitation equipment close by in the event of an anaphylactic reaction.
Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of Clostridioides difficile-associated diarrhea (CDAD). May begin up to several wk following cessation of therapy.

Lab Test Considerations:

May cause positive results for Coombs' test.
- Monitor prothrombin time and assess patient for bleeding (guaiac stools; check for hematuria, bleeding gums, ecchymosis) daily in high-risk patients; may cause hypoprothrombinemia.
- May cause ↑ AST, ALT, alkaline phosphatase, bilirubin, LDH, BUN, and serum creatinine.
- May rarely cause leukopenia, neutropenia, agranulocytosis, thrombocytopenia, and eosinophilia.

Implementation ⬆ ⬇

Do not confuse cefotetan with cefazolin, cefoxitin, ceftazidime, or ceftriaxone.
IM: Reconstitution: Reconstitute IM doses with sterile or bacteriostatic water for injection or 0.9% NaCl for injection.Diluent: May be diluted with lidocaine to minimize injection discomfort.
- Inject deep into a well-developed muscle mass; massage well.

IV Administration:

IV: Change sites every 48–72 hr to prevent phlebitis. Monitor site frequently for thrombophlebitis (pain, redness, swelling).
- If aminoglycosides are administered concurrently, administer in separate sites if possible, at least 1 hr apart. If second site is unavailable, flush line between medications.
Reconstitution: Reconstitute each gram with at least 10 mL of sterile water for injection and each 2 g vial with 10–20 mL. Do not use preparations containing benzyl alcohol for neonates.Concentration: 95 mg/mL for 1 g vial and 95 to 182 mg/mL for 2 g vial.
Rate: Administer slowly over 3–5 min.
Intermittent Infusion: Diluent: Reconstituted solution may be further diluted in 50–100 mL of D5W or 0.9% NaCl. Solution is stable for 24 hr at room temperature or 96 hr if refrigerated.Concentration: 4 to 40 mg/mL.
Rate: Administer over 30 min and over 20 to 60 min in pediatric patients.

Patient/Family Teaching ⬆ ⬇

Advise patient to report signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools) and allergy.
Caution patients that concurrent use of alcohol and cefotetan may cause a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headache, hypotension, palpitations, dyspnea, tachycardia, sweating, flushing). Alcohol and alcohol-containing medications should be avoided during and for several days after therapy.
Instruct patient to notify health care professional if fever and diarrhea develop, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Resolution of signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.
Decreased incidence of infection when used for prophylaxis.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0143- Hikma Pharmaceuticals USA Inc.
- 0143-9670- Cefotetan
  - 0143-9670-10- 10 VIAL in 1 CARTON (0143-9670-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9670-01)

0143- Hikma Pharmaceuticals USA Inc.
- 0143-9671- Cefotetan
  - 0143-9671-10- 10 VIAL in 1 CARTON (0143-9671-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9671-01)

52565- Teligent Pharma, Inc.
- 52565-052- Cefotan
  - 52565-052-10- 10 VIAL in 1 TRAY (52565-052-10) > 10 mL in 1 VIAL

52565- Teligent Pharma, Inc.
- 52565-053- CEFOTAN
  - 52565-053-10- 10 VIAL in 1 TRAY (52565-053-10) > 20 mL in 1 VIAL

63323- Fresenius Kabi USA, LLC
- 63323-385- Cefotetan
  - 63323-385-10- 10 VIAL in 1 CARTON (63323-385-10) > 10 mL in 1 VIAL

63323- Fresenius Kabi USA, LLC
- 63323-386- Cefotetan
  - 63323-386-20- 10 VIAL in 1 CARTON (63323-386-20) > 20 mL in 1 VIAL

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇