Cefotetan Disodium

(BANM, USAN, rINNM)
Synonyms: Cefotetán disódico; Céfotétan Disodique; Cefotetanum Dinatricum; ICI-156834 (cefotetan or cefotetan disodium); YM-09330 boxymethylene-1,3-dithietan-2yl)carboxamido]-7-methoxy-3[(1-methyl-1H-tetrazol-5-yl)thiomethyl]-3-cephem-4-carboxylic acid, disodium salt.
Cyrillic synonym: Динатрий Цефотетан.

💊 Chemical information

Chemical formula: C17H15N7Na2O8S4 = 619.6.
CAS — 74356-00-6.
ATC — J01DC05.
ATC Vet — QJ01DC05.

Pharmacopoeias.

In US.

USP 31

(Cefotetan Disodium). pH of a 10% solution in water is between 4.0 and 6.5. Store in airtight containers.

Incompatibility and stability.

There may be incompatibility with aminoglycosides. Precipitation has been reported with promethazine hydrochloride. 1. Das Gupta V, et al. Chemical stability of cefotetan disodium in 5% dextrose and 0.9% sodium chloride injections. J Clin Pharm Ther 1990; 15: 109–14. 2. Erickson SH, Ulici D. Incompatibility of cefotetan disodium and promethazine hydrochloride. Am J Health-Syst Pharm 1995; 52: 1347.

💊 Adverse Effects and Precautions

As for Cefalotin Sodium. Cefotetan contains an N-methylthiotetrazole side-chain and has the potential to cause hypoprothrombinaemia and bleeding. Cefotetan, especially at high doses, may interfere with the Jaffé method of measuring creatinine concentrations to produce falsely elevated values; this should be borne in mind when measuring renal function.

Effects on the blood.

Reviews1,2 and a case report3 of haemolytic anaemia associated with cefotetan.
1. Moes GS, MacPherson BR. Cefotetan-induced hemolytic anemia: a case report and review of the literature. Arch Pathol Lab Med 2000; 124: 1344–6
2. Viraraghavan R, et al. Cefotetan-induced haemolytic anaemia: a review of 85 cases. Adverse Drug React Toxicol Rev 2002; 21: 101–7
3. Robinson HE, et al. Cefotetan-induced life-threatening haemolysis. Med J Aust 2006; 184: 251.

Sodium content.

Each g of cefotetan disodium contains about 3.2 mmol of sodium.

💊 Interactions

As for Cefamandole.

💊 Antimicrobial Action

Cefotetan is a cephamycin antibiotic with a mode of action and spectrum of activity similar to those of cefoxitin. It is generally much more active in vitro than cefoxitin against the Gram-negative Enterobacteriaceae, but has similar activity against Bacteroides fragilis and may be less active against some other Bacteroides spp.

💊 Pharmacokinetics

On intramuscular injection of cefotetan, peak plasma concentrations of about 70 micrograms/mL at 1 hour and 90 micrograms/mL at 3 hours have been reported after doses of 1 and 2 g, respectively. The plasma half-life of cefotetan is usually in the range of 3.0 to 4.6 hours and is prolonged in patients with renal impairment. About 88% of cefotetan may be bound to plasma proteins, depending on the plasma concentration. Cefotetan is widely distributed in body tissues and fluids. It crosses the placenta and low concentrations have been detected in breast milk. High concentrations are achieved in bile. Cefotetan is excreted in the urine, primarily by glomerular filtration, as unchanged drug; 50 to 80% of a dose has been recovered in the urine in 24 hours and high concentrations are achieved. Small amounts of the tautomeric form of cefotetan have been detected in both plasma and urine. Biliary excretion of cefotetan probably accounts for nonrenal clearance. Some cefotetan is removed by dialysis.
1. Martin C, et al. Clinical pharmacokinetics of cefotetan. Clin Pharmacokinet 1994; 26: 248–58.

💊 Uses and Administration

Cefotetan is a cephamycin antibacterial generally classified with the second-generation cephalosporins and used similarly to cefoxitin in the treatment and prophylaxis of anaerobic and mixed bacterial infections, especially intra-abdominal and pelvic infections. It is given as the disodium salt by deep intramuscular injection or intravenously by slow injection over 3 to 5 minutes or by infusion. Doses are expressed in terms of the equivalent amount of cefotetan; 1.08 g of cefotetan disodium is equivalent to about 1 g of cefotetan. The usual dose is 1 or 2 g every 12 hours. For the treatment of life-threatening infections, 3 g every 12 hours may be given intravenously. Doses of cefotetan should be reduced in patients with moderate to severe renal impairment (see below). For infection prophylaxis during surgical procedures, an intravenous dose of 1 or 2 g is given 30 to 60 minutes before surgery or, in caesarean section, as soon as the umbilical cord is clamped.

Administration in renal impairment.

Dosage of cefotetan should be reduced in patients with moderate to severe renal impairment. US licensed product information gives the following dosing guidelines based on creatinine clearance (CC):
CC 10 to 30 mL/minute: the usual dose every 24 hours or onehalf the usual dose every 12 hours
CC less than 10 mL/minute: the usual dose every 48 hours or one-quarter the usual dose every 12 hours In patients undergoing haemodialysis, one-quarter the usual dose may be given every 24 hours on days between dialysis and onehalf the usual dose on the day of dialysis.

💊 Preparations

USP 31: Cefotetan for Injection; Cefotetan Injection.

Proprietary Preparations

Austral.: Apatef†; Belg.: Apacef†; Canad.: Cefotan†; Fr.: Apacef†; Ital.: Apatef†; Jpn: Yamatetan†; NZ: Apatef†; Port.: Apatef†; USA: Cefotan.
Published January 07, 2019.