Overview
DESCRIPTION Cefotetan for Injection, USP, as cefotetan disodium, is a sterile, semisynthetic, broad-spectrum, beta-lactamase resistant, cephalosporin (cephamycin) antibiotic for parenteral administration. It is the disodium salt of [6R-(6α,7α)]-7-[[[4-(2-amino-1-carboxy-2-oxoethylidene)-1,3-dithietan-2-yl]carbonyl]amino]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyc...
Mechanism of Action
CLINICAL PHARMACOLOGY High plasma levels of cefotetan are attained after intravenous and intramuscular administration of single doses to normal volunteers. PLASMA CONCENTRATIONS AFTER 1 GRAM IV a OR IM DOSE Mean Plasma Concentration (mcg/mL) Time after Injection Route 15 min 30 min 1 h 2 h 4 h 8 h 12 h IV 92 158 103 72 42 18 9 IM 34 56 71 68 47 20 9 a 30-minute infusion PLASMA CONCENTRATIONS AFTER 2 GRAM IV a OR IM DOSE Mean Plasma Concentration (mcg/mL) Time after Injection Route 5 min 10 min 1 h 3 h 5 h 9 h 12 h IV 237 223 135 74 48 22 12 b IM — 20 75 91 69 33 19 a Injected over 3 minutes b Concentrations estimated from regression line The plasma elimination half-life of cefotetan is 3 to 4.6 hours after either intravenous or intramuscular administration.
Indications
- INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotetan and other antibacterial drugs, cefotetan should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Common Doses
- 500 mg
- 2 g
- 1 g
- 3 g
Dosage
DOSAGE AND ADMINISTRATION Treatment The usual adult dosage is 1 or 2 grams of Cefotetan for Injection administered intravenously or intramuscularly. Proper dosage and route of administration should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organism. General Guidelines for Dosage of Cefotetan for Injection Type of Infection Daily Dose Frequency and Route Urinary Tract 1 to 4 grams 500 mg every 12 hours IV or IM 1 or 2 g every 24 hours IV or IM 1 or 2 g every 12 hours IV or IM Skin & Skin Structure Mild - Moderate a Severe 2...
Contraindications
- CONTRAINDICATIONS Cefotetan is contraindicated in patients with a known allergy to the cephalosporin group of antibiotics and in those individuals who have experienced a cephalosporin associated hemolytic anemia.
Side Effects
- ADVERSE REACTIONS 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.
Interactions
- Drug Interactions Increases in serum creatinine have occurred when cefotetan was given alone. If cefotetan and an aminoglycoside are used concomitantly, renal function should be carefully monitored, because nephrotoxicity may be potentiated.