Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Bottle of powder: Cefotetan
Powder and solvent for solution for injection
Box of 1 Bottle of powder + 5 ml solvent ampoule
They arise from the antibacterial activity and pharmacokinetics of cefotetan.
They take into account both the clinical studies that the drug has given and its place in the range of antibacterial products currently available.
They are limited in adults to severe infections caused by germs sensitive to cefotetan, with the exception of meningitis and bone infections.
Prophylaxis of postoperative infections:
- in colorectal surgery,
- during appendectomies,
- in biliary surgery,
- during prostate biopsies (transrectally)
- during vaginal and abdominal hysterectomies,
- during total cystectomies.
Official recommendations concerning the appropriate use of antibacterials should be taken into account.
Posology APACEF 1 g Powder and solvent for solution for injection Box of 1 vial of powder + ampoule of solvent of 5 ml
- IV-IM pathway :
2 g / day in two injections 12 hours apart.
This dosage may, in some cases, be increased to 4 g, or even 6 g / day in two injections at 12 hour intervals.
A dosage of 1 g / day in 1 or 2 injections may be sufficient to treat some uncomplicated urinary tract infections.
- Path IV :
Prophylaxis of postoperative infections in surgery:
Antibiotic prophylaxis should be short-term, usually limited to the intraoperative period, sometimes 24 hours, but never more than 48 hours:
. intravenous injection of 2 g at anesthetic induction,
. then reinjection of 1 g IV every 4 hours until the end of the procedure.
For appendectomy and prostate biopsies, a single dose is sufficient.
In case of renal insufficiency, the dosage will be adjusted according to the clearance of creatinine as follows:
. clearance of creatinine 40 or more ml / min: usual dosage,
. creatinine clearance 10 to 40 ml / min: half the dosage,
. Creatinine clearance 0 to 10 ml / min: 1/4 of the dosage.
In hemodialysis patients, half of the usual dosage will be injected on days of hemodialysis, a quarter of the usual dosage days without a hemodialysis session.
Mode of administration :
INTRAVENOUS OR INTRAMUSCULAR PATHWAY.
Intravenous: In slow IV direct injection (3-5 min) or infusion for up to 12 hours.
Cefotetan infusions may be prepared using the following injectable solutions: 5% glucose, 0.9% sodium chloride, mannitol, Ringer.
Intramuscular route: (see instructions for use, instructions for handling).
This medicine MUST NEVER BE USED in case:
- allergy to cephalosporin antibiotics,
- history of haemolytic anemia with beta-lactams.
NOT RECOMMENDED :
This medicine SHOULD NOT BE USED in the following situations:
- in case of breastfeeding: the passage in the breast milk is weak. Breastfeeding is not recommended because of the occurrence of hypoprothrombinemia in adults.
- in combination with alcoholic beverages or drugs containing alcohol (see interactions).
- Pregnancy: Studies in animals have not shown any adverse effects on the fetus during pregnancy, but the safety of cefotetan during pregnancy has not been established. Cefotetan should not be given during the first trimester of pregnancy without carefully assessing the anticipated benefit and possible risks.
Apacef side effects
- Digestive manifestations : diarrhea (see warnings: pseudomembranous colitis).
- Skin manifestations : rash.
- Manifestations of allergic origin : fever.
- Hematological manifestations : transient change in certain hematological parameters: eosinophilia, leuconeutropenia, neutropenia, thrombocytopenia; a few rare cases of severe neutropenia and immunoallergic haemolytic anemia, the course of which may be fatal, have been reported (see warnings).
- Hepatic manifestations : transient elevation of transaminases (ASAT, ALT) and alkaline phosphatases.
- Nephrotoxicity : Impairment of renal function has been observed with antibiotics in the same group, especially when combined with aminoglycosides and strong diuretics.
- The administration of high doses of betalactamines, particularly in patients with renal insufficiency, may lead to metabolic encephalopathy (disorders of consciousness, abnormal movements, convulsive seizures).
- Superinfection with candida and enterococci.
- Local reactions: venitis after IV injection, pain at the IM injection site.
- When drinking alcohol, flushing (antabuse effect) may occur. This reaction only occurs when alcohol ingestion follows cefotetan administration and can still be observed even 3 days after stopping treatment.