PERK

PRODUCT INFORMATION SHEET

AMCIL-T

250/500/1gm INJECTION

AMCIL-T INJECTION is a third generation cephalosporin antibiotic. It has a very broad spectrum of bactericidal activity. AMCIL-T INJECTION contains Sterile Cefotaxime Sodium I.P. equivalent to 250 mg / 500 mg / 1 gm of anhydrous Cefotaxime in each vial. It is provided in a combi-pack along with Sterile Water for Injection I.P.

ANTIMICROBIAL ACTION:

AMCIL-T INJECTION is highly stable to hydrolysis by most beta-lactamases and has far greater activity against gram negative bacteria than first or second-generation cephalosporins. Many streptococci and gram-positive bacteria are also very sensitive to AMCIL-T INJECTION. It is very active against gram negative bacteria like Enterobacteriaceae including Citrobacter and Enterobacter spp., Escherichia coli, Klebsiella spp., Salmonella, Serratia, Shigella, Yersinia spp., penicillin resistant strains like Haemophilus influenza, N. meningitidis etc. and gram positive bacteria like staphlococci and streptococci etc. AMCIL-T INJECTION is also active against some anaerobic bacteria Activity of this salt is enhanced by possible synergy by aminoglycosides such as gentamicin.

ADVERSE EFFECTS AND PRECAUTIONS:

All broad-spectrum third-generation cephalosporins have the potential for colonisation and superinfection with resistant organisms although the incidence is very low with AMCIL-T INJECTION. Changes in bowel flora are also quite low. AMCIL-T INJECTION should not be given in conjunction with ureidopenicillins azlocillin or mezlocillin. It should be monitored closely in patients with impaired renal activity.

 PHARMACOKINETICS:

 AMCIL-T INJECTION is administered by injection as the sodium salt. It is rapidly absorbed after intramuscular injection and mean peak plasma concentration have been reported 30 minutes after the injection. The plasma half-life is about one hour and that of the active metabolite desacerylcefotaxime is about 1.5 hours. Concentrations have been detected in serum 8 hours after injection by either route. It is widely distributed in body tissues and fluids; therapeutic concentrations are achieved in the cerebrospinal fluid when the meninges are inflamed. It crosses the placenta and is excreted in low concentrations in breast milk. Metabolism is in the liver and elimination is mainly by the kidneys.

USES  & INDICATIONS:

AMCIL-T INJECTION is a third generation cephalosporin antibiotic used in the treatment of infections due to susceptible organisms, especially serious and life threatening infections like : brain abscess, gonorrhoea, intensive care (selective parental and enteral antisepsis regimens), Lyme disease, meningitis, peritonitis, pneumonia, septicaemia, surgical infection (prophylaxis) and typhoid fever.

ADMINSTRATION AND DOSAGE:

AMCIL-T INJECTION is given as the sodium salt by deep intramuscular injection or intravenously by slow injection over 3 to 5 minutes or by infusion over 20 to 60 minutes. It is usually given in doses of 2 to 6 g daily in 2 or 3 divided doses. In Severe Infections upto 12 g may be given daily by the intravenous route in 6 divided doses. For pseudomonal infections usually 6 g daily is given.

In children, AMCIL-T INJECTION may be given in a dose of 100 to 150 mg per kg body weight daily in 2 to 4 divided doses and increased upto 200 mg per kg if necessary.

In neonates, AMCIL-T INJECTION is given in a dose of 50 mg per kg body weight daily, which may be increased to 150 to 200 mg if necessary. Dosage should be reduced in severe renal failure.

In the treatment of gonorrhoea a single 1-g dose of AMCIL-T INJECTION is given.

For surgical infection prophylaxis, 1 g is administered 30 to 90 minutes before surgery. At caesarean section 1 g is given intravenously to the mother as soon as the umbilical cord is clamped and two further doses intramuscularly or intravenously 6 and 12 hours later.

AMCIL-T INJECTION may be administered in association with an aminoglycoside as synergy may occur. It is also given along with metronidazole in the treatment of mixed aerobic-anaerobic infections.

A suggestion based on pharmacokinetic principles and clinical data, that AMCIL-T INJECTION could be given to children in a dose of 75 mg per kg body weight every 8 or 12 hours without comprising safety or efficacy.

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