CEFOTAX@
IV or IM Vials
Broad Spectrum Antibiotic
Composition:
Each vial contains:
Cefotaxime (as sodium salt) 250 mg. 500 mg, 19, or 2g.
Properties:
CEFOTAX@(cefotaxime) is a third gene:ration cephalosporin antibiotic which acts by inhibition 01 cell wall synthesis. It has greater bactericidal activity than first or second generation cephalosporins against Gram negative bacteria. CEFOTAX@is highly stable in the presence of beta-Iactamases produced by certain Gram-negative and Gram-positive bacteria.CEFOTAX@isgenerallyeffectiveagainst the following pathogens: E.coli, Klebsiella, Proteus, Providentia, Enterobacter, Serratia, Salmonella, Shigella, Citrobacter, Yerslnia, Neisseria, Haemophilus innuenzae, Moraxel1a catarrhalis, and Pseudomonas aeruginosa species; Staphylococcus aureus
(penicillinase and non-penicillinase producing str.), Staphylococcus epidermidis (non-penicillinase producing sIr.), and Slreptococci including Strep. Group A, group Band pneumoniae. CEFOTAX@ is also active against some anaerobic bacteria such as Bacteroides fragilis, and Clostridium perfringens. Other micro-organisms sensitive to CEFOTAX@ include the spirochaete Borrelia Burgdorferi and the causative (H’ganism of chancroid, Haemophilus ducreyi. Desacetylcefotaxime is an active metabolite of cefotaxime which exerts an additive or synergistic effect against
some species.
Pharmacokinetics:
CEFOTAX@ is administered by injection as the sodium salt. I! is rapidly absorbed alter IM injection and peak serum concentrations have been attained within 30 minutes. Alter IV injection, cefotaxime peak serum concentrations have been immediately achieved. The plasma halt-lite is about t hour and that of the major active metabolite, desacetyl derivative is about 1.5 hours. Hall-lives are
prolonged in patients with severe renal impairment. Cefotaxime is about 40 % bound to plasma proteins. Cefolaxime and the desacetyl metabolile, contributing to the bactericidal activity, are widely distributed in body tissues and fluids. Elimination is mainly by the kidneys and about 40-60 % of a dose has been recovered unchanged in the urine within 24 hours; a further 20 % is eliminated as the desacetyl metabolite. Relatively high concentrations of cefotaxime and desacetylcefotaxime are achieved in bile and about 20 % of a dose has been recovered in faeces.
Indications:
CEFOTAX@ is used in the treatment of infections due to susceptible organisms especially serious infections including:
– Lower respiratory tract infections including pneumonia. – Genito-urinary tract infections.
– G.1.tract infections including Typhoid lever.
– Gynecological infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis.
– Skin and sott tissue infections. – Bone and joint infections.
– Intra-abdominal infections including peritonitis. – CNS infections including meningitis and ventriculitis.
– Bacteremia I Septicemia. – Brain abscess and endocarditis.
– Perioperative prophylaxis.
Dosage:
Adults:Administer IV or IM. Maximum daily dosage should not exceed 12 g. The dose should be determined by the nature and the
severity of infection and by the patient’s condition.
CEFOTAX@DosesGuidelinesforAdults :
Type of infection Daily Dosage (g) Frequency and Route
Infections commonly needing higher dosage 6-8 2 g/6-8 hours IV
UncompliCated infections 3-6 1-2g/8 hourslM or IV
Moderate 10 Severe Infections 2 1 gl12hourslMorlV
Gonococcal urelhrilislcervicills 0.5 O.5gIM(single dose) Rectal gonorrhea in females 0.5 O.5gIM(single dose)
Rectal gonorrhea in lmales 1 1g IM (Single dose)
Life·threatening inieclions s 12 2 g/4 hours IV
Pertcpeeenve prophylaxls:
1 9 IV or IM, 30 to 90 minutes pnor to surgery.
Caesarian Section:
Administer the first 1 g dose IV as soon as the umbilical cord is clamped. Administer the second and third doses as 1 g IV or IM at 6 and 12 hour intervals alter the first dose.
Renal function impairment:
In patients with severe impaired renal function (creatinine clearance
< 2q mll min.), the dose should be reduced to half the normal dose.
Pediatrics:
11 is not necessary to differentiate between premature and normal gestational age infants. The following dosage recommendations
may serve as a guide.
Age Dosage Schedule Route
o • 1 week of age 50 mglkg/12 hours IV
1 – 4 weeks of age 50 mglkg/S hours IV
1 month – 12 years C< 50 kg) 50 • 180 mglkg/day IV or lM
in 4-6 divided doses
Children it>50 kg :
Use adult dose. Use higher doses lor more severe or serious infections including meningitis.
Administration:
CEFOTAX@ is given by deep IM injection or IV by slow injection over 3-5 minutes or by infusion over 20-60 minutes. Higher doses (> 2 9 daily dose) of CEFOTAX@areinjected preferably by IV administration or by IV infusion.
Preparation of Solutions:
To prepare initial dilution for IM use, 2, 3 and 5 rnl of sterile water for injection or Bacteriostatic water for injection should be added to each 500 mg, 1 g, and 2 9 vials respectively. To prepare initial dilution for IV use, 10 rnl of sterile water for injection should be added to each 500 mg, 1 g vial and 2 g vial. To prepare initial dilution for IV infusion, SO-lOO ml of 0.9 % Sodium Chloride injection or 5 % Dextrose injection should be added to each 500 mg, 1 g vial and 2 g vial. Solutions range in cctor from pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage. This does not affect their potency when stored per recommendations. Do not use with diluents having a pH above 7.5 (eg. Sodium bicarbonate injection).
Storage/Stability:
CEFOTAX@vialsinthedrystate should be stored below 20°C. The dry material as well as the solutions tend to darken depending on storage conditions. Protect from elevated temperatures and excessive light. Reconstituted solutions 01 CEFOTAX~ maintain potency lor 24 hours at room temperature, for 10 days under refrigeration and for at least 13 weeks frozen.
Admixture:
CEFOTAX@ solution should not be admixed with aminoglycoside solutions. If both solutions are 10 be given to the same patient, administer separately.
Drug Interactions:
As with many cephalosporins, probenecid reduces the renal clearance of CEFOTAX!l) resulting in higher plasma levels. Concomitant administration of ureidopenicillins decrease CEFOTAXill total body clearance.
Precautions:
Great care should be taken il CEFOTAX!l) is to be given to penicillin-sensitive patients or to patients with a history of allergy to other drugs. CEFOTAX@vialshouldbegivenwithcautiontopatientswith renal impairment; a dosage reduction may be necessary. CEFOTAX® vial may be used in association with an aminoglycoside, another beta-Iactam or with metronidazole. The drugs should be
administered separately. CEFOTAXl!lvials should be used with caution, and only if clearly needed, in patients with colitis. Pregnancy and lactation;the drug may be used only if potential benelit justifies the potential risk to the fetus Of 10 the breast-tee infant, respectively. For courses 01 treatment tasting longer than 10 days, blood counts should be monitored. To minimize the potentiallor tissue Ihflammation, infusion sites should be monitored regularly and changed when appropriate.
Contra-indications:
A known hypersensitivity to cepbaiosocnos or to related antibiotics.
Side effects:
CEFOTAX@ is generally well-tolerated. The most common side effects are local reactions: e.g. pain at the I.M. injection site, or inllammatory irritation with IV administration. Other side effects may include hypersensitivity reactions: e.g. rash, pruritus, effects on blood pressure, transient elevation in SGOT and SGPT, nausea, vomiting, diarrhea, pseudomembranous colitis, or granulocytopenia.
How Supplied:
CEFOTAX~50 mg, 500 mg, 1 9 ,and 2 9 vials: Box 011 vial + 1 or 2 ampoules Solvent
produced by :
EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO. E. L P. L CO.
loth OF RAMADAN CITY, INDUSTRIAL AREA Bl, P.O. BOX: 149 TENTH, EGYPT
