3-CIF 500
-
Chemical Name:
Cefotaxime (Sodium) -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Cephalosporin (Third Generation) -
Pharmaceutical Form:
Vial -
Composition:
Cefotaxime (Sodium) 500mg
3- CIF
Cefotaxime Sodiun
1-PROPERTIES:
3- CIF is a semisynthetic broad spectrum cephalosporin that is highly stable to hydrolysis by most Beta-lactamase. Following administration, 3- CIF distributes into a variety of tissues and body fluids and can penetrate inflamed meninges. In the body, 3- CIF is partially metabolized and both the parent drug and the metabolites are excreted renally, 3- CIF is bactericidal against a wide range of Gram-positive and Gram-negative bacteria, including Staphylococcus aureus (penicillinase and non-penicillinase producing staph.), Staphylococcus sp., Enterobacter sp., Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella sp., Neisseria gonorrhoea, Neisseria meningitidis, Proteus sp., (both indole-positive and indole-negative), Providencia, Morganella morganii, Salmonella, Serratia, Shigella and Acinetobacter.3- CIF is also active against some strains of Pseudomonas aeruginosa and some strains of Bacteroides (including Bacteroides fragillis) and some strains of Clostridium sp., Peptococcus, Peptostreptococcus and Fusobacterium sp.
2-INDICATIONS:
3- CIF is indicated in the treatment of infection due to susceptible organisms including: lower respiratory tract infections
Genitourinary infections.
Gynecologic infections.
Bacteremia and septicemia.
Skin and skin structure infections.
Intra-abdominal infections.
Bone and joint infections.
And other bacterial infections: Meningitis where the microorganism is known to be sensitive.
3- CIF is also used preoperatively for surgical prophylaxis.
3-CONTRAINDICATIONS:
Cefotaxime is contraindicated in patients with hypersensitivity to the cephalosporin antibiotics.
4-WARNINGS:
Before administering Cefotaxime, careful inquiry about any previous hypersensitivity reactions to Cefotaxime, Cephalosporin antibiotics or penicillins should be made.
5-PRECAUTIONS:
Cefotaxime should be administered with caution in individuals with a history of gastrointestinal diseases especially colitis.
6-PREGNANT & NURSING MOTHERS:
Use only if clearly needed in pregnancy and to nursing mothers.
7-SIDE EFFECTS:
Cefotaxime is well tolerated. The most common adverse reactions are rashes and diarrhea as well as injection site reactions (inflammation following IV injection, pain, induration and tenderness after IM administration).
8-DRUG INTERACTIONS:
Doses of cefotaxime may need to be reduced if used concomitantly with ureidopenicillins such as azlocillin or mezlocillin.
Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
9-DOSAGE & ADMINISTRATION:
3- CIF is administered by intramuscular injection, intravenous injection or intravenous infusion.
ADULTS: The usual dosages are as follows:
Gonorrhoea: 1 g as a single dose.
Uncomplicated infections: 1 g every 12 hours.
Moderate to severe infections: 1-2 g every 6-8 hours.
Infections commonly needing higher dosage (e.g. septicemia): 2 g every 6-8 hours.
In life-threatening infections: 2 g every 4 hours.
CHILDREN: The usual dosage is: 50-100 mg/kg body weight daily in 2-4 divided doses.
In very severe infections: Up to 150-200 mg/kg body weight may be required.
NEONATES: The recommended dosage is 50 mg/kg body weight in 2 to 4divided doses.
In very severe infections: 150-200mg/kg body weight/day in divided doses has been given.
Surgical prophylaxis: Single 1 g intravenously or intramuscularly 30-90 minutes prior to surgery.
Cesarean section: Administer the first 1 g dose IV as soon as the umbilical cord is clamped, administer the second and the third doses as 1 g IV or IM at 6 and 12 hours intervals after the first dose.
The Maximum Daily Dosage should not exceed 12g.
Dosage in renal impairment: Patients with impaired renal function (Creatinine clearance <20 ml/min/1.73 m2).
The dose should be halved without changing frequency of administration .
A supplemental dose equal to 50% of the maintenance dose should be given after hemodialysis.
RECONSTITUTION:
Intravenous and intramuscular administration:
Dissolve 3- CIF as follows:
Vial size Volume to be added
500 mg or 1 g or 2 gr IV 4 ml water for injection
500 mg or 1 g or 2 gr IM only 4 ml of 1% lidocaine
Intravenous Infusion
Dissolve 1 –2 g 3- CIF in 40- 100 ml of water for injection BP or one of the following solution in: 0.9% NaCI, 5% dextrose injection and 0.9% NaCI and 5% dextrose injection. The prepared infusion should be administered over 20-60 minutes.
Reconstituted solution retain satisfactory potency for up to 24 hours when refrigerated.
Intramuscularly reconstituted injections with 4 ml of 1% lidocaine should be used fresh. Reconstituted solutions may darken in color upon storage; however, this does not indicate change in potency or safety.
10-PACKAGING & COMPOSITION:
3- CIF 500 mg :Each vial contains: Sterile Cefotaxime sodium equivalent to Cefotaxime 500 mg.
3- CIF 1000 mg: Each vial contains: Sterile Cefotaxime sodium equivalent to Cefotaxime 1000 mg.
3- CIF 2000 mg: Each vial contains: Sterile Cefotaxime sodium equivalent to Cefotaxime 2000 mg.
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