Cefot^®

Cefot^® is the preparation of Cefotaxime Sodium which is a semi synthetic, broad-spectrum third generation cephalosporin antibiotic for parenteral administration. The bactericidal activity of Cefotaxime results from inhibition of cell wall synthesis. Cefotaxime has been shown to be active against wide range of Gram-positive and Gram-negative organisms sensitive or resistant to first or second generation cephalosporin.

No Data

Cefot^® is indicated for the treatment of patients with following serious infections, such as -

• Lower respiratory tract infections including pneumonia
• Genitourinary infections including urinary tract infections and also uncomplicated gonorrhea (cervical/urethral and rectal)
• Gynecologic infections including pelvic inflammatory disease, endometritis and pelvic cellulitis Bacteremia and septicemia
• Skin and skin structure infections Intra-abdominal infections including peritonitis Bone and/or joint infections
• Central nervous system infections (e.g., meningitis and ventriculitis)

Route of administration: Cefot^® should be administered in intramuscular or intravenous route.

Adult
Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection and the condition of the patient. Cefot^® may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 g.

• Life threatening infections: 12 g daily by IV injection every 4 hours in equal divided dosages (2 g per dose).
• Moderate to severe infections (e.g., meningitis): 3 to 6 g daily by IM or IV injection every 8 hours in equal divided dosages (1 to 2 g per dose).
• Uncomplicated infections: 2 g daily by IM or IV injection every 12 hours in equal divided dosages (1 g per dose).
• Infections commonly needing antibiotics in higher dosage (e.g., septicemia): 6 to 8 g daily by IV injection every 6 to 8 hours in equal divided dosages (2 g per dose).
• Gonococcal urethritis/cervicitis in males and females: 0.5 g as a single dose by IM injection.
• Rectal gonorrhea in females: 0.5 gas a single dose by IM injection.
• Rectal gonorrhea in males: 1 gas a single dose by IM injection.
• Cesarean section patients: The first dose of 1 g is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 g intravenously or intramuscularly at 6 and 12 hours after the first dose.
• Post-operative infections: Recommended dose is a single 1 g IM or IV administered 30 to 90 minutes prior surgery.

Infants and children (1 month to 12 years)
For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into 4 to 6 equal doses. The higher dosages should be used for more severe or serious infections including meningitis.
For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 g.

Neonates (birth to 1 month)
0- 1 week of age: 50 mg/kg per dose every 12 hours IV.
1- 4 weeks of age: 50 mg/kg per dose every 8 hours IV.

Patients with renal impairment: Because of extra-renal elimination, it is only necessary to reduce the dosage of cefotaxime in severe renal failure (GFR < 5 ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1 g, daily dose should be halved without change in the frequency of dosing.

Reconstitution procedure and administration
Reconstitution procedure
Cefot^® IM injection: 250 mg IM with 2 ml water for injection, 500 mg IM with 2 ml water for injection, 1 g IM with 3 ml water for injection, 2 g IM with 5 ml water for injection.
Cefot^® IV injection: 250 mg IV with 5 ml water for injection, 500 mg IV with 10 ml water for injection, 1 g IV with 10 ml water for injection, 2 g IV with 10 ml water for injection.
Cefot^® IV infusion: Cefot® may be administered by IV infusion. 1 g to 2 g are dissolved in 40-100 ml of water for injection or 50 ml or 100 ml of 0.9% sodium chloride injection or 5% dextrose injection.

Administration
Cefot^® IM injection: As with all lM preparations, Cefot® should be injected well within the body of a relatively large muscle, such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 g may be given if the dose is divided and is administered in different intramuscular sites.
Cefot^® IV injection: For intermittent IV administration, a solution containing 1 g or 2 g in 10 ml of sterile water for injection can be injected over a period of 3 to 5 minutes. Cefotaxime should not be administered over a period of less than 3 minutes.
Cefot^® IV infusion: The prepared infusion should be administered over 20-60 minutes. Cefot® may also be given over a longer period of time through the tubing system by which the patients can receive other IV solutions. It is advisable to discontinue temporarily the administration of other solutions at the same site.

Compatibility and stability: Use of freshly prepared solution is preferred. Reconstituted solution is stable up to 24 hours in refrigerator and 8 hours at room temperature.

Pregnancy: Cefotaxime is a pregnancy category B drug. Cefotaxime should be avoided during pregnancy especially during the first trimester, without carefully weighing the expected benefit against possible risks.

Lactation: Cefotaxime is excreted in milk and caution should be exercised when cefotaxime is administered to the nursing mother.

Use in children and adolescents
Use in children and adolescents is given in dose and administration segment.

Cefotaxime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Because high and prolonged antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when cefotaxime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. There is no clinical evidence supporting the necessity of changing the dosage of cefotaxime in patients with even profound renal dysfunction.

Cefotaxime is generally well tolerated. The most common side effects are injection site inflammation with IV administration; pain, induration and tenderness after IM injection; hypersensitivity reactions have been reported, these include skin rash, pruritus, fever, eosinophilia; gastrointestinal reactions (such as colitis, diarrhea, nausea and vomiting); symptoms of pseudomembranous colitis can appear during or after antibiotic treatment. The less frequent side effects are potentially life-threatening arrhythmias following rapid (less than 60 seconds) bolus administration via central venous catheter has been observed; neutropenia, transient leukopenia, eosinophilia, thrombocytopenia and agranulocytosis, moniliasis, vaginitis, headache, transient elevations in SGOT, SGPT, serum LOH and serum alkaline phosphatase levels have been reported. As with some other cephalosporins, interstitial nephritis and transient elevations of BUN and creatinine have been occasionally observed with cefotaxime. As with other cephalosporins, isolated cases of erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.

Cefotaxime is contraindicated in patients with known hypersensitivity to cefotaxime sodium or the cephalosporin group of antibiotics.

Drug interaction with medication: Increased nephrotoxicity has been reported concomitant administration of cephalosporins and aminoglycoside antibiotics.
Drug interaction with food and others: Not applicable.

Most cases have shown no overt toxicity. The most frequent reactions are elevations of BUN and creatinine. Serum levels of cefotaxime may be reduced by peritoneal dialysis or haemodialysis. In the case of high doses, there is a risk of reversible encephalopathy.

No Data

Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach of children.

Cefot^® 250 mg IM/IV injection: Each vial contains Cefotaxime 250 mg as Sodium USP.
Cefot^® 500 mg IM/IV injection: Each vial contains Cefotaxime 500 mg as Sodium USP.
Cefot^® 1 g IM/IV injection: Each vial contains Cefotaxime 1 gas Sodium USP.
Cefot^® 2 g IM/IV injection: Each vial contains Cefotaxime 2 gas Sodium USP.