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Eftax

Quadrant Healthcare Ltd
71, Jebba Street, Ebute-Metta (East), Lagos
Email: quaint998@hotmail.com
Tel: 08066122428, 07028090227, 08026044280

Brand Name

Eftax

Manufacturer

North China Pharmaceutical Co. Ltd.
No. 108, Haihe Road, High & New Technology Development Zone, Shijiazhuang, China.

Therapeutic Class

Antibacterial, Cefalosporins

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Injection(NRN:-): Each vial contains Cefotaxime Sodium BP equivalent to Cefotaxime 0.5 g, 1.0 g or 2.0 g. Exciplents: none

Pack Size:

Pharmacology

Cefotaxime is a broad-spectrum third-generation cephalosporin antibiotic, Among Gram-negative bacteria cefotaxime is active against many Enterobacteria including Escherichia coli, Proteous mirabilis, Klebsiellosis sp, and salmonella spp. As well Bacillus Proteus communis and Citrobacter. Enterobacter cloacae and Bacillus alcaligens.

This product is high active against Hamophilus influenzae, Niesseria gonorrhoea (including beta-lactamases producing strains). Neisseria meningitis and Moraxella catarrhalis.

Gram-positive. Staphylococcus aureus is less sensitive to it although cefotaxime is active against most of Gram-positive bacteria, such as hemolytic Streptococcus and Streptococcus pneumonia. Enterococci are resistant to cefotaxime.

Indications

Cefotaxime is indicated for the treatment of the infections due to susceptible organisms, including pneumonia and other lower respiratory tract infections, urinary tract infections, meningitis, septicemia, infections of abdominal cavity, pelvic infections, infections of the skin and soft tissues, genital infections, infections of the bones and joints. And it can also be used as a selective drug in the treatment of meningitis in infants.

Contra-indications

Cefotaxime is contra-indicated in patients with known hypersensitivity to the cephalosporin group of antibiotics, or with a history of penicillin allergic shocks or immediate reaction

Precautions/Warnings

1. Cross-hypersensitive reaction: The patients who are hypersensitive to one of the cephalosporin group of antibiotics, or to cephamycin, or to penicillin and penicillamine may be allergic to cefotaxime.

2. Cefotaxime may interfere with some diagnoses, including a positive result to the Coombs’ test, false-positive results for glycosuria using copper-reduction reactions. Rises in alkaline phosphates, in BUD, as well as in ALT, AST, and SLDH may occur.

3. For the patient with renal impairment, the dosages should be reduced with caution. For the patient with gastroenteric diseases cefotaxime should be used with caution.

4. Warning: do not mix cefotaxime with another amino glycoside in the same syringe or infusion. Before using Cefotaxime, the intradermic allergic test should be taken with 0.1 mL of test solution via intradermic injection.

Test Solution: dilute cefotaxime with sterile physiological saline to the concentration of 250 µg/mL.
The positive patient is a contraindication.

Pregnancy and Lactation:

Since cefotaxime can go into blood circulation of fetus through placental barrier, it should not be used during pregnancy, unless strictly indicated. Because cefotaxime can be excreted in breast milk, the breast-feeding should be discontinued during the treatment.

Interactions

Concomitant administration of gentamycin or tobramycin has the synergetic effects on Pseudomonas aeruginosa. Cefotaxime associated with amikacin has the synergetic effects on Escherichia coli, Klebsiella pneumonia and Pseudomonas aeruginosa. When cefotaxime is used in combination with aminoglycosde, the status of the patient's kidney should be often monitored.

The renal function should be monitored in patients who receive large dosage of cefotaxime and furosemide diuretics. Cefotaxime may be diluted by sodium chloride injection or glucose solution, but it is forbidden to be mixed with sodium bicarbonate solution. When administered with Axiocillin or Mezlocilin, the dosage of cefotaxime should be suitably reduced for the total rate of clearance of it will fall.

Adverse Effects

The most common adverse effects include skin rashes, drug fever, phlebitis, diarrhea, nausea, vomiting and anorexia. Temporary increases in liver enzyme values including serum transaminases and alkaline phosphatase have been noted besides blood urea nitrogen and serum creatinine.

Neutropenia, oesinophilis, thrombocytopenia or candidiasis of mucous membrane may rarely occur. Headache, numbness, dyspnea and flush may occur occasionally.

Dosage & Administration

1. for adults, cefotaxime is usually given in doses of 2 to 6 g daily in 2 to 3 divided doses by intramuscular injection, or intravenous injection, or intravenous infusion. In severe infections, it is usually given 2 to 3 g per 6 to 8 hours. The maximum daily dose should not exceed 12 g.

2. In the treatment of Streptococcus pneumonia without any complications or acute infections of urinary tract, cefotaxime is usually given 1 g per 12 hours.

3. For infants ≤7days, cefotaxime is given 50 mg/kg per 12 hours:
For infants >7 days, it is given 50 mg/kg per 8 hours. In the treatment of meningitis, the dosage may be increased up to 75 mg/kg per 6 hours. For the above-mentioned condition, it should be given by intravenous route.

4. For the patients with severe renal impairment, the dosage of cefotaxime should be reduced suitably. When the value of serum creatinine is more than 424 µmol/L (4.8 mg) or creatinine clearance is less than 20 mL/min, the maintaining dosage should be halved; when the value of serum creatinine is more than 751 µmol/L (8.5 mg), the maintaining dosage should be quartered.

For the patient who need hemodialysis, Cefotaxime should be given 0.5 to 2g daily, but after hemodialysis, the single dose should be given once more.

The injection should be freshly prepared. Do not refrigerate the reconstituted solution. Discard any unused portion.

For IV use: Should be reconstituted with sterile water for injection BP 9.5 mL.

For IM use: Should be reconstituted with 1% Lidocaine for injection BP 3.5 mL.

Overdose:

There is no specific antagonist for cefotaxime. In the case of overdosage, the treatment of overdosage should be symptomatic, and let the patient be given enough suitable fluid and drink water as much as they can.

Storage/Handling Recommendations

Store in a cool and dry place. Keep in a tight container and avoid light.

Shelf Life: Three years when stored as prescribed.

Review Date

2017-02-06 04:57:54