COMPOSITION :
Cefotaxime Sodium Powder for Injection 1 g, each vial contains : Cefotaxime sodium equivalent to Cefotaxime 1 g.
DESCRIPTIONS :
Cefotaxime Sodium with Cefotaxime sodium as active ingredient (equivalent to Cefotaxime) is available in powder for injection 1 g.
INDICATIONS :
Indicated for severe infections caused by Cefotaxime sensitive pathogens :
Infections of the respiratory tract (including nose and throat), ear, kidneys and urinary tract, skin and soft tissues, bones and joints, genital organs (including uncomplicated gonorrhoea), abdominal region, sepsis, endocarditis, meningitis; for perioperative prophylaxis in patients who are at increased risk from infection and for the prophylaxis in patients with reduced resistance.
DOSAGE AND ADMINISTRATIONS :
Dosage, mode and frequency of administration depend on the severity of the infection, susceptibility of the pathogen and condition of the patient.
- Adults and children > 12 years : 1 g every 12 hours.
- In severe infections, the daily dose may be raised to a maximum of 12 g. If the daily dose is 4 g, it may be divided into 2 equal doses, administered at intervals between the injections or serve as a guide :
| Guidelines for Dosage of Cefotaxime | ||
| Type of Infections | Daily Dose (g) | Frequency and Route |
| Gonorrhoea | 1 | 1 g IM (single dose) |
| Uncomplicated infections | 2 | 1 g every 12 hours (IM or IV) |
| Moderate to severe infections | 3 – 6 | 1 – 2 g every 8 hours (IM or IV) |
| Infections commonly needing antibiotic in higher dosage | 6 – 8 | 2 g every 6 – 8 hours IV |
| Life threatening infections | 2 | Every 4 hours IV |
- Patients with impaired renal function :
In patients with a creatinine clearance ≤ 5 ml/minute, the maintenance dose should be reduced to half the normal dose. The initial dose depends on the susceptibility of the pathogen and severity of the infection.
Duration of treatment :
The duration of the treatment depends on the patient’s response. It should be continued for a minimum of 48 – 72 hours after the body temperature has returned to normal or after evidence of bacterial eradication has been obtained.
Administrations :
Cefotaxime Sodium may be administered IV or IM.
- IV Injection :
Dissolve Cefotaxime Sodium injection 1 g in 4 ml water for injection. The solution is then injected over a period of 3 – 5 minutes, either directly into a vein or into the distal part of a clamped-off infusion tube.
- IV Infusion :
For short infusion, dissolve Cefotaxime Sodium injection 2 g in 40 ml water for injection and then administered over approximately 20 minutes. Sodium bicarbonate solutions must not be mixed with Cefotaxime Sodium.
- IM Administration :
Dissolve Cefotaxime Sodium injection 1 g in 4 ml water for injection and the solution is then injected deep into the gluteus muscle. It is advisable not to inject more than 4 ml into either side. IV injection is recommended if the daily dose exceeds 2 g or if Cefotaxime Sodium 1 g is administered more than twice daily.
After reconstitution, Cefotaxime Sodium can be stored for up to 24 hours at temperatures below 25°C.
CONTRAINDICATION :
Patient with a history of hypersensitivity reactions to Cephalosporins antibiotics.
WARNINGS AND PRECAUTIONS :
- Caution in patients with hypersensitive to Penicillins or other β-Lactam antibiotics.
- Renal function must be monitored in patients treated concomitantly with Aminoglycosides.
- The blood count should be monitored for course of treatment lasting > 10 days.
- Should not be used in patients with neutropenia.
- Use in Pregnancy and Lactation : Cefotaxime should not be used during pregnancy, especially in the first three months, unless strictly indicated. As Cefotaxime is excreted in breast milk, either breast-feeding or treatment of the mother with Cefotaxime should be discontinued.
DRUG INTERACTIONS :
- Concomitant administration with Probenecid increases Cefotaxime concentration in the serum and prolongs its duration of action.
- Concomitant administration with potentially nephrotoxic drugs (e.g., Aminoglycosides) should be closely monitored for renal function.
- Administration of Cephalosporins, including Cefotaxime may cause a transient reduction in plasma concentration of Estrogens and Gestagens. The effectiveness of oral contraceptives is therefore uncertain.
- Interference with laboratory tests : A false positive result for the Coombs’ test may be obtained in rare cases during treatment with Cefotaxime.
- Non-enzymatic methods for the determination of glycosuria may also give a false positive result. Glycosuria should therefore be determinated by enzymatic methods during Cefotaxime treatment.
ADVERSE REACTIONS :
- Effects on the blood picture : Thrombocytopenia, eosinophilia, leucopenia.
- Effects on the liver : Rise in serum liver enzymes (e.g., SGOT, SGPT, γ-GT, alkaline phosphatase, LDH) and bilirubin.
- Effects on the kidney : A transient increase in serum creatinine and urea, in rare cases, interstitial nephritis may occur.
- Effects on the gastrointestinal tract : Nausea and vomiting, abdominal pain, diarrhoea, pseudomembranous colitis.
- Local reactions : Inflammatory irritation and pain at the site of injection.
- Other : Allergic skin reactions (e.g., urticaria, exanthema) and itching may occur.
PRESENTATIONS :
Cefotaxime Sodium Powder for Injection 1 g Box, 10 vials @ 1 g Reg. No. GKL0602338644A1
STORAGE :
STORE BELOW 25°C AND DRY PLACE, PROTECT FROM LIGHT
After reconstitution, Cefotaxime Sodium can be stored for up to 24 hours at temperatures below 25°C.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
