COMPOSITION :
Ceftriaxone Sodium Sesquaterhydrate Powder for Injection 1 g, each vial contains : Ceftriaxone sodium sesquaterhydrate equivalent to Ceftriaxone 1 g.
DESCRIPTIONS :
Ceftriaxone Sodium Sesquaterhydrate with Ceftriaxone sodium sesquaterhydrate (equivalent to Ceftriaxone) as active ingredient is available in sterile powder for injection.
INDICATIONS :
Ceftriaxone Sodium Sesquaterhydrate is indicated for the treatment of the following infections :
- Lower respiratory tract infection
- Acute bacterial otitis media
- Skin and skin structure infections
- Urinary tract infections
- Uncomplicated gonorrhoeae
- Pelvic inflammatory disease
- Bacterial septicemia
- Bone and joint infections
- Intra-abdominal infections
- Meningitis
- Prevention of pre-operative
DOSAGE AND ADMINISTRATIONS :
Standard dose :
- Adult and children over 12 years :
Usual dose 1 a day 1 – 2 g, administered every 24 hours. In case of severe infections caused or moderate organisms sensitive to Ceftriaxone Sodium Sesquaterhydrate, the maximum daily dose can be increased up to 4 g per day (given 1 time daily).
- Neonates, infants and children up to the age of 12 years :
Neonates (up to 14 days) : 20 – 50 mg/kgBW/day, should not exceed 50 mg/kgBW.
No need to distinguish between preterm and non-preterm.
- Infants and children (15 days – 12 years) : 20 – 80 mg/kgBW/day.
For children weighing 50 kg or more should be administered intravenously at least 30 minutes or more.
- Patients with advanced age : As the dose for an adult dose, no modification is required in elderly patients.
Duration of treatment :
The duration of treatment varies depending on the cause of the disease. As treatment with antibiotics in general, administration of Ceftriaxone Sodium Sesquaterhydrate should be continued at least until 48 – 72 hours after the patient is free from fever or substantially eradicated germs.
Treatment combinations :
Synergistic effect between Ceftriaxone sodium and Aminoglycoside has been proven against a variety of gram-negative bacteria through experiments. Despite the high activity of the combination cannot always be determined, should be considered in severe infections, life-threatening infections caused by microorganisms such as Pseudomonas aeruginosa. Because physically the two drugs cannot be mixed, the two drugs must be given separately in accordance with the recommended dosage.
Special dosage instructions :
- Meningitis : For meningitis infections in infants and children, treatment was started at a dose of 100 mg/kgBW/day, not to exceed 4 g/day. The dose can be lowered, as soon as the sensitivity of the causative organism is known and determined.
- Duration of treatment is effective for :
- Neisseria meningitidis : 4 days.
- Haemophilus influenzae : 6 days.
- Streptococcus pneumoniae : 7 days.
- Gonorrhoeae : A single dose of 250 mg IM Ceftriaxone Sodium Sesquaterhydrate.
Prevention of pre-operative :
To prevent post-surgical infection in contaminated or likely to be contaminated surgery, the treatment of 1 – 2 g in a single dose, given 30 – 90 minutes before surgery.
In colorectal surgery, has proven effective in giving together (but separately) Ceftriaxone Sodium Sesquaterhydrate with or without 5-nitro-imidazole as Ornidazole.
Dosage in impaired renal function and liver function :
- In patients with renal and hepatic function, dose reduction is not necessary for the function of one kidney or liver still good.
- Only in the case of pre-terminal renal failure (creatinine clearance < 10 ml/minute), the dose should not exceed 2 g/day.
- In patients with impaired hepatic function, no need for dose reduction in kidney function is still good.
- In the case of severe renal failure and severe liver function disorders that occur together, Ceftriaxone Sodium Sesquaterhydrate plasma levels should be measured on a regular basis.
- In patients undergoing dialysis is not required additional doses during dialysis. Serum concentrations should be monitored, to determine whether the dosage was appropriate because the elimination rate may decrease.
Administration :
IV administration :
Ceftriaxone Sodium Sesquaterhydrate 1 g powder reconstituted with 10 ml of water for injection, then given IV immediately within 2 – 4 minutes.
IM administration :
Ceftriaxone Sodium Sesquaterhydrate 0.25 g powder dissolved in 2 ml Lidocaine 1% and give the injection in the intragluteal. Recommended for not more than 1 g injected at side.
CONTRAINDICATIONS :
- Hypersensitivity to Cephalosporins.
- Hypersensitivity to Penicillin or β-lactam antibiotics.
WARNINGS AND PRECAUTIONS :
-
- Before use should be tested against Cephalosporin and Penicillin hypersensitivity. Cephalosporin C derivatives should be administered with caution in patients who are hypersensitive to Penicillin.
- Be careful when used in the first trimester pregnant women and lactating women.
- Caution when used in patients with impaired renal function.
- In the long-term use may occur superinfection.
- As with other Cephalosporin antibiotics cannot be avoided despite the occurrence of anaphylactic shock have been performed anamnesis. Anaphylactic shock requires immediate action.
- Reported occurrence of pseudomembranous colitis in nearly antibiotic drugs including Ceftriaxone sodium, therefore the diagnosis should be considered in patients who develop diarrhea in connection with antibacterial drugs.
- The image on a sonogram examination of the gallbladder is usually interpreted as gallstones followed doses higher than the recommended standard dose. This shadow is a possibility of calcium Ceftriaxone sodium precipitate which disappeared when treatment was stopped. This phenomenon is very rare.
- In symptomatic cases, conservative treatment without surgery is recommended. Stopping the treatment in this case should be handed over to the doctor.
- Studies show that Ceftriaxone sodium as with other Cephalosporin can replace the bond of serum albumin.
- Consideration must be given when it is considered to provide Ceftriaxone sodium in neonates with hyperbilirubinemia.
- Should not be given to neonates (especially premature) who are at risk of formation of bilirubin encephalopathy.
- In the long-term use, blood profile should be checked regularly.
ADVERSE REACTIONS :
Ceftriaxone sodium is generally well tolerated.
- Local reactions : Pain, induration and softened.
After IV administration, has been reported to occur phlebitis.
After IM administration can occur warmth, tightness or induration.
- Hypersensitivity : Rash.
- Hematologic : Eosinophilia, thrombocytosis, leukopenia. Little reported anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia and prolonged prothrombin time.
- Gastrointestinal : Diarrhea may occur and are reported nausea or vomiting, and dysgeusia though rarely. After antibacterial treatment of pseudomembranous colitis symptoms may occur.
- Hepatic : Increased AST or ALT. Reported to be an increase in alkaline phosphate and increased bilirubin though rarely.
- Renal : Increased BUN (Urea Nitrogen Bases).
- Central nervous system : Sometimes reported headache or dizziness.
- Genitourinary : Sometimes moniliasis or vaginitis were reported.
- Other : Sometimes reported diaphoresis and flushing.
PRESENTATIONS :
Ceftriaxone Sodium Sesquaterhydrate Powder for Injection 1 g Box, 10 vials @ 1 g
Reg. No. GKL0502337944A1
Ceftriaxone Sodium Sesquaterhydrate Powder for Injection 1 g Box, 100 vials @ 1 g
Reg. No. GKL0502337944A1
STORAGE :
STORE BELOW 25°C AND DRY PLACE
After reconstitution solutions stable for 6 hours at temperature below 30°C or 24 hours at 5°C.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
