Composition :
Each vial CEPHAFLOX contain Ceftriaxone disodium equivalent with Ceftriaxone 1 gram

Pharmacology :
Ceftriaxone is bactericidal. The bactericidal activity of Ceftriaxone is the result of mucopeptide synthesis in the walls of bacterial cells. Based on its activity, Ceftriaxone is classified into third-generation cephalosporins. Like other third-generation cephalosporins, Ceftriaxone is generally in-vitro less active against Staphylococcus compared with the first derivative, but it has a very wide spectrum of gram-negative bacteria compared with first and second derivatives. Ceftriaxone is highly stable against a variety of beta-lactamases, both penicillinase and cephalosporinase from gram-positive and gram-negative bacteria. Generally Ceftriaxone is active in-vitro against microbes and clinical infections as follows:

Gram positive aerob bacteria :
Staphylococcus aureus (including strains that produce penicillinase), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus group A (Streptococcus pyogenes), Streptococcus group B (Streptococcus agalactiae), Streptococcus viridans, Streptococcus bovis

Gram negative aerobic bacteria :
Aeromonas spp, Alcaligenes spp, Branhamella catarrhalis (beta lactamase negative or positive), Citrobacter spp, Enterobacter spp, Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae (including strains that produce penicillinase), Haemophilus parainfluenzae, Klebsiella spp (including pneumoniae), Moraxella spp, Morganella morganii, Neisseria gonorrhoeae (including strains that produce penicillinase), Neisseria meningitidis, Plesiomonas shigelloides, Proteus mirabillis, Proteus vulgaris, Providencia spp, Pseudomonas aeruginosa, Salmonella spp (termasuk S. typhi), Serratia spp (including S. marcescens), Shigella spp, Vibrio spp (including V. cholerae), Yersinia spp (including Y. enterocolitica)

Anaerobic bacteria :
Bacteroides spp (including B. fragilis strains), Clostridium spp (except C. difficile), Fusobacterium spp, Peptococcus spp, Peptostreptococcus spp

Indication :
Infections caused by Ceftriaxone-sensitive bacteria included: lower respiratory tract infections, skin infections and skin structures, bone and joint infections, intra-abdominal infections, urinary tract infections, meningitis, septicemia, gonorrhea, prevention of preoperative infection

Dosage :
Adults and children over 12 years old: the usual dose: 1-2 g, given once daily (every 24 hours). In severe cases or severe infections caused by moderately sensitive bacteria, the dose may be increased to 4 g, given once daily.
Neonates, infants and children up to 12 years old: neonates (up to 2 weeks): daily dose of 20-50 mg / kg given once daily. Do not exceed 50 mg / kg, should be taken into the maturity of the baby’s enzyme system. There is no need to distinguish between premature and term infants.
Infants and children (3 weeks to 12 years old): daily dose of 20-80 mg / kg body weight.
For children weighing 50 kg or more are given in doses for adults. An intravenous dose of 50 mg / kg of body weight or more should be administered intravenously for at least 30 minutes.
Elderly sufferers: recommended doses such as in doses for adults. No dose changes needed in elderly patients.

Duration of treatment:
The duration of treatment varies depending on the cause of the disease. Like treatment with antibiotics in general, the administration of this drug should be continued at least 48-72 hours after the patient is free of fever (heat) or achieved with real eradication of bacteria. Combination treatment: a synergistic effect between Ceftriaxone and aminoglycosides has been shown to be a lot of gram-negative bacteria. Although high activity of such combinations can not always be determined, it is constantly being considered in life-threatening live infections caused by germs such as Pseudomonas aeruginosa. Since both of these drugs can not be mixed, they should be given separately according to the recommended dosage.

Special dose instructions:
Meningitis: In the treatment of meningitis in infants and children, treatment begins with a dose of 100 mg / kg (do not exceed 4 g) once daily. As soon as the causative organism has been identified and the sensitivity has been determined, the dose may be lowered. Satisfactory results have been identified according to the duration of treatment as follows: Neisseria meningitidis 4 days, Haemophilus influenzae 6 days, Streptococcus pneumoniae 7 days.
Gonorrhoe: for the treatment of gonorrhoe (a strain that produces penicillinase and which does not produce penicillinase), it is recommended to administer a single dose of 250 mg Ceftriaxone intramuscular.
Perioperative prevention: to prevent post-surgical infection in the event of contamination or possible contaminated surgery, the recommended dosage depends on the risk of infection, usually 1-2 grams of Ceftriaxone given 30-90 minutes before surgery.
In colorectal surgery, co-administration of Ceftriaxone and 5-nitro-imidazole such as ornidazole (separately) has proven to be effective.

Impaired renal function and liver function:
In patients with impaired renal function, no Ceftriaxone dose is required, as long as liver function is still good. Only in cases of preterminal kidneys (creatinine clearance <10 ml / min), ceftriaxone dose not exceeding 2 grams daily. In patients with liver damage, it is not necessary to lower the dose during good renal function. In cases of severe renal failure and severe liver function impairment, coincidental, ceftriaxone plasma levels should be measured regularly. In patients who undergo dialysis is not necessary addition of doses during dialysis. However, serum levels should be monitored to determine if dose adjustments are needed. Because in this state the ability of elimination from the sufferer decreases

Guide Administration :
The solution will be physically and chemically stable for 6 hours at room temperature (or 24 hours at 50C). As always the solution should be worn immediately after preparation. The color ranges between light yellow and red brown depending on the level and length of storage, this state does not affect the effectiveness or tolerance of the drug’s active substance. Intravenous injection: for injection of i.v CEPHAFLOX┬« 1 gram dissolved in 10 ml aqua for injection given intravenous injection for 2 to 4 minutes.

Presentation and Registration Number :
CEPHAFLOX Box, 1 vial @ 1 gram Ceftriaxone + 1 ampoule @ 10 ml water for injection ; DKL9908012244B1


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