Eluxone

Eluxone

ceftriaxone

Manufacturer:

Daewoong

Distributor:

Elin
Full Prescribing Info
Contents
Ceftriaxone sodium.
Description
Each vial contains Ceftriaxone (as Sodium) 1 g.
Indications/Uses
For the treatment of susceptible infection include chancroid, endocarditis, gastro-enteritis (invasive meningococcal salmonellosis; shigellosis; gonorrhea, Lyme disease, meningitis (include meningococcal meningitis prophylaxis), septicemia, syphilis, typhoid fever, and Whipple's disease.
Dosage/Direction for Use
Adults and children over 12 years of age: 1-2 g (potency) of ceftriaxone sodium administered once daily intravenously or intramuscularly. The total daily dose may increase up to 4 g (potency) depending on the type and severity of infection.
Neonates: In neonates (within 14 days of age), the usual dose is 25-50 mg (potency) per kg body-weight once daily. The total daily dose should not exceed 50 mg (potency) or more per kg body-weight. The dosage in neonates does not have to differentiate between premature and mature babies.
Infants and children (15 days to 12 years of age): 20-80 mg/kg (potency) is administered once daily. For children with body-weight of 50 kg or more, the usual adult dosage should be used. And intravenous doses of 50 mg (potency) or more per kg body-weight should be given by infusion over at least 30 minutes.
Elderly: The dosage recommended for adults is applied to elderly patients.
Meningitis: For the treatment of bactericidal meningitis, the initial dose for neonates and children 100 mg (potency) per kg (not to exceed 4 g (potency)) once daily. Dosages may be decreased immediately when pathogen and sensitivity of infection or organism are clarified. The following duration of therapy has been known effective.
(Neisseria meningitidis: 4 days, Haemophillus influenzae: 6 days).
Gonorrhea: For the treatment of gonorrhea (penicillinase producing and non-penicillinase producing strains), a single I.M. dose of 250 mg (potency) is recommended.
Perioperative Prophylaxis: To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended approach depending on the risk of infection is a single dose of 1-2 g (potency) administered 30-90 minutes prior to surgery. In colorectal surgery, concurrent (but separate) administration of ceftriaxone with 5-nitroimidazole (e.g. omidazole) has proven effective.
Renal and Hepatic Disorder: In patients with impaired renal function, there is no need to reduce the dosage of ceftriaxone provided hepatic function is intact, but in case of pre-terminal renal failure (creatinine clearance <10 mL/min) the dosage should not exceed 2 g (potency) daily. In patients with liver damage, there is no need for the dosage to be reduced provided renal function is intact. In cases of concomitant severe renal dysfunction, the plasma concentration of ceftriaxone should be determined at required intervals. In patients undergoing dialysis, no additional supplementary dosing is required following the dialysis. Serum concentrations should be monitored; however, to determine whether the dosage adjustment is necessary, since the elimination rate in these patients may be reduced.
Duration of Therapy: The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of ceftriaxone should be continued at a minimum of 48 to 72 hours after the patient has become a febrile or evidence of bacterial eradication has been obtained.
Reconstitution Method: Intramuscular Injection: For IM injection, ceftriaxone 0.25 g and 0.5 g are dissolved in 2 mL of 1% lidocaine hydrochloride solution, and ceftriaxone 1 g in 3.5 mL of 1% lidocaine hydrochloride solution and injected well within the body of a relatively large muscle. It is recommended that no more than 1 g be injected at one site. IM injection without lidocaine solution is painful. The lidocaine solution should not be administered intravenously.
Intravenous Injection: For IV injection, ceftriaxone 0.25 or 0.5 g is dissolved in 5 mL, ceftriaxone 1 g in 10 mL sterile water for injections. The intravenous administration should be given over two to four minutes. In case of intravenous infusion, the infusion should last at least 30 minutes. For IV infusion, 2 g ceftriaxone is dissolved in 40 mL of one of the following calcium-free infusion solutions: sodium chloride 0.9%, sodium chloride 0.45% + dextrose 2.5%, dextrose 5%, dextrose 10%, dextran 6% in dextrose 5%, hydroxyl ethyl starch 6-10% infusions, or sterile water for injection. Ceftriaxone solution should not be mixed with or piggybacked into solutions containing other antimicrobial drugs or diluent solutions other than those listed above, owing to the possible incompatibility.
Reconstituted solutions retain their physical and chemical stability for six hours at room temperature or 24 hours at +25°C. As a general rule, however, the solution should be used immediately after preparation. They range in color from pale yellow to amber, depending on the concentration and the length of storage. The characteristic of the active ingredient is of no significance for the efficacy or tolerance of the drug.
Contraindications
Patients with history of shock to this drug.
Patients with hypersensitivity to cephalosporins.
Patients with history of hypersensitivity to penicillins.
Patients with hypersensitivity to local anesthesia of anilides such as lidocaine, etc. (for intramuscular injection only).
Neonates with jaundice or hypoalbuminemia, acidosis, disorder of bilirubin binding such as immature infant. (This drug may take off the bilirubin bound on serum albumin).
Neonates administered solution or drug contains calcium. (Precipitation of ceftriaxone-calcium salt may occur).
Special Precautions
Patients with history of hypersensitivity to this drug or to any other cephem antibiotics.
Patients with history of drug allergy.
Patients oneself or whose parents, sisters, or brothers are prone to suffer from allergic symptoms such as bronchial asthma, exanthema, urticaria, etc.
Patients with severe renal disorder (as the plasma concentration is maintained for a long period of time, decreased dosage or increased interval between treatments are required).
Patients with poor oral ingestion or parenteral nutrition patients, with poor general conditions (Cautious monitoring is required since Vitamin K deficiency may occur).
General Precautions: Prior to the administration, susceptibility to the drug should be tested to prevent manifestation of resistant bacteria, and the duration therapy should be minimum needed for the treatment.
In order to predict side effects such as shock, etc., patient history should be taken in detail and skin reaction test should be performed.
Emergency measures have to be available in preparation for occurrence of shock (If anaphylactic shock occurs, intravenous epinephrine has to be followed by a glucocorticoid injection), and even after measures taken, the patient should be observed cautiously in stable condition.
It is desirable to perform regular clinical tests (hepatic function, renal function, blood, etc.) during treatment.
In patients who are generally administered higher dosages than the recommended value, shadows which are mistaken for gallstone have been observed in ultrasonography of the gall bladder; these shadows are, however, precipitates of calcium ceftriaxone, which disappears by discontinuance or completion of the administration. Rarely, some symptoms may be accompanied; in these cases, general non-surgical management is recommended and a clinician should determine the discontinuance of the therapy.
In overdosing, concentrations of the drug would not be reduced by hemodialysis or peritoneal dialysis. There is no specific antidote, thus symptomatic treatment should be performed.
There is no report that the drug would inhibit the ability of the user in driving an automobile or operating machinery.
Pancreatitis has potency of biliary obturation rarely, have been reported in the patients administered this drug. Most of them are patients with risk of preemptive main therapy, severe disease, TPN, gallstasis, gall sludge production.
The safety and efficacy to the patients with the neonates, infants, and children within recommended dosage are established, this drug can exchange the bilirubin from serum albumin such as other cephalosporin antibiotics.
This drug should not be used to neonates (especially premature infants) with the risk of bilirubin encephalopathy.
Use in Children: Safety use in neonates and premature have not been established.
Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin encephalopathy when considering ceftriaxone for hyperbilirubinenemic neonates, especially premature.
Use in Elderly: In the elderly, be careful with the following points, and observe the patients and administer this medicine very cautiously with concerning dose and interval of administration: Because physiological function decreases with age, adverse effects may manifest easily.
Hemorrhage may occur due to the deficiency of Vitamin K.
Use In Pregnancy & Lactation
Ceftriaxone is passed through placental barrier.
Since safety use in pregnancy has not been established, ceftriaxone should be used in pregnancy only when expected benefits clearly outweighs potential risks.
The drug has been distributed in human milk; therefore the administration to nursing mothers should be cautioned.
Adverse Reactions
Shock: As shock may rarely occur, cautious monitoring is required, and in case that unpleasantness, stridor, dizziness, tenesmus, tinnitus, perspiration, etc. occur, administration should be discontinued and appropriate treatment should be taken.
Hypersensitivity: In case exanthema, urticaria, erythema, flare, pruritus, shivering, fever, allergic dermatitis, edema, erythema multiforme, anaphylactic or anaphylactic-like reaction occur, further administration should be discontinued and appropriate measures taken.
Gastrointestinal Effects: Rarely severe enterocolitis with hemafecia such as pseudomembranous enterocolitis may occur. If abdominal pain and frequent diarrhea occur, appropriate measure such as immediate discontinuation of ceftriaxone should be taken. Also occasionally nausea, vomiting, loose stools, diarrhea, or rarely abdominal pain, anorexia, etc. may occur. And pancreatitis may occur, in this case, most of the patients have the risk factor occurring cholestatic or biliary sludge.
Respiratory Effects: Since interstitial pneumonia, PIR syndrome, etc. accompanied with fever, cough, dyspnea, abnormal chest X-ray, eosinophilia, etc. may rarely occur with other cephems, in case that such symptoms occur, further administration should be discontinued and appropriate measures such as administration of corticosteroids, etc. should be taken.
Hematological Effects: Occasionally granulocytopenia, eosinophilia, thrombocytosis, leukopenia, rarely anemia, hemolytic anemia, thrombocytopenia, prothrombin abnormality may occur.
Central Nervous System: Occasionally headache, dizziness, and rarely ataxia, dysaesthesia may occur.
Skin Effects: Rarely, Steven-Johnson's syndrome or toxic epidermal necrolysis may occur.
Hepatic Effects: In rare cases, increase of AST, ALT, and ALP, the symptom cause by precipitation of ceftriaxone-calcium in gallbladder may occur. Rarely increase of bilirubin, -GTP may occur.
Renal Effects: Rare cases of severe renal disorder including acute kidney failure have been reported, if this occurs, renal activity should be monitored regularly. If any symptoms occur the administration should be discontinued and/or appropriate therapy should be instituted. Also diabetic hematuria, oliguria, may occur. Very rarely, precipitations in renal ureterolith in children over 3 years of age have been reported. This case happens for patients exceeding daily dosage of 10 g associated with the risk of dipsotherapy or clinotherapy. The precipitation in renal can continue to the renal disorder as syndromic or non-syndromic, but it can recover when the administration is discontinued.
Microbial Substitution: Rarely stomatitis, candidiasis may occur.
Vitamin Deficiencies: Rarely vitamin K deficiencies such as hypoprothrombinemia or bleeding tendencies or vitamin B group deficiencies such as glossitis, anorexia, or neuritis may occur.
Others: Edema, premature ventricular contraction, increasing of blood creatinine, mycosis of genitalia, sweat, flush, palpitation, epistaxis, etc. may occur.
Drug Interactions
Drug Interaction: This drug should not be mixed with solution or drug that contains calcium, and they should not be administered at the same time even through a separate inlet.
Within 48 hours of administration of this drug, solution or drug that contains calcium should not be administered.
Lethal reaction accompanied with precipitation of calcium-ceftriaxone in the lung and kidney of neonates and premature infant, it also occurs when the solution contains calcium and the entrance are different.
Concomitant administration with similar compounds (other cephem series compounds) and diuretics such as furosemide may occur, increase of renal disorder, should therefore be cautioned.
In vitro studies with gram-negative Bacillus indicates that the antibacterial activity of ceftriaxone and aminoglycoside antibiotics may be additive or synergistic against some strains of Pseudomonas aeruginosa.
Concomitant administration of probenecid does not appear to affect the excretion of ceftriaxone.
The drug has no N-methylthiotetrazole side chain relating to intolerance and bleeding against ethanol in the administration of some other of cephalosporin antibiotics.
In test tube test, concomitant administration with chloramphenicol has been observed antagonism.
Bacterial agent can weaken the microbicidal effect.
Drug/Laboratory Test Interaction: Caution is required because a false-positive reaction for glucosuria test that uses Benedict's and Fehling's solution, Clinitest except testape reaction might occur.
Caution is required because it is positive to the direct Coombs test.
Ceftriaxone, like other antibiotics, may result in false-positive tests for galactosemia.
Caution For Usage
Cautions of Use: Ceftriaxone solution is stable at room temperature for 6 hours, or at 5°C for 24 hours, but normally, the solution should be used immediately after reconstitution. The solution light yellow to yellowish brown according to the preserve period, this characteristic of ceftriaxone is not related to the efficacy or tolerance.
Cautions for Application: A large volume of intravenous administration may cause rarely angioalgia, thrombophlebitis, flushing, nausea, and vomiting. The preparation of injectable solution, sites and methods of injection are considered with care and administration should be slow as possible (intravenous injection).
The reconstituted solution should be used immediately. Use of the reconstituted solution dissolved in glutathione products and a supplementary solution of amino acids series of high concentration. In case of infusion, do not use water for injection. (anisotonic solution).
Solutions containing calcium such as Linger solution or Hartman solution should not be used because particulate matter may form during dilution.
When this drug is co-administered with aminoglycoside antibiotics, do not administer mixing in the same syringe.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01DD04 - ceftriaxone ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Powd for inj (vial) 1 g (white to light yellow) x 10's.
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