Oncef

Oncef

ceftriaxone

Manufacturer:

Medhaus

Distributor:

Medhaus
Full Prescribing Info
Contents
Ceftriaxone sodium.
Description
Each vial contains: Ceftriaxone (as sodium) 1 g.
Indications/Uses
Susceptible strains: Staphylococcus aureus (including penicillinase-producing strains), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus group A (Streptococcus pyrogenes), Streptococcus group B (Streptococcus agalactiae), Streptococcus viridans, Streptococcus bovis, Aeromonas spp., Alcaligenes spp., Branhamella catarrhalis, Citrobacter spp., Enterobacter spp. (some strains are resistant), Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae (including Ampicillin resistant strains). Haemophilus parainfluenzae, Klebsiella spp (K. pneumoniae), Moraxella spp., Proteus morganii, Proteus mirabilis, Proteus vulgaris, Providencia spp., Neisseria gonorrhoeae (including penicillinase-producing strains), Neisseria meningitides, Plesiomonas shigelloides, Pseudomonas aeruginosa (some strains are resistant), Salmonella spp. (including S. typhi), Serratia spp. (including S. marcescens), Shigella spp., Yersinia spp. (including Y. enterocolitica), Treponema pallidum, Bacteroides spp. (including some strains of B. fragilis), Clostridium spp. (except C. difficile), Fusobacterium (except F. mortiferum and F. varium), Peptococcus, Peptostreptococcus.
Uses: Main indications: Respiratory tract infections such as pneumonia, bronchitis, etc.; Ear, nose and throat infections; Renal and urinary tract infections, genital infection such as gonorrhea; Sepsis; Perioperative prophylaxis of infections; Infections of skin, wounds and soft tissue; Peritonitis, cholecystitis, cholangitis and infections of gastrointestinal tract; Infections in patients with immunodeficiency; Meningitis.
Dosage/Direction for Use
Adults and children over 12 years old of age: 1-2 g (potency) of ceftriaxone sodium administered once daily intravenously or intramuscularly. In severe cases or in infections caused by moderately sensitive organisms, the dosage may be increased to 4 g (potency) once daily.
Neonates (within 14 days): A daily dose of 20-50 mg/kg (potency) of body weight, not to exceed 50 mg/kg (potency). It is not necessary to differentiate between premature and infants born at full term.
Infants and children (15 days to twelve years): 20-80 mg/kg (potency) is administered once daily. For children with bodyweight of 50 kg or more, the usual adult dosage should be used. An intravenous doses of 50 mg (potency) or more per kg bodyweight should be given by infusion over at least 30 minutes.
Geriatric patients: the dosage recommended for adults is applied to geriatric patients.
Meningitis: In bacterial meningitis in infants and children, treatment begins with doses of 100 mg (potency) per kg (not to exceed 4 g (potency) once daily. As soon as the causative organism has been identified and its sensitivity determined, the dosage can be reduced accordingly. The following duration of therapy has shown to be effective (N. meningitidis: 4 days, H. influenzae: 6 days, S. pneumoniae: 7 days).
Gonorrhea: For the treatment of gonorrhea (penicillinase producing and nonpenicillinase-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.
Impaired renal and hepatic function: 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 and dysfunction, the plasma concentration of ceftriaxone should be determined at require intervals. In patients undergoing dialysis, no additional supplementary dosing is required following the dialysis. Serum concentrations should be monitored, however, to determine whether dosage adjustments are 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 for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.
Overdosage
In the case of overdosage, drug concentration would not be reduced by hemodialysis or peritoneal dialysis.
Contraindications
This drug is contraindicated to the following: Patients with history of shock to ceftriaxone sodium.
Patients with hypersensitivity to cephalosporin.
Patients with hypersensitivity or history of hypersensitivity to penicillins.
Patients with hypersensitivity to local anesthesia of anilides such as lidocaine, etc. for intramuscular injection only).
Special Precautions
This drug is administered with caution to the following patients: 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 in 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, elderly patients, with poor general conditions (cautious monitoring is required since vitamin K deficiency may occur).
In order to prevent appearance of the resistant microorganisms, susceptibility should be determined and treatment should be continued only for the minimum period of time required.
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 concurrence 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 laboratory test (hepatic function, renal function, blood etc.) at regular intervals during treatment.
Shadows which have been mistaken of gallstones have been detected on sonograms of the gallbladder, usually following doses higher than the standard recommended dose. These shadows are, however, precipitates of calcium ceftriaxone which disappear on completion or discontinuation of ceftriaxone therapy. Rarely, these findings have been associated with symptoms, in symptomatic cases, conservative nonsurgical management is recommended. Discontinuation of ceftriaxone treatment in symptomatic case should be at the discretion of clinician.
In the case of overdosage, drug concentration would not be reduced by hemodialysis or peritoneal dialysis.
Ceftriaxone is not reported to have side effects on a persons ability to drive vehicles or operate machinery.
Interference with laboratory test: Caution is required because a false positive reaction for glucosuria test that uses Benedict's and Fehling's solution, clinical test except testape reaction might occur.
Caution is required because it is positive to the direct Coombs test.
Ceftriaxone, like other antibiotics, may results in false-positive tests for galactosemia.
Precaution on Application: As vascular pain, venous thrombosis, flushing, nausea, vomiting may rarely occur by large intravenous dose, caution should be taken on preparation of injectable solution, site of injection, method of administration, etc., and injection should be given as slowly as possible (I.V. injection).
Ceftriaxone should be used immediately after reconstitution. Particularly, caution is required when dissolving in glutathione or high concentration amino acids solution.
Use in Pregnancy & Lactation: Ceftriaxone is passed through placental barrier.
As safety in human pregnancy has not been established, women who are pregnant or considering pregnancy should be administered only if therapeutic benefits justifies the possible risks.
As ceftriaxone is excreted in the breast milk at low concentrations, caution is advised in nursing mothers.
Use in Children: Safety and effectiveness of this drug in neonates, infants and children have been established.
Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin. Special caution should be exercised on the development of bilirubin encephalopathy when considering ceftriaxone for hyperbilirubinemic neonates, especially premature.
Use in Elderly: It is recommended that a very cautious dosage schedule and careful observation be adopted in elderly patients.
Generally elderly person have low biological function. Therefore adverse reaction is prone to occur more frequently.
In elderly patients, bleeding tendency due to Vitamin K deficiency may occur.
Side Effects
Shock: As a shock may rarely occur, cautious monitoring is required, and in case that unpleasantness, stridor, dizziness, tenesmus tinnitus, etc. occur, administration should be discontinued and appropriated 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.
Blood: Occasionally granulocytopenia, eosinophilia, thrombocytosis, leukopenia, rarely anemia, hemolytic anemia, thrombocytopenia, prothrombin abnormality may occur.
Liver: Occasionally elevation of AST, ALT, ALP, and symptomatic precipitation ceftriaxone calcium salt in the gall-bladder rarely elevation of bilirubin. GPT may occur.
Kidney: As severe renal disorder such as an acute renal insufficiency is reported rarely, cautious monitoring is required and if abnormality acknowledged further administration should be discontinued and appropriate measures taken.
GI System: Rarely severe enterocolitis with hemafecia such as pseudomembranous enterocolitis may occur. If abdominal pain and frequent diarrhea occur, appropriate measures such as immediate discontinuation of ceftriaxone should be taken. Also occasionally nausea, vomiting, loose tools, diarrhea or rarely abdominal pain, anorexia, etc. may occur.
Respiratory system: Since interstitial pneumonia, PIE 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.
Superinfection: Rarely stomatitis, candidiasis may occur.
Vitamin deficiency: Rarely symptoms of vitamin K deficiency (hypoprothrombinemia, hemorrhage tendency, etc.) and vitamin B deficiency (glossitis, stomatitis, anorexia, neuritis, etc.) may occur.
Others: Occasionally headache and rarely dizziness, edema, precipitation in gallbladder, ventricular extrasystole, elevated creatinine of blood, genital mycosis may occur.
Drug Interactions
Cautious treatment is required as renal insufficiency may be worsened with combination of similar compounds (other cephem antibiotics) and diuretics such as furosemide, etc.
Synergy between ceftriaxone and aminoglycosides has been demonstrated with many gram-negative bacilli under experimental conditions and it is of special importance in severe life-threatening infections due to micro-organisms such as Pseudomonas aeruginosa. Because of physical incompatibility the two drugs must administered separately at the recommended dosages. There is no evidence that ceftriaxone increases renal toxicity of aminoglycosides.
No effect similar to that of disulfiram has been demonstrated after ingestion of alcohol subsequent to the administration of ceftriaxone.
The elimination of ceftriaxone is not altered by probenecid.
Ceftriaxone does not contain an N-methylthiotetrazole moiety associated with possible ethanol intolerance and bleeding problems of certain other cephalosporins.
In vitro study antagonistic effects have been observed with the combination of chloramphenicol and ceftriaxone.
Caution For Usage
Reconstitution: Intramuscular injection: For I.M. injection, ceftriaxone 0.25 or 5.0 g is dissolved in 2 mL of 1% lidocaine. Therapy in general, administration of 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 not more than 1 g be injected at one site. I.M. injection without lidocaine solution is painful. The lidocaine solution never be administration intravenously.
Intravenous injection: For I.V injection, ceftriaxone 0.25 or 0.5 g is dissolved in 5 mL, and 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 I.V. infusion, 2 g of 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%, hydroxy ethyl starch 6-10% infusions or sterile water for injection. Ceftriaxone solution should not be mixed with or piggybacked into solutions containing other antimicrobial drug or into diluent solutions other than those listed previously, owing to 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. This characteristic of the active ingredient is no significance for the efficacy or tolerance of the drug.
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 x 10's.
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