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  • Ceftriaxone-VIT
    / Vitamed


    Active Ingredient
    Ceftriaxone as Disodium Hemiheptahydrate 1 g

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    (Powder for solution for IM/IV injection): 10 X 10 ml

    partial basket chart 17057

    Dosage

    The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient.
    Adults and children over 12 years of age (≥ 50 kg):
    Community acquired pneumonia, Acute exacerbations of chronic obstructive pulmonary disease, Intra-abdominal infections, Complicated urinary tract infections,(including pyelonephritis) :1-2 g , once daily.
    Hospital acquired pneumonia, complicated skin and soft tissue infections, Infections of bones and joints: 2 g, once daily.
    Management of neutropenic patients with fever that is suspected to be due to a bacterial infection Bacterial endocarditis Bacterial meningitis:  2-4 g once daily.
    In documented bacteraemia, the higher end of the recommended dose range should be considered.
    Twice daily (12 hourly) administration may be considered where doses greater than 2 g daily are administered.
    Indications for adults and children over 12 years of age (≥ 50 kg) that require specific dosage schedules:
    Acute otitis media: A single intramuscular dose of Ceftriaxone  1-2 g can be given. Limited data suggest that in cases where the patient is severely ill or previous therapy has failed, Ceftriaxone may be effective when given as an intramuscular dose of 1-2 g daily for 3 days.
    Pre-operative prophylaxis of surgical site infections: 2 g as a single preoperative dose.
    Gonorrhoea: 500 mg as a single intramuscular dose.
    Syphilis: The generally recommended doses are 500 mg-1 g once daily increased to 2 g once daily for neurosyphilis for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on limited data.
    National or local guidance should be taken into consideration.
    Disseminated Lyme borreliosis (early [Stage II] and late [Stage III]): 2 g once daily for 14-21 days. The recommended treatment durations vary and national or local guidelines should be taken into consideration.
    Paediatric population
    Neonates, infants and children 15 days to 12 years of age (< 50 kg): 
    For children with bodyweight of 50 kg or more, the usual adult dosage should be given.
    Intra-abdominal infections, Complicated urinary tract infections (including pyelonephritis), Community acquired pneumonia, Hospital acquired pneumonia: 50-80 mg/kg, once daily.
    Complicated skin and soft tissue infections, Infections of bones and joints, Management of neutropenic patients, with fever that is suspected to be due to a bacterial infection: 50-100 mg/kg (Max 4 g),  once daily.
    Bacterial meningitis: 100 mg/kg (max 4 g) once daily.
    Bacterial endocarditis: 100 mg/kg (max 4 g) once daily.
    In documented bacteraemia, the higher end of the recommended dose range should be considered.
    Twice daily (12 hourly) administration may be considered where doses greater than 2 g daily are administered.
    Indications for neonates, infants and children 15 days to 12 years (< 50 kg) that require specific dosage schedules:
    Acute otitis media: For initial treatment of acute otitis media, a single intramuscular dose of Ceftriaxone- 50 mg/kg can be given. Limited data suggest that in cases where the child is severely ill or initial therapy has failed, Ceftriaxone- may be effective when given as an intramuscular dose of 50 mg/kg daily for 3 days.
    Pre-operative prophylaxis of surgical site infections: 50-80 mg/kg as a single pre-operative dose.
    Syphilis: The generally recommended doses are 75-100 mg/kg (max 4 g) once daily for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on very limited data. National or local guidance should be taken into consideration.
    Disseminated Lyme borreliosis (early [Stage II] and late [Stage III]): 50–80 mg/kg once daily for 14-21 days. The recommended treatment durations vary and national or local guidelines should be taken into considerations.
    Neonates 0-14 days: Ceftriaxone- is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age).
    Intra-abdominal infections, Complicated skin and soft tissue, infections, complicated urinary tract infections, (including pyelonephritis), Community acquired pneumonia, Hospital acquired pneumonia, Infections of bones and joints, Management of neutropenic patients with, fever that is suspected to be due to a bacterial infection: 20-50 mg/kg, once daily.
    Bacterial meningitis, Bacterial endocarditis: 50 mg/kg.
    In documented bacteraemia, the higher end of the recommended dose range should be considered.
    A maximum daily dose of 50 mg/kg should not be exceeded.
    Indications for neonates 0-14 days that require specific dosage schedules:
    Acute otitis media: For initial treatment of acute otitis media, a single intramuscular dose of Ceftriaxone  50 mg/kg can be given.
    Pre-operative prophylaxis of surgical site infections: 20-50 mg/kg as a single pre-operative dose.
    Syphilis: The generally recommended dose is 50 mg/kg once daily for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on very limited data. National or local guidance should be taken into consideration.
    Duration of therapy: The duration of therapy varies according to the course of the disease.
    Older people: The dosages recommended for adults require no modification in older people provided that renal and hepatic function is satisfactory.
    Patients with hepatic impairment: Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment provided renal function is not impaired. There are no study data in patients with severe hepatic impairment.
    Patients with renal impairment: In patients with impaired renal function, there is no need to reduce the dosage of ceftriaxone provided hepatic function is not impaired. Only in cases of preterminal renal failure (creatinine clearance < 10 ml/min) should the ceftriaxone dosage not exceed 2 g daily.
    In patients undergoing dialysis no additional supplementary dosing is required following the dialysis.
    Ceftriaxone is not removed by peritoneal- or haemodialysis. Close clinical monitoring for safety and efficacy is advised.
    Patients with severe hepatic and renal impairment: In patients with both severe renal and hepatic dysfunction, close clinical monitoring for safety and
    efficacy is advised.
    See prescribing information for full details.


    Indications

    Treatment of the following infections in adults and children including term neonates (from birth):
    – Bacterial Meningitis
    – Community acquired pneumonia
    – Hospital acquired pneumonia
    – Acute otitis media
    – Intra-abdominal infections
    – Complicated urinary tract infections (including pyelonephritis).
    – Infections of bones and  joints
    – Complicated skin and soft tissue infections.
    – Gonorrhoea
    – Syphilis
    – Bacterial endocarditis
    Ceftriaxone VIT may be used:
    For treatment of  acute exacerbations of chronic obstructive pulmonary disease in adults.
    For treatment of disseminated Lyme borreliosis (early (stage II) and late (stageIII) in adults and children including neonates from 15 days of age.
    For pre-operative prophylaxis of surgical site infections.
    In the management of neutropenic patients with fever that is suspected to be due to a ceftriaxone.
    Susceptible bacterial infection.
    In the treatment of patients with bacteremia that occurs in association with, oris suspected to be associated with, any of the infections listed above.
    Ceftriaxone should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum.


    Contra-Indications

    Hypersensitivity to ceftriaxone, to any other cephalosporin or to any of the excipients. History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).
    Premature neonates up to a postmenstrual age of 41 weeks (gestational age+ chronological age).
    Full-term neonates (up to 28 days of age):
    – with hyperbilirubinaemia, jaundice, or who are hypoalbuminaemic or acidotic because these are conditions in which bilirubin binding is likely to be impaired,
    – if they require (or are expected to require) intravenous calcium treatment, or calcium-containing infusions due to the risk of precipitation of a ceftriaxone-calcium salt.
    In vitro studies have shown that ceftriaxone can displace bilirubin from its serum albumin binding sites leading to a possible risk of bilirubin encephalopathy in these patients.
    Contraindications to lidocaine must be excluded before intramuscular injection of ceftriaxone when lidocaine solution is used as a solvent. Ceftriaxone solutions containing lidocaine should never be administered intravenously.


    Special Precautions

    Hypersensitivity reactions: As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with ceftriaxone must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to ceftriaxone, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if ceftriaxone is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.
    Severe cutaneous adverse reactions (Stevens Johnson syndrome or Lyell’s syndrome/toxic epidermal necrolysis) have been reported; however, the frequency of these events is not known.
    Interaction with calcium containing products: Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and fullterm neonates aged less than 1 month have been described. At least one of them had received ceftriaxone and calcium at different times and through different intravenous lines.
    Paediatric population: Safety and effectiveness of Ceftriaxone – VIT in neonates, infants and children have been established for the dosages above. Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin.
    Ceftriaxone – VIT is contraindicated in premature and full-term neonates at risk of developing bilirubin encephalopathy.
    Immune mediated haemolytic anaemia: An immune mediated haemolytic anaemia has been observed in patients receiving cephalosporin class
    antibacterials including Ceftriaxone – VIT. Severe cases of haemolytic anaemia,
    including fatalities, have been reported during v treatment in both adults and children.
    If a patient develops anaemia while on ceftriaxone, the diagnosis of a cephalosporin-associated anaemia should be considered and ceftriaxone discontinued until the aetiology is determined.
    Long term treatment: During prolonged treatment complete blood count should be performed at regular intervals.
    Colitis/Overgrowth of non-susceptible microorganisms: Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all antibacterial agents, including ceftriaxone, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftriaxone. Discontinuation of therapy with ceftriaxone and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
    Superinfections with non-susceptible micro-organisms may occur as with other antibacterial agents.
    Severe renal and hepatic insufficiency: In severe renal and hepatic insufficiency, close clinical monitoring for safety and efficacy is advised.
    See prescribing information for full details.


    Side Effects

    The most frequently reported adverse reactions for ceftriaxone are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and hepatic enzymes increased.
    See prescribing information for full details.


    Drug interactions

    Calcium-containing diluents, such as Ringer’s solution or Hartmann’s solution, should not be used to reconstitute Ceftriaxone – VIT vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line.
    Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid. In vitro studies using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium.
    Concomitant use with oral anticoagulants may increase the anti-vitamin K effect and the risk of bleeding.
    It is recommended that the International Normalised Ratio (INR) is monitored frequently and the posology of the anti-vitamin K drug adjusted accordingly, both during and after treatment with ceftriaxone.
    There is conflicting evidence regarding a potential increase in renal toxicity of aminoglycosides when used with cephalosporins. The recommended monitoring of aminoglycoside levels (and renal function) in clinical practice should be closely adhered to in such cases.
    In an in-vitro study antagonistic effects have been observed with the combination of chloramphenicol and ceftriaxone. The clinical relevance of this finding is unknown.
    There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (intravenous or oral).
    In patients treated with ceftriaxone, the Coombs’ test may lead to false-positive test results.
    Ceftriaxone, like other antibiotics, may result in false-positive tests for galactosaemia.
    Likewise, non-enzymatic methods for glucose determination in urine may yield false-positive results.
    For this reason, glucose level determination in urine during therapy with ceftriaxone should be carried out enzymatically.
    No impairment of renal function has been observed after concurrent administration of large doses of ceftriaxone and potent diuretics (e.g. furosemide).
    Simultaneous administration of probenecid does not reduce the elimination of ceftriaxone.


    Pregnancy and Lactation

    Pregnancy: Ceftriaxone crosses the placental barrier. There are limited amounts of data from the use of ceftriaxone in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal, perinatal and postnatal development. Ceftriaxone should only be administered during pregnancy and in particular in the first trimester of pregnancy if the benefit outweighs the risk.
    Lactation: Ceftriaxone is excreted into human milk in low concentrations but at therapeutic doses of ceftriaxone no effects on the breastfed infants are anticipated. However, a risk of diarrhoea and fungal infection of the mucous membranes cannot be excluded. The possibility of sensitisation should be taken into account. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ceftriaxone therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.


    Overdose

    In overdose, the symptoms of nausea, vomiting and diarrhoea can occur. Ceftriaxone concentrations cannot be reduced by haemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdose should be symptomatic.


    Important notes

    Incompatibilities: Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides. See prescribing information for full details.
    Storage: Do not store above 25°C. Keep in the outer carton in order to protect from light. After reconstitution: 24 hours at 2-8°C. 6 hours below 25°C.


    Manufacturer
    Facta Farmaceutici S.P.A Italy
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