Ceftriaxone 1000 Injection Resmed 1000 mg Injection

Ceftriaxone 1000 Injection Resmed is indicated for the treatment of the following infections when caused by susceptible organisms:

• Bacterial septicaemia caused by Methicillin Sensitive Staphylococcus aureus (MSSA), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae.
• Meningitis caused by Haemophilus influenzae, Neisseria meningitidis, or Streptococcus pneumoniae.
• Intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species.
• Skin and skin structure infections caused by Methicillin Sensitive Staphylococcus aureus (MSSA), Streptococcus pyogenes, Streptococcus viridans group, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Pseudomonas aeruginosa, Serratia marcescens, or Peptostreptococcus species.
• Bone and joint infections caused by Methicillin Sensitive Staphylococcus aureus (MSSA), Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species.
• Renal and urinary tract infections (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae.
• Respiratory tract infections caused by Streptococcus pneumoniae, Methicillin Sensitive Staphylococcus aureus (MSSA), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens.
• Ear, nose and throat infections (acute bacterial otitis media) caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains).
• Uncomplicated gonorrhoea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both beta-lactamase- and non-beta-lactamase-producing strains, and pharyngeal gonorrhoea caused by non-beta-lactamase-producing strains of Neisseria gonorrhoeae.
• Surgical prophylaxis: The pre-operative administration of a single 1 g dose of Ceftriaxone 1000 Injection Resmed may reduce the incidence of post-operative infections.

Posology

Standard Dosage

Adults and children over 12 years:

The usual dosage is 1 u2013 2 g Ceftriaxone 1000 Injection Resmed once daily (every 24 hours). In severe cases or in infections caused by moderately sensitive organisms, the dosage may be raised to 4 g, once daily.

Neonates, infants and children up to 12 years:

The following dosage schedules are recommended for once daily administration:

• Neonates (up to 14 days): 20 u2013 50 mg/kg bodyweight once daily. The daily dose should not exceed 50 mg/kg. It is not necessary to differentiate between premature and term infants.
• Infants and children (15 days to 12 years): 20 u2013 80 mg/kg once daily. For children with bodyweights of 50 kg or more, the usual adult dose should be used. Intravenous doses of u2265 50 mg/kg bodyweight should be given by infusion over at least 30 minutes.

Elderly patients: No dose modification is needed in the elderly.

Duration of therapy

The duration of therapy varies according to the course of the disease. Administration of Ceftriaxone 1000 Injection Resmed 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.

Special dosage instructions

Meningitis: In bacterial meningitis in neonates, infants and children, treatment begins with doses of 100 mg/kg (not to exceed 4 g) once daily. As soon as the causative organism has been identified and its sensitivity determined, the dose can be adapted accordingly. For bacterial meningitis in adults, the recommended dose is 4 g once daily.

Gonorrhoea: For the treatment of uncomplicated gonorrhoea (both beta-lactamase-producing and non-beta-lactamase-producing strains), a single intramuscular (i.m.) dose of 125 mg Ceftriaxone 1000 Injection Resmed is recommended.

Peri-operative prophylaxis: A single dose of 1 u2013 2 g Ceftriaxone 1000 Injection Resmed administered 30 u2013 90 minutes prior to surgery. In colorectal surgery, administration of Ceftriaxone 1000 Injection Resmed with or without a 5-nitroimidazole, e.g., metronidazole, has been proven effective.

Impaired renal and hepatic function: In patients with impaired renal function, there is no need to reduce the dosage of Ceftriaxone 1000 Injection Resmed provided that hepatic function is intact. In cases of severe renal failure (creatinine clearance < 10 ml/min) the Ceftriaxone 1000 Injection Resmed dosage should not exceed 2 g daily. In patients with liver damage, there is no need for the dosage to be reduced, provided that renal function is intact.

Method of Administration

For intramuscular and intravenous injection. Ceftriaxone 1000 Injection Resmed must be reconstituted prior to use. For reconstitution see section 6.6.

Hypersensitivity to ceftriaxone, or to any of the excipients of Ceftriaxone 1000 Injection Resmed listed in section 6.1. Hypersensitivity to cephalosporins. Hypersensitivity to penicillins, due to the possibility of cross-reactivity. Hyperbilirubinaemic neonates, especially prematures, should not be treated with Ceftriaxone 1000 Injection Resmed. In vitro studies have shown that ceftriaxone can displace bilirubin from its binding to serum albumin and bilirubin encephalopathy can possibly develop in the patients. Ceftriaxone 1000 Injection Resmed should not be administered concurrently with calcium-containing solutions or products in newborns because of the risk of precipitation of ceftriaxone-calcium salt (see section 4.4).

Ceftriaxone must not be mixed or administered simultaneously with calcium-containing solutions or products, even via different lines. Calcium-containing solutions or products must not be administered within 48 hours of last administration of ceftriaxone. Cases of fatal reactions with ceftriaxone-calcium precipitates in lung and kidneys in both term and premature neonates have been described. In some cases, the infusion lines and times of administration of ceftriaxone and calcium containing solutions differed (see section 4.3). Do not use diluents containing calcium, such as Ringeru2019s solutions or Hartmanu2019s solution to reconstitute Ceftriaxone 1000 Injection Resmed. Particulate formation can result.

Interaction with Calcium-Containing Products: There are no reports to date of intravascular or pulmonary precipitations in patients, other than neonates, treated with ceftriaxone and calcium-containing IV solutions. However, the theoretical possibility exists for an interaction between ceftriaxone and IV calcium-containing solutions in patients other than neonates. Therefore, Ceftriaxone 1000 Injection Resmed and calcium-containing solutions, including continuous calcium-containing infusions such as parenteral nutrition, should not be mixed or co-administered to any patient, irrespective of age, even via different infusion lines at different sites. As a further theoretical consideration and based on 5 half-lives of ceftriaxone, Ceftriaxone 1000 Injection Resmed and IV calcium-containing solutions should not be administered within 48 hours of each other in any patient (see sections 4.3 and 6.6).

No data are available on potential interactions between ceftriaxone and oral calcium-containing products or interactions between intramuscular ceftriaxone and calcium-containing products (IV or oral).

Hypersensitivity reactions: Serious and occasionally fatal hypersensitivity reactions have been reported (see section 4.8). In case of severe hypersensitivity reactions, treatment with Ceftriaxone 1000 Injection Resmed 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 medicine. Caution should be used if Ceftriaxone 1000 Injection Resmed is given to patients with a history of non-severe hypersensitivity to other beta-lactam medicines.

Severe cutaneous adverse reactions (Stevens Johnson syndrome or Lyell's syndrome/toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS)) which can be life-threatening or fatal have been reported in association of ceftriaxone treatment; however, the frequency of these events is not known (see section 4.8).

Paediatric population: Safety and effectiveness of Ceftriaxone 1000 Injection Resmed in neonates, infants and children have been established for the dosages described under Posology and Method of Administration (see section 4.2). Studies have shown that ceftriaxone can displace bilirubin from serum albumin. Ceftriaxone 1000 Injection Resmed is contraindicated in premature and full-term neonates at risk of developing bilirubin encephalopathy (see section 4.3).

Immune mediated haemolytic anaemia: An immune mediated haemolytic anaemia has been observed in patients receiving cephalosporin class antibacterials. (see section 4.8). Severe cases of haemolytic anaemia, including fatalities, have been reported during ceftriaxone treatment in both adults and children. If a patient develops anaemia while on Ceftriaxone 1000 Injection Resmed, the diagnosis of a cephalosporin - associated anaemia should be considered, and Ceftriaxone 1000 Injection Resmed discontinued until the aetiology is determined.

Long term treatment: During prolonged treatment complete blood count should be performed at regular intervals.

Severe renal and hepatic insufficiency: In severe renal and hepatic insufficiency, close clinical monitoring for safety and efficacy is advised (see section 4.2).

Interference with serological testing: Interference with Coombs tests may occur, as Ceftriaxone 1000 Injection Resmed may lead to false-positive test results. Ceftriaxone 1000 Injection Resmed can also lead to false-positive test results for galactosaemia (see section 4.8). Non-enzymatic methods for the glucose determination in urine may give false-positive results. Urine glucose determination during therapy with Ceftriaxone 1000 Injection Resmed should be done enzymatically (see section 4.8). The presence of ceftriaxone may falsely lower estimated blood glucose values obtained with some blood glucose monitoring systems. Please refer to instructions for use for each system. Alternative testing methods should be used if necessary.

Antibacterial spectrum: Ceftriaxone has a limited spectrum of antibacterial activity and may not be suitable for use as a single medicine for the treatment of some types of infections unless the pathogen has already been confirmed (see section 4.2). In polymicrobial infections, where suspected pathogens include organisms resistant to ceftriaxone, administration of an additional antibiotic should be considered.

Use of lidocaine: In case a lidocaine solution is used as a solvent, ceftriaxone solutions must only be used for intramuscular injection. Contraindications to lidocaine, warnings and other relevant information as detailed in the Professional information of lidocaine must be considered before use (see section 4.3). The lidocaine solution should never be administered intravenously.

Renal lithiasis: Cases of renal lithiasis have been reported, which is reversible upon discontinuation of ceftriaxone (see section 4.8). In symptomatic cases, sonography should be performed. Use in patients with history of renal lithiasis or with hypercalciuria should be considered by the medical practitioner based on specific benefit risk assessment.

Jarisch-Herxheimer reaction (JHR): Some patients with spirochete infections may experience a Jarisch-Herxheimer reaction (JHR) shortly after Ceftriaxone 1000 Injection Resmed treatment is started. JHR is usually a self-limiting condition or can be managed by symptomatic treatment. The antibiotic treatment should not be discontinued if such reaction occurs.

Sodium content: Ceftriaxone 1000 Injection Resmed powder for solution for injection or infusion contains approximately 83 mg sodium per 1g vial, equivalent to approximately 4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Precautions: Pseudomembranous enterocolitis and coagulation disorders have been reported with Ceftriaxone 1000 Injection Resmed. It is important to consider pseudomembranous enterocolitis in patients who present with diarrhoea subsequent to the administration of Ceftriaxone 1000 Injection Resmed. Superinfections with non-susceptible micro-organisms may occur. Shadows, which have been mistaken for 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 1000 Injection Resmed therapy. In symptomatic cases, conservative non-surgical management is recommended. Cases of pancreatitis, possibly of biliary obstruction aetiology, have been reported in patients treated with Ceftriaxone 1000 Injection Resmed. Most patients presented with risk factors for biliary stasis and biliary sludge, e.g., severe illness and total parenteral nutrition. Ceftriaxone displaces bilirubin from serum albumin. Caution should be exercised when considering Ceftriaxone 1000 Injection Resmed treatment in hyperbilirubinaemic neonates. Ceftriaxone 1000 Injection Resmed is not recommended for use in neonates (especially premature) at risk of developing bilirubin encephalopathy.

Calcium-containing diluents, such as Ringer's solution or Hartmann's solution, should not be used to reconstitute Ceftriaxone 1000 Injection Resmed 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 (see sections 4.2, 4.3, 4.4, and 4.8).

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 medicine adjusted accordingly, both during and after treatment with Ceftriaxone 1000 Injection Resmed (see section 4.8).

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 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.

Safety in pregnancy and lactation has not been established. Ceftriaxone crosses the placental barrier and is excreted into breast milk; therefore, caution is advised in nursing mothers.

During treatment with Ceftriaxone 1000 Injection Resmed, undesirable effects such as dizziness may occur, which may influence the ability to drive and use machines (see section 4.8). Patients should be cautious when driving or operating machinery.

The most frequently reported adverse reactions for ceftriaxone are eosinophilia, leucopoenia, thrombocytopenia, diarrhoea, rash, and hepatic enzymes increased.

The following undesirable effects may occur with frequencies:

* Isolated cases of agranulocytosis (<500/mm 3 ) have been reported, most of them following total doses of 20 g or more.

** Cases of medicine precipitation in the kidneys have been reported, mostly in children older than 3 years and who have been treated with either high daily doses (e.g., u2265 80 mg/kg/day) or total doses exceeding 10 g and presenting with other risk factors (e.g., fluid restrictions, confinement to bed, etc.). This event may lead to renal insufficiency and is usually reversible upon discontinuation of Ceftriaxone 1000 Injection Resmed.

*** Phlebitic reactions may occur after i.v. administration. These may be minimized by slow (2 u2013 4 minutes) injection of the medicine. Intramuscular injection without lignocaine solution is painful.

In the case of overdosage, plasma concentration would not be reduced by haemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdosage is symptomatic and supportive.