MEDAXONE POWDER FOR SOLUTION FOR INJECTION OR INFUSION 2 G/VIAL [SIN16288P]

Product Info

MEDAXONE POWDER FOR SOLUTION FOR INJECTION OR INFUSION 2 G/VIAL

[SIN16288P]

4.1 Therapeutic indications

Medaxone is indicated for the 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

Medaxone 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 (stage III)) in adults and children including neonates from 15 days of age.

• For pre-operative prophylaxis of surgical site infections.

• Infections in patients with impaired defense mechanisms

Ceftriaxone should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Consideration should be given to official guidelines on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

General
Standard dosage
Adults and children over 12 years
The usual dosage is 1–2 g of Ceftriaxone 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.
Duration of Treatment
The duration of treatment varies according to the course of the disease. As with antibiotic therapy in general, administration of Ceftriaxone should be continued for a minimum of 48–72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.
Combination treatment
Synergy between Ceftriaxone and aminoglycosides has been demonstrated with many gram-negative bacteria under experimental conditions. Although enhanced activity of such combinations is not always predictable, it should be considered in severe, life-threatening infections due to micro-organisms such as Pseudomonas aeruginosa. Due to chemical incompatibility between Ceftriaxone and aminoglycosides, the two drugs must be administered separately at the recommended dosages.
Chemical incompatibility with Ceftriaxone has also been observed with IV administration of amsacrine, vancomycin and fluconazole.

Method of administration
As a general rule the solutions should be used immediately after preparation.
Reconstituted solutions retain their physical and chemical stability for 6 hours at room temperature (or 24 hours in the refrigerator at 2 – 8 °C). The solutions range in colour from pale yellow to amber, depending on the concentration and length of storage. The coloration of the solutions is of no significance for the efficacy or tolerance of the drug.
Intramuscular injection
For i.m. injection, Ceftriaxone 1 g is dissolved 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. The lidocaine solution should never be administered intravenously (see section 4.3).
Intravenous injection
For i.v. injection, Ceftriaxone 1 g is dissolved in 10 ml sterile water for injections. The intravenous administration should be given over 2–4 minutes.
Intravenous infusion
The infusion should be given over at least 30 minutes. For i.v. 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%, water for injections. Ceftriaxone solutions should not be mixed with or piggybacked into solutions containing other antimicrobial drugs or into diluent solutions other than those listed above, owing to possible incompatibility.
Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute Ceftriaxone vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when Ceftriaxone is mixed with calcium-containing solutions in the same IV administration line. Ceftriaxone must not be administered simultaneously with calcium-containing IV 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 (see sections 4.3, 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral).

Special Dosage Instructions
Pediatric use
Neonates, infants and children up to 12 years
The following dosage schedules are recommended for once daily administration:
Neonates (up to 14 days): 20–50 mg/kg body weight once daily. The daily dose should not exceed 50 mg/kg.
Ceftriaxone is contraindicated in premature neonates up to a postmenstrual age of 41weeks (gestational age + chronological age) (see section 4.3).
Ceftriaxone is contraindicated in neonates (≤28 days) if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see 4.3).
For neonates, infants, and children (15 days to 12 years): 20–80 mg/kg once daily.
For children with body weights of 50 kg or more, the usual adult dosage should be used. Intravenous doses of ≥ 50 mg/kg body weight, in infants and children up to 12 years of age, should be given by infusion over at least 30 minutes. In neonates, intravenous doses should be given over 60 minutes to reduce the potential risk of bilirubin encephalopathy.
Meningitis
In bacterial meningitis in infants and children, treatment begins with doses of 100 mg/kg (up to a maximum of 4 g) 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:
Neisseria meningitidis 4 days
Haemophilus influenza 6 days
Streptococcus pneumoniae 7 days
Geriatric use
No dose adjustment of Ceftriaxone is required in patients ≥ 65 years of age provided there is no severe renal and hepatic impairment.
Renal impairment
No dose adjustment is required, 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.
Ceftriaxone is not removed by peritoneal- or hemodialysis. In patients undergoing dialysis no additional supplementary dosing is required following the dialysis.
Hepatic impairment
No dose adjustment of Ceftriaxone is required, provided renal function is not impaired.
Severe renal and hepatic impairment
In patients with both severe renal and hepatic dysfunction, clinical monitoring for safety and efficacy is advised.
Lyme borreliosis
50 mg/kg to a maximum of 2 g in children and adults, once daily for 14 days.
Gonorrhea (penicillinase-producing and nonpenicillinase-producing strains)
A single i.m. dose of 250 mg.
Perioperative prophylaxis
A single dose of 1–2 g depending on the risk of infection of 30–90 minutes prior to surgery. In colorectal surgery, administration of Ceftriaxone with or without a 5-nitroimidazole, e.g. ornidazole (separate administration) has been proven effective.

4.3 Contraindications

Hypersensitivity to ceftriaxone, to any other cephalosporin or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).

Ceftriaxone is contraindicated in:

• Premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age)*

• Full-term neonates (up to 28 days of age):

  • with hyperbilirubinemia, 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 (see sections 4.4, 4.8 and 6.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

*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 (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Ceftriaxone solutions containing lidocaine should never be administered intravenously.