ROCEPHIN FOR INJECTION 1 g/vial (INTRAMUSCULAR)

ROCHE SINGAPORE PTE. LTD.

ROCHE SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

INJECTION, POWDER, FOR SOLUTION

**2.2. DOSAGE AND ADMINISTRATION** **General** _**Standard dosage**_ Adults and children over 12 years The usual dosage is 1–2 g of Rocephin 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 Rocephin 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 Rocephin 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 Rocephin and aminoglycosides, the two drugs must be administered separately at the recommended dosages. Chemical incompatibility with Rocephin 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, Rocephin 250 mg or 500 mg is dissolved in 2 ml, and Rocephin 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. The lidocaine solution should never be administered intravenously _(see section 2.3 Contraindications)_. Intravenous injection For i.v. injection, Rocephin 250 mg or 500 mg is dissolved in 5 ml, and Rocephin 1 g 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 Rocephin 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. Rocephin 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 Rocephin vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when Rocephin is mixed with calcium-containing solutions in the same IV administration line. Rocephin 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, Rocephin 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 2.3 Contraindications, 2.4.1 Warnings and Precautions General and 2.8 Interactions with other Medicinal Products and other Forms of Interaction – _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). **2.2.1. 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 bodyweight once daily. The daily dose should not exceed 50 mg/kg. Rocephin is contraindicated in premature neonates up to a postmenstrual age of 41weeks (gestational age + chronological age) (see section 2.3 Contraindications). Rocephin 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 2.3 Contraindications). For neonates, infants, and children (15 days to 12 years): 20–80 mg/kg once daily. For children with bodyweights of 50 kg or more, the usual adult dosage should be used. Intravenous doses of ≥ 50 mg/kg bodyweight, 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 meningitidis4 daysHaemophilus influenza6 daysStreptococcus pneumoniae7 days _Geriatric use_ No dose adjustment of Rocephin 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 Rocephin 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 Rocephin 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 Rocephin with or without a 5-nitroimidazole, e.g. ornidazole (separate administration, see 2.2 Dosage and Administration) has been proven effective.